Breast Cancer, Breast Carcinoma, Cancer of Breast
Conditions
Brief summary
The investigators propose to influence estrogen receptor (ER) signaling by combining endocrine therapy with CDK4/6 inhibition along with trastuzumab in ER+/ human epidermal growth factor receptor 2 (HER2)+ early stage breast cancer.
Interventions
DRUGPalbociclib
Palbociclib is an oral drug given at a dose of 125 mg daily on Days 1-21 of each 28-day cycle for a total of 4 cycles.
DRUGLetrozole
Letrozole is an oral drug given at a dose of 2.5 mg orally once a day. It will be taken continuously (Days 1-28 of each cycle) until the day of definitive surgery.
BIOLOGICALTrastuzumab
* Or FDA approved biosimilar * Trastuzumab will be administered on a weekly basis for 16 weeks (on Days 1, 8, 15, and 22 of each 28-day cycle for a total of 4 cycles). The first dose of trastuzumab on Cycle 1 Day 1 will be a loading dose of 4 mg/kg IVPB over 90 minutes. Subsequent doses of trastuzumab will be 2 mg/kg IVPB over 30 minutes. Weekly trastuzumab will continue after the completion of Cycle 4 of palbociclib until surgery.
DRUGGoserelin
Goserelin is given subcutaneously at a dose of 3.6 mg on Day 1 of each cycle. Goserelin will be continued (once every 28-days) after the completion of Cycle 4 of palbociclib if required.
PROCEDUREBreast surgery
Standard of care
PROCEDUREResearch tumor biopsy
Baseline, cycle 1 day 15, and surgery
PROCEDUREResearch bone marrow (OPTIONAL)
Baseline and surgery
PROCEDUREResearch blood sample
Baseline, cycle 1 day 15, surgery, and yearly post-surgery for 5 years
GENETICResearch blood for germline DNA
Baseline
PROCEDUREBlood for detection of circulating tumor cells
Baseline
Sponsors
Pfizer
Rising Tide Foundation
Washington University School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Newly diagnosed clinical stage II or III ER+/HER2+ breast cancer with complete surgical excision of the breast cancer after neoadjuvant therapy as the treatment goal, staging criteria is to be based on AJCC 7. * Tumor size at least 2 cm in one dimension by clinical or radiographic exam (World Health Organization (WHO) criteria). Patients with histologically confirmed palpable lymph nodes may be enrolled regardless of breast tumor size. A palpable mass is not required as long as the mass is at least 2 cm in one dimension by radiographic exam. * At least 18 years of age. * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 * Normal bone marrow and organ function as defined below: * Leukocytes ≥ 3,000/mcL * Absolute neutrophil count ≥ 1,500/mcl * Platelets ≥ 100,000/mcl * Total bilirubin ≤ institutional upper limit of normal (IULN) * AST(SGOT)/ALT(SGPT) ≤ 2.5 x IULN * Creatinine ≤ IULN OR creatinine clearance ≥ 60 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal * Left ventricular ejection fraction (LVEF) ≥ 50% by transthoracic echocardiogram or multigated acquisition scan (MUGA) * Baseline corrected QT interval (QTcF) \< 480 ms * Women of childbearing potential must agree to undergo pregnancy testing within 14 days of study entry and agree to use adequate contraception (barrier method of birth control, abstinence, not hormonal) prior to study entry and for the duration of study participation as well as chemical LHRH Agonist with goserelin. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. * Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).
