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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03575065
Recruitment Status : Completed
First Posted : July 2, 2018
Results First Posted : September 7, 2022
Last Update Posted : September 7, 2022
Sponsor:
Information provided by (Responsible Party):
BeiGene

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.

Condition or disease Intervention/treatment Phase
HER2-negative Breast Cancer Drug: BGB-290 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : June 22, 2018
Actual Primary Completion Date : October 9, 2020
Actual Study Completion Date : April 14, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Cohort 1: Triple-negative breast cancer (TNBC)
Locally advanced or metastatic TNBC
Drug: BGB-290
Administered orally
Other Name: Pamiparib

Experimental: Cohort 2: HR(+)/HER2(-) breast cancer
Locally advanced or metastatic Hormone receptor-positive(HR+) human epidermal growth factor receptor2 Negative(HER2-) breast cancer
Drug: BGB-290
Administered orally
Other Name: Pamiparib




Primary Outcome Measures :
  1. Objective Response Rate (ORR) as Assessed by Independent Radiology Review (IRC) [ Time Frame: From the first dose of pamiparib to first documentation of disease progression while participant is alive (Approximately 2 years and 4 months) ]
    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)


Secondary Outcome Measures :
  1. ORR as Assessed by Investigator [ Time Frame: From the first dose of pamiparib to first documentation of disease progression while participant is alive (Approximately 2 years and 10 months) ]
    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 the investigator per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)

  2. Progression-free Survival (PFS) as Assessed by IRC and Investigator [ Time Frame: From the first dose of pamiparib to first documentation of disease progression or death (Approximately 2 years and 10 months) ]
    PFS is defined as the time from first dose of pamiparib to the first documented disease progression or death due to any cause, assessed by IRC or the investigator

  3. Duration of Response (DOR) as Assessed by IRC [ Time Frame: From first documentation of confirmed CR or PR to first documentation of disease progression or death (Approximately 2 years and 10 months) ]
    DOR is defined as the time from first determination of a confirmed best overall response until the first documentation of progression or death, whichever comes first, assessed by IRC

  4. Duration of Response (DOR) as Assessed by the Investigator [ Time Frame: From first documentation of confirmed CR or PR to first documentation of disease progression or death (Approximately 2 years and 10 months) ]
    DOR is defined as the time from first determination of a confirmed best overall response until the first documentation of progression or death, whichever comes first, assessed by the investigator

  5. Confirmed Best Overall Response (BOR) as Assessed by IRC and Investigator [ Time Frame: Approximately 2 years and 10 months ]
    BOR is defined as the percentage of participants with best overall response recorded from the start of the treatment until disease progression or recurrence, assessed by IRC or the investigator. BOR included complete response [CR], partial response [PR], stable disease [SD], disease progression and not evaluable [NE].

  6. Disease Control Rate (DCR) as Assessed by IRC and Investigator [ Time Frame: From the first dose of pamiparib to first documentation of disease progression while participant is alive (Approximately 2 years and 10 months). ]
    DCR is defined as the percentage of participants who achieved a confirmed BOR of CR, PR, or stable disease (SD), assessed by IRC or the investigator

  7. Clinical Benefit Rate (CBR) as Assessed by IRC and Investigator [ Time Frame: From the first dose of pamiparib to first documentation of disease progression while participant is alive (Approximately 2 years and 10 months) ]
    CBR is defined as percentage of participants with confirmed CR or confirmed PR or a durable SD (SD lasting ≥ 24 weeks), assessed by IRC or the investigator

  8. Overall Survival (OS) [ Time Frame: From the first dose of pamiparib until death (approximately 2 years and 10 months) ]
    OS is defined as time from the first dose of pamiparib to the date of death due to any cause

  9. Number of Participants With Treatment-Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE) [ Time Frame: Up to approximately 2 years and 10 months ]
    A TEAE is defined as an adverse event (AE) that had an onset date on or after the first dose of study drug up to 30 days following study drug discontinuation. SAE is defined as any AE that leads to death or is life-threatening.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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/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:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03575065


Locations
Show Show 22 study locations
Sponsors and Collaborators
BeiGene
Investigators
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Study Director: Study Director BeiGene
  Study Documents (Full-Text)

Documents provided by BeiGene:
Study Protocol  [PDF] October 30, 2018
Statistical Analysis Plan  [PDF] October 13, 2020

Publications:
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.
Sun T, Shi Y, Cui J et al; A phase 2 study of pamiparib in the treatment of patients with locally advanced or metastatic HER2-negative breast cancer with germline BRCA mutation. J Clin Oncol 39, 2021 (suppl 15; abstr 1087)

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Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT03575065    
Other Study ID Numbers: BGB-290-201
CTR20171623 ( Registry Identifier: National Medical Products Administration- NMPA )
First Posted: July 2, 2018    Key Record Dates
Results First Posted: September 7, 2022
Last Update Posted: September 7, 2022
Last Verified: March 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases