Breast Cancer
Conditions
Brief summary
This study will evaluate the pharmacodynamics, pharmacokinetics, safety, and biologic activity of giredestrant in participants with Stage I-III operable estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, untreated breast cancer.
Interventions
DRUGGiredestrant
Giredestrant will be administered orally once daily (QD) starting on Day 1 up to and including the day of surgery (if allowed per local process) on Day 15 (+/-2 days).
PROCEDURESurgery
Breast cancer surgery will take place on Day 15 (+/-2 days).
Sponsors
Genentech, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Ability to comply with the study protocol, in the investigator's judgment * Histologically confirmed invasive breast carcinoma, with all of the following characteristics: Primary tumor greater than or equal to (≥)1.5 centimeters (cm) in largest diameter by ultrasound; Stage I-III operable breast cancer; Documentation confirming the absence of distant metastasis (M0) as determined by institutional practice. * ER-positive tumor and HER2-negative breast cancer as per local laboratory testing * Postmenopausal status * Breast cancer eligible for primary surgery * Submission of a representative tumor tissue specimen * Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to (≤)1 * Adequate organ function
Exclusion criteria
* Diagnosis of inflammatory breast cancer * Diagnosis of bilateral breast cancer * Concurrent use of hormone replacement therapies * Previous systemic or local treatment for the primary breast cancer currently under investigation * Concurrent treatment with other experimental drugs or participation in another clinical trial with any investigational drug within 30 days prior to study entry * Current treatment with any systemic anti-cancer therapies * Major surgery within 4 weeks prior to enrollment * Radiation therapy within 2 weeks prior to enrollment * Diagnosis of any secondary malignancy within 3 years prior to enrollment, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or Stage I uterine cancer * Active inflammatory bowel disease or chronic diarrhea, short bowel syndrome, or upper gastrointestinal surgery including gastric resection * Known HIV infection * Known clinically significant history of liver disease consistent with Child-Pugh Class B or C, including active viral or other hepatitis, current alcohol abuse, or cirrhosis * Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study * History of allergy to giredestrant or any of its excipients * Any condition requiring anti-coagulants, such as warfarin, heparin, or thrombolytic drugs * History of documented hemorrhagic diathesis or coagulopathy * History or presence of symptomatic bradycardia or sick sinus syndrome * Baseline heart rate ≤55 beats per minute (bpm) prior to enrollment * History or presence of an abnormal electrocardiogram (ECG) that is clinically significant in the investigator's opinion, including complete left bundle branch block, second- or third-degree heart block, or evidence of prior myocardial infarction * QT interval corrected through use of Fridericia's formula (QTcF) \>470 milliseconds demonstrated by at least two ECGs \>30 minutes apart * History of ventricular dysrhythmias or risk factors for ventricular dysrhythmias such as structural heart disease, coronary heart disease, clinically significant electrolyte abnormalities, or family history of sudden unexplained death or long QT syndrome * Current treatment with medications that are well known to prolong the QT interval * History or presence of uncontrolled hypothyroidism * Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, in the investigator's opinion, gives reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Tumor Cell Proliferation, as Measured by the Proportion of Nuclei Staining Ki67-Positive at Surgery Relative to Baseline in Pre- and Post-Treatment Tumor Biopsy Samples | Baseline and Surgery (Day 15) | The biological response to the study treatment was assessed by measuring changes in cell proliferation (Ki67 expression) using formalin-fixed paraffin-embedded histopathology sections of the tumor biopsy specimens taken at baseline and at day of surgery. Baseline was defined as a sample taken prior to initiation of study drug. The results show the proportion of nuclei staining Ki67-positive (Ki67+) in the tumor biopsy sample taken post-treatment (at surgery) relative to that in the pre-treatment sample (at baseline). |
| Change From Baseline in Tumor Cell Proliferation, as Measured by the Difference in the Percentage of Nuclei Staining Ki67-Positive at Surgery Compared With Baseline in Pre- and Post-Treatment Tumor Biopsy Samples | Baseline and Surgery (Day 15) | The biological response to the study treatment was assessed by measuring changes in cell proliferation (Ki67 expression) using formalin-fixed paraffin-embedded histopathology sections of the tumor biopsy specimens taken at baseline and at day of surgery. Baseline was defined as a sample taken prior to initiation of study drug. The results show the percentage of nuclei staining Ki67-positive (Ki67+) in the pre- and post-treatment tumor biopsy samples (taken at baseline and surgery, respectively) and the absolute difference in the percentage of Ki67+ nuclei between the two samples (calculated as surgery minus baseline). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Pulse Rate | Baseline, Day 8, Surgery (Day 15), and Post-Surgery (Day 43) | Pulse rate was measured while the participant was in a seated position. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit. Baseline was defined as the participant's last value prior to initiation of study drug. |
| Change From Baseline in Systolic Blood Pressure | Baseline, Day 8, Surgery (Day 15), and Post-Surgery (Day 43) | Systolic blood pressure was measured while the participant was in a seated position. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit. Baseline was defined as the participant's last value prior to initiation of study drug. |
| Change From Baseline in Diastolic Blood Pressure | Baseline, Day 8, Surgery (Day 15), and Post-Surgery (Day 43) | Diastolic blood pressure was measured while the participant was in a seated position. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit. Baseline was defined as the participant's last value prior to initiation of study drug. |
| Change From Baseline in Body Temperature | Baseline, Day 8, Surgery (Day 15), and Post-Surgery (Day 43) | Body temperature was measured according to institutional practice. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit. Baseline was defined as the participant's last value prior to initiation of study drug. |
| Number of Participants With at Least One Adverse Event and by Severity, Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI-CTCAE v5.0) | From Baseline to Day 43 | All adverse events (AEs) were recorded and the investigator independently assessed the seriousness and severity of each AE. AE severity was graded on a scale from 1 to 5 using the NCI-CTCAE v5.0; any events not specifically listed in the scale were defined as: Grade 1 is mild; Grade 2 is moderate; Grade 3 is severe or medically significant; Grade 4 is life-threatening; and Grade 5 is death related to an AE. Investigators used their knowledge of the patient, the circumstances surrounding the event, and an evaluation of any potential alternative causes to determine whether an AE was considered to be related to the study drug. |
| Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Baseline, Days 1, 8, and 15 | Laboratory parameters for blood chemistry and coagulation were measured and compared with a standard reference range. Any of the laboratory test results that were outside of a parameter's normal reference range (in the specified direction - low or high) were considered abnormalities. Not every laboratory abnormality qualified as an adverse event (AE). A laboratory test result was reported as an AE if it met any of the following criteria: was accompanied by clinical symptoms; resulted in a change in study treatment; resulted in a medical intervention or a change in concomitant therapy; or was clinically significant in the investigator's judgment. SGPT/ALT = alanine aminotransferase; SGOT/AST = aspartate aminotransferase |
| Percentage of Participants With Abnormal Electrocardiogram Parameters During Treatment | Baseline, Days 1, 8, and 15 | Electrocardiogram (ECG) recordings were performed after the participant had been resting in a supine position for at least 10 minutes. ECG parameters included heart rate, PR and QRS durations, and QT and QTcF intervals. Per the protocol, ECG readings post-treatment were limited to those for whom it was clinically indicated. Any of the ECG parameters that were outside of the normal reference range (in the specified direction - low or high) were considered abnormalities. Not every abnormality qualified as an adverse event (AE). An ECG test result was reported as an AE if it met any of the following criteria: was accompanied by clinical symptoms; resulted in a change in study treatment; resulted in a medical intervention or a change in concomitant therapy; or was clinically significant in the investigator's judgment. |
| Plasma Concentration of Giredestrant at Steady State by Dose Level | Predose on day of surgery (Day 15), or prior to biopsy (Day 14) | Plasma samples were obtained on the day of surgery (Day 15), or prior to biopsy on Day 14. |
| Percentage of Participants With Laboratory Abnormalities in Hematology Tests During Treatment, Among Participants Without the Abnormality at Baseline | Baseline, Days 1, 8, and 15 | Laboratory parameters for hematology will be measured and compared with a standard reference range. Any of the laboratory test results that were outside of a parameter's normal reference range (in the specified direction - low or high) were considered abnormalities. Not every laboratory abnormality qualified as an adverse event (AE). A laboratory test result was reported as an AE if it met any of the following criteria: was accompanied by clinical symptoms; resulted in a change in study treatment; resulted in a medical intervention or a change in concomitant therapy; or was clinically significant in the investigator's judgment. |