Exclusion criteria
* Prior systemic therapy for indexed breast cancer. * Indeterminate or negative HER2 status. * Inflammatory breast cancer. * A history of other malignancy ≤ 5 years from diagnosis of indexed BC with the exception of basal cell or squamous cell carcinoma of the skin treated with local resection only or carcinoma in situ of the cervix. * Currently receiving any other investigational agents or received any within the past 28 days. * Know to be HIV positive. * Known hepatitis B or C infection. * A history of allergic reactions attributed to compounds of similar chemical or biologic composition to palbociclib, letrozole, trastuzumab, any other aromatase inhibitor, any other monoclonal antibody, or other agents used in the study. * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia. * Current use or anticipated need for food or drugs that are known strong CYP3A4 inhibitors (i.e., grapefruit juice, verapamil, ketoconazole, miconazole, itraconazole, posaconazole, erythromycin, clarithromycin, telithromycin, indinavir, saquinavir, ritonavir, nelfinavir, lopinavir, atazanavir, amprenavir, fosamprenavir, nefazodone, diltiazem, and delavirdine) or inducers (i.e. dexamethasone, glucocorticoids, progesterone, rifampin, phenobarbital, St. John's wort). * Any condition that impairs the ability to swallow or absorb oral medication (e.g., gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affective absorption). * Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Pathologic Complete Response (pCR) | Completion of 4 cycles of treatment (approximately 16 weeks) | A pathologic complete response (pCR) is defined as no histology evidence of invasive tumor cells in the surgical breast specimen and sentinel or axillary lymph nodes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability of Palbociclib in Combination With Neoadjuvant Letrozole and Trastuzumab (or FDA Approved Biosimilar) as Measured by Number of Participants With Grade 3 & 4 Adverse Events | 30 days after completion of neoadjuvant therapy (approximately 21 weeks) | -The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting. |
| Change in Patient Reported Outcomes as Measured by NCI PRO-CTCAE | Baseline, cycle 2 day 1 (approximately 29 days), and end of cycle 4 (approximately 16 weeks) | * Answers ranging from None to Very Severe (none=0 to very severe=4); Not at All to Very Much (not at all=0 to very much=4), Never to Almost Constantly (0=never to almost constantly=4) * PRO-CTCAE responses are scored from 0 to 4, and there are no standardized scoring rules yet established for how to combine attributes into a single score or how best to analyze PRO-CTCAE data longitudinally. * PRO-CTCAE scores for each attribute (frequency, severity and/or interference) will be presented descriptively |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Palbociclib + Letrozole + Trastuzumab +/- Goserelin * Neoadjuvant palbociclib + letrozole (plus goserelin if premenopausal) + trastuzumab for a total of 16 weeks, consisting of (4) 28-day cycles
* Definitive surgery will be performed preferably within 6 weeks after the end of Cycle 4. Letrozole and trastuzumab will continue until the day of surgery. Letrozole will continue to be taken daily and trastuzumab will be given every 3 weeks per standard of care guidelines. Adjuvant therapy following definitive surgery will be at the discretion of the treating physician | 26 |
| Total | 26 |
Baseline characteristics
| Characteristic | Palbociclib + Letrozole + Trastuzumab +/- Goserelin |
|---|---|
| Age, Continuous | 59 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 26 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 24 Participants |
| Region of Enrollment United States | 26 participants |
| Sex: Female, Male Female | 26 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 26 |
| other Total, other adverse events | 26 / 26 |
| serious Total, serious adverse events | 2 / 26 |
Outcome results
Primary
Number of Participants With Pathologic Complete Response (pCR)
A pathologic complete response (pCR) is defined as no histology evidence of invasive tumor cells in the surgical breast specimen and sentinel or axillary lymph nodes.
