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.
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
- SECONDARY ID:
CTR20171623
- NCT ID:
NCT03575065
Conditions
- HER2-negative Breast Cancer
Interventions
Drug | Synonyms | Arms |
---|
BGB-290 | | Cohort 1: Triple-negative breast cancer (TNBC) |
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
Name | Type | Description | Interventions |
---|
Cohort 1: Triple-negative breast cancer (TNBC) | Experimental | Locally advanced or metastatic TNBC | |
Cohort 2: HR(+)/HER2(-) breast cancer | Experimental | Locally advanced or metastatic HR(+)/HER2(-) breast cancer | |
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: | Completed |
Lead Sponsor: | BeiGene |
Last Updated
August 31, 2021