Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Jules Bordet Institute
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
1. Age ≥18 years old.
2. Female.
3. Histological diagnosis of triple-negative breast cancer (TNBC) breast adenocarcinoma (ER\<1%, PR\<1% by (IHC) and HER-2 0-1+ by IHC or IHC 2+ and FISH or CISH negative per updated ASCO guidelines).
4. No clinical or radiologic evidence of distant metastasis.
5. Presence of residual primary disease of at least 1.5 cm by U/S or MRI within 14 days preceding the last cycle of standard anthracycline and taxane-based neoadjuvant chemotherapy.
Patients with synchronous synchronous bilateral cancer and unilateral multifocal or multicentric or bilateral disease breast cancer will be allowed provided histologic diagnosis of TNBC is found on all performed biopsies.
6. Completion of standard anthracycline and taxane-based neoadjuvant chemotherapy. The use of platinum agents in combination with standard neoadjuvant chemotherapy is allowed.
7. ECOG Performance Status (PS) 0 or 1
8. Adequate Bone Marrow Function: Absolute Neutrophil Count (ANC) ≥ 1500/μL or ≥1.5 x 109/L; Platelets ≥100000/μL or ≥100 x 109/L; Hemoglobin ≥ 9 g/dL.
9. Adequate Renal Function: Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or estimated creatinine clearance ≥ 60 ml/min.
10. Adequate Liver Function:Total serum bilirubin ≤ 1.0 x ULN or ≤ 2 x ULN in cases of known Gilberts syndrome; Aspartate and Alanine Aminotransferase (AST and ALT) ≤ 1.5 x ULN; Alkaline phosphatase ≤ 2.5 x ULN.
11. For patients of childbearing potential: negative serum/urine pregnancy test and use accepted forms of non-hormonal contraception during the study period and up to 6 months after treatment completion.
You may not be if
1. Concurrent anti-cancer therapy for current breast cancer (hormone therapy, chemotherapy, radiotherapy, immunotherapy). Patients already included in another therapeutic trial involving an experimental drug.
2. Pregnant or lactating women.
3. Any prior history of invasive breast cancer.
4. Any previous history of non-breast malignancies (excepted basal cell carcinoma or squamous cell carcinoma of the skin) in the preceding 5 years.
5. Known hypersensitivity to the study drug or excipients.
6. Patients with other concurrent severe and/or uncontrolled medical disease or infection which could compromise participation in the study.
7. Subjects unable to swallow oral medications.
Clareo Health | Biomarker Research Study for PF-03084014 in cHEmoresistant Triple-negative Breast cAncer
