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

February 5, 2026 updated by: Gilead Sciences

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Approximately 330 eligible participants will be randomly allocated to one of the following 2 treatment arms in a 1:1 ratio:

Investigational Arm:

Sacituzumab Govitecan-hziy 10 mg/kg via intravenous (IV) injection administered on Day 1 and Day 8 (21-day cycle).

Control Arm:

Recommended doses and schedules as per package insert depending on region. Eribulin; Capecitabine; Gemcitabine; Vinorelbine Participants will be treated until disease progression as judged by local investigator review, development of unacceptable toxicity, or withdrawal of consent.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
331

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Chinese PLA General Hospital
      • Beijing, China
        • Peking University People's Hospital
      • Beijing, China
        • Cancer Hospital Chinese Academy of Medical Science
      • Changchun, China
        • Jilin Cancer Hospital
      • Changchun, China
        • The First Hospital of Jilin University
      • Chengdu, China
        • West China Hospital, Sichuan University
      • Chengdu, China
        • Chongqing University Cancer Hospital
      • Fuzhou, China
        • Fujian Medical University Union Hospital
      • Guangzhou, China
        • Guangdong Provincial People's Hospital
      • Guangzhou, China
        • Sun yat-sen University Cancer Center
      • Guangzhou, China
        • Sun Yat Sen Memorial Hospital of Sun Yat sen University
      • Hangzhou, China
        • Sir Run Run Shaw Hospital Zhejiang University School of Medicine
      • Hangzhou, China
        • Zhejiang Cancer Hospital
      • Hefei, China
        • Anhui Provincial Hospital
      • Hefei, China
        • The Second Hospital of Anhui Medical University
      • Jinan, China
        • Shandong Cancer Hospital
      • Kunming, China
        • Yunnan Cancer Hospital
      • Linyi, China
        • LinYi Cancer Hospital
      • Nanjing, China
        • Jiangsu Province Hospital
      • Nanjing, China
        • Nanjing Drum Tower Hospital
      • Shanghai, China
        • Shanghai General Hospital
      • Tianjin, China
        • Tianjin Medical University Cancer Institute & Hospital
      • Wuhan, China
        • Hubei Cancer Hospital
      • Wuhan, China
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
      • Xi'an, China
        • The First Affiliated Hospital of Xi'an Jiaotong University
      • Zhengzhou, China
        • Henan Cancer Hospital
      • Ürümqi, China
        • Affiliated Tumor Hospital of Xinjiang Medical University
  • South Korea
      • Busan, South Korea
        • Dong-A University Hospital
      • Seongnam, South Korea
        • Seoul National University Bundang Hospital
      • Seoul, South Korea
        • Asan Medical Center
      • Seoul, South Korea
        • Korea University Anam Hospital
      • Seoul, South Korea
        • Samsung Medical Center
      • Seoul, South Korea
        • Seoul National University Hospital
      • Seoul, South Korea
        • Severance Hospital Yonsei University Health System
      • Suwon, South Korea
        • Ajou University Hospital
  • Taiwan
      • Changhua, Taiwan
        • Changhua Christian Medical Foundation Changhua Christian Hospital
      • Kaohsiung City, Taiwan
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
      • Taichung, Taiwan
        • China Medical University Hospital
      • Tainan, Taiwan
        • National Cheng Kung University Hospital
      • Taipei, Taiwan
        • Tri-Service General Hospital
      • Taipei, Taiwan
        • National Taiwan University Hospital
      • Taipei, Taiwan
        • Taipei Veterans General Hospital
      • Taoyuan District, Taiwan
        • Chang Gung Memorial Hospital, Linkou

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Key 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]

Key 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Sacituzumab Govitecan-hziy
Participants will receive Sacituzumab Govitecan-hziy 10 mg/kg on Days 1 and 8 of a 21-day cycle.
Drug: Sacituzumab Govitecan-hziy
Sacituzumab govitecan 10 mg/kg via IV injection administered on Days 1 and 8 of a 21-day cycle. Subjects will continue to receive study treatment until PD as judged by local investigator review, development of unacceptable toxicity, or withdrawal of consent.
Other Names:
  • IMMU-132
  • GS-0132
  • Trodelvy™
Active Comparator: Treatment of Physician's Choice (TPC)

Participants will receive recommended doses and schedules as per package insert depending on region.