Time frame: Completion of 4 cycles of treatment (approximately 16 weeks)
Population: One participant is not evaluable for this outcome measure because the participant experienced progressive disease after completion of treatment but prior to surgery.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Palbociclib + Letrozole + Trastuzumab +/- Goserelin | Number of Participants With Pathologic Complete Response (pCR) | 2 Participants |
Secondary
Change in Patient Reported Outcomes as Measured by NCI PRO-CTCAE
* Answers ranging from None to Very Severe (none=0 to very severe=4); Not at All to Very Much (not at all=0 to very much=4), Never to Almost Constantly (0=never to almost constantly=4) * PRO-CTCAE responses are scored from 0 to 4, and there are no standardized scoring rules yet established for how to combine attributes into a single score or how best to analyze PRO-CTCAE data longitudinally. * PRO-CTCAE scores for each attribute (frequency, severity and/or interference) will be presented descriptively
Time frame: Baseline, cycle 2 day 1 (approximately 29 days), and end of cycle 4 (approximately 16 weeks)
Population: 3 participants at the end of cycle 4 did not complete the questionnaire.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Palbociclib + Letrozole + Trastuzumab +/- Goserelin | Change in Patient Reported Outcomes as Measured by NCI PRO-CTCAE | In the last 7 days, did you have any hair loss? | 1.0769231 score on a scale | Standard Deviation 0.2717465 |
| Palbociclib + Letrozole + Trastuzumab +/- Goserelin | Change in Patient Reported Outcomes as Measured by NCI PRO-CTCAE | In the last 7 days, how much did decreased appetite interfere with your usual or daily activities? | 1.0769231 score on a scale | Standard Deviation 0.8448942 |
| Palbociclib + Letrozole + Trastuzumab +/- Goserelin | Change in Patient Reported Outcomes as Measured by NCI PRO-CTCAE | In the last 7 days, what was the severity of your arm or leg swelling at its worst? | 0.8846154 score on a scale | Standard Deviation 0.3258126 |
| Palbociclib + Letrozole + Trastuzumab +/- Goserelin | Change in Patient Reported Outcomes as Measured by NCI PRO-CTCAE | In the last 7 days, how often did you feel a pounding or racing heartbeat (palpitations)? | 1.1538462 score on a scale | Standard Deviation 0.4640955 |
| Palbociclib + Letrozole + Trastuzumab +/- Goserelin | Change in Patient Reported Outcomes as Measured by NCI PRO-CTCAE | In the last 7 days, how often did you have nausea? | 1.2307692 score on a scale | Standard Deviation 0.5870395 |
| Palbociclib + Letrozole + Trastuzumab +/- Goserelin | Change in Patient Reported Outcomes as Measured by NCI PRO-CTCAE | In the last 7 days, what was the severity of your dry skin at its worst? | 1.3076923 score on a scale | Standard Deviation 0.5491252 |
| Palbociclib + Letrozole + Trastuzumab +/- Goserelin | Change in Patient Reported Outcomes as Measured by NCI PRO-CTCAE | In the last 7 days, how much did your cough interfere with your usual and daily activities? | 1.0000000 score on a scale | Standard Deviation 0.2828427 |
| Palbociclib + Letrozole + Trastuzumab +/- Goserelin | Change in Patient Reported Outcomes as Measured by NCI PRO-CTCAE | In the last 7 days, what was the severity of your nausea at its worst? | 1.1923077 score on a scale | Standard Deviation 0.800961 |
| Palbociclib + Letrozole + Trastuzumab +/- Goserelin | Change in Patient Reported Outcomes as Measured by NCI PRO-CTCAE | In the last 7 days, what was the severity of your problems with concentration at their worst? | 1.1923077 score on a scale | Standard Deviation 0.4914656 |
| Palbociclib + Letrozole + Trastuzumab +/- Goserelin | Change in Patient Reported Outcomes as Measured by NCI PRO-CTCAE | In the last 7 days, did you have any rash? | 1.8461538 score on a scale | Standard Deviation 0.3679465 |
| Palbociclib + Letrozole + Trastuzumab +/- Goserelin | Change in Patient Reported Outcomes as Measured by NCI PRO-CTCAE | In the last 7 days, what was the severity of your shortness of breath (SOB) at its worst? | 1.1923077 score on a scale | Standard Deviation 0.5670436 |
