Clinical Trials /

Efficacy and Safety of BGB-290 in the Treatment of Metastatic HER2-Negative Breast Cancer Patients With BRCA Mutation in China

NCT03575065

Description:

This is a Phase 2, open-label, multi-center study of BGB-290 administered orally (PO) twice daily (BID) in adult Chinese patients with advanced HER2(-) breast cancer harboring germline BRCA mutation, which have progressed despite standard therapy, or for which no standard therapy exists.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Efficacy and Safety of BGB-290 in the Treatment of Metastatic HER2-Negative Breast Cancer Patients With BRCA Mutation in China
  • Official Title: An Open Label, Multi-Center Phase 2 Study to Evaluate Efficacy and Safety of BGB-290 in the Treatment of Metastatic HER2-Negative Breast Cancer Patients With BRCA Mutation in China

Clinical Trial IDs

  • ORG STUDY ID: BGB-290-201
  • NCT ID: NCT03575065

Conditions

  • HER2-negative Breast Cancer

Interventions

DrugSynonymsArms
BGB-290TNBC

Purpose

This is a Phase 2, open-label, multi-center study of BGB-290 administered orally (PO) twice daily (BID) in adult Chinese patients with advanced HER2(-) breast cancer harboring germline BRCA mutation, which have progressed despite standard therapy, or for which no standard therapy exists.

Trial Arms

NameTypeDescriptionInterventions
TNBCExperimentalLocally advanced or metastatic TNBC with confirmed either deleterious or suspected deleterious germline BRCA1/2 mutation.
  • BGB-290
HR(+)/HER2(-) breast cancerExperimentalLocally advanced or metastatic HR(+)/HER2(-) breast cancer with confirmed either deleterious or suspected deleterious germline BRCA1/2 mutation.
  • BGB-290

Eligibility Criteria

        Inclusion Criteria:

          1. Confirmed deleterious or suspected deleterious germline BRCA1 or BRCA2 mutation

          2. Locally advanced or metastatic breast cancer despite standard therapy and the
             following:

               1. Histologically or cytologically confirmed HER2(-) breast cancer (TNBC or estrogen
                  receptor-positive and/or PR+)

               2. ≤ 2 prior lines of chemotherapy in advanced or metastatic setting

               3. Prior platinum therapy allowed as long as no disease progression while on
                  treatment, or if given in neoadjuvant/adjuvant setting with ≥ 6 months from last
                  platinum to relapse

               4. Prior therapy with an anthracycline and a taxane in neoadjuvant/adjuvant or
                  metastatic setting

               5. Archival tumor tissues will be collected from all patients, if available

               6. For HR(+)/HER2(-) breast cancer only: patients must have received and progressed
                  on at least one endocrine therapy either in adjuvant or metastatic setting, or
                  have disease that the treating physician believes to be inappropriate for
                  endocrine therapy

          3. Measurable disease as defined per RECIST, version 1.1

          4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1

          5. Adequate hematologic and organ function

        Exclusion Criteria:

          1. Unresolved acute effects of prior therapy of ≥ Grade 2

          2. Prior treatment with a PARP inhibitor

          3. Chemotherapy, radiotherapy, biologic therapy, immunotherapy, investigational agent,
             anticancer Chinese medicine, or anticancer herbal remedies ≤ 14 days (or ≤ 5 half
             lives, if applicable, whichever is shorter) prior to Day 1 of Cycle 1

          4. Major surgical procedure, open biopsy, or significant traumatic injury ≤ 14 days prior
             to Day 1 of Cycle 1, or anticipation of need for major surgical procedure during the
             course of the study

          5. Diagnosis of MDS

          6. Other diagnosis of malignancy

          7. Untreated and/or active brain metastases.

          8. Active infection requiring systemic treatment, active viral hepatitis, or active
             tuberculosis

          9. Clinically significant cardiovascular disease

         10. Pregnancy or nursing

         11. Known history of intolerance to the excipients of the BGB-290 capsule
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Objective response rate
Time Frame:up to 2 years
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Progression-free survival of response
Time Frame:up to 2 years
Safety Issue:
Description:
Measure:Progression-free duration of response
Time Frame:up to 2 years
Safety Issue:
Description:
Measure:Disease control rate
Time Frame:up to 2 years
Safety Issue:
Description:
Measure:Best overall response
Time Frame:up to 2 years
Safety Issue:
Description:
Measure:Clinical benefit rate
Time Frame:up to 2 years
Safety Issue:
Description:
Measure:Overall survival
Time Frame:Up to 2 years
Safety Issue:
Description:
Measure:Incidence of treatment-emergent adverse events, graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events, version 4.03 (Common Toxicity Criteria Version 4.03) or higher
Time Frame:Up to 2 years
Safety Issue:
Description:
Measure:Timing of treatment-emergent adverse events, graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events, version 4.03 (Common Toxicity Criteria Version 4.03) or higher
Time Frame:Up to 2 years
Safety Issue:
Description:
Measure:Severity of treatment-emergent adverse events, graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events, version 4.03 (Common Toxicity Criteria Version 4.03) or higher
Time Frame:Up to 2 years
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:BeiGene

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