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STATUS Recruitment Complete

Asian Study of Sacituzumab Govitecan (IMMU-132) in HR+/HER2- Metastatic Breast Cancer (MBC)

LAST UPDATED

July 31 2025

Clinicaltrials.gov ID

NCT04639986

OVERVIEW

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

PROTOCOL SUMMARY

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.

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Participation Requirements

Calendar

Age

18 Years +

Condition

Sex

ALL

Healthy Icon

Healthy Volunteers

No

Study Details

Medical Condition

Metastatic Breast Cancer

Gender

N/A

Date

November 2020 - December 2025

Study Type

INTERVENTIONAL

Study Phase

PHASE3

Product

Sacituzumab Govitecan-hziy, Eribulin Mesylate Injection, Capecitabine Oral Product, Gemcitabine Injection, Vinorelbine injection

Eligibility Information

Inclusion

Inclusion Criteria

  • Female or male individuals aged ≥18 years at the time of signing the informed consent form
  • Documented evidence of hormone receptor-positive HER2-negative (HR+/HER2-) MBC confirmed
  • Refractory to or relapsed after at least 2, and no more than 4, prior systemic chemotherapy regimens for MBC
  • Should have been previously treated with at least 1 taxane in any setting, at least 1 prior anticancer hormonal treatment in any setting
  • Eligible for one of the chemotherapy options listed in the TPC arm
  • Documented radiographic disease progression after the most recent therapy
  • Measurable disease by CT or MRI in accordance with RECIST v 1.1, bone-only disease is not measurable and is not permitted.
  • Adequate bone marrow function, hepatic and renal function
  • Females must not be lactating or pregnant at Screening or Baseline (as documented by a negative beta human chorionic gonadotropin [ß-hCG]
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Exclusion

Exclusion Criteria

  • Previous treatment with Topoisomerase 1 Inhibitors as a free form or as other formulations
  • Individuals who have known brain metastases.
  • Have an active second malignancy within 3 years prior to providing informed consent
  • Individuals with active hepatitis B virus (HBV), or hepatitis C virus infection (measurable viral RNA load with polymerase chain reaction).
  • Active serious infection requiring systemic antibiotic use within 7 days before Cycle1 Day 1.
  • 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.
  • Known hypersensitivity or intolerance to either of the study treatments or any of the excipients.
  • Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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Locations

Locations (43)
Other

Cancer Hospital Chinese Academy of Medical Science

Beijing, China

Other

Chinese PLA General Hospital

Beijing, China

Other

Peking University People's Hospital

Beijing, China

Other

Jilin Cancer Hospital

Changchun, China

Other

The First Hospital of Jilin University

Changchun, China

Other

Chongqing University Cancer Hospital

Chengdu, China

Other

West China Hospital, Sichuan University

Chengdu, China

Other

Fujian Medical University Union Hospital

Fuzhou, China

Other

Guangdong Provincial People's Hospital

Guangzhou, China

Other

Sun Yat Sen Memorial Hospital of Sun Yat sen University

Guangzhou, China

Other

Sun Yat-sen University Cancer Center

Guangzhou, China

Other

Sir Run run Shaw hospital Zhejiang University School of Medicine

Hangzhou, China

Other

Zhejiang Cancer Hospital

Hangzhou, China

Other

Anhui Provincial Hospital

Hefei, China

Other

The second Hospital of Anhui Medical University

Hefei, China

Other

Shandong Cancer Hospital

Jinan, China

Other

Yunnan Cancer Hospital

Kunming, China

Other

Linyi Cancer Hospital

Linyi, China

Other

Jiangsu Province Hospital

Nanjing, China

Other

Nanjing Drum Tower Hospital

Nanjing, China

Other

Shanghai General Hospital

Shanghai, China

Other

Tianjin Medical University Cancer Institute & Hospital

Tianjin, China

Other

Affiliated Tumor Hospital of Xinjiang Medical University

Ürümqi, China

Other

Hubei Cancer Hospital

Wuhan, China

Other

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, China

Other

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, China

Other

Henan Cancer Hospital

Zhengzhou, China

Other

Dong-A University Hospital

Busan, South Korea

Other

Seoul National University Bundang Hospital

Seongnam, South Korea

Other

Asan Medical Center

Seoul, South Korea

Other

Korea University Anam Hospital

Seoul, South Korea

Other

Samsung Medical Center

Seoul, South Korea

Other

Seoul National University Hospital

Seoul, South Korea

Other

Severance Hospital Yonsei University Health System

Seoul, South Korea

Other

Ajou University Hospital

Suwon, South Korea

Other

Changhua Christian Medical Foundation Changhua Christian Hospital

Changhua, Taiwan

Other

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

Other

China Medical University Hospital

Taichung, Taiwan

Other

National Cheng Kung University Hospital

Tainan City, Taiwan

Other

National Taiwan University Hospital

Taipei, Taiwan

Other

Taipei Veterans General Hospital

Taipei, Taiwan

Other

Tri-Service General Hospital

Taipei, Taiwan

Other

Chang Gung Memorial Hospital, Linkou

Taoyuan District, Taiwan