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Brief Title: Cyclin dEpendent Kinase in tRiple nEGatIVe brEast canceR - a "Window of Opportunity" Study
Official Title: Cyclin dEpendent Kinase in tRiple nEGatIVe brEast canceR - a "Window of Opportunity" Study
Study ID: NCT05067530
Brief Summary: CAREGIVER is a prospective, randomized, multicenter, open, five-arm study with unequal allocation ratios of 1:1:2:1:2 (palbociclib : paclitaxel : palbociclib + paclitaxel : carboplatin : carboplatin + paclitaxel). Study will be performed in untreated patients with triple-negative breast cancer (TNBC). Potential candidates without previously established diagnosis of TNBC will be included in a Pre-screening Phase, when a biopsy of breast tumor will be taken to confirm the diagnosis of cancer, select patients with TNBC and collect tissue for translational research.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Dolnośląskie Centrum Onkologii we Wrocławiu, Oddział Onkologii Klinicznej/Chemioterapii, Poradnia Chemioterapii; Leczenie Nowotworów Piersi, Wrocław, Dolnośląskie, Poland
Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie, Warsaw, Mazowieckie, Poland
SP ZOZ Opolskie Centrum Onkologii im. Prof. Tadeusza Koszarowskiego, Opole, Opolskie, Poland
Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii, Gdańsk, Pomorskie, Poland
Wielkopolskie Centrum Onkologii im. Marii Skłodowskiej-Curie, Oddział Onkologii Klinicznej i Immunoonkologii z Pododdziałem Dziennym, Poznań, Wielkopolskie, Poland
Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie, Państwowy Instytut Badawczy, Oddział w Gliwicach, Gliwice, Śląskie, Poland