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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

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ClinicalTrials.gov Identifier: NCT03575065
Recruitment Status : Recruiting
First Posted : July 2, 2018
Last Update Posted : July 2, 2018
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)
Estimated Enrollment : 75 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 : May 23, 2018
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: TNBC
Locally advanced or metastatic TNBC with confirmed either deleterious or suspected deleterious germline BRCA1/2 mutation.
Drug: BGB-290
BGB-290 BID continuously from Day 1 of Cycle 1 and in subsequent 28 day cycles until occurrence of disease progression as assessed by the investigator, unacceptable toxicity, death, withdrawal of consent, lost to follow-up, or study termination by sponsor.

Experimental: HR(+)/HER2(-) breast cancer
Locally advanced or metastatic HR(+)/HER2(-) breast cancer with confirmed either deleterious or suspected deleterious germline BRCA1/2 mutation.
Drug: BGB-290
BGB-290 BID continuously from Day 1 of Cycle 1 and in subsequent 28 day cycles until occurrence of disease progression as assessed by the investigator, unacceptable toxicity, death, withdrawal of consent, lost to follow-up, or study termination by sponsor.




Primary Outcome Measures :
  1. Objective response rate [ Time Frame: up to 2 years ]

Secondary Outcome Measures :
  1. Progression-free survival of response [ Time Frame: up to 2 years ]
  2. Progression-free duration of response [ Time Frame: up to 2 years ]
  3. Disease control rate [ Time Frame: up to 2 years ]
  4. Best overall response [ Time Frame: up to 2 years ]
  5. Clinical benefit rate [ Time Frame: up to 2 years ]
  6. Overall survival [ Time Frame: Up to 2 years ]
  7. Incidence of treatment-emergent adverse events, graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events, version 4.03 (Common Toxicity Criteria Version 4.03) or higher [ Time Frame: Up to 2 years ]
  8. Timing of treatment-emergent adverse events, graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events, version 4.03 (Common Toxicity Criteria Version 4.03) or higher [ Time Frame: Up to 2 years ]
  9. Severity of treatment-emergent adverse events, graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events, version 4.03 (Common Toxicity Criteria Version 4.03) or higher [ Time Frame: Up to 2 years ]


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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 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 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 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


Contacts
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Contact: Luping Zhang +86 10 5895 8000 clinicaltrials@beigene.com

Locations
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China, Heilongjiang
Harbin Cancer Hospital Recruiting
Harbin, Heilongjiang, China, 150000
Sponsors and Collaborators
BeiGene

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Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT03575065     History of Changes
Other Study ID Numbers: BGB-290-201
First Posted: July 2, 2018    Key Record Dates
Last Update Posted: July 2, 2018
Last Verified: June 2018

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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