Early Breast Cancer
Conditions
Keywords
Estrogen receptor positive, ER+, Human epidermal growth factor receptor 2 negative, HER2-
Brief summary
The purpose of this study is to understand treatment adherence and patient-reported outcomes of switching to giredestrant due to prior aromatase inhibitor (AI) intolerance. Giredestrant will be administered as adjuvant endocrine therapy for participants with low-, medium-, and high-risk, Stage I-III, histologically confirmed, estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-), early breast cancer (eBC), as defined by the investigator. Participants will enroll if considered to be intolerant to a prior adjuvant AI therapy.
Interventions
DRUGGiredestrant
Participants will receive giredestrant at a dose of 30 mg orally once daily on Days 1-28 of each 28-day cycle for up to 4.5 years or until disease recurrence or unacceptable toxicity (whichever occurs first).
Sponsors
Genentech, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Considered appropriate for treatment with endocrine therapy (ET) * Histologically confirmed diagnosis of ER+/HER2-, Stage I-III (low-/medium-/high-risk) early breast cancer (eBC) * Documented ER+ tumor according to American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP), defined as ≥1% of tumor cells stained positive * Documented HER2- tumor according to ASCO/CAP * Postmenopausal females at the time of signing the Informed Consent Form * Documented use of a prior adjuvant aromatase inhibitor (AI) (i.e., anastrozole, exemestane, or letrozole) for a total of ≥6 months * Documented use of an adjuvant AI (i.e., anastrozole, exemestane, or letrozole) for the consecutive ≥3 months immediately prior to consent * Participant and investigator agree that current symptoms on AI are intolerable and warrant a switch in therapy to attempt sustained treatment * Documented Grade 2 or 3 adverse events, per NCI CTCAE v6.0, determined by the investigator to be associated with AI therapy's intolerance * Participant and investigator planning the first switch from an AI * Has completed the following: (neo)adjuvant chemotherapy (if administered), definitive surgery of primary breast tumor(s) and/or axillary lymph nodes dissection (ALND) and/or sentinel lymph node biopsy (SLNB) and/or radiotherapy * Eastern Cooperative Oncology Group Performance (ECOG) Performance Status 0 or 1
Exclusion criteria
* Participation within 6 months before enrollment in any other clinical study involving an investigational adjuvant treatment including anti-cancer agents * Diagnosis of rheumatoid arthritis, psoriatic arthritis, or other inflammatory connective tissue disease * Any prior fulvestrant or any oral selective estrogen receptor degraders (SERDs) * Have active cardiac disease or history of cardiac dysfunction * Have clinically significant liver disease consistent with Child-Pugh Class B or C, including active hepatitis (e.g., hepatitis B virus \[HBV\] or hepatitis C virus \[HCV\]), current alcohol abuse, cirrhosis, or positive test for viral hepatitis * Treatment with strong CYP3A inhibitors or inducers within 14 days or 5 drug elimination half-lives (whichever is longer) prior to initiation of study treatment * Have had any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes an individual's safe participation in and completion of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Participants Who Have Discontinued Giredestrant for Any Reason at 12 Months | At 12 months |
| Incidence and Severity of Adverse Events, with Severity Determined According to the National Cancer Institute Common Terminology Criteria of Adverse Events, version 6.0 (NCI CTCAE v6.0) | From baseline until 28 days after the final dose of study drug (up to 4 years, 7 months) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving an Improvement in Individual Endocrine Therapy-specific Symptoms at 6 and 12 Months, Using the FACT-ES Questionnaire | Baseline, 6 and 12 months | An improvement in individual endocrine therapy-specific symptoms (joint pain, hot flashes, vaginal dryness, and sexual dysfunction) is defined as ≥1-point/shift increase from baseline in the respective Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES) questionnaire items. |
| Percentage of Participants Categorized as Improved, Stable, or Worsening in Endocrine Therapy-specific Symptom Burden at 6 and 12 Months, Using the FACT-ES Questionnaire | Baseline, 6 and 12 months | Categories are defined by a change from baseline in the Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES) questionnaire Additional Concerns subscale score using a minimal important difference (MID) threshold of ±3 points. |
| Percentage of Participants Categorized as Improved, Stable, or Worsened in Pain-related Burden at 6 and 12 Months, Using the BPI-SF Questionnaire | Baseline, 6 and 12 months | Categories are defined by a change from baseline in the Brief Pain Inventory-Short Form (BPI-SF) Pain Severity composite score (minimal important difference \[MID\] of ±2 points) and the BPI-SF Pain Interference composite score (MID of ±1 point). |
| Percentage of Participants Achieving an Improvement in Global Treatment Bother at 6 and 12 Months, Using the FACT-ES Questionnaire's GP5 Item | Baseline, 6 and 12 months | An improvement is defined as a ≥1-point increase from baseline in the Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES) GP5 item ('I am bothered by side-effects of treatment'). |
| Percentage of Participants Categorized as Improved, Stable, or Worsened in Domain-specific Physical Well-Being at 6 and 12 Months, Using the FACT-ES Questionnaire | Baseline, 6 and 12 months | Categories are defined by a change from baseline in the respective Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES) Physical Well-Being subscale scores using a minimal important difference (MID) threshold of ±2 points. |
| Percentage of Participants Categorized as Improved, Stable, or Worsened in Domain-specific Functional Well-Being at 6 and 12 Months, Using the FACT-ES Questionnaire | Baseline, 6 and 12 months | Categories are defined by a change from baseline in the respective Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES) Functional Well-Being subscale scores using a minimal important difference (MID) threshold of ±2 points. |
| Percentage of Participants Categorized as Improved, Stable, or Worsened in Global Health-Related Quality of Life (HRQoL) at 6 and 12 Months, Using the FACT-ES Questionnaire | Baseline, 6 and 12 months | Categories are defined by a change from baseline in the Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES) Total Score using a minimal important difference (MID) threshold of ±7 points. |
Contacts
CONTACTReference Study ID Number: GO46747 https://forpatients.roche.com/
STUDY_DIRECTORClinical Trials
Genentech, Inc.
Outcome results
None listed