Clinical Trials /

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

NCT04454437

Description:

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.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Sacituzumab Govitecan in Chinese Patients With mTNBC of at Least 2 Prior Treatments
  • 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

Clinical Trial IDs

  • ORG STUDY ID: EVER-132-001
  • NCT ID: NCT04454437

Conditions

  • Metastatic Triple-negative Breast Cancer

Interventions

DrugSynonymsArms
Sacituzumab GovitecanArm A

Purpose

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.

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.
    

Trial Arms

NameTypeDescriptionInterventions
Arm AOther
  • Sacituzumab Govitecan

Eligibility 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:

               -  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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Objective response rate (ORR) by IRC according to RECIST v 1.1
Time Frame:3 years
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Duration of response [DOR] by Independent Review Committee (IRC)
Time Frame:3 years
Safety Issue:
Description:Defined as the time between the date when response is first observed until the earlier date of disease progression or death.
Measure:Clinical benefit rate [CBR]
Time Frame:3 years
Safety Issue:
Description:Includes CR, PR and stable disease (SD) of at least 6 months.
Measure:Progression-free survival [PFS]
Time Frame:3 years
Safety Issue:
Description:Defined as the time since the first dose of trial treatment until the earlier date of disease progression or death
Measure:Overall survival [OS]
Time Frame:3 years
Safety Issue:
Description:Defined as the time since the first dose of trial treatment until death
Measure:Safety and tolerability
Time Frame:3 years
Safety Issue:
Description:AEs, serious adverse events [SAEs] according to National Cancer Institute-Common Terminology Criteria for Adverse Events version 5.0 [NCI-CTCAE v 5.0]
Measure:PK parameters; T1/2
Time Frame:3 years
Safety Issue:
Description:
Measure:PK parameters; AUC0-168h
Time Frame:3 years
Safety Issue:
Description:
Measure:PK parameters; Cmax
Time Frame:3 years
Safety Issue:
Description:
Measure:Anti-drug antibody
Time Frame:3 years
Safety Issue:
Description:If ADA is positive or negative during treatment, and ADA titer if positive

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Everest Medicines

Last Updated

June 27, 2020