  • Eribulin (1.4 mg/m^2 of eribulin mesylate or 1.23 mg/m^2 of eribulin on Days 1 and 8 of a 21-day cycle)
  • Capecitabine (1000 to 1250 mg/m^2 twice daily on Days 1 to 14 of a 21-day cycle)
  • Gemcitabine (800 to 1200 mg/m^2 on Days 1, 8, and 15 of a 28-day cycle)
  • Vinorelbine (25 mg/m^2 on Day 1 weekly)
Drug: Eribulin Mesylate Injection
Eribulin is administered by intravenous (IV) following recommended doses and regimens as per approved package inserts.
Other Names:
  • Halaven
Drug: Capecitabine Oral Product
Capecitabine is administered orally (PO) following recommended doses and regimens as per approved package inserts.
Other Names:
  • Xeloda
Drug: Gemcitabine Injection
Gemcitabine is administered by intravenous (IV) following recommended doses and regimens as per approved package inserts.
Other Names:
  • Gemzar
Drug: Vinorelbine injection
Vinorelbine is administered by intravenous (IV) following recommended doses and regimens as per approved package inserts.
Other Names:
  • Navelbine

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
Up to 4 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants Experiencing Adverse Events (AEs) According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Time Frame: First dose date up to 4 years plus 30 days
First dose date up to 4 years plus 30 days
Percentage of Participants Experiencing Serious Adverse Events (SAEs) According to NCI CTCAE Version 5.0
Time Frame: First dose date up to 4 years plus 30 days
First dose date up to 4 years plus 30 days
Pharmacokinetic (PK) Parameter: Cmax of Sacituzumab Govitecan-hziy and Free SN-38
Time Frame: Up to 4 years
Cmax is defined as the maximum observed concentration of drug.
Up to 4 years
PK Parameter: Ctrough of Sacituzumab Govitecan-hziy and Free SN-38
Time Frame: Up to 4 years
Ctrough is defined as the concentration of drug at the end of the dosing interval.
Up to 4 years
Overall Survival (OS)
Time Frame: Up to 4 years
OS is defined as from the date of randomization to death from any cause.
Up to 4 years
Objective Response Rate (ORR) by IRC
Time Frame: Up to 4 years
ORR is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR).
Up to 4 years
Duration of Response (DOR) by IRC
Time Frame: Up to 4 years
DOR is defined as from the date of first onset of tumor response (CR or PR) to PD or death, whichever occurs earlier.
Up to 4 years
Clinical Benefit Rate (CBR) by IRC
Time Frame: Up to 4 years
CBR is defined as best overall response of CR or PR or durable stable disease (SD) (duration of SD ≥ 6 months after randomization).
Up to 4 years
Change From Baseline of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Core 30, Version 3.0 (EORTC QLQ-C30) Score
Time Frame: Baseline, up to 4 years
The EORTC QLQ-C30 is a questionnaire to assess quality of life of cancer patients, it is composed of 30 questions (items) to assess 15 scales; 1 global health status/quality of life (QOL), 5 functional scales (physical, role, cognitive, emotional, and social), and 9 symptom/item scales(fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus, a high score for a functional scale represents a high/healthy level of function, a high score for the global health status/QOL represents a high QOL, but a high score for a symptom scale/item represents a high level of symptomatology/problems.
Baseline, up to 4 years
Change From Baseline of the European Quality of Life 5-Dimensions 5 Levels Instrument (EuroQOL EQ-5D-5L) Score
Time Frame: Baseline, up to 4 years
The EQ-5D-5L is an instrument for use as a measure of health outcome.The EQ-5D-5L consists of 2 sections: the EuroQoL (5 dimensions) (EQ-5D) descriptive system and the EuroQoL visual analogue scale (EQ-VAS). The descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Rating gets recorded on a vertical VAS in which the endpoints are labeled best imaginable health state is 100 (on the top) and worst imaginable health state is 0 (on the bottom). Higher scores of EQ-VAS indicate better health.
Baseline, up to 4 years
Percentage of Participants Experiencing Treatment-Emergent Adverse Events Assessed by Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (NCI PRO-CTCAE)
Time Frame: Baseline, up to 4 years
NCI PRO-CTCAE is a patient-reported item library used to evaluate symptomatic treatment-emergent adverse events in participants on cancer clinical trials. The items selected for this study include: decreased appetite, nausea, vomiting, constipation, diarrhea, abdominal pain, shortness of breath, hair loss, and fatigue.
Baseline, up to 4 years
PK Parameter: Tmax of of Sacituzumab Govitecan-hziy and Free SN-38
Time Frame: Up to 4 years
Tmax is defined as the time to maximum drug concentration.
Up to 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gilead Sciences

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Parexel
IQVIA Pty Ltd
Medidata Solutions

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Gilead Study Director, Gilead Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 23, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 17, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 17, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 23, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EVER-132-002
  • CTR20210096 (Registry Identifier: China: Drug Clinical Trial Registration and Information Disclosure Platform)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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