A Study to Evaluate the Safety and Tolerability of Venetoclax Tablets in Combination With Capecitabine Tablets in Adult Participants With Hormone Receptor-Positive HER2-Negative Locally Advanced or Metastatic Breast Cancer Who Had Disease Progression During or After CDK4/6 Inhibitor Therapy

  • STATUS
    Recruiting
  • participants needed
    42
  • sponsor
    AbbVie
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Updated on 16 February 2024
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cancer
breast cancer
epidermal growth factor receptor
measurable disease
hormone therapy
growth factor
endocrine therapy
metastatic breast cancer
capecitabine
primary tumor
epidermal growth factor
blood test
stage iv breast cancer
erbb2
venetoclax
HER2
capecitabine tablets

Summary

Endocrine therapy is the initial treatment for most hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) breast cancers. This study will evaluate the use of venetoclax in combination with capecitabine in adult participants with HR+, HER2-, metastatic breast cancer (MBC) who had disease progression following treatment that included a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor.

Venetoclax is an investigational drug being developed for the treatment of breast cancer. This study is open-label meaning both the participants and study doctors will know what treatment is being given. The study includes two phases: dose escalation and dose expansion. In dose escalation, participants will receive various doses of venetoclax in combination with capecitabine. In dose expansion, participants will receive the recommended dose of venetoclax determined during dose escalation in combination with capecitabine. Adult participants with locally advanced or MBC that is not amenable to curative therapy will be enrolled. Around 42 participants will be enrolled at approximately 20 sites worldwide.

Venetoclax and capecitabine will be administered on a 21-day cycle. During dose escalation, participants will take various doses of venetoclax as a tablet by mouth once a day and capecitabine as a tablet by mouth twice per day on days 1 - 14 of each cycle for approximately 30 weeks. During dose expansion, participants will take venetoclax at the dose identified during dose escalation as a tablet by mouth once a day and capecitabine as a tablet by mouth twice per day on days 1 - 14 of each cycle for approximately 30 weeks.

There will be a higher burden for participants in this trial compared to standard of care. Participants will attend weekly visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, and evaluating for side effects.

Details
Condition Cancer, Breast Cancer, Breast Cancer
Age 18years - 100years
Treatment Capecitabine, Venetoclax
Clinical Study IdentifierNCT04274933
SponsorAbbVie
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Diagnosis of advanced or metastatic breast cancer that is hormone receptor positive (HR+) and HER2 negative (HER2-)
Eastern Cooperative Oncology Group (ECOG) performance score of 0-1
Willing to provide tissue biopsy sample prior to start of study treatment, and in participants with measurable disease, at Day 1 of Cycle 3
Escalation cohort: Able to provide a tissue sample obtained at any time in disease history prior to start of study treatment
Expansion cohort: Able to provide a fresh tissue sample from either primary tumor or metastatic site; if fresh sample collection is deemed unsafe by the investigator, then an archival tissue block is acceptable if obtained at time of most recent progression and within 16 weeks of study treatment
Experienced disease progression during or after CDK4/6 inhibitor therapy administered for a minimum of 8 weeks prior to progression

Exclusion Criteria

History of receiving systemic cytotoxic chemotherapy in the locally advanced or metastatic setting
Received anti-cancer therapy within the previous 21 days prior to the start of study drugs
No known uncontrolled metastases to the central nervous system (CNS). Participants with brain metastases are eligible provided they have shown positive clinical and radiographic stable disease for at least 4 weeks after definitive therapy and have not used steroids for at least 2 weeks prior to first dose of study drugs
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