| Percentage of Participants With Abnormal Vital Signs During Treatment | Baseline, Days 1, 8, and 15 | Vital signs, which included diastolic and systolic blood pressure, pulse rate, and body temperature, were measured while the participant was sitting and according to institutional practices. Any of the vital signs that were outside of the normal reference range (in the specified direction - low or high) were considered abnormalities. Not every abnormality qualified as an adverse event (AE). A vital sign result had to be reported as an AE if it met any of the following criteria: was accompanied by clinical symptoms; resulted in a change in study treatment; resulted in a medical intervention or a change in concomitant therapy; or was clinically significant in the investigator's judgment. |
Countries
Australia, Belgium, Spain, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Giredestrant 10 mg Giredestrant 10 milligrams (mg) was administered orally once daily up to and including the day of surgery (if allowed per local process) on Day 15. Surgery should have been performed within 24 hours after the last dose of giredestrant. Following surgery, participants had a post-surgery follow-up visit after a period of 28 days. | 17 |
| Giredestrant 30 mg Giredestrant 30 milligrams (mg) was administered orally once daily up to and including the day of surgery (if allowed per local process) on Day 15. Surgery should have been performed within 24 hours after the last dose of giredestrant. Following surgery, participants had a post-surgery follow-up visit after a period of 28 days. | 40 |
| Giredestrant 100 mg Giredestrant 100 milligrams (mg) was administered orally once daily up to and including the day of surgery (if allowed per local process) on Day 15. Surgery should have been performed within 24 hours after the last dose of giredestrant. Following surgery, participants had a post-surgery follow-up visit after a period of 28 days. | 18 |
| Total | 75 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 1 | 2 |
Baseline characteristics
| Characteristic | Giredestrant 10 mg | Giredestrant 30 mg | Giredestrant 100 mg | Total |
|---|---|---|---|---|
| Age, Continuous | 63.4 Years STANDARD_DEVIATION 8.9 | 64.1 Years STANDARD_DEVIATION 9.4 | 64.1 Years STANDARD_DEVIATION 7.7 | 63.9 Years STANDARD_DEVIATION 8.8 |
| Eastern Cooperative Oncology Group (ECOG) Performance Status at Baseline ECOG Performance Status of 0 | 17 Participants | 36 Participants | 17 Participants | 70 Participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status at Baseline ECOG Performance Status of 1 | 0 Participants | 4 Participants | 0 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 4 Participants | 0 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants | 19 Participants | 6 Participants | 29 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 13 Participants | 17 Participants | 12 Participants | 42 Participants |
| Initial Staging of Breast Cancer (Breast Cancer History) Stage I | 9 Participants | 19 Participants | 10 Participants | 38 Participants |
| Initial Staging of Breast Cancer (Breast Cancer History) Stage II | 8 Participants | 21 Participants | 7 Participants | 36 Participants |
| Initial Staging of Breast Cancer (Breast Cancer History) Stage III | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Nodal Status (Breast Cancer History) Missing | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Nodal Status (Breast Cancer History) Negative | 14 Participants | 37 Participants | 17 Participants | 68 Participants |
| Nodal Status (Breast Cancer History) Positive | 2 Participants | 3 Participants | 1 Participants | 6 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Black or African American | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Multiple | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Unknown | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 16 Participants | 38 Participants | 17 Participants | 71 Participants |
| Sex: Female, Male Female | 17 Participants | 40 Participants | 18 Participants | 75 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Tumor Grade (Breast Cancer History) Grade 1 | 6 Participants | 13 Participants | 4 Participants | 23 Participants |
| Tumor Grade (Breast Cancer History) Grade 2 | 9 Participants | 23 Participants | 12 Participants | 44 Participants |
| Tumor Grade (Breast Cancer History) Grade 3 | 2 Participants | 4 Participants | 2 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 40 | 0 / 17 | 0 / 74 |
| other Total, other adverse events | 12 / 17 | 21 / 40 | 14 / 17 | 47 / 74 |
| serious Total, serious adverse events | 1 / 17 | 2 / 40 | 1 / 17 | 4 / 74 |
Outcome results
Primary
Change From Baseline in Tumor Cell Proliferation, as Measured by the Difference in the Percentage of Nuclei Staining Ki67-Positive at Surgery Compared With Baseline in Pre- and Post-Treatment Tumor Biopsy Samples
The biological response to the study treatment was assessed by measuring changes in cell proliferation (Ki67 expression) using formalin-fixed paraffin-embedded histopathology sections of the tumor biopsy specimens taken at baseline and at day of surgery. Baseline was defined as a sample taken prior to initiation of study drug. The results show the percentage of nuclei staining Ki67-positive (Ki67+) in the pre- and post-treatment tumor biopsy samples (taken at baseline and surgery, respectively) and the absolute difference in the percentage of Ki67+ nuclei between the two samples (calculated as surgery minus baseline).
Time frame: Baseline and Surgery (Day 15)
Population: Efficacy Evaluable Population: all participants who 1) had non-missing baseline and post-baseline Ki67 results available, 2) did not discontinue early from the study, 3) had taken at least 12 doses, and 4) had no more than one modified dose. A total of 10 participants (2 in the 10mg cohort, 5 in the 30mg cohort, and 3 in the 100mg cohort) were excluded from efficacy evaluation for not meeting the criteria.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Giredestrant 10 mg | Change From Baseline in Tumor Cell Proliferation, as Measured by the Difference in the Percentage of Nuclei Staining Ki67-Positive at Surgery Compared With Baseline in Pre- and Post-Treatment Tumor Biopsy Samples | Baseline (BL) - Value at Visit | 15.70 Percentage of nuclei Ki67+ | Standard Deviation 9.25 |
| Giredestrant 10 mg | Change From Baseline in Tumor Cell Proliferation, as Measured by the Difference in the Percentage of Nuclei Staining Ki67-Positive at Surgery Compared With Baseline in Pre- and Post-Treatment Tumor Biopsy Samples | Change from BL at Surgery (Surgery minus BL) | -11.49 Percentage of nuclei Ki67+ | Standard Deviation 7.84 |
| Giredestrant 10 mg | Change From Baseline in Tumor Cell Proliferation, as Measured by the Difference in the Percentage of Nuclei Staining Ki67-Positive at Surgery Compared With Baseline in Pre- and Post-Treatment Tumor Biopsy Samples | Surgery - Value at Visit | 4.22 Percentage of nuclei Ki67+ | Standard Deviation 4.7 |
| Giredestrant 30 mg | Change From Baseline in Tumor Cell Proliferation, as Measured by the Difference in the Percentage of Nuclei Staining Ki67-Positive at Surgery Compared With Baseline in Pre- and Post-Treatment Tumor Biopsy Samples | Baseline (BL) - Value at Visit | 15.10 Percentage of nuclei Ki67+ | Standard Deviation 11.23 |
| Giredestrant 30 mg | Change From Baseline in Tumor Cell Proliferation, as Measured by the Difference in the Percentage of Nuclei Staining Ki67-Positive at Surgery Compared With Baseline in Pre- and Post-Treatment Tumor Biopsy Samples | Change from BL at Surgery (Surgery minus BL) | -10.98 Percentage of nuclei Ki67+ | Standard Deviation 8.53 |
| Giredestrant 30 mg | Change From Baseline in Tumor Cell Proliferation, as Measured by the Difference in the Percentage of Nuclei Staining Ki67-Positive at Surgery Compared With Baseline in Pre- and Post-Treatment Tumor Biopsy Samples | Surgery - Value at Visit | 4.12 Percentage of nuclei Ki67+ | Standard Deviation 4.35 |
| Giredestrant 100 mg | Change From Baseline in Tumor Cell Proliferation, as Measured by the Difference in the Percentage of Nuclei Staining Ki67-Positive at Surgery Compared With Baseline in Pre- and Post-Treatment Tumor Biopsy Samples | Surgery - Value at Visit | 4.08 Percentage of nuclei Ki67+ | Standard Deviation 3.8 |
| Giredestrant 100 mg | Change From Baseline in Tumor Cell Proliferation, as Measured by the Difference in the Percentage of Nuclei Staining Ki67-Positive at Surgery Compared With Baseline in Pre- and Post-Treatment Tumor Biopsy Samples | Baseline (BL) - Value at Visit | 15.58 Percentage of nuclei Ki67+ | Standard Deviation 9.95 |
| Giredestrant 100 mg | Change From Baseline in Tumor Cell Proliferation, as Measured by the Difference in the Percentage of Nuclei Staining Ki67-Positive at Surgery Compared With Baseline in Pre- and Post-Treatment Tumor Biopsy Samples | Change from BL at Surgery (Surgery minus BL) | -11.49 Percentage of nuclei Ki67+ | Standard Deviation 8.23 |
| All Participants, Efficacy: Giredestrant (10, 30, or 100 mg) | Change From Baseline in Tumor Cell Proliferation, as Measured by the Difference in the Percentage of Nuclei Staining Ki67-Positive at Surgery Compared With Baseline in Pre- and Post-Treatment Tumor Biopsy Samples | Baseline (BL) - Value at Visit | 15.35 Percentage of nuclei Ki67+ | Standard Deviation 10.36 |
| All Participants, Efficacy: Giredestrant (10, 30, or 100 mg) | Change From Baseline in Tumor Cell Proliferation, as Measured by the Difference in the Percentage of Nuclei Staining Ki67-Positive at Surgery Compared With Baseline in Pre- and Post-Treatment Tumor Biopsy Samples | Change from BL at Surgery (Surgery minus BL) | -11.21 Percentage of nuclei Ki67+ | Standard Deviation 8.18 |
| All Participants, Efficacy: Giredestrant (10, 30, or 100 mg) | Change From Baseline in Tumor Cell Proliferation, as Measured by the Difference in the Percentage of Nuclei Staining Ki67-Positive at Surgery Compared With Baseline in Pre- and Post-Treatment Tumor Biopsy Samples | Surgery - Value at Visit | 4.13 Percentage of nuclei Ki67+ | Standard Deviation 4.25 |
Primary
Change From Baseline in Tumor Cell Proliferation, as Measured by the Proportion of Nuclei Staining Ki67-Positive at Surgery Relative to Baseline in Pre- and Post-Treatment Tumor Biopsy Samples
The biological response to the study treatment was assessed by measuring changes in cell proliferation (Ki67 expression) using formalin-fixed paraffin-embedded histopathology sections of the tumor biopsy specimens taken at baseline and at day of surgery. Baseline was defined as a sample taken prior to initiation of study drug. The results show the proportion of nuclei staining Ki67-positive (Ki67+) in the tumor biopsy sample taken post-treatment (at surgery) relative to that in the pre-treatment sample (at baseline).
