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Metastatic Triple-negative Breast CancerPhase 2NCT04454437

Study of Sacituzumab Govitecan in Chinese Patients With Metastatic Triple-negative Breast Cancer Who Received at Least Two Prior Treatments

A Phase 2 study testing Sacituzumab Govitecan-hziy in people with Metastatic Triple-negative Breast Cancer, run by Gilead Sciences at 17 sites in China.

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 learn more about the effectiveness of the study drug, sacituzumab govitecan-hziy, in Chinese participants with metastatic triple-negative breast cancer (mTNBC) who received at least 2 systemic chemotherapy regimens. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Triple-negative Breast Cancer
What is being tested?
Sacituzumab Govitecan-hziy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
17 sitesChina
Study dates
23 Oct 2020to Dec 2027
Phase
Phase 2
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

  • Male or female Chinese, 18 years of age or older providing written informed consent.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Histologically or cytologically confirmed Triple-negative Breast Cancer (TNBC).
  • Refractory to or relapsed after at least 2 prior standard of care chemotherapy regimens for unresectable, locally advanced or metastatic breast cancer.
  • Measurable disease by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) in accordance with Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1.
  • Availability of archival tumor tissue or newly acquired biopsy (FFPE block or a minimum of number 10 unstaining tumor slides, recommended from recurrent or metastatic sites).
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  • For individuals with a documented germ-line BRCA1/BRCA2 mutation who received an approved PARP inhibitor, the PARP inhibitor can be used to meet the criteria for one of 2 prior standard of care chemotherapies.
  • All individuals must have been previously treated with a taxane regardless of disease stage (adjuvant, neoadjuvant or advanced) when it was given. Individuals who have contraindications or are intolerant to taxanes are eligible provided that they received at least 1 cycle of a taxane and showed contraindications or intolerance during or at the end of that cycle.
  • Adequate bone marrow, hepatic and renal function, defined as:
  • hemoglobin > 9 g/dL, absolute neutrophil count > 1,500 per mm^3, platelets > 100,000 per mm^3.
  • creatinine clearance of > 60 ml/min calculated using Cockcroft-Gault equation.
  • bilirubin ≤ 1.5 Upper Limit of Normal (ULN), aspartate amino transferase and alanine amino transferase ≤ 2.5 × ULN or ≤ 5 × ULN if known liver metastases and serum albumin ≥ 3 g/dL.
  • Recovered from all prior treatment-related toxicities to Grade 1 or less by National Cancer Institute-Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v 5.0) (except alopecia or peripheral neuropathy that may be Grade 2 or less).
  • Individuals must have completed all prior cancer treatments at least 2 weeks prior to the first dose including chemotherapy (includes also endocrine treatment), radiotherapy and major surgery. Prior antibody treatment for cancer must have been completed at least 3 weeks prior to the first dose.
  • Individuals must have at least a 3-month life expectancy.

Who cannot join

  • Previous treatment with topoisomerase 1 inhibitors as a free form or as other formulations.
  • Individuals with a history of or current central nervous system (CNS) metastases. A scan to confirm the absence of brain metastases is not required. Individuals with unknown CNS metastatic status and any clinical signs indicative of CNS metastases are eligible if CNS metastases are excluded using CT and/or MRI scans.
  • Individuals with Gilbert's disease.
  • Individuals with non-melanoma skin cancer or carcinoma in situ of the cervix are eligible, while individuals with other prior malignancies must have had at least a 3-year disease-free interval.
  • Individuals known to be human immunodeficiency virus positive.
  • Individuals with active hepatitis B virus (HBV), or hepatitis C virus (HCV) infection. In individuals with a history of HBV, hepatitis B core antibody (HBcAb) testing is required and if positive, then HBV DNA testing will be performed and if positive the individual will be excluded.
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  • Known history of unstable angina, myocardial infarction (MI), or chronic heart failure present within 6 months of first dose or clinically significant cardiac arrhythmia (other than stable atrial fibrillation) requiring anti-arrhythmia therapy or left ventricular ejection fraction < 50%.
  • Known history of clinically significant active chronic obstructive pulmonary disease, or other moderate-to-severe chronic respiratory illness present within 6 months of the first dose.
  • Infection requiring systematic antibiotic use within 1 week of the first dose.
  • Individuals with active chronic inflammatory bowel disease (ulcerative colitis, Crohn disease) and individuals with a history of bowel obstruction or gastrointestinal (GI) perforation.
  • High dose systemic corticosteroids within 2 weeks prior to the first dose (however, low dose corticosteroids ≤ 10 mg prednisone or equivalent daily are permitted provided the dose is stable for 4 weeks).
  • Scheduled surgery during the study, other than minor surgery which would not delay study treatment.
  • Individuals who have received a live vaccine within 30 days of first dose.
  • Rapid deterioration during Screening prior to the first dose, eg, significant change in performance status, unstable pain symptoms requiring modifications in analgesic management.
  • 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.
  • Females who are pregnant or lactating.
  • Females of childbearing potential or fertile males unwilling to use highly effective* contraception during study and up to 6 months after treatment discontinuation in females of childbearing potential and 3 months in males post last Investigational Medicinal Product (IMP) administration.
  • Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

