Phase 3
N=543
Study of Sacituzumab Govitecan-hziy Versus Treatment of Physician's Choice in Participants With HR+/HER2- Metastatic Breast Cancer
Metastatic Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03901339 ↗Enrolled (actual)
543
Serious AEs
23.6%
Results posted
Oct 2024
Primary outcome: Primary: Progression-Free Survival (PFS) by Blinded Independent Central Review (BICR) Assessment — 5.5; 4.0 months — p=0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Sacituzumab Govitecan-hziy (Drug); Eribulin (Drug); Capecitabine (Drug); Gemcitabine (Drug); Vinorelbine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Gilead Sciences
- Primary completion
- Oct 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-Free Survival (PFS) by Blinded Independent Central Review (BICR) Assessment |
5.5; 4.0 | 0.0001 sig |
| SECONDARY Overall Survival (OS) |
14.5; 11.2 | 0.0133 sig |
| SECONDARY Objective Response Rate (ORR) by BICR and Local Investigator Review (LIR) Assessment |
21.3; 14.0; 16.5; 9.2 | 0.0268 sig |
| SECONDARY Duration of Response (DOR) by BICR and LIR Assessment |
8.1; 5.6; 7.0; 4.3 | — |
| SECONDARY Clinical Benefit Rate (CBR) by BICR and LIR Assessment |
33.8; 22.1; 32.4; 21.0 | 0.0025 sig |
| SECONDARY PFS by LIR Assessment |
4.3; 3.1 | 0.0010 sig |
| SECONDARY Time to Deterioration (TTD) of Global Health Status/Quality of Life (QoL) Scale as Measured by European Organization for Research and Treatment of Cancer Quality of Life for Cancer Patients, Core Questionnaire Version 3.0 (EORTC QLQ-C30) |
4.3; 3.0 | 0.0059 sig |
| SECONDARY TTD of Pain Score as Measured by EORTC QLQ-C30 |
3.8; 3.5 | 0.4151 |
| SECONDARY TTD of Fatigue Score as Measured by EORTC QLQ-C30 |
2.2; 1.4 | 0.0021 sig |
| SECONDARY Percentage of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs) |
100.0; 96.0 | — |
| SECONDARY Percentage of Participants Who Experienced Treatment Emergent Serious Adverse Events (TESAEs) |
27.6; 19.3 | — |
| SECONDARY Percentage of Participants Who Experienced the Worst Laboratory Abnormalities Grade 3 or 4 Post-Baseline |
1.1; 2.1; 0; 0.4; 0; 0.8 | — |
| SECONDARY Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) - Shift From Baseline Value to Best Value During Treatment |
34.9; 38.7; 7.8; 8.9; 0; 0.4 | — |
Summary
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).
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 metastatic disease:
- At least 1 taxane in any setting.
- At least 1 prior anticancer hormonal treatment in any setting.
- At least 1 cyclin-dependent kinase inhibitor 4/6 in any 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 liver function (bilirubin ≤ 1.5 institutional upper limit of normal (IULN), or ≤ 3 IULN for individuals with documented Gilbert's syndrome, aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 2.5 x IULN (in the case of liver metastases ≤ 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.
- Active serious infection requiring antibiotics.
- Any medical or other condition which, in the opinion of the Investigator, causes the individual to be medically unfit to receive sacituzumab govitecan or unsuitable for any reason.
- 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.
Data sourced from ClinicalTrials.gov (NCT03901339). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.