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New drug shows promise for Hard-to-Treat breast cancer

NCT ID NCT04639986

Disease control Sponsor: Gilead Sciences Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 study tests a drug called sacituzumab govitecan (Trodelvy) against standard chemotherapy in 331 Asian patients with HR+/HER2- metastatic breast cancer who have already tried at least two prior chemotherapies. The goal is to see if the new drug can delay cancer growth or improve survival. Participants receive either the study drug or a doctor-chosen standard treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Sacituzumab govitecan (Trodelvy)
What this could lead to
If successful, this could offer a new, more effective treatment option for people with HR+/HER2- metastatic breast cancer who have run out of standard chemotherapy options.
What could go wrong
This is a late-stage trial, but the drug may still not prove better than existing treatments. Side effects like diarrhea and low blood cell counts are common and can be serious.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

331 people

The number who actually took part.

Started

Nov 2020

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

breast cancer breast carcinoma breast neoplasm hormone receptor-positive breast cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Metastatic breast cancer

Contacts and locations

Locations

  • Affiliated Tumor Hospital of Xinjiang Medical University

    Ürümqi, China

  • Ajou University Hospital

    Suwon, South Korea

  • Anhui Provincial Hospital

    Hefei, China

  • Asan Medical Center

    Seoul, South Korea

  • Cancer Hospital Chinese Academy of Medical Science

    Beijing, China

  • Chang Gung Memorial Hospital, Linkou

    Taoyuan, Taiwan

  • Changhua Christian Medical Foundation Changhua Christian Hospital

    Changhua, Taiwan

  • China Medical University Hospital

    Taichung, Taiwan

  • Chinese PLA General Hospital

    Beijing, China

  • Chongqing University Cancer Hospital

    Chengdu, China

  • Dong-A University Hospital

    Busan, South Korea

  • Fujian Medical University Union Hospital

    Fuzhou, China

  • Guangdong Provincial People's Hospital

    Guangzhou, China

  • Henan Cancer Hospital

    Zhengzhou, China

  • Hubei Cancer Hospital

    Wuhan, China

  • Jiangsu Province Hospital

    Nanjing, China

  • Jilin Cancer Hospital

    Changchun, China

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, Taiwan

  • Korea University Anam Hospital

    Seoul, South Korea

  • Linyi Cancer Hospital

    Linyi, China

  • Nanjing Drum Tower Hospital

    Nanjing, China

  • National Cheng Kung University Hospital

    Tainan, Taiwan

  • National Taiwan University Hospital

    Taipei, Taiwan

  • Peking University People's Hospital

    Beijing, China

  • Samsung Medical Center

    Seoul, South Korea

  • Seoul National University Bundang Hospital

    Seongnam, South Korea

  • Seoul National University Hospital

    Seoul, South Korea

  • Severance Hospital Yonsei University Health System

    Seoul, South Korea

  • Shandong Cancer Hospital

    Jinan, China

  • Shanghai General Hospital

    Shanghai, China

  • Sir Run run Shaw hospital Zhejiang University School of Medicine

    Hangzhou, China

  • Sun Yat Sen Memorial Hospital of Sun Yat sen University

    Guangzhou, China

  • Sun Yat-sen University Cancer Center

    Guangzhou, China

  • Taipei Veterans General Hospital

    Taipei, Taiwan

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, China

  • The First Hospital of Jilin University

    Changchun, China

  • The second Hospital of Anhui Medical University

    Hefei, China

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, China

  • Tri-Service General Hospital

    Taipei, Taiwan

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

    Wuhan, China

  • West China Hospital, Sichuan University

    Chengdu, China

  • Yunnan Cancer Hospital

    Kunming, China

  • Zhejiang Cancer Hospital

    Hangzhou, China

More trials for these conditions

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