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Sacituzumab Govitecan in Chinese Patients With mTNBC of at Least 2 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04454437
Recruitment Status : Not yet recruiting
First Posted : July 1, 2020
Last Update Posted : July 1, 2020
IQVIA RDS (Shanghai) Co., Ltd.
Medidata Solutions
Q Squared Solutions (Beijing) Co., Ltd
Information provided by (Responsible Party):
Everest Medicines

Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of sacituzumab govitecan in Chinese patients with metastatic triple-negative breast cancer (TNBC) who received at least two prior chemotherapy treatments.

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

Detailed Description:

This is a Phase IIb, single arm, multicenter study of sacituzumab govitecan 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 ORR per RECIST v 1.1 by Independent Review Committee (IRC) in all treated patients.

Patients 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 patients will visit the Investigator at regular intervals for assessment of safety parameters and AEs.

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : July 3, 2020
Estimated Primary Completion Date : October 31, 2021
Estimated Study Completion Date : November 27, 2022

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Arm A Biological: Sacituzumab Govitecan
10 mg/kg intravenously on Days 1 and 8 of a 21-day cycleNA. Number of Cycles: until disease progression or intolerable toxicity or consent withdrawal for any reason.

Primary Outcome Measures :
  1. Objective response rate (ORR) by IRC according to RECIST v 1.1 [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Duration of response [DOR] by Independent Review Committee (IRC) [ Time Frame: 3 years ]
    Defined as the time between the date when response is first observed until the earlier date of disease progression or death.

  2. Clinical benefit rate [CBR] [ Time Frame: 3 years ]
    Includes CR, PR and stable disease (SD) of at least 6 months.

  3. Progression-free survival [PFS] [ Time Frame: 3 years ]
    Defined as the time since the first dose of trial treatment until the earlier date of disease progression or death

  4. Overall survival [OS] [ Time Frame: 3 years ]
    Defined as the time since the first dose of trial treatment until death

  5. Safety and tolerability [ Time Frame: 3 years ]
    AEs, serious adverse events [SAEs] according to National Cancer Institute-Common Terminology Criteria for Adverse Events version 5.0 [NCI-CTCAE v 5.0]

  6. PK parameters; T1/2 [ Time Frame: 3 years ]
  7. PK parameters; AUC0-168h [ Time Frame: 3 years ]
  8. PK parameters; Cmax [ Time Frame: 3 years ]
  9. Anti-drug antibody [ Time Frame: 3 years ]
    If ADA is positive or negative during treatment, and ADA titer if positive

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

Inclusion Criteria:

  1. Male or female Chinese, 18 years of age or older providing written informed consent.
  2. ECOG performance status of 0 or 1.
  3. Histologically or cytologically confirmed 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 CT or MRI in accordance with 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 patients 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 patients must have been previously treated with a taxane regardless of disease stage (adjuvant, neoadjuvant or advanced) when it was given. Patients 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 mm3, platelets > 100,000 per mm3.
    • creatinine clearance of > 60 ml/min calculated using Cockcroft-Gault equation.
    • bilirubin ≤ 1.5 IULN, aspartate amino transferase and alanine amino transferase ≤ 2.5 × IULN or ≤ 5 × IULN 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. Patients 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. Patients must have at least a 3-month life expectancy.

Exclusion Criteria:

  1. Previous treatment with topoisomerase 1 inhibitors as a free form or as other formulations.
  2. Patients with a history of or current central nervous system (CNS) metastases. A scan to confirm the absence of brain metastases is not required. Patients 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. Patients with Gilbert's disease.
  4. Patients with non-melanoma skin cancer or carcinoma in situ of the cervix are eligible, while patients with other prior malignancies must have had at least a 3-year disease-free interval.
  5. Patients known to be human immunodeficiency virus positive.
  6. Patients with active hepatitis B virus (HBV), or hepatitis C virus (HCV) infection. In patients 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 patient 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. Patients with active chronic inflammatory bowel disease (ulcerative colitis, Crohn disease) and patients with a history of bowel obstruction or 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. Patients 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. Women who are pregnant or lactating.
  17. Women of childbearing potential or fertile men unwilling to use highly effective* contraception during study and up to 6 months after treatment discontinuation in women of childbearing potential and 3 months in males post last IMP administration.

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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Contact: Zhai Qingbo 86 185 0210 3467

Sponsors and Collaborators
Everest Medicines
IQVIA RDS (Shanghai) Co., Ltd.
Medidata Solutions
Q Squared Solutions (Beijing) Co., Ltd
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Principal Investigator: Binghe Xu, MD Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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Responsible Party: Everest Medicines Identifier: NCT04454437    
Other Study ID Numbers: EVER-132-001
First Posted: July 1, 2020    Key Record Dates
Last Update Posted: July 1, 2020
Last Verified: June 2020

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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