Rak piersi: badanie fazy II leku palbociclib i paclitaxel

Kryteria włączenia kto może wziąć udział (27)

1. females or males >18 years old at the time of informed consent signature;
2. diagnosis of potentially resectable or de novo metastatic (stage II-IV) invasive carcinoma of the breast;
3. eligible for standard neoadjuvant or palliative paclitaxel and/or carboplatin-based chemotherapy as determined by Investigator;
4. triple negative tumor defined as:
5. hormone receptor-negative (<1% ER/PgR expression);
6. HER2-negative (Immunohistochemistry (IHC) score ≤1 or IHC score =2 and negative for the amplification by in situ hybridization);
7. multicentric/multifocal disease is allowed, provided that all lesions have been biopsied and their phenotype has been confirmed pathologically as TNBC;
8. no previous anticancer therapy for this malignancy;
9. 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;
10. multicentric or multifocal disease is allowed if at least 1 lesion is >2 cm;
11. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
12. adequate bone marrow and organ function as defined by the following local laboratory values:
13. hemoglobin ≥9 g/dL;
14. absolute neutrophil count (ANC) ≥1500/μL;
15. platelets ≥100,000/μL;
16. total bilirubin ≤ institutional upper limit of normal (ULN), unless diagnosis of Gilbert syndrome;
17. aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5x ULN;
18. creatinine ≤ ULN OR creatinine clearance ≥50 mL/min per Cockcroft-Gault equation for patients with creatinine levels greater than ULN.
19. blood glucose level <120 mg/dL after at least 6 hours of fasting;
20. standard 12-lead electrocardiogram (ECG) without clinically significant abnormalities;
21. ability to undergo contrast-enhanced MRI;
22. ability to swallow and retain oral medication;
23. 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);
24. 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;
25. prior bisphosphonate therapy is allowed;
26. willing and able to undergo all the procedures required by the study protocol;
27. provision of written informed consent form prior to receiving any study related procedure.