Description:
The primary objective of this study is to assess and compare the efficacy and safety of
sacituzumab govitecan-hzi versus treatment of physician's choice (TPC) in participants with
hormonal receptor-positive (HR+) human epidermal growth factor receptor 2 (HER2-) negative
metastatic breast cancer (MBC).
Title
- Brief Title: Study of Sacituzumab Govitecan-hziy Versus Treatment of Physician's Choice in Participants With HR+/HER2- Metastatic Breast Cancer
- Official Title: Phase 3 Study of Sacituzumab Govitecan (IMMU-132) Versus Treatment of Physician's Choice (TPC) in Subjects With Hormonal Receptor-Positive (HR+) Human Epidermal Growth Factor Receptor 2 (HER2) Negative Metastatic Breast Cancer (MBC) Who Have Failed at Least Two Prior Chemotherapy Regimens
Clinical Trial IDs
- ORG STUDY ID:
IMMU-132-09
- SECONDARY ID:
2018-004201-33
- NCT ID:
NCT03901339
Conditions
Interventions
Drug | Synonyms | Arms |
---|
Sacituzumab Govitecan-hziy | IMMU-132 | Sacituzumab Govitecan-hziy |
Eribulin | | Treatment of Physician's Choice (TPC) |
Capecitabine | | Treatment of Physician's Choice (TPC) |
Gemcitabine | | Treatment of Physician's Choice (TPC) |
Vinorelbine | | Treatment of Physician's Choice (TPC) |
Purpose
The primary objective of this study is to assess and compare the efficacy and safety of
sacituzumab govitecan-hzi versus treatment of physician's choice (TPC) in participants with
hormonal receptor-positive (HR+) human epidermal growth factor receptor 2 (HER2-) negative
metastatic breast cancer (MBC).
Trial Arms
Name | Type | Description | Interventions |
---|
Sacituzumab Govitecan-hziy | Experimental | Participants will receive sacituzumab govitecan-hziy 10 mg/kg via intravenous (IV) injection administered on Day 1 and Day 8 of a 21-day cycle. | - Sacituzumab Govitecan-hziy
|
Treatment of Physician's Choice (TPC) | Active Comparator | Participants will receive TPC determined prior to randomization from one of the following single-agent treatment:
Dosing per National Comprehensive Cancer Network (NCCN) guidelines (with dose modifications for if toxic)
Eribulin: 1.4 mg/m^2 for North American sites, 1.23 mg/m^2 for European sites) via IV on Days 1 and 8 of a 21-day cycle
Capecitabine: 1000-1250 mg/m^2 orally twice daily for 2 weeks followed by a 1-week rest period given as a 21-day cycle
Gemcitabine: 800-1200 mg/m^2 via IV on Days 1, 8, and 15 of each 28-day cycle or per institution
Vinorelbine: 25 mg/m^2 via IV on Day 1 weekly cycle per institution | - Eribulin
- Capecitabine
- Gemcitabine
- Vinorelbine
|
Eligibility Criteria
Key Inclusion Criteria:
- Documented evidence of hormone receptor-positive human epidermal growth factor
receptor 2 negative (HER2-negative) (hormonal receptor-positive (HR+)/HER2-)
metastatic breast cancer (MBC) confirmed
- Refractory to or relapsed after at least 2, and no more than 4, prior systemic
chemotherapy regimens for MBC including:
- At least 1 prior anticancer hormonal treatment.
- At least 1 cyclin-dependent kinase inhibitor 4/6 in the metastatic setting.
- Eligible for one of the chemotherapy options listed in the TPC arm
- Documented disease progression after the most recent therapy
- Adequate bone marrow function (hemoglobin ≥ 9 g/dL, absolute neutrophil count (ANC) ≥
1,500 per mm^3, platelets ≥ 100,000 per mm^3).
- Adequate renal function: calculated creatinine clearance ≥ 30 mL/minute according to
the Cockcroft and Gault formula
- Adequate hepatic function (bilirubin ≤ 1.5 institutional upper limit of normal (IULN),
aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 2.5 x IULN or
5.0 x IULN)
- Females must not be lactating or pregnant at Screening or Baseline (as documented by a
negative beta human chorionic gonadotropin (ß-hCG))
Key Exclusion Criteria:
- Previous treatment with topoisomerase 1 Inhibitors as a free form or as other
formulations
- History of significant cardiovascular disease or clinically significant
electrocardiogram (ECG) abnormality
- Individuals with Gilbert's disease.