| Palbociclib + Letrozole + Trastuzumab +/- Goserelin | Change in Patient Reported Outcomes as Measured by NCI PRO-CTCAE | In the past 7 days, how much did problems with concentration interfere with usual/daily activities? | 1.1538462 score on a scale | Standard Deviation 0.543493 |
| Palbociclib + Letrozole + Trastuzumab +/- Goserelin | Change in Patient Reported Outcomes as Measured by NCI PRO-CTCAE | In the last 7 days, how much did arm or leg swelling interfere with your usual or daily activities? | 0.9230769 score on a scale | Standard Deviation 0.2717465 |
| Palbociclib + Letrozole + Trastuzumab +/- Goserelin | Change in Patient Reported Outcomes as Measured by NCI PRO-CTCAE | In the last 7 days, how much did your SOB interfere with your usual or daily activities? | 0.9615385 score on a scale | Standard Deviation 0.4454902 |
| Palbociclib + Letrozole + Trastuzumab +/- Goserelin | Change in Patient Reported Outcomes as Measured by NCI PRO-CTCAE | In the last 7 days, what was the severity of your cough at its worst? | 1.1923077 score on a scale | Standard Deviation 0.4019185 |
| Palbociclib + Letrozole + Trastuzumab +/- Goserelin | Change in Patient Reported Outcomes as Measured by NCI PRO-CTCAE | In the last 7 days, what was the severity of your decreased appetite at its worst? | 1.3461538 score on a scale | Standard Deviation 0.8918434 |
| Palbociclib + Letrozole + Trastuzumab +/- Goserelin | Change in Patient Reported Outcomes as Measured by NCI PRO-CTCAE | In the last 7 days, what was the severity of your pounding or racing heartbeat at its worst? | 1.0384615 score on a scale | Standard Deviation 0.4454902 |
| Palbociclib + Letrozole + Trastuzumab +/- Goserelin | Change in Patient Reported Outcomes as Measured by NCI PRO-CTCAE | In the last 7 days, how often did you have arm or leg swelling? | 1.0000000 score on a scale | Standard Deviation 0 |
| Cycle 2 Day 1: Palbociclib + Letrozole + Trastuzumab +/- Goserelin | Change in Patient Reported Outcomes as Measured by NCI PRO-CTCAE | In the last 7 days, what was the severity of your problems with concentration at their worst? | 1.5000000 score on a scale | Standard Deviation 0.8602325 |
| Cycle 2 Day 1: Palbociclib + Letrozole + Trastuzumab +/- Goserelin | Change in Patient Reported Outcomes as Measured by NCI PRO-CTCAE | In the last 7 days, what was the severity of your pounding or racing heartbeat at its worst? | 1.1923077 score on a scale | Standard Deviation 0.6939297 |
| Cycle 2 Day 1: Palbociclib + Letrozole + Trastuzumab +/- Goserelin | Change in Patient Reported Outcomes as Measured by NCI PRO-CTCAE | In the last 7 days, what was the severity of your arm or leg swelling at its worst? | 1.0384615 score on a scale | Standard Deviation 0.5276946 |
| Cycle 2 Day 1: Palbociclib + Letrozole + Trastuzumab +/- Goserelin | Change in Patient Reported Outcomes as Measured by NCI PRO-CTCAE | In the last 7 days, what was the severity of your dry skin at its worst? | 1.6923077 score on a scale | Standard Deviation 0.8375789 |
| Cycle 2 Day 1: Palbociclib + Letrozole + Trastuzumab +/- Goserelin | Change in Patient Reported Outcomes as Measured by NCI PRO-CTCAE | In the last 7 days, how often did you feel a pounding or racing heartbeat (palpitations)? | 1.1923077 score on a scale | Standard Deviation 0.5670436 |
| Cycle 2 Day 1: Palbociclib + Letrozole + Trastuzumab +/- Goserelin | Change in Patient Reported Outcomes as Measured by NCI PRO-CTCAE | In the last 7 days, did you have any rash? | 1.6153846 score on a scale | Standard Deviation 0.5710988 |
| Cycle 2 Day 1: Palbociclib + Letrozole + Trastuzumab +/- Goserelin | Change in Patient Reported Outcomes as Measured by NCI PRO-CTCAE | In the last 7 days, did you have any hair loss? | 1.1153846 score on a scale | Standard Deviation 0.4314555 |
| Cycle 2 Day 1: Palbociclib + Letrozole + Trastuzumab +/- Goserelin | Change in Patient Reported Outcomes as Measured by NCI PRO-CTCAE | In the last 7 days, what was the severity of your cough at its worst? | 1.2307692 score on a scale | Standard Deviation 0.5870395 |
