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Metastatic Breast CancerPhase 3NCT04639986

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

A Phase 3 study testing Sacituzumab Govitecan-hziy, Eribulin Mesylate Injection and Capecitabine Oral Product in people with Metastatic Breast Cancer, run by Gilead Sciences at 43 sites in 3 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Breast Cancer
What is being tested?
Sacituzumab Govitecan-hziy, Eribulin Mesylate Injection and Capecitabine Oral Product
Could I receive a placebo?
No, everyone receives an active treatment
How many people
331 participants
Where
43 sitesin 3 countries
Study dates
23 Nov 2020to Dec 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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]

Who cannot join

  • 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.

Trial locations and contacts

43 sites in 3 countries.

43 sites in 3 countries

China27 sites

  • Cancer Hospital Chinese Academy of Medical Science

    Beijing

  • Chinese PLA General Hospital

    Beijing

  • Peking University People's Hospital

    Beijing

  • Jilin Cancer Hospital

    Changchun

  • The First Hospital of Jilin University

    Changchun

  • Chongqing University Cancer Hospital

    Chengdu

  • West China Hospital, Sichuan University

    Chengdu

  • Fujian Medical University Union Hospital

    Fuzhou

  • Guangdong Provincial People's Hospital

    Guangzhou

  • Sun Yat Sen Memorial Hospital of Sun Yat sen University

    Guangzhou

  • Sun Yat-sen University Cancer Center

    Guangzhou

  • Sir Run run Shaw hospital Zhejiang University School of Medicine

    Hangzhou

  • Zhejiang Cancer Hospital

    Hangzhou

  • Anhui Provincial Hospital

    Hefei

  • The second Hospital of Anhui Medical University

    Hefei

  • Shandong Cancer Hospital

    Jinan

  • Yunnan Cancer Hospital

    Kunming

  • Linyi Cancer Hospital

    Linyi

  • Jiangsu Province Hospital

    Nanjing

  • Nanjing Drum Tower Hospital

    Nanjing

  • Shanghai General Hospital

    Shanghai

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin

  • Affiliated Tumor Hospital of Xinjiang Medical University

    Ürümqi

  • Hubei Cancer Hospital

    Wuhan

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

    Wuhan

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an

  • Henan Cancer Hospital

    Zhengzhou

Other trials in China

South Korea8 sites

  • Dong-A University Hospital

    Busan

  • Seoul National University Bundang Hospital

    Seongnam

  • Asan Medical Center

    Seoul

  • Korea University Anam Hospital

    Seoul

  • Samsung Medical Center

    Seoul

  • Seoul National University Hospital

    Seoul

  • Severance Hospital Yonsei University Health System

    Seoul

  • Ajou University Hospital

    Suwon

Other trials in South Korea

Taiwan8 sites

  • Changhua Christian Medical Foundation Changhua Christian Hospital

    Changhua

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City

  • China Medical University Hospital

    Taichung

  • National Cheng Kung University Hospital

    Tainan

  • National Taiwan University Hospital

    Taipei

  • Taipei Veterans General Hospital

    Taipei

  • Tri-Service General Hospital

    Taipei

  • Chang Gung Memorial Hospital, Linkou

    Taoyuan

Other trials in Taiwan

About this study

Official title: 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.

Read the 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.

Being tested
Sacituzumab Govitecan-hziy, Eribulin Mesylate Injection, Capecitabine Oral Product, Gemcitabine Injection, Vinorelbine injection
Keywords
sacituzumab govitecan, IMMU-132, Unresectable or Metastatic Breast Cancer, hormonal receptor, HR positive, Anti-TROP2, Human epidermal growth factor receptor 2 (HER2) Negative, Antibody Drug Conjugate
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sacituzumab Govitecan-hziyDrug

    Also called IMMU-132, Trodelvy™, GS-0132

    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.

  • Eribulin Mesylate InjectionDrug

    Also called Halaven

    Eribulin is administered by intravenous (IV) following recommended doses and regimens as per approved package inserts.

  • Capecitabine Oral ProductDrug

    Also called Xeloda

    Capecitabine is administered orally (PO) following recommended doses and regimens as per approved package inserts.