- Active serious infection requiring antibiotics
- Individuals with a history of an anaphylactic reaction to irinotecan
- Other concurrent medical or psychiatric conditions that, in the Investigator's
opinion, may be likely to confound study interpretation or prevent completion of study
procedures and follow-up examinations.
- Locally advanced MBC (stage IIIc) in individuals who are candidates for curative
intent therapy at the time of study enrollment
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Progression-free survival (PFS) |
Time Frame: | Up to approximately 3 years |
Safety Issue: | |
Description: | PFS is defined as the time from the date of randomization to the date of the first documentation of disease progression or death (whichever occurs first) according to blinded independent central review (BICR) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). |
Secondary Outcome Measures
Measure: | Objective Response Rate (ORR) |
Time Frame: | Up to approximately 3 years |
Safety Issue: | |
Description: | ORR is defined as the proportion of participants who have a best overall response of either Complete Remission (CR) or Partial Response (PR) that is confirmed ≥ 4 weeks later according to BICR using RECIST 1.1. |
Measure: | Overall Survival (OS) |
Time Frame: | Up to approximately 5 years |
Safety Issue: | |
Description: | OS is defined as the time from the date of randomization to the date of death from any cause. |
Measure: | Duration of Response (DOR) |
Time Frame: | Up to approximately 3 years |
Safety Issue: | |
Description: | DOR is defined as the time from the date a response was first documented until the date of the first documentation of disease progression or date of death (whichever occurs first). |
Measure: | Clinical Benefit Rate (CBR) |
Time Frame: | Up to approximately 3 years |
Safety Issue: | |
Description: | CBR is defined as best overall response of CR or PR or durable stable disease (duration of SD ≥ 6 months after randomization). |
Measure: | European Organisation for Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) Questionnaire Score |
Time Frame: | Up to approximately 3 years |
Safety Issue: | |
Description: | The EORTC QLQ-C30 is a questionnaire to assess quality of life of cancer patients, it is composed of 30 questions (items) resulting in 5 functional scales, 1 global health status scale, 3 symptom scales, and 6 single items. Scoring of the QLQ-C30 is performed according to QLQ-C30 Scoring manual. All of the scales and single-item measures range in score from 0 to 100. Higher score for the functioning scales and global health status denote a better level of functioning (i.e. a better state of the participant), while higher scores on the symptom and single-item scales indicate a higher level of symptoms (i.e. a worse state of the participant). |
Measure: | European Quality of Life 5-Dimensions 5-Levels (EQ-5D-5L) Questionnaire Score |
Time Frame: | Up to approximately 3 years |
Safety Issue: | |
Description: | The EQ-5D-5L is a standard measure of health-related quality of life. The tool consists of the EQ-5D-5L descriptive part and the EQ visual analogue scale (VAS). The descriptive part comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each of these 5 dimensions has 5 levels (no problem, slight problems, moderate problems, severe problems, and extreme problems). Results for each of the 5 dimensions are combined into a 5-digit number to describe the participant's health state.
The EQ-VAS records the participant's health on a 0-100 mm VAS scale, with 0 indicating "the worst health you can imagine" and 100 indicating "the best health you can imagine." Higher scores of EQ VAS indicate better health. |
Measure: | Patient Reported Outcomes Version of the Common Terminology Criteria for Adverse Events Questionnaire Score (PRO-CTCAE™) |
Time Frame: | Up to approximately 3 years |
Safety Issue: | |
Description: | Nine selected symptoms (decreased appetite, nausea, vomiting, constipation, diarrhea, abdominal pain, shortness of breath, hair loss, and fatigue) from the PRO-CTCAE™ will be assessed. Responses are scored from 0 to 4 with no standardized scoring rules. |
Measure: | Percentage of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) |
Time Frame: | Up to approximately 3 years |
Safety Issue: | |
Description: | |
Measure: | Percentage of Participants Experiencing Treatment Emergent Serious Adverse Events (TESAEs) |
Time Frame: | Up to approximately 3 years |
Safety Issue: | |
Description: | |
Measure: | Percentage of Participants Experiencing any Clinically Significant Laboratory Abnormalities |
Time Frame: | Up to approximately 3 years |
Safety Issue: | |
Description: | |
Measure: | Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status |
Time Frame: | Baseline, Up to approximately 3 years |
Safety Issue: | |
Description: | |
Measure: | Immunogenicity Assessment |
Time Frame: | Up to approximately 3 years |
Safety Issue: | |
Description: | Number of participants who test positive for anti-drug antibodies to sacituzumab govitecan-hziy will be reported. |
Details
Phase: | Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | Gilead Sciences |
Last Updated
June 24, 2021