| Cycle 2 Day 1: Palbociclib + Letrozole + Trastuzumab +/- Goserelin | Change in Patient Reported Outcomes as Measured by NCI PRO-CTCAE | In the past 7 days, how much did problems with concentration interfere with usual/daily activities? | 1.3076923 score on a scale | Standard Deviation 0.6793662 |
| Cycle 2 Day 1: Palbociclib + Letrozole + Trastuzumab +/- Goserelin | Change in Patient Reported Outcomes as Measured by NCI PRO-CTCAE | In the last 7 days, how often did you have arm or leg swelling? | 1.0384615 score on a scale | Standard Deviation 0.3441824 |
| Cycle 2 Day 1: Palbociclib + Letrozole + Trastuzumab +/- Goserelin | Change in Patient Reported Outcomes as Measured by NCI PRO-CTCAE | In the last 7 days, how much did decreased appetite interfere with your usual or daily activities? | 0.9615385 score on a scale | Standard Deviation 0.3441824 |
| Cycle 2 Day 1: Palbociclib + Letrozole + Trastuzumab +/- Goserelin | Change in Patient Reported Outcomes as Measured by NCI PRO-CTCAE | In the last 7 days, what was the severity of your decreased appetite at its worst? | 1.3461538 score on a scale | Standard Deviation 0.6894814 |
| Cycle 2 Day 1: Palbociclib + Letrozole + Trastuzumab +/- Goserelin | Change in Patient Reported Outcomes as Measured by NCI PRO-CTCAE | In the last 7 days, how often did you have nausea? | 1.5000000 score on a scale | Standard Deviation 0.9899495 |
| Cycle 2 Day 1: Palbociclib + Letrozole + Trastuzumab +/- Goserelin | Change in Patient Reported Outcomes as Measured by NCI PRO-CTCAE | In the last 7 days, what was the severity of your nausea at its worst? | 1.4230769 score on a scale | Standard Deviation 0.8566482 |
| Cycle 2 Day 1: Palbociclib + Letrozole + Trastuzumab +/- Goserelin | Change in Patient Reported Outcomes as Measured by NCI PRO-CTCAE | In the last 7 days, how much did your cough interfere with your usual and daily activities? | 1.0384615 score on a scale | Standard Deviation 0.5276946 |
| Cycle 2 Day 1: Palbociclib + Letrozole + Trastuzumab +/- Goserelin | Change in Patient Reported Outcomes as Measured by NCI PRO-CTCAE | In the last 7 days, what was the severity of your shortness of breath (SOB) at its worst? | 1.1153846 score on a scale | Standard Deviation 0.515901 |
| Cycle 2 Day 1: Palbociclib + Letrozole + Trastuzumab +/- Goserelin | Change in Patient Reported Outcomes as Measured by NCI PRO-CTCAE | In the last 7 days, how much did your SOB interfere with your usual or daily activities? | 1.0384615 score on a scale | Standard Deviation 0.4454902 |
| Cycle 2 Day 1: Palbociclib + Letrozole + Trastuzumab +/- Goserelin | Change in Patient Reported Outcomes as Measured by NCI PRO-CTCAE | In the last 7 days, how much did arm or leg swelling interfere with your usual or daily activities? | 0.8846154 score on a scale | Standard Deviation 0.3258126 |
| End of Cycle 4: Palbociclib + Letrozole + Trastuzumab +/- Goserelin | Change in Patient Reported Outcomes as Measured by NCI PRO-CTCAE | In the past 7 days, how much did problems with concentration interfere with usual/daily activities? | 1.3478261 score on a scale | Standard Deviation 0.9820524 |
| End of Cycle 4: Palbociclib + Letrozole + Trastuzumab +/- Goserelin | Change in Patient Reported Outcomes as Measured by NCI PRO-CTCAE | In the last 7 days, what was the severity of your decreased appetite at its worst? | 1.3043478 score on a scale | Standard Deviation 0.8756703 |
| End of Cycle 4: Palbociclib + Letrozole + Trastuzumab +/- Goserelin | Change in Patient Reported Outcomes as Measured by NCI PRO-CTCAE | In the last 7 days, what was the severity of your cough at its worst? | 1.5217391 score on a scale | Standard Deviation 1.0816471 |
| End of Cycle 4: Palbociclib + Letrozole + Trastuzumab +/- Goserelin | Change in Patient Reported Outcomes as Measured by NCI PRO-CTCAE | In the last 7 days, what was the severity of your dry skin at its worst? | 1.5652174 score on a scale | Standard Deviation 0.7277666 |
