Phase 3
Completed N=529
Trial of Sacituzumab Govitecan in Participants With Refractory/Relapsed Metastatic Triple-Negative Breast Cancer (TNBC)
Source: ClinicalTrials.gov NCT02574455 ↗Enrolled (actual)
529
Serious AEs
27.6%
Results posted
Apr 2021
Primary outcomePrimary: Progression-Free Survival (PFS) by Independent Review Committee (IRC) Assessment in Brain Metastasis Negative (BM-ve) Population — 5.6; 1.7 months — p=<0.0001
◆ Published Evidence
Highly cited
146citations · ~73 / year
Final Results From the Randomized Phase III ASCENT Clinical Trial in Metastatic Triple-Negative Breast Cancer and Association of Outcomes by Human Epidermal Growth Factor Receptor 2 and Trophoblast Cell Surface Antigen 2 Expression.
Summary
The primary objective of this study is to compare the efficacy of sacituzumab govitecan to the treatment of physician's choice (TPC) as measured by independently-reviewed Independent Review Committee (IRC) progression-free survival (PFS) in participants with locally advanced or metastatic triple-negative breast cancer (TNBC) previously treated with at least two systemic chemotherapy regimens for unresectable, locally advanced or metastatic disease, and without brain metastasis at baseline.
Linked Publications (5)
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Final Results From the Randomized Phase III ASCENT Clinical Trial in Metastatic Triple-Negative Breast Cancer and Association of Outcomes by Human Epidermal Growth Factor Receptor 2 and Trophoblast Cell Surface Antigen 2 Expression.
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Subgroup analyses from the phase 3 ASCENT study of sacituzumab govitecan in metastatic triple-negative breast cancer.
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Analysis of patients without and with an initial triple-negative breast cancer diagnosis in the phase 3 randomized ASCENT study of sacituzumab govitecan in metastatic triple-negative breast cancer.
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A plain language summary of the ASCENT study: Sacituzumab Govitecan for metastatic triple-negative breast cancer.
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Summary of quality of life in the ASCENT phase 3 clinical trial for people with metastatic triple-negative breast cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-Free Survival (PFS) by Independent Review Committee (IRC) Assessment in Brain Metastasis Negative (BM-ve) Population |
5.6; 1.7 | <0.0001 sig |
| SECONDARY Progression-Free Survival (PFS) by IRC Assessment in the ITT Population |
4.8; 1.7 | <0.0001 sig |
| SECONDARY Overall Survival (OS) in BM-ve Population |
12.1; 6.7 | <0.0001 sig |
| SECONDARY Overall Survival (OS) in ITT Population |
11.8; 6.9 | <0.0001 sig |
| SECONDARY Objective Response Rate (ORR) by IRC and Investigator Assessment in BM-ve Population |
34.9; 4.7; 33.2; 6.4 | <0.0001 sig |
| SECONDARY Time to Objective Response by the Investigator Assessment in BM-ve Population |
2.14; 2.72 | — |
| SECONDARY Time to Objective Response by the IRC Assessment in BM-ve Population |
2.67; 1.86 | — |
| SECONDARY Duration of Response (DOR) by IRC and Investigator Assessment in BM-ve Population |
6.3; 3.6; 6.9; 3.0 | 0.0683 |
| SECONDARY Time to Progression (TTP) by Investigator Assessment in BM-ve Population |
5.7; 1.8 | <0.0001 sig |
| SECONDARY Time to Progression (TTP) by IRC Assessment in BM-ve Population |
5.8; 2.1 | <0.0001 sig |
| SECONDARY Clinical Benefit Rate (CBR) by IRC and Investigator Assessment in BM-ve Population |
44.7; 8.6; 45.5; 10.3 | <0.0001 sig |
| SECONDARY Percentage of Participants Experiencing Any Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation of Study Drug |
99.6; 97.8; 26.7; 28.6; 4.7; 5.4 | — |
| SECONDARY Change From Baseline in European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 (EORTC QLQ-C30) Score |
61.9; 56.4; -5.8; -9.4; 73.2; 71.2 | — |
| SECONDARY Percentage of Participants Experiencing the Worst Laboratory Abnormalities Grade 3 or 4 Post-Baseline |
8.9; 5.4; 33.3; 25.0; 48.8; 35.3 | — |
Eligibility Criteria
Key Inclusion Criteria
- Histologically or cytologically confirmed TNBC based on the most recent analyzed biopsy or other pathology specimen. Triple negative is defined as 9 g/dL, absolute neutrophil count (ANC) > 1,500 per mm^3, platelets > 100,000 per mm^3).
- Adequate renal and hepatic function (creatinine clearance [CrCL] > 60 mL/min, bilirubin ≤ 1.5 institutional upper limit of normal [IULN], aspartate aminotransferase [AST] and alanine aminotransferase [ALT] ≤ 2.5 x IULN or ≤ 5 x IULN if known liver metastases and serum albumin ≥3 g/dL).
- Recovered from all toxicities to Grade 1 or less by National Cancer Institute common terminology criteria for adverse events (NCI CTCAE) v4.03 (except alopecia or peripheral neuropathy that may be Grade 2 or less) at the time of randomization. Participants with Grade 2 neuropathy are eligible but may not receive vinorelbine as TPC.
- Participants with treated, non-progressive brain metastases, off high-dose steroids (>20 mg prednisone or equivalent) for at least 4 weeks can be enrolled in the trial.
Key Exclusion Criteria
- Women who are pregnant or lactating.
- Women of childbearing potential or fertile men unwilling to use effective contraception during study and up to three months after treatment discontinuation in women of child-bearing potential and six months in males post last study drug.
- Participants with Gilbert's disease.
- Participants with non-melanoma skin cancer or carcinoma in situ of the cervix are eligible, while participants with other prior malignancies must have had at least a 3-year disease-free interval.
- Participants known to be human immunodeficiency (HIV) positive, hepatitis B positive, or hepatitis C positive.
- Infection requiring antibiotic use within one week of randomization.
- 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.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02574455) and the linked publication. 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. Informational only — not medical advice.