Phase 2
N=88
Efficacy and Safety of BGB-290 in the Treatment of Metastatic HER2-Negative Breast Cancer Patients With BRCA Mutation in China
HER2-negative Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03575065 ↗Enrolled (actual)
88
Serious AEs
21.6%
Results posted
Sep 2022
Primary outcome: Primary: Objective Response Rate (ORR) as Assessed by Independent Radiology Review (IRC) — 38.2; 61.9 Percentage of participants — p=0.0210
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- BGB-290 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- BeiGene
- Primary completion
- Oct 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate (ORR) as Assessed by Independent Radiology Review (IRC) |
38.2; 61.9 | 0.0210 sig |
| SECONDARY ORR as Assessed by Investigator |
36.4; 57.1 | — |
| SECONDARY Progression-free Survival (PFS) as Assessed by IRC and Investigator |
5.49; 9.20; 3.78; 9.69 | — |
| SECONDARY Duration of Response (DOR) as Assessed by IRC |
6.97; 7.49 | — |
| SECONDARY Duration of Response (DOR) as Assessed by the Investigator |
6.28; 11.57 | — |
| SECONDARY Confirmed Best Overall Response (BOR) as Assessed by IRC and Investigator |
5.5; 4.8; 32.7; 57.1; 34.5; 28.6 | — |
| SECONDARY Disease Control Rate (DCR) as Assessed by IRC and Investigator |
72.7; 90.5; 72.7; 81.0 | — |
| SECONDARY Clinical Benefit Rate (CBR) as Assessed by IRC and Investigator |
43.6; 71.4; 41.8; 66.7 | — |
| SECONDARY Overall Survival (OS) |
17.08; 27.89 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE) |
61; 26; 37; 18; 12; 7 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Confirmed deleterious or suspected deleterious germline BRCA1 or BRCA2 mutation
- Locally advanced or metastatic breast cancer despite standard therapy and the following:
- Histologically or cytologically confirmed HER2(-) breast cancer (TNBC or estrogen receptor-positive and/or PR+)
- ≤ 2 prior lines of chemotherapy in advanced or metastatic setting
- 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
- Prior therapy with an anthracycline and/or a taxane in neoadjuvant/adjuvant or metastatic setting
- Archival tumor tissues will be collected from all patients, if available
- 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
- Measurable disease as defined per RECIST, version 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
- Adequate hematologic and organ function
Exclusion Criteria
- Unresolved acute effects of prior therapy of ≥ Grade 2
- Prior treatment with a poly[ADP-ribose] polymerase (PARP) inhibitor
- 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
- 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
- Diagnosis of myelodysplastic syndrome (MDS)
- Other diagnosis of malignancy
- Untreated and/or active brain metastases.
- Active infection requiring systemic treatment, active viral hepatitis, or active tuberculosis
- Clinically significant cardiovascular disease
- Pregnancy or nursing
- Known history of intolerance to the excipients of the BGB-290 capsule
Data sourced from ClinicalTrials.gov (NCT03575065). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.