Time frame: Baseline and Surgery (Day 15)
Population: Efficacy Evaluable Population: all participants who 1) had non-missing baseline and post-baseline Ki67 results available, 2) did not discontinue early from the study, 3) had taken at least 12 doses, and 4) had no more than one modified dose. A total of 10 participants (2 in the 10mg cohort, 5 in the 30mg cohort, and 3 in the 100mg cohort) were excluded from efficacy evaluation for not meeting the criteria.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Giredestrant 10 mg | Change From Baseline in Tumor Cell Proliferation, as Measured by the Proportion of Nuclei Staining Ki67-Positive at Surgery Relative to Baseline in Pre- and Post-Treatment Tumor Biopsy Samples | 0.20 Proportion of Ki67+ nuclei |
| Giredestrant 30 mg | Change From Baseline in Tumor Cell Proliferation, as Measured by the Proportion of Nuclei Staining Ki67-Positive at Surgery Relative to Baseline in Pre- and Post-Treatment Tumor Biopsy Samples | 0.24 Proportion of Ki67+ nuclei |
| Giredestrant 100 mg | Change From Baseline in Tumor Cell Proliferation, as Measured by the Proportion of Nuclei Staining Ki67-Positive at Surgery Relative to Baseline in Pre- and Post-Treatment Tumor Biopsy Samples | 0.22 Proportion of Ki67+ nuclei |
| All Participants, Efficacy: Giredestrant (10, 30, or 100 mg) | Change From Baseline in Tumor Cell Proliferation, as Measured by the Proportion of Nuclei Staining Ki67-Positive at Surgery Relative to Baseline in Pre- and Post-Treatment Tumor Biopsy Samples | 0.22 Proportion of Ki67+ nuclei |
Secondary
Change From Baseline in Body Temperature
Body temperature was measured according to institutional practice. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit. Baseline was defined as the participant's last value prior to initiation of study drug.
Time frame: Baseline, Day 8, Surgery (Day 15), and Post-Surgery (Day 43)
Population: Safety Evaluable Population: all participants who received at least one dose of giredestrant. One participant from the ITT population did not receive the study drug because of early withdrawal from the study. The number analyzed indicates all participants who had a non-missing assessment at a given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Giredestrant 10 mg | Change From Baseline in Body Temperature | Baseline (BL) - Value at Visit | 36.36 degrees Celsius (C) | Standard Deviation 0.48 |
| Giredestrant 10 mg | Change From Baseline in Body Temperature | Change from BL at Day 8 | -0.03 degrees Celsius (C) | Standard Deviation 0.41 |
| Giredestrant 10 mg | Change From Baseline in Body Temperature | Change from BL at Surgery | 0.14 degrees Celsius (C) | Standard Deviation 0.51 |
| Giredestrant 10 mg | Change From Baseline in Body Temperature | Change from BL at Post-Surgery | -0.03 degrees Celsius (C) | Standard Deviation 0.56 |
| Giredestrant 10 mg | Change From Baseline in Body Temperature | Change from BL at Post-BL Minimum | -0.20 degrees Celsius (C) | Standard Deviation 0.52 |
| Giredestrant 10 mg | Change From Baseline in Body Temperature | Change from BL at Post-BL Maximum | 0.28 degrees Celsius (C) | Standard Deviation 0.42 |
| Giredestrant 30 mg | Change From Baseline in Body Temperature | Change from BL at Post-BL Maximum | 0.15 degrees Celsius (C) | Standard Deviation 0.44 |
| Giredestrant 30 mg | Change From Baseline in Body Temperature | Change from BL at Post-Surgery | -0.05 degrees Celsius (C) | Standard Deviation 0.39 |
| Giredestrant 30 mg | Change From Baseline in Body Temperature | Baseline (BL) - Value at Visit | 36.41 degrees Celsius (C) | Standard Deviation 0.38 |
| Giredestrant 30 mg | Change From Baseline in Body Temperature | Change from BL at Surgery | -0.09 degrees Celsius (C) | Standard Deviation 0.46 |
| Giredestrant 30 mg | Change From Baseline in Body Temperature | Change from BL at Day 8 | -0.06 degrees Celsius (C) | Standard Deviation 0.51 |
| Giredestrant 30 mg | Change From Baseline in Body Temperature | Change from BL at Post-BL Minimum | -0.34 degrees Celsius (C) | Standard Deviation 0.44 |
| Giredestrant 100 mg | Change From Baseline in Body Temperature | Change from BL at Day 8 | -0.09 degrees Celsius (C) | Standard Deviation 0.43 |
| Giredestrant 100 mg | Change From Baseline in Body Temperature | Change from BL at Surgery | -0.18 degrees Celsius (C) | Standard Deviation 0.43 |
| Giredestrant 100 mg | Change From Baseline in Body Temperature | Change from BL at Post-Surgery | -0.11 degrees Celsius (C) | Standard Deviation 0.5 |
| Giredestrant 100 mg | Change From Baseline in Body Temperature | Change from BL at Post-BL Maximum | 0.12 degrees Celsius (C) | Standard Deviation 0.32 |
| Giredestrant 100 mg | Change From Baseline in Body Temperature | Change from BL at Post-BL Minimum | -0.39 degrees Celsius (C) | Standard Deviation 0.42 |
| Giredestrant 100 mg | Change From Baseline in Body Temperature | Baseline (BL) - Value at Visit | 36.25 degrees Celsius (C) | Standard Deviation 0.24 |
| All Participants, Efficacy: Giredestrant (10, 30, or 100 mg) | Change From Baseline in Body Temperature | Change from BL at Post-BL Minimum | -0.32 degrees Celsius (C) | Standard Deviation 0.45 |
| All Participants, Efficacy: Giredestrant (10, 30, or 100 mg) | Change From Baseline in Body Temperature | Change from BL at Post-BL Maximum | 0.17 degrees Celsius (C) | Standard Deviation 0.41 |
| All Participants, Efficacy: Giredestrant (10, 30, or 100 mg) | Change From Baseline in Body Temperature | Change from BL at Day 8 | -0.06 degrees Celsius (C) | Standard Deviation 0.47 |
| All Participants, Efficacy: Giredestrant (10, 30, or 100 mg) | Change From Baseline in Body Temperature | Change from BL at Post-Surgery | -0.06 degrees Celsius (C) | Standard Deviation 0.45 |
| All Participants, Efficacy: Giredestrant (10, 30, or 100 mg) | Change From Baseline in Body Temperature | Baseline (BL) - Value at Visit | 36.36 degrees Celsius (C) | Standard Deviation 0.38 |
| All Participants, Efficacy: Giredestrant (10, 30, or 100 mg) | Change From Baseline in Body Temperature | Change from BL at Surgery | -0.05 degrees Celsius (C) | Standard Deviation 0.47 |
Secondary
Change From Baseline in Diastolic Blood Pressure
Diastolic blood pressure was measured while the participant was in a seated position. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit. Baseline was defined as the participant's last value prior to initiation of study drug.
Time frame: Baseline, Day 8, Surgery (Day 15), and Post-Surgery (Day 43)
Population: Safety Evaluable Population: all participants who received at least one dose of giredestrant. One participant from the ITT population did not receive the study drug because of early withdrawal from the study. The number analyzed indicates all participants who had a non-missing assessment at a given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Giredestrant 10 mg | Change From Baseline in Diastolic Blood Pressure | Change from BL at Surgery | -3.2 millimetres of mercury (mmHg) | Standard Deviation 7.9 |
| Giredestrant 10 mg | Change From Baseline in Diastolic Blood Pressure | Change from BL at Day 8 | -3.4 millimetres of mercury (mmHg) | Standard Deviation 7.3 |
| Giredestrant 10 mg | Change From Baseline in Diastolic Blood Pressure | Change from BL at Post-BL Minimum | -6.4 millimetres of mercury (mmHg) | Standard Deviation 6.6 |
| Giredestrant 10 mg | Change From Baseline in Diastolic Blood Pressure | Change from BL at Post-Surgery | 4.1 millimetres of mercury (mmHg) | Standard Deviation 8 |
| Giredestrant 10 mg | Change From Baseline in Diastolic Blood Pressure | Baseline (BL) - Value at Visit | 78.4 millimetres of mercury (mmHg) | Standard Deviation 10.3 |
| Giredestrant 10 mg | Change From Baseline in Diastolic Blood Pressure | Change from BL at Post-BL Maximum | 5.6 millimetres of mercury (mmHg) | Standard Deviation 7 |
| Giredestrant 30 mg | Change From Baseline in Diastolic Blood Pressure | Change from BL at Post-BL Maximum | 3.8 millimetres of mercury (mmHg) | Standard Deviation 10.8 |
| Giredestrant 30 mg | Change From Baseline in Diastolic Blood Pressure | Baseline (BL) - Value at Visit | 75.2 millimetres of mercury (mmHg) | Standard Deviation 10.7 |
| Giredestrant 30 mg | Change From Baseline in Diastolic Blood Pressure | Change from BL at Day 8 | -0.5 millimetres of mercury (mmHg) | Standard Deviation 7.4 |
| Giredestrant 30 mg | Change From Baseline in Diastolic Blood Pressure | Change from BL at Surgery | -2.1 millimetres of mercury (mmHg) | Standard Deviation 12.5 |
| Giredestrant 30 mg | Change From Baseline in Diastolic Blood Pressure | Change from BL at Post-Surgery | 0.1 millimetres of mercury (mmHg) | Standard Deviation 10.5 |
| Giredestrant 30 mg | Change From Baseline in Diastolic Blood Pressure | Change from BL at Post-BL Minimum | -6.2 millimetres of mercury (mmHg) | Standard Deviation 8.7 |
| Giredestrant 100 mg | Change From Baseline in Diastolic Blood Pressure | Change from BL at Post-BL Minimum | -12.2 millimetres of mercury (mmHg) | Standard Deviation 8.5 |
| Giredestrant 100 mg | Change From Baseline in Diastolic Blood Pressure | Change from BL at Surgery | -8.3 millimetres of mercury (mmHg) | Standard Deviation 10.7 |
| Giredestrant 100 mg | Change From Baseline in Diastolic Blood Pressure | Change from BL at Post-Surgery | -4.5 millimetres of mercury (mmHg) | Standard Deviation 9.8 |
| Giredestrant 100 mg | Change From Baseline in Diastolic Blood Pressure | Change from BL at Post-BL Maximum | -2.8 millimetres of mercury (mmHg) | Standard Deviation 9.2 |
| Giredestrant 100 mg | Change From Baseline in Diastolic Blood Pressure | Change from BL at Day 8 | -9.5 millimetres of mercury (mmHg) | Standard Deviation 10.3 |
| Giredestrant 100 mg | Change From Baseline in Diastolic Blood Pressure | Baseline (BL) - Value at Visit | 76.9 millimetres of mercury (mmHg) | Standard Deviation 10.8 |
| All Participants, Efficacy: Giredestrant (10, 30, or 100 mg) | Change From Baseline in Diastolic Blood Pressure | Change from BL at Day 8 | -3.1 millimetres of mercury (mmHg) | Standard Deviation 8.7 |
| All Participants, Efficacy: Giredestrant (10, 30, or 100 mg) | Change From Baseline in Diastolic Blood Pressure | Change from BL at Post-BL Minimum | -7.6 millimetres of mercury (mmHg) | Standard Deviation 8.5 |
| All Participants, Efficacy: Giredestrant (10, 30, or 100 mg) | Change From Baseline in Diastolic Blood Pressure | Change from BL at Post-BL Maximum | 2.7 millimetres of mercury (mmHg) | Standard Deviation 10.1 |
| All Participants, Efficacy: Giredestrant (10, 30, or 100 mg) | Change From Baseline in Diastolic Blood Pressure | Change from BL at Post-Surgery | 0.0 millimetres of mercury (mmHg) | Standard Deviation 10.1 |
| All Participants, Efficacy: Giredestrant (10, 30, or 100 mg) | Change From Baseline in Diastolic Blood Pressure | Change from BL at Surgery | -3.7 millimetres of mercury (mmHg) | Standard Deviation 11.2 |
| All Participants, Efficacy: Giredestrant (10, 30, or 100 mg) | Change From Baseline in Diastolic Blood Pressure | Baseline (BL) - Value at Visit | 76.3 millimetres of mercury (mmHg) | Standard Deviation 10.6 |
Secondary
Change From Baseline in Pulse Rate
Pulse rate was measured while the participant was in a seated position. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit. Baseline was defined as the participant's last value prior to initiation of study drug.
