Phase
Condition
Breast Cancer
Neoplasms
Cancer
Treatment
Fulvestrant
BGB-43395
Letrozole
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Phase 1a (Dose Escalation): Participants with histologically or cytologicallyconfirmed locally advanced or metastatic solid tumors associated with CDK4dependency, including HR+/HER2- breast cancer. Participants must have received priorstandard-of-care therapies for their disease, unless the therapy is not available ornot tolerated, or is determined not appropriate based on the investigator'sjudgment.
Phase 1b (Dose Expansion): Participants with selected solid tumors including locallyadvanced or metastatic HR+/HER2- breast cancer.
Female participants with metastatic HR+/HER2- breast cancer will be required to haveovarian function suppression using gonadotropin-releasing hormone (GnRH) agonistssuch as goserelin or be postmenopausal.
Male participants with HR+/HER2- breast cancer will be required to have gonadalsuppression using GnRH agonists when being treated with letrozole or fulvestrant.
Patients must have ≥1 measurable lesion per RECIST v1.1.
Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.
Adequate organ function without symptomatic visceral disease.
Exclusion
Exclusion Criteria:
Prior therapy selectively targeting CDK4 (prior CDK4/6 inhibitor therapy ispermitted).
Known leptomeningeal disease or uncontrolled untreated brain metastasis.
Any malignancy ≤ 3 years before the first dose of study drug(s) except for thespecific cancer under investigation in this study and any locally recurring cancerthat has been treated with curative intent (eg, resected basal or squamous cell skincancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast).
Uncontrolled diabetes.
Infection requiring systemic antibacterial, antifungal, or antiviral therapy ≤ 28days before the first dose of study drug(s), or symptomatic COVID-19 infection.Patients receiving prophylactic antibiotics (eg, for prevention of urinary tractinfection, chronic obstructive pulmonary disease, or for dental extraction) areeligible. Patients who have recovered from symptomatic COVID-19 infection can berescreened for this study.
Untreated chronic hepatitis B or active hepatitis C infection.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study Design
Connect with a study center
Beijing Cancer Hospital
Beijing, Beijing 100142
ChinaActive - Recruiting
Fujian Cancer Hospital
Fuzhou, Fujian 350014
ChinaActive - Recruiting
Sun Yat Sen Memorial Hospital, Sun Yat Sen University (South)
Guangzhou, Guangdong 510245
ChinaActive - Recruiting
Guangxi Medical University Cancer Hospital
Nanning, Guangxi 530021
ChinaActive - Recruiting
The First Affiliated Hospital of Nanchang University Branch Donghu
Nanchang, Jiangxi 330006
ChinaActive - Recruiting
The First Hospital of China Medical University
Shenyang, Liaoning 110001
ChinaActive - Recruiting
Shandong Cancer Hospital
Jinan, Shandong 250117
ChinaSite Not Available
Fudan University Shanghai Cancer Center
Shanghai, Shanghai 200000
ChinaActive - Recruiting
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