EUCTR2014-004358-32-BEActive, not recruitingPhase 1
Biomarker Research Study for PF-03084014 in cHEmoresistant triple negative breast cAncer - RHEA” study - RHEA
Institut Jules Bordet0 sites35 target enrollmentStarted: March 19, 2015Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 35
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- Female
Inclusion Criteria
- •1.Age =18 years old.
- •3.Histological diagnosis of breast adenocarcinoma that is estrogen receptor-negative, progesterone receptor-negative and HER2-negative as per the updated American Society of Clinical Oncology (ASCO) - College of American Pathologists (CAP) guidelines (1) (triple negative).
- •Patients with inflammatory breast cancer are eligible.
- •Patients with synchronous bilateral cancer and unilateral multifocal or multicentric disease will be allowed to enter the study as long as:
- •Histologic diagnosis of triple-negative breast adenocarcinoma is found in both breast tumor biopsies in case of synchronous bilateral disease.
- •Histologic diagnosis of triple-negative breast adenocarcinoma can be found in all tumor foci biopsies either in same or different breast quadrants in the case of multifocal and multicentric disease, respectively. Biopsy of all tumor foci at diagnosis is not required for study eligibility.
- •4.No clinical or radiologic evidence of distant metastasis.
- •5.Residual tumor breast adenocarcinoma of at least 1.5 cm (largest focus for bilateral, multifocal or multicentric disease) as assessed by breast magnetic resonance imaging (MRI) or ultrasound (US), performed within 14 days prior to or on the day of the neoadjuvant chemotherapy administration.
- •6.Completion of standard anthracycline and taxane-based neoadjuvant chemotherapy. The use of platinum agents in combination with standard neoadjuvant chemotherapy is allowed. The screening schedule is based on the last chemotherapy regimen, and is as follows:
- •for patients receiving taxanes every 3 weeks or taxanes in combination with a platinum agent: the screening period is at least 21 days but no later than 27 days after the day of last chemotherapy administration;
- •for patients receiving weekly taxanes: the screening period is at least 7 days but no later than 13 days after the day of last chemotherapy administration.
- •7.ECOG Performance Status (PS) 0 or 1 assessed within 6 days of first PF-03084014 administration.
- •8.Adequate Bone Marrow Function to be assessed within 6 days of first PF-03084014 administration, including:
- •a.Absolute Neutrophil Count (ANC) =1500/µL or =1.5 x 109/L;
- •b.Platelets =100000/µL or =100 x 109/L;
- •c.Hemoglobin = 9 g/dL.
- •9.Adequate Renal Function to be assessed within 6 days of first PF-03084014 administration, including: Serum creatinine = 1.5 x upper limit of normal (ULN) or estimated creatinine clearance = 60 ml/min as calculated using the method standard for the institution.
- •10.Adequate Liver Function to be assessed within 6 days of first PF-03084014 administration, including all of the following parameters:
- •a.Total serum bilirubin = 1.0 x ULN ; in case of known Gilberts syndrome a total bilirubin of up to 2 x ULN is permitted.
- •b.Aspartate and Alanine Aminotransferase (AST and ALT) = 1.5 x ULN;
- •c.Alkaline phosphatase = 2.5 x ULN.
- •11.Serum/urine pregnancy test (for patients of childbearing potential) negative within 6 days prior to first PF-03084014.
- •12.Patients of childbearing potential (i.e. not permanently sterilized or not meeting criteria for postmenopausal status) must agree to the use of two (2) methods of highly effective contraception while receiving treatment with PF-03084014 and continued for at least 90 days after the last dose (including non-hormonal (copper-containing) intrauterine device, condom with spermicidal foam/gel/film/cream/suppository, occlusive cap (diaphragm or cervical/vault caps) wit
Exclusion Criteria
- •1.Concurrent treatment with chemotherapy, hormone replacement therapy, oral contraceptives, radiotherapy, bisphosphonates (either in oral, subcutaneous and intravenous administration forms), Denosumab, and any investigational therapy under evaluation in another clinical study, during the time of PF-03084014 administration.
- •2.Pregnant or lactating women.
- •3.Any prior history of invasive breast cancer.
- •4.Any history of non-breast malignancies within the 5 years preceding study entry except for basal cell and squamous cell carcinomas of the skin or any ongoing non-breast malignancy diagnosed more than 5 years ago.
- •5.Known hypersensitivity to the study drug or excipients.
- •6.Any illness or medical condition that is unstable or could jeopardize the safety of the patient or her compliance with study requirements.
- •7.Evidence of any residual grade 2 or worse toxicity (with the exception of alopecia) related to chemotherapy.
- •8.Subjects unable to swallow oral medications.
Investigators
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