| End of Cycle 4: Palbociclib + Letrozole + Trastuzumab +/- Goserelin | Change in Patient Reported Outcomes as Measured by NCI PRO-CTCAE | In the last 7 days, did you have any hair loss? | 1.6086957 score on a scale | Standard Deviation 0.8913284 |
| End of Cycle 4: Palbociclib + Letrozole + Trastuzumab +/- Goserelin | Change in Patient Reported Outcomes as Measured by NCI PRO-CTCAE | In the last 7 days, how much did decreased appetite interfere with your usual or daily activities? | 1.0434783 score on a scale | Standard Deviation 0.3665888 |
| End of Cycle 4: Palbociclib + Letrozole + Trastuzumab +/- Goserelin | Change in Patient Reported Outcomes as Measured by NCI PRO-CTCAE | In the last 7 days, how often did you have nausea? | 1.2608696 score on a scale | Standard Deviation 0.5408236 |
| End of Cycle 4: Palbociclib + Letrozole + Trastuzumab +/- Goserelin | Change in Patient Reported Outcomes as Measured by NCI PRO-CTCAE | In the last 7 days, what was the severity of your nausea at its worst? | 1.2173913 score on a scale | Standard Deviation 0.6712622 |
| End of Cycle 4: Palbociclib + Letrozole + Trastuzumab +/- Goserelin | Change in Patient Reported Outcomes as Measured by NCI PRO-CTCAE | In the last 7 days, what was the severity of your shortness of breath (SOB) at its worst? | 1.4347826 score on a scale | Standard Deviation 0.8957519 |
| End of Cycle 4: Palbociclib + Letrozole + Trastuzumab +/- Goserelin | Change in Patient Reported Outcomes as Measured by NCI PRO-CTCAE | In the last 7 days, how much did your SOB interfere with your usual or daily activities? | 1.173913 score on a scale | Standard Deviation 0.6503268 |
| End of Cycle 4: Palbociclib + Letrozole + Trastuzumab +/- Goserelin | Change in Patient Reported Outcomes as Measured by NCI PRO-CTCAE | In the last 7 days, how much did your cough interfere with your usual and daily activities? | 1.3043478 score on a scale | Standard Deviation 0.9739695 |
| End of Cycle 4: Palbociclib + Letrozole + Trastuzumab +/- Goserelin | Change in Patient Reported Outcomes as Measured by NCI PRO-CTCAE | In the last 7 days, how often did you have arm or leg swelling? | 1.2608696 score on a scale | Standard Deviation 0.9153832 |
| End of Cycle 4: Palbociclib + Letrozole + Trastuzumab +/- Goserelin | Change in Patient Reported Outcomes as Measured by NCI PRO-CTCAE | In the last 7 days, what was the severity of your arm or leg swelling at its worst? | 1.1304348 score on a scale | Standard Deviation 0.4576966 |
| End of Cycle 4: Palbociclib + Letrozole + Trastuzumab +/- Goserelin | Change in Patient Reported Outcomes as Measured by NCI PRO-CTCAE | In the last 7 days, how much did arm or leg swelling interfere with your usual or daily activities? | 1.0434783 score on a scale | Standard Deviation 0.474654 |
| End of Cycle 4: Palbociclib + Letrozole + Trastuzumab +/- Goserelin | Change in Patient Reported Outcomes as Measured by NCI PRO-CTCAE | In the last 7 days, how often did you feel a pounding or racing heartbeat (palpitations)? | 1.173913 score on a scale | Standard Deviation 0.4910262 |
| End of Cycle 4: Palbociclib + Letrozole + Trastuzumab +/- Goserelin | Change in Patient Reported Outcomes as Measured by NCI PRO-CTCAE | In the last 7 days, what was the severity of your pounding or racing heartbeat at its worst? | 1.1304348 score on a scale | Standard Deviation 0.5480833 |
| End of Cycle 4: Palbociclib + Letrozole + Trastuzumab +/- Goserelin | Change in Patient Reported Outcomes as Measured by NCI PRO-CTCAE | In the last 7 days, did you have any rash? | 1.826087 score on a scale | Standard Deviation 0.3875534 |
| End of Cycle 4: Palbociclib + Letrozole + Trastuzumab +/- Goserelin | Change in Patient Reported Outcomes as Measured by NCI PRO-CTCAE | In the last 7 days, what was the severity of your problems with concentration at their worst? | 1.4782609 score on a scale | Standard Deviation 0.7902569 |
Secondary
Safety and Tolerability of Palbociclib in Combination With Neoadjuvant Letrozole and Trastuzumab (or FDA Approved Biosimilar) as Measured by Number of Participants With Grade 3 & 4 Adverse Events
-The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.
