NCT04639986

A Phase 3 Asian 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 Negative (HER2-) Metastatic Breast Cancer (MBC) Who Have Failed at Least 2 Prior Chemotherapy Regimens

Active, enrolled Phase 3 Last updated 5 February 2026

What this trial tests

Phase 3 trial testing Sacituzumab Govitecan-hziy in Metastatic Breast Cancer in 331 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

23 November 2020

Primary endpoint
1 December 2026

1 December 2026

Quick facts

Lead sponsor	Gilead Sciences
Phase	Phase 3
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	331
Start date	23 November 2020
Primary completion	1 December 2026
Estimated completion	1 December 2026
Sites	43 locations across China, South Korea, Taiwan

Drugs / interventions tested

• Sacituzumab Govitecan-hziy — full drug profile →
• Eribulin Mesylate Injection — full drug profile →
• Capecitabine Oral Product — full drug profile →
• Gemcitabine Injection
• Vinorelbine injection

Conditions studied

• Metastatic Breast Cancer — all drugs for Metastatic Breast Cancer →

Sponsor

Gilead Sciences — full company profile →

Who can join

18 and older, any sex, with Metastatic Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Progression-free Survival (PFS)
  Time frame: Up to 4 years
  PFS is defined as from the date of randomization until the date of disease progression (PD) or death, whichever occurs earlier. Disease progression will be determined according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v 1.1) by Independent Reviewing Committee (IRC).

Sponsor's own description

The goal of this study is to compare the study drug, sacituzumab govitecan-hziy, versus doctors' treatment of choice in participants with HR+/HER2- metastatic breast cancer (MBC) who have failed at least 2 prior chemotherapy regimens.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Emerging new therapeutic antibody derivatives for cancer treatment.
   Jin S, Sun Y, Liang X, Gu X, et al · · 2022 · cited 304× · PMID 35132063 · DOI 10.1038/s41392-021-00868-x
2. Antibody-drug conjugates targeting TROP-2: Clinical development in metastatic breast cancer.
   Shastry M, Jacob S, Rugo HS, Hamilton E. · · 2022 · cited 104× · PMID 36302269 · DOI 10.1016/j.breast.2022.10.007
3. Antibody-Drug Conjugates for the Treatment of Breast Cancer.
   Corti C, Giugliano F, Nicolò E, Ascione L, et al · · 2021 · cited 51× · PMID 34207890 · DOI 10.3390/cancers13122898
4. Current Landscape of Targeted Therapy in Hormone Receptor-Positive and HER2-Negative Breast Cancer.
   Andrahennadi S, Sami A, Manna M, Pauls M, et al · · 2021 · cited 43× · PMID 34064867 · DOI 10.3390/curroncol28030168
5. Overview of Trop-2 in Cancer: From Pre-Clinical Studies to Future Directions in Clinical Settings.
   Lombardi P, Filetti M, Falcone R, Altamura V, et al · · 2023 · cited 41× · PMID 36980630 · DOI 10.3390/cancers15061744
6. Sacituzumab govitecan and trastuzumab deruxtecan: two new antibody-drug conjugates in the breast cancer treatment landscape.
   Adams E, Wildiers H, Neven P, Punie K. · · 2021 · cited 40× · PMID 34225076 · DOI 10.1016/j.esmoop.2021.100204
7. Emerging systemic therapy options beyond CDK4/6 inhibitors for hormone receptor-positive HER2-negative advanced breast cancer.
   Ma J, Chan JJ, Toh CH, Yap YS. · · 2023 · cited 38× · PMID 37684290 · DOI 10.1038/s41523-023-00578-3
8. Trop2-targeted therapy in breast cancer.
   Hu Y, Zhu Y, Qi D, Tang C, et al · · 2024 · cited 28× · PMID 39135109 · DOI 10.1186/s40364-024-00633-6