Time frame: Baseline, Day 8, Surgery (Day 15), and Post-Surgery (Day 43)
Population: Safety Evaluable Population: all participants who received at least one dose of giredestrant. One participant from the ITT population did not receive the study drug because of early withdrawal from the study. The number analyzed indicates all participants who had a non-missing assessment at a given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Giredestrant 10 mg | Change From Baseline in Pulse Rate | Baseline (BL) - Value at Visit | 75.3 beats per minute | Standard Deviation 9.5 |
| Giredestrant 10 mg | Change From Baseline in Pulse Rate | Change from BL at Day 8 | 1.4 beats per minute | Standard Deviation 8.5 |
| Giredestrant 10 mg | Change From Baseline in Pulse Rate | Change from BL at Surgery | 2.4 beats per minute | Standard Deviation 9.7 |
| Giredestrant 10 mg | Change From Baseline in Pulse Rate | Change from BL at Post-Surgery | 2.2 beats per minute | Standard Deviation 12 |
| Giredestrant 10 mg | Change From Baseline in Pulse Rate | Change from BL at Post-BL Minimum | -4.2 beats per minute | Standard Deviation 9.2 |
| Giredestrant 10 mg | Change From Baseline in Pulse Rate | Change from BL at Post-BL Maximum | 9.5 beats per minute | Standard Deviation 7.2 |
| Giredestrant 30 mg | Change From Baseline in Pulse Rate | Change from BL at Post-BL Maximum | 6.7 beats per minute | Standard Deviation 11.1 |
| Giredestrant 30 mg | Change From Baseline in Pulse Rate | Change from BL at Post-Surgery | 3.5 beats per minute | Standard Deviation 11.4 |
| Giredestrant 30 mg | Change From Baseline in Pulse Rate | Baseline (BL) - Value at Visit | 72.6 beats per minute | Standard Deviation 11.1 |
| Giredestrant 30 mg | Change From Baseline in Pulse Rate | Change from BL at Surgery | -3.8 beats per minute | Standard Deviation 10.7 |
| Giredestrant 30 mg | Change From Baseline in Pulse Rate | Change from BL at Day 8 | -1.9 beats per minute | Standard Deviation 11.3 |
| Giredestrant 30 mg | Change From Baseline in Pulse Rate | Change from BL at Post-BL Minimum | -7.4 beats per minute | Standard Deviation 9.9 |
| Giredestrant 100 mg | Change From Baseline in Pulse Rate | Change from BL at Day 8 | -11.1 beats per minute | Standard Deviation 10.6 |
| Giredestrant 100 mg | Change From Baseline in Pulse Rate | Change from BL at Surgery | -13.9 beats per minute | Standard Deviation 10.8 |
| Giredestrant 100 mg | Change From Baseline in Pulse Rate | Change from BL at Post-Surgery | 4.2 beats per minute | Standard Deviation 11.3 |
| Giredestrant 100 mg | Change From Baseline in Pulse Rate | Change from BL at Post-BL Maximum | 4.8 beats per minute | Standard Deviation 10 |
| Giredestrant 100 mg | Change From Baseline in Pulse Rate | Change from BL at Post-BL Minimum | -14.4 beats per minute | Standard Deviation 10.7 |
| Giredestrant 100 mg | Change From Baseline in Pulse Rate | Baseline (BL) - Value at Visit | 72.1 beats per minute | Standard Deviation 10.6 |
| All Participants, Efficacy: Giredestrant (10, 30, or 100 mg) | Change From Baseline in Pulse Rate | Change from BL at Post-BL Minimum | -8.3 beats per minute | Standard Deviation 10.4 |
| All Participants, Efficacy: Giredestrant (10, 30, or 100 mg) | Change From Baseline in Pulse Rate | Change from BL at Post-BL Maximum | 6.9 beats per minute | Standard Deviation 10.1 |
| All Participants, Efficacy: Giredestrant (10, 30, or 100 mg) | Change From Baseline in Pulse Rate | Change from BL at Day 8 | -3.1 beats per minute | Standard Deviation 11.3 |
| All Participants, Efficacy: Giredestrant (10, 30, or 100 mg) | Change From Baseline in Pulse Rate | Change from BL at Post-Surgery | 3.4 beats per minute | Standard Deviation 11.4 |
| All Participants, Efficacy: Giredestrant (10, 30, or 100 mg) | Change From Baseline in Pulse Rate | Baseline (BL) - Value at Visit | 73.1 beats per minute | Standard Deviation 10.6 |
| All Participants, Efficacy: Giredestrant (10, 30, or 100 mg) | Change From Baseline in Pulse Rate | Change from BL at Surgery | -4.5 beats per minute | Standard Deviation 11.8 |
Secondary
Change From Baseline in Systolic Blood Pressure
Systolic blood pressure was measured while the participant was in a seated position. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit. Baseline was defined as the participant's last value prior to initiation of study drug.
Time frame: Baseline, Day 8, Surgery (Day 15), and Post-Surgery (Day 43)
Population: Safety Evaluable Population: all participants who received at least one dose of giredestrant. One participant from the ITT population did not receive the study drug because of early withdrawal from the study. The number analyzed indicates all participants who had a non-missing assessment at a given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Giredestrant 10 mg | Change From Baseline in Systolic Blood Pressure | Change from BL at Surgery | -2.2 millimetres of mercury (mmHg) | Standard Deviation 15.7 |
| Giredestrant 10 mg | Change From Baseline in Systolic Blood Pressure | Change from BL at Post-Surgery | -2.1 millimetres of mercury (mmHg) | Standard Deviation 14.6 |
| Giredestrant 10 mg | Change From Baseline in Systolic Blood Pressure | Baseline (BL) - Value at Visit | 135.4 millimetres of mercury (mmHg) | Standard Deviation 18.6 |
| Giredestrant 10 mg | Change From Baseline in Systolic Blood Pressure | Change from BL at Post-BL Maximum | 5.9 millimetres of mercury (mmHg) | Standard Deviation 13.6 |
| Giredestrant 10 mg | Change From Baseline in Systolic Blood Pressure | Change from BL at Day 8 | -1.1 millimetres of mercury (mmHg) | Standard Deviation 12.3 |
| Giredestrant 10 mg | Change From Baseline in Systolic Blood Pressure | Change from BL at Post-BL Minimum | -9.5 millimetres of mercury (mmHg) | Standard Deviation 12 |
| Giredestrant 30 mg | Change From Baseline in Systolic Blood Pressure | Change from BL at Surgery | 5.7 millimetres of mercury (mmHg) | Standard Deviation 15.2 |
| Giredestrant 30 mg | Change From Baseline in Systolic Blood Pressure | Change from BL at Post-Surgery | 1.0 millimetres of mercury (mmHg) | Standard Deviation 13.2 |
| Giredestrant 30 mg | Change From Baseline in Systolic Blood Pressure | Change from BL at Post-BL Minimum | -5.5 millimetres of mercury (mmHg) | Standard Deviation 11.2 |
| Giredestrant 30 mg | Change From Baseline in Systolic Blood Pressure | Change from BL at Day 8 | 2.9 millimetres of mercury (mmHg) | Standard Deviation 14 |
| Giredestrant 30 mg | Change From Baseline in Systolic Blood Pressure | Baseline (BL) - Value at Visit | 128.0 millimetres of mercury (mmHg) | Standard Deviation 14.2 |
| Giredestrant 30 mg | Change From Baseline in Systolic Blood Pressure | Change from BL at Post-BL Maximum | 11.8 millimetres of mercury (mmHg) | Standard Deviation 13.4 |
| Giredestrant 100 mg | Change From Baseline in Systolic Blood Pressure | Change from BL at Surgery | -1.4 millimetres of mercury (mmHg) | Standard Deviation 17.3 |
| Giredestrant 100 mg | Change From Baseline in Systolic Blood Pressure | Baseline (BL) - Value at Visit | 129.4 millimetres of mercury (mmHg) | Standard Deviation 14.7 |
| Giredestrant 100 mg | Change From Baseline in Systolic Blood Pressure | Change from BL at Day 8 | -7.9 millimetres of mercury (mmHg) | Standard Deviation 14.3 |
| Giredestrant 100 mg | Change From Baseline in Systolic Blood Pressure | Change from BL at Post-Surgery | -3.2 millimetres of mercury (mmHg) | Standard Deviation 15.3 |
| Giredestrant 100 mg | Change From Baseline in Systolic Blood Pressure | Change from BL at Post-BL Minimum | -12.5 millimetres of mercury (mmHg) | Standard Deviation 14.6 |
| Giredestrant 100 mg | Change From Baseline in Systolic Blood Pressure | Change from BL at Post-BL Maximum | 3.2 millimetres of mercury (mmHg) | Standard Deviation 15.2 |
| All Participants, Efficacy: Giredestrant (10, 30, or 100 mg) | Change From Baseline in Systolic Blood Pressure | Change from BL at Post-BL Maximum | 8.5 millimetres of mercury (mmHg) | Standard Deviation 14.2 |
| All Participants, Efficacy: Giredestrant (10, 30, or 100 mg) | Change From Baseline in Systolic Blood Pressure | Change from BL at Post-BL Minimum | -8.0 millimetres of mercury (mmHg) | Standard Deviation 12.4 |
| All Participants, Efficacy: Giredestrant (10, 30, or 100 mg) | Change From Baseline in Systolic Blood Pressure | Baseline (BL) - Value at Visit | 130.0 millimetres of mercury (mmHg) | Standard Deviation 15.5 |
| All Participants, Efficacy: Giredestrant (10, 30, or 100 mg) | Change From Baseline in Systolic Blood Pressure | Change from BL at Surgery | 2.2 millimetres of mercury (mmHg) | Standard Deviation 16 |
| All Participants, Efficacy: Giredestrant (10, 30, or 100 mg) | Change From Baseline in Systolic Blood Pressure | Change from BL at Post-Surgery | -0.7 millimetres of mercury (mmHg) | Standard Deviation 13.9 |
| All Participants, Efficacy: Giredestrant (10, 30, or 100 mg) | Change From Baseline in Systolic Blood Pressure | Change from BL at Day 8 | -0.3 millimetres of mercury (mmHg) | Standard Deviation 14.2 |
Secondary
Number of Participants With at Least One Adverse Event and by Severity, Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI-CTCAE v5.0)
All adverse events (AEs) were recorded and the investigator independently assessed the seriousness and severity of each AE. AE severity was graded on a scale from 1 to 5 using the NCI-CTCAE v5.0; any events not specifically listed in the scale were defined as: Grade 1 is mild; Grade 2 is moderate; Grade 3 is severe or medically significant; Grade 4 is life-threatening; and Grade 5 is death related to an AE. Investigators used their knowledge of the patient, the circumstances surrounding the event, and an evaluation of any potential alternative causes to determine whether an AE was considered to be related to the study drug.
