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

NCT03575065 | Completed Phase 2 Results

• 2 other identifiers: BGB-290-201CTR20171623
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 20

Brief 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.

Conditions

HER2-negative Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR) as Assessed by Independent Radiology Review (IRC)

  ORR is defined as the percentage of participants who achieved a best overall response of confirmed complete response (CR) or partial response (PR), assessed by IRC per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)

  From the first dose of pamiparib to first documentation of disease progression while participant is alive (Approximately 2 years and 4 months)

Secondary Outcomes (9)

• ORR as Assessed by Investigator

  From the first dose of pamiparib to first documentation of disease progression while participant is alive (Approximately 2 years and 10 months)

• Progression-free Survival (PFS) as Assessed by IRC and Investigator

  From the first dose of pamiparib to first documentation of disease progression or death (Approximately 2 years and 10 months)

• Duration of Response (DOR) as Assessed by IRC

  From first documentation of confirmed CR or PR to first documentation of disease progression or death (Approximately 2 years and 10 months)

• Duration of Response (DOR) as Assessed by the Investigator

  From first documentation of confirmed CR or PR to first documentation of disease progression or death (Approximately 2 years and 10 months)

• Confirmed Best Overall Response (BOR) as Assessed by IRC and Investigator

  Approximately 2 years and 10 months

Study Arms (2)

Cohort 1: Triple-negative breast cancer (TNBC)

EXPERIMENTAL

Locally advanced or metastatic TNBC

Drug: BGB-290

Cohort 2: HR(+)/HER2(-) breast cancer

EXPERIMENTAL

Locally advanced or metastatic Hormone receptor-positive(HR+) human epidermal growth factor receptor2 Negative(HER2-) breast cancer

Drug: BGB-290

Interventions

BGB-290 DRUG

Administered orally

Also known as: Pamiparib

Cohort 1: Triple-negative breast cancer (TNBC); Cohort 2: HR(+)/HER2(-) breast cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• BeiGene: lead

Study Sites (20)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

Location

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

Location

Sun Yat Sen Memorial Hospital, Sun Yat Sen University (North)

Guangzhou, Guangdong, 510000, China

Location

Sun Yat Sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150000, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, 450000, China

Location

Zhongnan Hospital of Wuhan University Wuhan

Wuhan, Hubei, 430071, China

Location

Xiangya Hospital of Central South University

Changsha, Hunan, 410008, China

Location

Hunan Cancer Hospital

Changsha, Hunan, 410013, China

Location

Jiangsu Province Cancer Hospital

Nanjing, Jiangsu, 210008, China

Location

Jiangsu Province Hospital

Nanjing, Jiangsu, 210029, China

Location

The First Hospital of Jilin University

Changchun, Jilin, 130021, China

Location

The Second Hospital of Jilin University

Changchun, Jilin, 130022, China

Location

Liaoning Cancer Hospital and Institute

Shenyang, Liaoning, 110042, China

Location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200000, China

Location

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

Location

Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital

Chengdu, Sichuan, 610071, China

Location

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300060, China

Location

Zhejiang University College of Medicine Second Affiliated Hospital

Hangzhou, Zhejiang, 310009, China

Location

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

Location

Related Publications (2)

• 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.

  BACKGROUND

• 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.

  PMID: 36459284 BACKGROUND

MeSH Terms

Interventions

pamiparib

Results Point of Contact

• Title: Study Director
• Organization: BeiGene

clinicaltrials@beigene.com

+1 - 877-828-5568

Study Officials

• Study Director

  BeiGene

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2018
• First Posted: July 2, 2018
• Study Start: June 22, 2018
• Primary Completion: October 9, 2020
• Study Completion: April 14, 2021
• Last Updated: October 26, 2024
• Results First Posted: September 7, 2022

Record last verified: 2024-10

Locations

CN (20)