Clinical trial · Interventional
Trial of Sacituzumab Govitecan in Participants With Refractory/Relapsed Metastatic Triple-Negative Breast Cancer (TNBC)
An International, Multi-Center, Open-Label, Randomized, Phase III Trial of Sacituzumab Govitecan Versus Treatment of Physician Choice in Patients With Metastatic Triple-Negative Breast Cancer Who Received at Least Two Prior Treatments
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| Eribulin | Drug | Eribulin | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Sacituzumab govitecan | Drug | Sacituzumab Govitecan | ALIAS |
| Vinorelbine | Drug | Vinorelbine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Sacituzumab Govitecan
- description
- Participants will receive sacituzumab govitecan on Days 1 and 8 of a 21-day treatment cycle for up to 29.6 months. Participants will continue treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable adverse events (AEs).
- interventionNames
- Drug: Sacituzumab govitecan
- type
- ACTIVE_COMPARATOR
- label
- Treatment of Physician's Choice (TPC)
- description
- Participants will receive TPC (ie, eribulin, capecitabine, gemcitabine, or vinorelbine), administered as a single-agent regimen that is selected by the investigator before participant randomization. Participants will continue treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs.
- interventionNames
- Drug: Eribulin
- Drug: Capecitabine
- Drug: Gemcitabine
- Drug: Vinorelbine
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Key Inclusion Criteria: * Histologically or cytologically confirmed TNBC based on the most recent analyzed biopsy or other pathology specimen. Triple negative is defined as \<1% expression for estrogen receptor (ER) and progesterone receptor (PR) and negative for human epidermal growth factor receptor 2 (HER2) by in-situ hybridization. * Refractory to or relapsed after at least two prior standard therapeutic regimens for advanced/metastatic TNBC. * Prior exposure to a taxane in localized or advanced/metastatic setting. * Eligible for one of the chemotherapy options listed as TPC (eribulin, capecitabine, gemcitabine, or vinorelbine) as per investigator assessment. * Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1. * Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). Bone-only disease is not permitted. * At least 2 weeks beyond prior anti-cancer treatment (chemotherapy, endocrine therapy, radiotherapy, and/or major surgery), and recovered from all acute toxicities to Grade 1 or less (except alopecia and peripheral neuropathy). * At least 2 weeks beyond high dose systemic corticosteroids (however, low dose corticosteroids \< 20 mg prednisone or equivalent daily are permitted provided the dose is stable for 4 weeks). * Adequate hematology without ongoing transfusional support (hemoglobin \> 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.
References
Publications (15)
- BACKGROUNDBardia A, Mayer IA, Vahdat LT, Tolaney SM, Isakoff SJ, Diamond JR, O'Shaughnessy J, Moroose RL, Santin AD, Abramson VG, Shah NC, Rugo HS, Goldenberg DM, Sweidan AM, Iannone R, Washkowitz S, Sharkey RM, Wegener WA, Kalinsky K. Sacituzumab Govitecan-hziy in Refractory Metastatic Triple-Negative Breast Cancer. N Engl J Med. 2019 Feb 21;380(8):741-751. doi: 10.1056/NEJMoa1814213. PMID 30786188
- RESULTHuvitz SA, Tolaney SM, Punie K, et al. 2020 SABCS GS3-06. Biomarker evaluation in the phase 3 ASCENT study of sacituzumab govitecan versus chemotherapy in patients with metastatic triple-negative breast cancer. San Antonio Breast Cancer Symposium; December 8-11, 2020; San Antonio, TX.
- RESULTDieras V, Weaver R, Tolaney SM, et al. 2020 SABCS PD13-07. Subgroup analysis of patients with brain metastases from the phase 3 ASCENT study of sacituzumab govitecan versus chemotherapy in metastatic triple-negative breast cancer. San Antonio Breast Cancer Symposium; December 8-11, 2020; San Antonio, TX.
- RESULTRugo HS, Tolaney SM, Loirat D, et al. 2020 SABCS PS11-09. Impact of UGT1A1 status on the safety profile of sacituzumab govitecan in the phase 3 ASCENT study in patients with metastatic triple-negative breast cancer. San Antonio Breast Cancer Symposium; December 8-11, 2020; San Antonio, TX.
- RESULTBardia A, Tolaney SM, Loirat D, et al. ASCENT: A randomized phase III study of sacituzumab govitecan (SG) vs treatment of physician's choice (TPC) in patients (pts) with previously treated metastatic triple-negative breast cancer (mTNBC). Annals of Oncology (2020) 31 (suppl_4): S1142-S1215. 10.1016/annonc/annonc325
- RESULTBardia A, Rugo RS, Horne H, et al. A phase III, randomized trial of sacituzumab govitecan (IMMU-132) vs treatment of physician choice (TPC) for metastatic triple-negative breast cancer (mTNBC). Cancer Res. 2018;78 (4 Supplement): OT2-07-05
- DERIVEDSathe AG, Jones AK, Diderichsen PM, Wang X, Chang P, Verret W, Girish S. Sacituzumab Govitecan Population Pharmacokinetics: Updated Analyses Using HR+/HER2- Metastatic Breast Cancer Data From the Phase 3 TROPiCS-02 Trial. Clin Transl Sci. 2025 Jul;18(7):e70291. doi: 10.1111/cts.70291.