Time frame: From Baseline to Day 43
Population: Safety Evaluable Population: all participants who received at least one dose of giredestrant. One participant from the ITT population did not receive the study drug because of early withdrawal from the study.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Giredestrant 10 mg | Number of Participants With at Least One Adverse Event and by Severity, Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI-CTCAE v5.0) | Serious AE | 1 Participants |
| Giredestrant 10 mg | Number of Participants With at Least One Adverse Event and by Severity, Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI-CTCAE v5.0) | AE with Fatal Outcome | 0 Participants |
| Giredestrant 10 mg | Number of Participants With at Least One Adverse Event and by Severity, Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI-CTCAE v5.0) | Any Adverse Event (AE) | 12 Participants |
| Giredestrant 10 mg | Number of Participants With at Least One Adverse Event and by Severity, Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI-CTCAE v5.0) | Related Serious AE | 0 Participants |
| Giredestrant 10 mg | Number of Participants With at Least One Adverse Event and by Severity, Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI-CTCAE v5.0) | Related Grade 3-4 AE | 0 Participants |
| Giredestrant 10 mg | Number of Participants With at Least One Adverse Event and by Severity, Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI-CTCAE v5.0) | AE Leading to Withdrawal from Study Drug | 0 Participants |
| Giredestrant 10 mg | Number of Participants With at Least One Adverse Event and by Severity, Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI-CTCAE v5.0) | Grade 3-4 AE | 1 Participants |
| Giredestrant 10 mg | Number of Participants With at Least One Adverse Event and by Severity, Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI-CTCAE v5.0) | AE Leading to Interruption of Study Drug | 1 Participants |
| Giredestrant 10 mg | Number of Participants With at Least One Adverse Event and by Severity, Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI-CTCAE v5.0) | Related AE | 7 Participants |
| Giredestrant 30 mg | Number of Participants With at Least One Adverse Event and by Severity, Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI-CTCAE v5.0) | AE with Fatal Outcome | 0 Participants |
| Giredestrant 30 mg | Number of Participants With at Least One Adverse Event and by Severity, Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI-CTCAE v5.0) | Grade 3-4 AE | 3 Participants |
| Giredestrant 30 mg | Number of Participants With at Least One Adverse Event and by Severity, Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI-CTCAE v5.0) | Related Grade 3-4 AE | 0 Participants |
| Giredestrant 30 mg | Number of Participants With at Least One Adverse Event and by Severity, Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI-CTCAE v5.0) | Any Adverse Event (AE) | 27 Participants |
| Giredestrant 30 mg | Number of Participants With at Least One Adverse Event and by Severity, Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI-CTCAE v5.0) | Serious AE | 2 Participants |
| Giredestrant 30 mg | Number of Participants With at Least One Adverse Event and by Severity, Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI-CTCAE v5.0) | Related Serious AE | 0 Participants |
| Giredestrant 30 mg | Number of Participants With at Least One Adverse Event and by Severity, Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI-CTCAE v5.0) | AE Leading to Withdrawal from Study Drug | 0 Participants |
| Giredestrant 30 mg | Number of Participants With at Least One Adverse Event and by Severity, Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI-CTCAE v5.0) | AE Leading to Interruption of Study Drug | 0 Participants |
| Giredestrant 30 mg | Number of Participants With at Least One Adverse Event and by Severity, Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI-CTCAE v5.0) | Related AE | 17 Participants |
| Giredestrant 100 mg | Number of Participants With at Least One Adverse Event and by Severity, Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI-CTCAE v5.0) | AE Leading to Withdrawal from Study Drug | 0 Participants |
| Giredestrant 100 mg | Number of Participants With at Least One Adverse Event and by Severity, Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI-CTCAE v5.0) | Serious AE | 1 Participants |
| Giredestrant 100 mg | Number of Participants With at Least One Adverse Event and by Severity, Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI-CTCAE v5.0) | Related Grade 3-4 AE | 0 Participants |
| Giredestrant 100 mg | Number of Participants With at Least One Adverse Event and by Severity, Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI-CTCAE v5.0) | Related AE | 8 Participants |
| Giredestrant 100 mg | Number of Participants With at Least One Adverse Event and by Severity, Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI-CTCAE v5.0) | AE Leading to Interruption of Study Drug | 1 Participants |
| Giredestrant 100 mg | Number of Participants With at Least One Adverse Event and by Severity, Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI-CTCAE v5.0) | AE with Fatal Outcome | 0 Participants |
| Giredestrant 100 mg | Number of Participants With at Least One Adverse Event and by Severity, Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI-CTCAE v5.0) | Any Adverse Event (AE) | 14 Participants |
| Giredestrant 100 mg | Number of Participants With at Least One Adverse Event and by Severity, Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI-CTCAE v5.0) | Related Serious AE | 0 Participants |
| Giredestrant 100 mg | Number of Participants With at Least One Adverse Event and by Severity, Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI-CTCAE v5.0) | Grade 3-4 AE | 1 Participants |
| All Participants, Efficacy: Giredestrant (10, 30, or 100 mg) | Number of Participants With at Least One Adverse Event and by Severity, Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI-CTCAE v5.0) | Related Grade 3-4 AE | 0 Participants |
| All Participants, Efficacy: Giredestrant (10, 30, or 100 mg) | Number of Participants With at Least One Adverse Event and by Severity, Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI-CTCAE v5.0) | Any Adverse Event (AE) | 53 Participants |
| All Participants, Efficacy: Giredestrant (10, 30, or 100 mg) | Number of Participants With at Least One Adverse Event and by Severity, Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI-CTCAE v5.0) | AE with Fatal Outcome | 0 Participants |
| All Participants, Efficacy: Giredestrant (10, 30, or 100 mg) | Number of Participants With at Least One Adverse Event and by Severity, Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI-CTCAE v5.0) | Related Serious AE | 0 Participants |
| All Participants, Efficacy: Giredestrant (10, 30, or 100 mg) | Number of Participants With at Least One Adverse Event and by Severity, Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI-CTCAE v5.0) | AE Leading to Withdrawal from Study Drug | 0 Participants |
| All Participants, Efficacy: Giredestrant (10, 30, or 100 mg) | Number of Participants With at Least One Adverse Event and by Severity, Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI-CTCAE v5.0) | AE Leading to Interruption of Study Drug | 2 Participants |
| All Participants, Efficacy: Giredestrant (10, 30, or 100 mg) | Number of Participants With at Least One Adverse Event and by Severity, Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI-CTCAE v5.0) | Related AE | 32 Participants |
| All Participants, Efficacy: Giredestrant (10, 30, or 100 mg) | Number of Participants With at Least One Adverse Event and by Severity, Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI-CTCAE v5.0) | Grade 3-4 AE | 5 Participants |
| All Participants, Efficacy: Giredestrant (10, 30, or 100 mg) | Number of Participants With at Least One Adverse Event and by Severity, Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI-CTCAE v5.0) | Serious AE | 4 Participants |
Secondary
Percentage of Participants With Abnormal Electrocardiogram Parameters During Treatment
Electrocardiogram (ECG) recordings were performed after the participant had been resting in a supine position for at least 10 minutes. ECG parameters included heart rate, PR and QRS durations, and QT and QTcF intervals. Per the protocol, ECG readings post-treatment were limited to those for whom it was clinically indicated. Any of the ECG parameters that were outside of the normal reference range (in the specified direction - low or high) were considered abnormalities. Not every abnormality qualified as an adverse event (AE). An ECG test result was reported as an AE if it met any of the following criteria: was accompanied by clinical symptoms; resulted in a change in study treatment; resulted in a medical intervention or a change in concomitant therapy; or was clinically significant in the investigator's judgment.
