For Healthcare Professionals

Sacituzumab Govitecan in Chinese Patients With mTNBC of at Least 2 Prior Treatments

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About the study

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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

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:
  10. hemoglobin > 9 g/dL, absolute neutrophil count > 1,500 per mm3, platelets > 100,000 per mm3.
  11. creatinine clearance of > 60 ml/min calculated using Cockcroft-Gault equation.
  12. 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.
  13. 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).
  14. 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.
  15. 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.
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall 86 185 0210 3467Email iconEmail Study Center

Study’s details


Contition

Metastatic Triple-negative Breast Cancer

Age (in years)

18 - 200

Phase

Phase 2

Participants needed

80

Est. Completion Date

Nov 2022

Treatment type

Interventional


Sponsor

Everest Medicines

ClinicalTrials.gov identifier

NCT04454437

Study number

EVER-132-001

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