  • Gemcitabine InjectionDrug

    Also called Gemzar

    Gemcitabine is administered by intravenous (IV) following recommended doses and regimens as per approved package inserts.

  • Vinorelbine injectionDrug

    Also called Navelbine

    Vinorelbine is administered by intravenous (IV) following recommended doses and regimens as per approved package inserts.

Study groups in NCT04639986
Study groupRoleWhat they receive
Sacituzumab Govitecan-hziyExperimentalParticipants will receive Sacituzumab Govitecan-hziy 10 mg/kg on Days 1 and 8 of a 21-day cycle.
Receives: Drug: Sacituzumab Govitecan-hziy
Treatment of Physician's Choice (TPC)Active comparatorParticipants 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)
Receives: Drug: Eribulin Mesylate Injection; Drug: Capecitabine Oral Product; Drug: Gemcitabine Injection; Drug: Vinorelbine injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free Survival (PFS)

    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).

    Measured: Up to 4 years

Secondary outcomes (12)

  1. Overall Survival (OS)

    OS is defined as from the date of randomization to death from any cause.

    Measured: Up to 4 years

  2. Objective Response Rate (ORR) by IRC

    ORR is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR).

    Measured: Up to 4 years

  3. Duration of Response (DOR) by IRC

    DOR is defined as from the date of first onset of tumor response (CR or PR) to PD or death, whichever occurs earlier.

    Measured: Up to 4 years

  4. Clinical Benefit Rate (CBR) by IRC

    CBR is defined as best overall response of CR or PR or durable stable disease (SD) (duration of SD ≥ 6 months after randomization).

    Measured: Up to 4 years

  5. Percentage of Participants Experiencing Adverse Events (AEs) According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0

    Measured: First dose date up to 4 years plus 30 days

  6. Percentage of Participants Experiencing Serious Adverse Events (SAEs) According to NCI CTCAE Version 5.0

    Measured: First dose date up to 4 years plus 30 days

  7. 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

    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.

    Measured: Baseline, up to 4 years

  8. Change From Baseline of the European Quality of Life 5-Dimensions 5 Levels Instrument (EuroQOL EQ-5D-5L) Score

    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.

    Measured: Baseline, up to 4 years

  9. 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)

    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.

    Measured: Baseline, up to 4 years

  10. Pharmacokinetic (PK) Parameter: Cmax of Sacituzumab Govitecan-hziy and Free SN-38

    Cmax is defined as the maximum observed concentration of drug.

    Measured: Up to 4 years

  11. PK Parameter: Tmax of of Sacituzumab Govitecan-hziy and Free SN-38

    Tmax is defined as the time to maximum drug concentration.

    Measured: Up to 4 years

  12. PK Parameter: Ctrough of Sacituzumab Govitecan-hziy and Free SN-38

    Ctrough is defined as the concentration of drug at the end of the dosing interval.

    Measured: Up to 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Nov 2020
  2. Study start23 Nov 2020
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
331 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04639986
Sponsor's protocol ID
EVER-132-002
Other IDs
CTR20210096
Status last verified
Feb 2026
First submitted
17 Nov 2020
Last updated
9 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Xu B, Wang S, Yan M, Sohn J, Li W, Tang J, Wang X, Wang Y, Im SA, Jiang D, Valdez T, Dasgupta A, Zhang Y, Yan Y, Komatsubara KM, Chung WP, Ma F, Dai MS. Sacituzumab govitecan in HR+HER2- metastatic breast cancer: the randomized phase 3 EVER-132-002 trial. Nat Med. 2024 Dec;30(12):3709-3716. doi: 10.1038/s41591-024-03269-z. Epub 2024 Oct 1.

    PubMed 39354196

  • Kwapisz D. Sacituzumab Govitecan-hziy in Breast Cancer. Am J Clin Oncol. 2022 Jul 1;45(7):279-285. doi: 10.1097/COC.0000000000000919. Epub 2022 May 12.

    PubMed 35728046

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sacituzumab Govitecan-hziy, Eribulin Mesylate Injection and Capecitabine Oral Product in people with Metastatic Breast Cancer, run by Gilead Sciences at 43 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 sites in China, South Korea, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival (PFS) (time frame: Up to 4 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04639986, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.

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