Time frame: Baseline, Days 1, 8, and 15
Population: The analysis included a small number of participants who had ECG readings post-treatment because, per the protocol, ECGs were limited to those for whom it was clinically indicated.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Giredestrant 10 mg | Percentage of Participants With Abnormal Electrocardiogram Parameters During Treatment | PR Duration - High | 0 Percentage of participants |
| Giredestrant 10 mg | Percentage of Participants With Abnormal Electrocardiogram Parameters During Treatment | PR Duration - Low | 12.5 Percentage of participants |
| Giredestrant 30 mg | Percentage of Participants With Abnormal Electrocardiogram Parameters During Treatment | PR Duration - High | 0 Percentage of participants |
| Giredestrant 30 mg | Percentage of Participants With Abnormal Electrocardiogram Parameters During Treatment | PR Duration - Low | 0 Percentage of participants |
| Giredestrant 100 mg | Percentage of Participants With Abnormal Electrocardiogram Parameters During Treatment | PR Duration - High | 25.0 Percentage of participants |
| Giredestrant 100 mg | Percentage of Participants With Abnormal Electrocardiogram Parameters During Treatment | PR Duration - Low | 0 Percentage of participants |
| All Participants, Efficacy: Giredestrant (10, 30, or 100 mg) | Percentage of Participants With Abnormal Electrocardiogram Parameters During Treatment | PR Duration - High | 5.3 Percentage of participants |
| All Participants, Efficacy: Giredestrant (10, 30, or 100 mg) | Percentage of Participants With Abnormal Electrocardiogram Parameters During Treatment | PR Duration - Low | 5.3 Percentage of participants |
Secondary
Percentage of Participants With Abnormal Vital Signs During Treatment
Vital signs, which included diastolic and systolic blood pressure, pulse rate, and body temperature, were measured while the participant was sitting and according to institutional practices. Any of the vital signs that were outside of the normal reference range (in the specified direction - low or high) were considered abnormalities. Not every abnormality qualified as an adverse event (AE). A vital sign result had to be reported as an AE if it met any of the following criteria: was accompanied by clinical symptoms; resulted in a change in study treatment; resulted in a medical intervention or a change in concomitant therapy; or was clinically significant in the investigator's judgment.
Time frame: Baseline, Days 1, 8, and 15
Population: Safety Evaluable Population: all participants who received at least one dose of giredestrant. One participant from the ITT population did not receive the study drug because of early withdrawal from the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Giredestrant 10 mg | Percentage of Participants With Abnormal Vital Signs During Treatment | Body Temperature - Low | 88.2 Percentage of participants |
| Giredestrant 10 mg | Percentage of Participants With Abnormal Vital Signs During Treatment | Pulse Rate - Low | 11.8 Percentage of participants |
| Giredestrant 10 mg | Percentage of Participants With Abnormal Vital Signs During Treatment | Diastolic Blood Pressure - High | 64.7 Percentage of participants |
| Giredestrant 10 mg | Percentage of Participants With Abnormal Vital Signs During Treatment | Systolic Blood Pressure - High | 82.4 Percentage of participants |
| Giredestrant 10 mg | Percentage of Participants With Abnormal Vital Signs During Treatment | Pulse Rate - High | 0 Percentage of participants |
| Giredestrant 10 mg | Percentage of Participants With Abnormal Vital Signs During Treatment | Diastolic Blood Pressure - Low | 5.9 Percentage of participants |
| Giredestrant 30 mg | Percentage of Participants With Abnormal Vital Signs During Treatment | Pulse Rate - High | 2.5 Percentage of participants |
| Giredestrant 30 mg | Percentage of Participants With Abnormal Vital Signs During Treatment | Body Temperature - Low | 82.5 Percentage of participants |
| Giredestrant 30 mg | Percentage of Participants With Abnormal Vital Signs During Treatment | Diastolic Blood Pressure - High | 35.0 Percentage of participants |
| Giredestrant 30 mg | Percentage of Participants With Abnormal Vital Signs During Treatment | Diastolic Blood Pressure - Low | 12.5 Percentage of participants |
| Giredestrant 30 mg | Percentage of Participants With Abnormal Vital Signs During Treatment | Systolic Blood Pressure - High | 70.0 Percentage of participants |
| Giredestrant 30 mg | Percentage of Participants With Abnormal Vital Signs During Treatment | Pulse Rate - Low | 27.5 Percentage of participants |
| Giredestrant 100 mg | Percentage of Participants With Abnormal Vital Signs During Treatment | Diastolic Blood Pressure - Low | 23.5 Percentage of participants |
| Giredestrant 100 mg | Percentage of Participants With Abnormal Vital Signs During Treatment | Diastolic Blood Pressure - High | 11.8 Percentage of participants |
| Giredestrant 100 mg | Percentage of Participants With Abnormal Vital Signs During Treatment | Pulse Rate - High | 0 Percentage of participants |
| Giredestrant 100 mg | Percentage of Participants With Abnormal Vital Signs During Treatment | Pulse Rate - Low | 64.7 Percentage of participants |
| Giredestrant 100 mg | Percentage of Participants With Abnormal Vital Signs During Treatment | Body Temperature - Low | 94.1 Percentage of participants |
| Giredestrant 100 mg | Percentage of Participants With Abnormal Vital Signs During Treatment | Systolic Blood Pressure - High | 58.8 Percentage of participants |
| All Participants, Efficacy: Giredestrant (10, 30, or 100 mg) | Percentage of Participants With Abnormal Vital Signs During Treatment | Body Temperature - Low | 86.5 Percentage of participants |
| All Participants, Efficacy: Giredestrant (10, 30, or 100 mg) | Percentage of Participants With Abnormal Vital Signs During Treatment | Diastolic Blood Pressure - Low | 13.5 Percentage of participants |
| All Participants, Efficacy: Giredestrant (10, 30, or 100 mg) | Percentage of Participants With Abnormal Vital Signs During Treatment | Diastolic Blood Pressure - High | 36.5 Percentage of participants |
| All Participants, Efficacy: Giredestrant (10, 30, or 100 mg) | Percentage of Participants With Abnormal Vital Signs During Treatment | Systolic Blood Pressure - High | 70.3 Percentage of participants |
| All Participants, Efficacy: Giredestrant (10, 30, or 100 mg) | Percentage of Participants With Abnormal Vital Signs During Treatment | Pulse Rate - Low | 32.4 Percentage of participants |
| All Participants, Efficacy: Giredestrant (10, 30, or 100 mg) | Percentage of Participants With Abnormal Vital Signs During Treatment | Pulse Rate - High | 1.4 Percentage of participants |
Secondary
Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline
Laboratory parameters for blood chemistry and coagulation were measured and compared with a standard reference range. Any of the laboratory test results that were outside of a parameter's normal reference range (in the specified direction - low or high) were considered abnormalities. Not every laboratory abnormality qualified as an adverse event (AE). A laboratory test result was reported as an AE if it met any of the following criteria: was accompanied by clinical symptoms; resulted in a change in study treatment; resulted in a medical intervention or a change in concomitant therapy; or was clinically significant in the investigator's judgment. SGPT/ALT = alanine aminotransferase; SGOT/AST = aspartate aminotransferase
Time frame: Baseline, Days 1, 8, and 15
Population: Safety Evaluable Population: the number of participants analyzed includes all participants who received at least one dose of giredestrant. The number analyzed for a given laboratory parameter represents the number of participants without an abnormality (in the specified direction) at baseline for that parameter.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Giredestrant 10 mg | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Bilirubin - High | 0 Percentage of participants |
| Giredestrant 10 mg | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Direct Bilirubin - Low | 10.0 Percentage of participants |
| Giredestrant 10 mg | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Activated Partial Thromboplastin Time - Low | 13.3 Percentage of participants |
| Giredestrant 10 mg | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Direct Bilirubin - High | 11.1 Percentage of participants |
| Giredestrant 10 mg | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Alkaline Phosphatase - High | 0 Percentage of participants |
| Giredestrant 10 mg | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Phosphorus - High | 0 Percentage of participants |
| Giredestrant 10 mg | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Glucose, Fasting - High | 0 Percentage of participants |
| Giredestrant 10 mg | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Glucose, Fasting Unknown - High | 33.3 Percentage of participants |
| Giredestrant 10 mg | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Phosphorus - Low | 10.0 Percentage of participants |
| Giredestrant 10 mg | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Magnesium - High | 0 Percentage of participants |
| Giredestrant 10 mg | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | SGPT/ALT - High | 0 Percentage of participants |
| Giredestrant 10 mg | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Protein, Total - High | 0 Percentage of participants |
| Giredestrant 10 mg | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | International Normalized Ratio - High | 0 Percentage of participants |
| Giredestrant 10 mg | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | SGOT/AST - High | 0 Percentage of participants |
| Giredestrant 10 mg | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Prothrombin Time - High | 0 Percentage of participants |
| Giredestrant 10 mg | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Bicarbonate HCO3 - Low | 0 Percentage of participants |
| Giredestrant 10 mg | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Albumin - Low | 0 Percentage of participants |
| Giredestrant 10 mg | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Bicarbonate HCO3 - High | 16.7 Percentage of participants |
| Giredestrant 10 mg | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Blood Urea Nitrogen - High | 10.0 Percentage of participants |
| Giredestrant 10 mg | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Protein, Total - Low | 0 Percentage of participants |
| Giredestrant 10 mg | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Calcium - High | 0 Percentage of participants |
| Giredestrant 10 mg | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Potassium - High | 0 Percentage of participants |
| Giredestrant 10 mg | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Carbon Dioxide - High | 33.3 Percentage of participants |
| Giredestrant 10 mg | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Chloride - Low | 10.0 Percentage of participants |
| Giredestrant 10 mg | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Albumin - High | 0 Percentage of participants |
| Giredestrant 10 mg | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Sodium - Low | 0 Percentage of participants |
| Giredestrant 10 mg | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Chloride - High | 0 Percentage of participants |
| Giredestrant 10 mg | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Creatinine - High | 0 Percentage of participants |
| Giredestrant 30 mg | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Bicarbonate HCO3 - Low | 3.1 Percentage of participants |
| Giredestrant 30 mg | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Activated Partial Thromboplastin Time - Low | 16.2 Percentage of participants |
| Giredestrant 30 mg | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Direct Bilirubin - Low | 0 Percentage of participants |
| Giredestrant 30 mg | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Protein, Total - High | 3.2 Percentage of participants |
| Giredestrant 30 mg | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Phosphorus - High | 3.2 Percentage of participants |
