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Trial of H3B-6545, in Women With Locally Advanced or Metastatic Estrogen Receptor-positive, HER2 Negative Breast Cancer
Bu çalışma, lokal ileri veya metastatik, östrojen reseptörü pozitif ve HER2 negatif meme kanseri (breast cancer) olan kadınlarda H3B-6545 adlı ilacı incelemektedir. Daha önce tedavi görmüş ve hastalığı ilerlemiş kadınlar için tasarlanmıştır. Çalışma Faz 1/Faz 2 aşamasında yürütülmüş ve tamamlanmıştır.
Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.
Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.
Inclusion Criteria: 1. Pre- or post-menopausal women. 2. ER-positive, HER2-negative breast cancer that is advanced or metastatic. 3. Progressed on prior therapy. Multiple prior lines of therapy allowed in Phase 1 and 2. Participants under amendment 6 (or subsequent amendments) must have received prior cyclin-dependent kinase (CDK4/6) inhibitor therapy. Up to one prior chemotherapy in the metastatic setting is allowed. 4. A recent archival tumor tissue obtained within 6 months prior to enrollment or a fresh tumor biopsy must be provided. A second biopsy after initiating trial therapy is not required. 5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1. 6. Adequate bone marrow and organ function. 7. Participants under amendment 6 (or subsequent amendments) must have measurable disease at baseline as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. 8. Participants under amendment 6 (or subsequent amendments) must have ESR1 Y537S mutation in absence of ESR1 D538G mutation as per the results of a central laboratory from a Nucleic Acids Whole Blood sample. Exclusion Criteria: 1. Participants must have at least one measurable lesion. 2. Participant with inflammatory breast cancer. 3. Participant has received more than one prior chemotherapy regimen for metastatic disease (Phase 2 only). 4. Females of childbearing potential who are unable or unwilling to follow adequate contraceptive measures.