Status:
TERMINATED
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
Lead Sponsor:
AbbVie
Conditions:
Breast Cancer
Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 venet...
Eligibility Criteria
Inclusion
- 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 in combination with endocrine therapy for a minimum of 8 weeks prior to progression.
Exclusion
- 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.
Key Trial Info
Start Date :
May 21 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 8 2020
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT04274933
Start Date
May 21 2020
End Date
October 8 2020
Last Update
October 29 2020
Active Locations (18)
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1
Joliet Oncology-Hematology Associates, LTD /ID# 215051
Joliet, Illinois, United States, 60435
2
Massachusetts General Hospital /ID# 214833
Boston, Massachusetts, United States, 02114
3
Dana-Farber Cancer Institute /ID# 214832
Boston, Massachusetts, United States, 02215
4
Masonic Cancer Center /ID# 216101
Minneapolis, Minnesota, United States, 55455