| Giredestrant 30 mg | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Sodium - Low | 3.1 Percentage of participants |
| Giredestrant 30 mg | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Direct Bilirubin - High | 3.4 Percentage of participants |
| Giredestrant 30 mg | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Bicarbonate HCO3 - High | 9.5 Percentage of participants |
| Giredestrant 30 mg | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Albumin - Low | 3.3 Percentage of participants |
| Giredestrant 30 mg | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Protein, Total - Low | 3.3 Percentage of participants |
| Giredestrant 30 mg | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Glucose, Fasting - High | 31.3 Percentage of participants |
| Giredestrant 30 mg | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Alkaline Phosphatase - High | 3.4 Percentage of participants |
| Giredestrant 30 mg | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Phosphorus - Low | 0 Percentage of participants |
| Giredestrant 30 mg | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Albumin - High | 3.3 Percentage of participants |
| Giredestrant 30 mg | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Glucose, Fasting Unknown - High | 21.4 Percentage of participants |
| Giredestrant 30 mg | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | International Normalized Ratio - High | 2.6 Percentage of participants |
| Giredestrant 30 mg | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Blood Urea Nitrogen - High | 3.1 Percentage of participants |
| Giredestrant 30 mg | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Chloride - Low | 3.2 Percentage of participants |
| Giredestrant 30 mg | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Magnesium - High | 0 Percentage of participants |
| Giredestrant 30 mg | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Potassium - High | 3.1 Percentage of participants |
| Giredestrant 30 mg | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | SGPT/ALT - High | 6.7 Percentage of participants |
| Giredestrant 30 mg | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Calcium - High | 3.1 Percentage of participants |
| Giredestrant 30 mg | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Bilirubin - High | 6.7 Percentage of participants |
| Giredestrant 30 mg | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Chloride - High | 9.4 Percentage of participants |
| Giredestrant 30 mg | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | SGOT/AST - High | 3.1 Percentage of participants |
| Giredestrant 30 mg | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Creatinine - High | 3.1 Percentage of participants |
| Giredestrant 30 mg | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Prothrombin Time - High | 3.0 Percentage of participants |
| Giredestrant 30 mg | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Carbon Dioxide - High | 25.0 Percentage of participants |
| Giredestrant 100 mg | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Albumin - High | 0 Percentage of participants |
| Giredestrant 100 mg | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Blood Urea Nitrogen - High | 0 Percentage of participants |
| Giredestrant 100 mg | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Sodium - Low | 0 Percentage of participants |
| Giredestrant 100 mg | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Bilirubin - High | 0 Percentage of participants |
| Giredestrant 100 mg | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Albumin - Low | 0 Percentage of participants |
| Giredestrant 100 mg | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Alkaline Phosphatase - High | 0 Percentage of participants |
| Giredestrant 100 mg | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | SGPT/ALT - High | 14.3 Percentage of participants |
| Giredestrant 100 mg | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | SGOT/AST - High | 14.3 Percentage of participants |
| Giredestrant 100 mg | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Bicarbonate HCO3 - Low | 0 Percentage of participants |
| Giredestrant 100 mg | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Bicarbonate HCO3 - High | 40.0 Percentage of participants |
| Giredestrant 100 mg | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Calcium - High | 0 Percentage of participants |
| Giredestrant 100 mg | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Carbon Dioxide - High | 0 Percentage of participants |
| Giredestrant 100 mg | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Chloride - Low | 12.5 Percentage of participants |
| Giredestrant 100 mg | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Chloride - High | 0 Percentage of participants |
| Giredestrant 100 mg | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Creatinine - High | 0 Percentage of participants |
| Giredestrant 100 mg | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Direct Bilirubin - Low | 0 Percentage of participants |
| Giredestrant 100 mg | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Direct Bilirubin - High | 0 Percentage of participants |
| Giredestrant 100 mg | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Glucose, Fasting - High | 0 Percentage of participants |
| Giredestrant 100 mg | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Glucose, Fasting Unknown - High | 33.3 Percentage of participants |
| Giredestrant 100 mg | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Magnesium - High | 12.5 Percentage of participants |
| Giredestrant 100 mg | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Phosphorus - Low | 0 Percentage of participants |
| Giredestrant 100 mg | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Phosphorus - High | 0 Percentage of participants |
| Giredestrant 100 mg | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Potassium - High | 0 Percentage of participants |
| Giredestrant 100 mg | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Protein, Total - Low | 0 Percentage of participants |
| Giredestrant 100 mg | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Protein, Total - High | 0 Percentage of participants |
| Giredestrant 100 mg | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Prothrombin Time - High | 0 Percentage of participants |
| Giredestrant 100 mg | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | International Normalized Ratio - High | 0 Percentage of participants |
| Giredestrant 100 mg | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Activated Partial Thromboplastin Time - Low | 11.8 Percentage of participants |
| All Participants, Efficacy: Giredestrant (10, 30, or 100 mg) | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Phosphorus - High | 2.0 Percentage of participants |
| All Participants, Efficacy: Giredestrant (10, 30, or 100 mg) | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Creatinine - High | 2.0 Percentage of participants |
| All Participants, Efficacy: Giredestrant (10, 30, or 100 mg) | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Chloride - High | 6.3 Percentage of participants |
| All Participants, Efficacy: Giredestrant (10, 30, or 100 mg) | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Activated Partial Thromboplastin Time - Low | 14.5 Percentage of participants |
| All Participants, Efficacy: Giredestrant (10, 30, or 100 mg) | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Potassium - High | 2.0 Percentage of participants |
| All Participants, Efficacy: Giredestrant (10, 30, or 100 mg) | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Chloride - Low | 6.1 Percentage of participants |
| All Participants, Efficacy: Giredestrant (10, 30, or 100 mg) | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Carbon Dioxide - High | 25.0 Percentage of participants |
| All Participants, Efficacy: Giredestrant (10, 30, or 100 mg) | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Sodium - Low | 2.0 Percentage of participants |
| All Participants, Efficacy: Giredestrant (10, 30, or 100 mg) | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Calcium - High | 2.0 Percentage of participants |
| All Participants, Efficacy: Giredestrant (10, 30, or 100 mg) | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Bilirubin - High | 4.2 Percentage of participants |
| All Participants, Efficacy: Giredestrant (10, 30, or 100 mg) | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Blood Urea Nitrogen - High | 4.1 Percentage of participants |
| All Participants, Efficacy: Giredestrant (10, 30, or 100 mg) | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Bicarbonate HCO3 - High | 15.6 Percentage of participants |
| All Participants, Efficacy: Giredestrant (10, 30, or 100 mg) | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | International Normalized Ratio - High | 1.4 Percentage of participants |
| All Participants, Efficacy: Giredestrant (10, 30, or 100 mg) | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Protein, Total - Low | 2.2 Percentage of participants |
| All Participants, Efficacy: Giredestrant (10, 30, or 100 mg) | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Bicarbonate HCO3 - Low | 2.0 Percentage of participants |
| All Participants, Efficacy: Giredestrant (10, 30, or 100 mg) | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Albumin - High | 2.1 Percentage of participants |
| All Participants, Efficacy: Giredestrant (10, 30, or 100 mg) | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Protein, Total - High | 2.0 Percentage of participants |
| All Participants, Efficacy: Giredestrant (10, 30, or 100 mg) | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | SGOT/AST - High | 4.2 Percentage of participants |
| All Participants, Efficacy: Giredestrant (10, 30, or 100 mg) | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Albumin - Low | 2.1 Percentage of participants |
| All Participants, Efficacy: Giredestrant (10, 30, or 100 mg) | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Prothrombin Time - High | 1.6 Percentage of participants |
| All Participants, Efficacy: Giredestrant (10, 30, or 100 mg) | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Magnesium - High | 2.0 Percentage of participants |
| All Participants, Efficacy: Giredestrant (10, 30, or 100 mg) | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Glucose, Fasting Unknown - High | 25.0 Percentage of participants |
| All Participants, Efficacy: Giredestrant (10, 30, or 100 mg) | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Glucose, Fasting - High | 19.2 Percentage of participants |
| All Participants, Efficacy: Giredestrant (10, 30, or 100 mg) | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | SGPT/ALT - High | 6.5 Percentage of participants |
| All Participants, Efficacy: Giredestrant (10, 30, or 100 mg) | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Phosphorus - Low | 2.0 Percentage of participants |
| All Participants, Efficacy: Giredestrant (10, 30, or 100 mg) | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Direct Bilirubin - High | 4.3 Percentage of participants |
| All Participants, Efficacy: Giredestrant (10, 30, or 100 mg) | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Direct Bilirubin - Low | 2.4 Percentage of participants |
| All Participants, Efficacy: Giredestrant (10, 30, or 100 mg) | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Alkaline Phosphatase - High | 2.3 Percentage of participants |
Secondary
Percentage of Participants With Laboratory Abnormalities in Hematology Tests During Treatment, Among Participants Without the Abnormality at Baseline
Laboratory parameters for hematology will be measured and compared with a standard reference range. Any of the laboratory test results that were outside of a parameter's normal reference range (in the specified direction - low or high) were considered abnormalities. Not every laboratory abnormality qualified as an adverse event (AE). A laboratory test result was reported as an AE if it met any of the following criteria: was accompanied by clinical symptoms; resulted in a change in study treatment; resulted in a medical intervention or a change in concomitant therapy; or was clinically significant in the investigator's judgment.
