RH- and Her2- operable breast cancer, in neoadjuvant situation MedDRA version: 9.1 Level: LLT Classification code 10022882 Term: Invasive ductal breast cancer
Conditions
Interventions
Trade Name: FLUOROURACILE
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: fluorouracile
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number
Sponsors
Centre Jean Perrin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Age superior or equal to 18. -Performance status inferior or equal to 2 (according to WHO criteria). -Patient has histologically confirmed, non-metastatic breast cancer, with a clinical tumour diameter of superior or equal to 2 cm -HR negative and Her-2 negative. -Clinical stage II and IIIa. -Patients not previously treated by surgery, radiotherapy, hormone therapy or chemotherapy. ·Haematology: Neutrophil count =1.5x109/L Platelet count =100x109/L Leucocyte count > 3,000/mm Hb> 9g/dl ·Hepatic Function: Total bilirubin = 1.5 time the upper normal limit (UNL) ASAT = 2.5xUNL in absence of liver metastases, or =5xUNL in presence of liver metastases ALAT = 2.5xUNL in absence of liver metastases, or =5xUNL in presence of liver metastases Alkaline phosphatase = 2.5 time the upper normal limit (UNL) ·Renal Function ·Creatinine clearance =50 mL/min and serum creatinine =1.5xUNL ·Metabolic Function Magnesium = lower limit of normal. Calcium = lower limit of normal. -Patient with no progressive heart disease, and for whom anthracyclins are not contraindicated (normal FEV). -Patient has signed the consent forms for participation before inclusion in the trial. -Member of a Social Security scheme (or a beneficiary of such a scheme) according to the provisions of the law of 9 August 2004. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -Male patients. -Her-2 positive patients -Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment. -Subject (male or female) is not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment. -Any form of breast cancer other than those described in the inclusion criteria, particularly inflammatory and/or overlooked forms (T4b or T4d). -Non-measurable tumour. -Patients have already undergone surgery for their disease or have had primary axillary dissection. -Patient has already been treated for new breast cancer. -Patient is a ward. -Patient has a history of second cancer, with exception of in situ cervical cancer or basocellular skin cancer which is regarded as cured. -Patient has another disease which is deemed incompatible with the patient being included in the protocol. -Heart or kidney failure, medullary, respiratory or liver failure. -Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) inferior or equal to 1 year before enrollment/randomization -History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan -Significant neurological or psychiatric abnormalities. -Symptomatic or progressive disorder of the central nervous system (CNS) or metastasis at the initial check-up. -Peripheral neuropathy > grade 2 (NCI-CTCAE criteria, Version 3.0). -History of allergy to polysorbate 80. -Concomitant treatment with a trial drug, participation in another clinical trial within < 30 days or previous chemotherapy. -Patient with no fixed address in the next 6 months or living at a distance from the treatment centre so it is difficult to check her progress. -Prior anti-EGFr antibody therapy (e.g.:cetuximab) or treatment with small molecule EGFr tyrosine kinase inhibitors (e.g.: erlotinib). -Known previous or ongoing abuse of narcotic drug, other medication or alcohol. -Any investigational agent within 30 days before initiation of study treatment. -Must not have had a major surgical procedure within 28 days of initiation of treatment. -Subject unwilling or unable to comply with study requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the rate of complete histological response, according to Chevallier’s classification;Secondary Objective: -To assess the rate of complete histological response, according to Sataloff’s classification. -To assess the rate of clinical, ultrasound, mammogram response, according to the WHO criteria -To assess progression-free and overall survival. -To assess the tolerance. -Investigation of predictive factors of response to the treatments : pharmacogenomic and biological study (transversal study): ·analysis of tumour markers (EGFR, Ras, PTEN, Akt,…) using frozen samples in paraffin taken before and after chemotherapy +/- Vectibix ® ·investigation of predictive markers of chemoresistance using the biochip method with frozen biopsy ·analysis of genetic polymorphism which makes up the transmembrane domain of EGFR using blood samples ·BRCA1 and BRCA2 status assessment using blood samples;Primary end point(s): Complete histological response, using Chevallier’s classification (breast and nodes) in accordance with appendix 10 | — |
Countries
France
Outcome results
None listed