Tests palbociclib and chemotherapy in untreated triple-negative breast cancer

Trial details

Who runs it

Medical University of Gdansk

Trial code

NCT05067530

Record updated

5 October 2021

Original description

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.Read full original descriptionShow less

Cyclin dEpendent Kinase in tRiple nEGatIVe brEast canceR - a "Window of Opportunity" Study

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.

Inclusion: 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; triple negative tumor defined as:; hormone receptor-negative (<1% ER/PgR expression); HER2-negative (Immunohistochemistry (IHC) score ≤1 or IHC score =2 and negative for the amplification by in situ hybridization); multicentric/multifocal disease is allowed, provided that all lesions have been biopsied and their phenotype has been confirmed pathologically as TNBC; no previous anticancer therapy for this malignancy; clinically or radiographically measurable disease (discrete lesion only, enhancement is not included) within the breast, that can be biopsied, defined as longest diameter >2 cm; multicentric or multifocal disease is allowed if at least 1 lesion is >2 cm; Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; adequate bone marrow and organ function as defined by the following local laboratory values:; hemoglobin ≥9 g/dL; absolute neutrophil count (ANC) ≥1500/μL; platelets ≥100,000/μL; total bilirubin ≤ institutional upper limit of normal (ULN), unless diagnosis of Gilbert syndrome; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5x ULN; creatinine ≤ ULN OR creatinine clearance ≥50 mL/min per Cockcroft-Gault equation for patients with creatinine levels greater than ULN; blood glucose level <120 mg/dL after at least 6 hours of fasting; standard 12-lead electrocardiogram (ECG) without clinically significant abnormalities; ability to undergo contrast-enhanced MRI; ability to swallow and retain oral medication; all study participants of child-bearing potential must agree to use adequate contraceptive methods prior to study entry, during the study and for the following 3 weeks (females) or 14 weeks (males); prior chemotherapy, other targeted anticancer therapies, or prior radiation therapy (outside of treated breast) for other malignancy treated with radical intent is allowed, provided the treatment was completed ≥1 year before informed consent signature; prior bisphosphonate therapy is allowed; willing and able to undergo all the procedures required by the study protocol; provision of written informed consent form prior to receiving any study related procedure.

Exclusion: prior systemic treatment for this malignancy; prior treatment with CDK4/6 inhibitor; major surgery or radiotherapy (apart from limited field radiotherapy for symptom control) within 14 days prior to randomization; concurrent invasive malignancy; concurrent treatment with systemic immunosuppressive agents, including steroids, within 3 weeks of enrolment; presence of implants or devices not compatible with MRI; receiving strong inhibitors or inducers of CYP3A4/5 or medications with narrow therapeutic window that are predominantly metabolized through CYP3A4/5; any other concurrent severe and/or uncontrolled medical condition that would, in the Investigator's judgment, contraindicate patient participation in the clinical trial or compromise compliance with the protocol; inflammatory breast cancer; known hypersensitivity to study medications or any of their excipients; known HIV, active HBV or HCV infection; active autoimmune disease requiring ongoing immunosuppressive therapy; history of allotransplantation; impairment of GI function that may significantly alter the absorption of the oral trial treatments; any condition which in the Investigator's opinion deems the participant an unsuitable candidate to receive study drugs; pregnant or nursing female participants; unwilling or unable to follow protocol requirements, including obligatory biopsies.

ClinicalTrials.gov NCT05067530