Time frame: Baseline, Days 1, 8, and 15
Population: Safety Evaluable Population: the number of participants analyzed includes all participants who received at least one dose of giredestrant. The number analyzed for a given laboratory parameter represents the number of participants without an abnormality (in the specified direction) at baseline for that parameter.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Giredestrant 10 mg | Percentage of Participants With Laboratory Abnormalities in Hematology Tests During Treatment, Among Participants Without the Abnormality at Baseline | Hemoglobin - Low | 10.0 Percentage of participants |
| Giredestrant 10 mg | Percentage of Participants With Laboratory Abnormalities in Hematology Tests During Treatment, Among Participants Without the Abnormality at Baseline | Hematocrit - High | 22.2 Percentage of participants |
| Giredestrant 10 mg | Percentage of Participants With Laboratory Abnormalities in Hematology Tests During Treatment, Among Participants Without the Abnormality at Baseline | Hematocrit - Low | 0 Percentage of participants |
| Giredestrant 10 mg | Percentage of Participants With Laboratory Abnormalities in Hematology Tests During Treatment, Among Participants Without the Abnormality at Baseline | Lymphocytes, Absolute Count (Abs) - Low | 0 Percentage of participants |
| Giredestrant 10 mg | Percentage of Participants With Laboratory Abnormalities in Hematology Tests During Treatment, Among Participants Without the Abnormality at Baseline | Hemoglobin - High | 0 Percentage of participants |
| Giredestrant 10 mg | Percentage of Participants With Laboratory Abnormalities in Hematology Tests During Treatment, Among Participants Without the Abnormality at Baseline | Total Leukocyte Count - Low | 0 Percentage of participants |
| Giredestrant 10 mg | Percentage of Participants With Laboratory Abnormalities in Hematology Tests During Treatment, Among Participants Without the Abnormality at Baseline | Erythrocytes - Low | 22.2 Percentage of participants |
| Giredestrant 10 mg | Percentage of Participants With Laboratory Abnormalities in Hematology Tests During Treatment, Among Participants Without the Abnormality at Baseline | Lymphocytes, Abs - High | 0 Percentage of participants |
| Giredestrant 10 mg | Percentage of Participants With Laboratory Abnormalities in Hematology Tests During Treatment, Among Participants Without the Abnormality at Baseline | Neutrophils, Total, Abs - Low | 0 Percentage of participants |
| Giredestrant 30 mg | Percentage of Participants With Laboratory Abnormalities in Hematology Tests During Treatment, Among Participants Without the Abnormality at Baseline | Hematocrit - High | 0 Percentage of participants |
| Giredestrant 30 mg | Percentage of Participants With Laboratory Abnormalities in Hematology Tests During Treatment, Among Participants Without the Abnormality at Baseline | Erythrocytes - Low | 6.7 Percentage of participants |
| Giredestrant 30 mg | Percentage of Participants With Laboratory Abnormalities in Hematology Tests During Treatment, Among Participants Without the Abnormality at Baseline | Total Leukocyte Count - Low | 3.1 Percentage of participants |
| Giredestrant 30 mg | Percentage of Participants With Laboratory Abnormalities in Hematology Tests During Treatment, Among Participants Without the Abnormality at Baseline | Hematocrit - Low | 3.2 Percentage of participants |
| Giredestrant 30 mg | Percentage of Participants With Laboratory Abnormalities in Hematology Tests During Treatment, Among Participants Without the Abnormality at Baseline | Hemoglobin - Low | 0 Percentage of participants |
| Giredestrant 30 mg | Percentage of Participants With Laboratory Abnormalities in Hematology Tests During Treatment, Among Participants Without the Abnormality at Baseline | Hemoglobin - High | 3.1 Percentage of participants |
| Giredestrant 30 mg | Percentage of Participants With Laboratory Abnormalities in Hematology Tests During Treatment, Among Participants Without the Abnormality at Baseline | Lymphocytes, Absolute Count (Abs) - Low | 3.1 Percentage of participants |
| Giredestrant 30 mg | Percentage of Participants With Laboratory Abnormalities in Hematology Tests During Treatment, Among Participants Without the Abnormality at Baseline | Lymphocytes, Abs - High | 3.2 Percentage of participants |
| Giredestrant 30 mg | Percentage of Participants With Laboratory Abnormalities in Hematology Tests During Treatment, Among Participants Without the Abnormality at Baseline | Neutrophils, Total, Abs - Low | 3.2 Percentage of participants |
| Giredestrant 100 mg | Percentage of Participants With Laboratory Abnormalities in Hematology Tests During Treatment, Among Participants Without the Abnormality at Baseline | Lymphocytes, Absolute Count (Abs) - Low | 0 Percentage of participants |
| Giredestrant 100 mg | Percentage of Participants With Laboratory Abnormalities in Hematology Tests During Treatment, Among Participants Without the Abnormality at Baseline | Hemoglobin - Low | 0 Percentage of participants |
| Giredestrant 100 mg | Percentage of Participants With Laboratory Abnormalities in Hematology Tests During Treatment, Among Participants Without the Abnormality at Baseline | Total Leukocyte Count - Low | 0 Percentage of participants |
| Giredestrant 100 mg | Percentage of Participants With Laboratory Abnormalities in Hematology Tests During Treatment, Among Participants Without the Abnormality at Baseline | Neutrophils, Total, Abs - Low | 0 Percentage of participants |
| Giredestrant 100 mg | Percentage of Participants With Laboratory Abnormalities in Hematology Tests During Treatment, Among Participants Without the Abnormality at Baseline | Lymphocytes, Abs - High | 12.5 Percentage of participants |
| Giredestrant 100 mg | Percentage of Participants With Laboratory Abnormalities in Hematology Tests During Treatment, Among Participants Without the Abnormality at Baseline | Hematocrit - High | 0 Percentage of participants |
| Giredestrant 100 mg | Percentage of Participants With Laboratory Abnormalities in Hematology Tests During Treatment, Among Participants Without the Abnormality at Baseline | Hemoglobin - High | 0 Percentage of participants |
| Giredestrant 100 mg | Percentage of Participants With Laboratory Abnormalities in Hematology Tests During Treatment, Among Participants Without the Abnormality at Baseline | Hematocrit - Low | 0 Percentage of participants |
| Giredestrant 100 mg | Percentage of Participants With Laboratory Abnormalities in Hematology Tests During Treatment, Among Participants Without the Abnormality at Baseline | Erythrocytes - Low | 0 Percentage of participants |
| All Participants, Efficacy: Giredestrant (10, 30, or 100 mg) | Percentage of Participants With Laboratory Abnormalities in Hematology Tests During Treatment, Among Participants Without the Abnormality at Baseline | Total Leukocyte Count - Low | 2.0 Percentage of participants |
| All Participants, Efficacy: Giredestrant (10, 30, or 100 mg) | Percentage of Participants With Laboratory Abnormalities in Hematology Tests During Treatment, Among Participants Without the Abnormality at Baseline | Hematocrit - Low | 2.0 Percentage of participants |
| All Participants, Efficacy: Giredestrant (10, 30, or 100 mg) | Percentage of Participants With Laboratory Abnormalities in Hematology Tests During Treatment, Among Participants Without the Abnormality at Baseline | Hematocrit - High | 4.3 Percentage of participants |
| All Participants, Efficacy: Giredestrant (10, 30, or 100 mg) | Percentage of Participants With Laboratory Abnormalities in Hematology Tests During Treatment, Among Participants Without the Abnormality at Baseline | Hemoglobin - Low | 2.0 Percentage of participants |
| All Participants, Efficacy: Giredestrant (10, 30, or 100 mg) | Percentage of Participants With Laboratory Abnormalities in Hematology Tests During Treatment, Among Participants Without the Abnormality at Baseline | Lymphocytes, Absolute Count (Abs) - Low | 2.0 Percentage of participants |
| All Participants, Efficacy: Giredestrant (10, 30, or 100 mg) | Percentage of Participants With Laboratory Abnormalities in Hematology Tests During Treatment, Among Participants Without the Abnormality at Baseline | Lymphocytes, Abs - High | 4.1 Percentage of participants |
| All Participants, Efficacy: Giredestrant (10, 30, or 100 mg) | Percentage of Participants With Laboratory Abnormalities in Hematology Tests During Treatment, Among Participants Without the Abnormality at Baseline | Neutrophils, Total, Abs - Low | 2.0 Percentage of participants |
| All Participants, Efficacy: Giredestrant (10, 30, or 100 mg) | Percentage of Participants With Laboratory Abnormalities in Hematology Tests During Treatment, Among Participants Without the Abnormality at Baseline | Erythrocytes - Low | 8.5 Percentage of participants |
| All Participants, Efficacy: Giredestrant (10, 30, or 100 mg) | Percentage of Participants With Laboratory Abnormalities in Hematology Tests During Treatment, Among Participants Without the Abnormality at Baseline | Hemoglobin - High | 2.0 Percentage of participants |
Secondary
Plasma Concentration of Giredestrant at Steady State by Dose Level
Plasma samples were obtained on the day of surgery (Day 15), or prior to biopsy on Day 14.
Time frame: Predose on day of surgery (Day 15), or prior to biopsy (Day 14)
Population: The Pharmacokinetics Analysis Population consisted of all participants who received at least one dose of giredestrant and had a measurable concentration at the specific timepoint collected.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Giredestrant 10 mg | Plasma Concentration of Giredestrant at Steady State by Dose Level | 58.8 nanograms per millilitre (ng/mL) | Geometric Coefficient of Variation 58.1 |
| Giredestrant 30 mg | Plasma Concentration of Giredestrant at Steady State by Dose Level | 130 nanograms per millilitre (ng/mL) | Geometric Coefficient of Variation 59.1 |
| Giredestrant 100 mg | Plasma Concentration of Giredestrant at Steady State by Dose Level | 441 nanograms per millilitre (ng/mL) | Geometric Coefficient of Variation 71.2 |