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.
females or males >18 years old at the time of informed consent signature;
diagnosis of potentially resectable or de novo metastatic (stage II-IV) invasive carcinoma of the breast;
eligible for standard neoadjuvant or palliative paclitaxel and/or carboplatin-based chemotherapy as determined by Investigator;
hormone receptor-negative (<1% ER/PgR expression);
inflammatory breast cancer;
prior systemic treatment for this malignancy;
prior treatment with CDK4/6 inhibitor;
known hypersensitivity to study medications or any of their excipients;