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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04454437
Recruitment Status : Active, not recruiting
First Posted : July 1, 2020
Last Update Posted : March 3, 2023
Information provided by (Responsible Party):
Gilead Sciences

Brief 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.

Condition or disease Intervention/treatment Phase
Metastatic Triple-negative Breast Cancer Drug: Sacituzumab Govitecan-hziy Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : October 23, 2020
Actual Primary Completion Date : August 6, 2021
Estimated Study Completion Date : May 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Sacituzumab Govitecan-hziy
Participants 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.
Drug: Sacituzumab Govitecan-hziy
Administered intravenously
Other Names:
  • IMMU-132
  • Trodelvy™
  • GS-0132

Primary Outcome Measures :
  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) [ Time Frame: Up to 3 years ]
    ORR is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR).

Secondary Outcome Measures :
  1. Duration of Response (DOR) by IRC [ Time Frame: Up to 3 years ]
    DOR is defined as the time between the date until the earlier date of disease progression or death.

  2. Clinical Benefit Rate (CBR) [ Time Frame: Up to 3 years ]
    CBR is defined as best overall response of CR or PR or stable disease (SD) of at least 6 months.

  3. Progression-free Survival (PFS) [ Time Frame: Up to 3 years ]
    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.

  4. Overall survival (OS) [ Time Frame: Up to 3 years ]
    OS is defined as the time since the first dose of trial treatment until death due to any cause.

  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 [ Time Frame: 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 [ Time Frame: First dose date up to 3 years plus 30 days ]
  7. Pharmacokinetic (PK) Parameter: Cmax of Sacituzumab Govitecan-hziy and Free SN-38 [ Time Frame: Up to 3 years ]
    Cmax is defined as the maximum observed concentration of drug.

  8. Percentage of Participants Who Developed Anti-Drug Antibodies (ADAs) Against Sacituzumab Govitecan-hziy [ Time Frame: Up to 3 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Key Inclusion Criteria:

  1. Male or female Chinese, 18 years of age or older providing written informed consent.
  2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  3. Histologically or cytologically confirmed Triple-negative Breast Cancer (TNBC).
  4. Refractory to or relapsed after at least 2 prior standard of care chemotherapy regimens for unresectable, locally advanced or metastatic breast cancer.
  5. Measurable disease by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) in accordance with Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1.
  6. 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).
  7. 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.
  8. 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.
  9. 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.
  10. 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).
  11. 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.
  12. Individuals must have at least a 3-month life expectancy.

Key Exclusion Criteria:

  1. Previous treatment with topoisomerase 1 inhibitors as a free form or as other formulations.
  2. 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.
  3. Individuals with Gilbert's disease.
  4. 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.
  5. Individuals known to be human immunodeficiency virus positive.
  6. 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.
  7. 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%.
  8. 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.
  9. Infection requiring systematic antibiotic use within 1 week of the first dose.
  10. Individuals with active chronic inflammatory bowel disease (ulcerative colitis, Crohn disease) and individuals with a history of bowel obstruction or gastrointestinal (GI) perforation.
  11. 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).
  12. Scheduled surgery during the study, other than minor surgery which would not delay study treatment.
  13. Individuals who have received a live vaccine within 30 days of first dose.
  14. Rapid deterioration during Screening prior to the first dose, eg, significant change in performance status, unstable pain symptoms requiring modifications in analgesic management.
  15. 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.
  16. Females who are pregnant or lactating.
  17. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04454437

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Sponsors and Collaborators
Gilead Sciences
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Study Director: Gilead Study Director Gilead Sciences
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Responsible Party: Gilead Sciences Identifier: NCT04454437    
Other Study ID Numbers: EVER-132-001
CTR20200914 ( Other Identifier: )
First Posted: July 1, 2020    Key Record Dates
Last Update Posted: March 3, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Sacituzumab govitecan
Immunologic Factors
Physiological Effects of Drugs