Time frame: 30 days after completion of neoadjuvant therapy (approximately 21 weeks)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Palbociclib + Letrozole + Trastuzumab +/- Goserelin | Safety and Tolerability of Palbociclib in Combination With Neoadjuvant Letrozole and Trastuzumab (or FDA Approved Biosimilar) as Measured by Number of Participants With Grade 3 & 4 Adverse Events | Pulmonary edema | 1 Participants |
| Palbociclib + Letrozole + Trastuzumab +/- Goserelin | Safety and Tolerability of Palbociclib in Combination With Neoadjuvant Letrozole and Trastuzumab (or FDA Approved Biosimilar) as Measured by Number of Participants With Grade 3 & 4 Adverse Events | Ventricular tachycardia | 1 Participants |
| Palbociclib + Letrozole + Trastuzumab +/- Goserelin | Safety and Tolerability of Palbociclib in Combination With Neoadjuvant Letrozole and Trastuzumab (or FDA Approved Biosimilar) as Measured by Number of Participants With Grade 3 & 4 Adverse Events | Alanine aminotransferase increased | 1 Participants |
| Palbociclib + Letrozole + Trastuzumab +/- Goserelin | Safety and Tolerability of Palbociclib in Combination With Neoadjuvant Letrozole and Trastuzumab (or FDA Approved Biosimilar) as Measured by Number of Participants With Grade 3 & 4 Adverse Events | Aspartate aminotransferase increased | 1 Participants |
| Palbociclib + Letrozole + Trastuzumab +/- Goserelin | Safety and Tolerability of Palbociclib in Combination With Neoadjuvant Letrozole and Trastuzumab (or FDA Approved Biosimilar) as Measured by Number of Participants With Grade 3 & 4 Adverse Events | Colonic obstruction | 1 Participants |
| Palbociclib + Letrozole + Trastuzumab +/- Goserelin | Safety and Tolerability of Palbociclib in Combination With Neoadjuvant Letrozole and Trastuzumab (or FDA Approved Biosimilar) as Measured by Number of Participants With Grade 3 & 4 Adverse Events | Neutrophil count decreased | 13 Participants |
| Palbociclib + Letrozole + Trastuzumab +/- Goserelin | Safety and Tolerability of Palbociclib in Combination With Neoadjuvant Letrozole and Trastuzumab (or FDA Approved Biosimilar) as Measured by Number of Participants With Grade 3 & 4 Adverse Events | Lymphocyte count decreased | 1 Participants |
| Palbociclib + Letrozole + Trastuzumab +/- Goserelin | Safety and Tolerability of Palbociclib in Combination With Neoadjuvant Letrozole and Trastuzumab (or FDA Approved Biosimilar) as Measured by Number of Participants With Grade 3 & 4 Adverse Events | Hypertension | 8 Participants |
| Palbociclib + Letrozole + Trastuzumab +/- Goserelin | Safety and Tolerability of Palbociclib in Combination With Neoadjuvant Letrozole and Trastuzumab (or FDA Approved Biosimilar) as Measured by Number of Participants With Grade 3 & 4 Adverse Events | White blood cell decreased | 2 Participants |
| Palbociclib + Letrozole + Trastuzumab +/- Goserelin | Safety and Tolerability of Palbociclib in Combination With Neoadjuvant Letrozole and Trastuzumab (or FDA Approved Biosimilar) as Measured by Number of Participants With Grade 3 & 4 Adverse Events | Colitis | 1 Participants |
| Palbociclib + Letrozole + Trastuzumab +/- Goserelin | Safety and Tolerability of Palbociclib in Combination With Neoadjuvant Letrozole and Trastuzumab (or FDA Approved Biosimilar) as Measured by Number of Participants With Grade 3 & 4 Adverse Events | Hypokalemia | 1 Participants |