Efficacy and Safety of BGB-290 in the Treatment of Metastatic HER2-Negative Breast Cancer Patients With BRCA Mutation in China
NCT ID: NCT03575065
Last Updated: 2024-10-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
88 participants
INTERVENTIONAL
2018-06-22
2021-04-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort 1: Triple-negative breast cancer (TNBC)
Locally advanced or metastatic TNBC
BGB-290
Administered orally
Cohort 2: HR(+)/HER2(-) breast cancer
Locally advanced or metastatic Hormone receptor-positive(HR+) human epidermal growth factor receptor2 Negative(HER2-) breast cancer
BGB-290
Administered orally
Interventions
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BGB-290
Administered orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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/or 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
2. Prior treatment with a poly\[ADP-ribose\] polymerase (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 myelodysplastic syndrome (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
18 Years
ALL
No
Sponsors
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BeiGene
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
BeiGene
Locations
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Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Sun Yat Sen Memorial Hospital, Sun Yat Sen University (North)
Guangzhou, Guangdong, China
Sun Yat Sen University Cancer Center
Guangzhou, Guangdong, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Zhongnan Hospital of Wuhan University Wuhan
Wuhan, Hubei, China
Xiangya Hospital of Central South University
Changsha, Hunan, China
Hunan Cancer Hospital
Changsha, Hunan, China
Jiangsu Province Cancer Hospital
Nanjing, Jiangsu, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
The First Hospital of Jilin University
Changchun, Jilin, China
The Second Hospital of Jilin University
Changchun, Jilin, China
Liaoning Cancer Hospital and Institute
Shenyang, Liaoning, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
Chengdu, Sichuan, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
Zhejiang University College of Medicine Second Affiliated Hospital
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Countries
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References
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Xu B, Zhang QY, Yang H, Gu T, Zhang K, Liang J, Qiu JJ, Yang R, Zhang L, Mu S, Sun J, Huang V, Dong M. An Open-Label, Multicenter, Phase 2 Study to Evaluate the Antitumor Activity and Safety of Pamiparib in the Treatment of Metastatic HER2-Negative Breast Cancer Patients With BRCA Mutation in China. Chinese Society of Clinical Oncology. 2018.
Xu B, Sun T, Shi Y, Cui J, Yin Y, Ouyang Q, Liu Q, Zhang Q, Chen Y, Wang S, Wang X, Tong Z, Zhong Y, Wang J, Yan M, Yan X, Wang C, Feng J, Wang X, Hu G, Cheng Y, Ge R, Zhu Z, Zhang W, Shao Z. Pamiparib in patients with locally advanced or metastatic HER2-negative breast cancer with germline BRCA mutations: a phase II study. Breast Cancer Res Treat. 2023 Feb;197(3):489-501. doi: 10.1007/s10549-022-06785-z. Epub 2022 Dec 2.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CTR20171623
Identifier Type: REGISTRY
Identifier Source: secondary_id
BGB-290-201
Identifier Type: -
Identifier Source: org_study_id
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