China17 sites

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021

  • Chinese PLA General Hospital

    Beijing, 100853

  • The First Hospital of Jilin University

    Changchun, 130021

  • Hunan Cancer Hospital

    Changsha, 410013

  • West China Hospital, Sichuan University

    Chengdu

  • Chongqing University Cancer Hospital

    Chongqing, 404100

  • Sun Yat-sen University, Cancer Center

    Guangzhou, 510000

  • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

    Guangzhou, 510120

  • Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine

    Hangzhou, Zhejiang

  • Zhejiang Cancer Hospital

    Hangzhou, 310022

  • Anhui Provincial Hospital

    Hefei, 230001

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, 230022

  • Liaoning Cancer Hospital & Institute

    Shenyang, Liaoning

  • The First Hospital of China Medical University

    Shenyang, 110001

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, 300060

  • Hubei Cancer Hospital

    Wuhan, 430000

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, 710061

Other trials in China

About this study

Official title: A Phase IIb, Single Arm, Multicenter Trial of Sacituzumab Govitecan in Chinese Patients With Metastatic Triple-negative Breast Cancer Who Received at Least Two Prior Treatments

The goal of this study is to learn more about the effectiveness of the study drug, sacituzumab govitecan-hziy, in Chinese participants with metastatic triple-negative breast cancer (mTNBC) who received at least 2 systemic chemotherapy regimens.

Read the detailed description

This is a Phase IIb, single arm, multicenter study of sacituzumab govitecan-hziy in locally advanced or metastatic TNBC patients who are refractory or relapsing after at least 2 prior standard chemotherapy regimens for unresectable, locally advanced or metastatic breast cancer, and these regimens will qualify regardless of triple-negative status at the time they were given. The primary endpoint of the trial will be the objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v 1.1) by Independent Review Committee (IRC) in all treated patients.

Participants will be treated until progression requiring discontinuation of further treatment, unacceptable toxicity, study withdrawal, or death, whichever comes first. Tumor response and progression will be assessed using RECIST v 1.1 and assessment by Investigator at the trial center will be sufficient for decisions on continuation of treatment. An independent analysis of response will also be performed by IRC, but this will not be used to make treatment decisions. All participants will visit the Investigator at regular intervals for assessment of safety parameters and adverse events.

Being tested
Sacituzumab Govitecan-hziy
Medical subject headings
Triple Negative 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

    Administered intravenously

Study groups in NCT04454437
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. Participants will continue treatment until disease progression or intolerable toxicity or consent withdrawal for any reason.
Receives: Drug: Sacituzumab Govitecan-hziy

What is being measured

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

  1. Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v 1.1) By Independent Review Committee (IRC)

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

    Measured: Up to 3 years

Secondary outcomes (8)

  1. Duration of Response (DOR) by IRC

    DOR is defined as the time between the date until the earlier date of disease progression or death.

    Measured: Up to 3 years

  2. Clinical Benefit Rate (CBR)

    CBR is defined as best overall response of CR or PR or stable disease (SD) of at least 6 months.

    Measured: Up to 3 years

  3. Progression-free Survival (PFS)

    PFS is defined as the time since the first dose of trial treatment until the earlier date of disease progression as defined by RECIST v1.1 or death due to any cause.

    Measured: Up to 3 years

  4. Overall survival (OS)

    OS is defined as the time since the first dose of trial treatment until death due to any cause.

    Measured: Up to 3 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 3 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 3 years plus 30 days

  7. 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 3 years

  8. Percentage of Participants Who Developed Anti-Drug Antibodies (ADAs) Against Sacituzumab Govitecan-hziy

    Measured: Up to 3 years

Timeline

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

  1. First posted1 Jul 2020
  2. Study start23 Oct 2020
  3. Primary completion6 Aug 2021
  4. Study completionDec 2027 (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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04454437
Sponsor's protocol ID
EVER-132-001
Other IDs
CTR20200914
Status last verified
Jan 2026
First submitted
5 Jun 2020
Last updated
2 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Xu B, Ma F, Wang T, Wang S, Tong Z, Li W, Wu X, Wang X, Sun T, Pan Y, Yao H, Wang X, Luo T, Yang J, Zeng X, Zhao W, Cong XJ, Chen J. A Phase IIb, single arm, multicenter trial of sacituzumab govitecan in Chinese patients with metastatic triple-negative breast cancer who received at least two prior treatments. Int J Cancer. 2023 May 15;152(10):2134-2144. doi: 10.1002/ijc.34424. Epub 2023 Jan 30.

    PubMed 36621000

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sacituzumab Govitecan-hziy in people with Metastatic Triple-negative Breast Cancer, run by Gilead Sciences at 17 sites in China.

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 15 inclusion and 18 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 2 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 17 sites in China. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v 1.1) By Independent Review Committee (IRC) (time frame: Up to 3 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 NCT04454437, which also lists 1 linked publication.

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 2 Feb 2026.

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