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Completed

NCT Number: NCT03575065

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

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.

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Key information

Conditions

HER2-negative Breast Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cancer Hospital Chinese Academy of Medical Sciences, Beijing, Beijing Municipality, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BGB-290

Drug

Administered orally

Other names: Pamiparib

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

BeiGene

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Jul 2, 2018
Registry last updated
Oct 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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