Untreated, operable, non-metastatic and HER2-positive breast cancer (BC) MedDRA version: 16.1 Level: PT Classification code 10065430 Term: HER-2 positive breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: FLUOROURACILE
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: FLUOROURACILE
Other descriptive name: 5-FLOUROURACIL
Concentration unit: mg/ml milligram(s)/millilitre
Concent
Sponsors
UNICANCER
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Women aged = 18; 2) Patient has histologically confirmed breast cancer, with a clinical tumour diameter of > 1 cm and = 2 cm (T1c); 3) Clinical stage I and IIa; 4) No clinically or radiologically detectable metastases (M0); 5) HR status known and Her-2 positive (i.e. ICH score 3+ or FISH/SISH/CISH positive); 6) Performance status = 1 (according to WHO criteria); 7) Patients not previously treated by surgery, radiotherapy, hormone therapy or chemotherapy; 8) Hæmatology: Absolute neutrophil count (ANC) =1,500/mm3; Platelets =100,000/mm3; Total white blood cell count (WBC) =3.000/mm3 ; Hb> 9g/dl; 9) Hepatic Function: Total bilirubin =1.5 time the upper normal limit (UNL); 10) ASAT = 1.5xUNL; ALAT = 1.5xUNL; Alkaline phosphatase = 2.5xUNL; 11) Renal Function: Serum creatinine =1.5xUNL (and if Serum creatinine >1.5xUNL, Creatinine clearance =50 mL/min (MDRD formula); 12) Metabolic Function: Magnesium = lower limit of normal; Calcium = lower limit of normal; 13) Patient with not controlled heart disease and for whom anthracyclines are not contraindicated. Cardiac ejection fraction =50% measured by MUGA or ECHO done within 4 weeks before inclusion; 14) Patient agreeing to use effective contraception during and for = 7 months after completion of study treatment; 15) Patient able to comply with the protocol; 16) Patient must have signed a written informed consent form prior to any study specific procedures; 17) Patient must be affiliated to a Social Health Insurance. 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 45 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 45
Exclusion criteria
Exclusion criteria: 1) Bilateral or multifocal breast cancer; 2) Non-measurable tumour; 3) Any form of breast cancer other than those described in the inclusion criteria, particularly inflammatory and/or overlooked forms (T4b or T4d); 4) HER2 negative status (i.e. IHC score 0 or 1+, or IHC score 2+ and FISH/SISH/CISH negative); 5) RH status unknown; 6) Patient has a history of second cancer, with exception of in situ cervical cancer or basocellular skin cancer which is regarded as cured; 7) Patient has already been treated for new breast cancer; 8) Patients have already undergone surgery for their disease or have had primary axillary dissection; 9) Prior docetaxel administration or anti-HER2 antibody therapy (e.g.: trastuzumab or pertuzumab); 10) Patients with other concurrent severe and/or uncontrolled medical disease which could compromise participation in the study, such as, but not limited to: a) Heart or kidney failure, medullary, respiratory or liver failure, dypsnea b) Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia, poorly controlled hypertension) inferior or equal to 1 year before enrollment c) Uncontrolled diabetes d) Significant neurological or psychiatric abnormalities e) Symptomatic or progressive disorder of the central nervous system (CNS) or metastasis at the initial check-up. f) Peripheral neuropathy > grade 2 g) Acute urinary infection, ongoing hemorrhagic cystitis; 11) Patients with a known history of HIV seropositivity; 12) Sensitivity to any of the study medications or any of the ingredients or excipients of these medications; 13) Patients receiving of the concomitant medications with phenytoin; 14) Patients who received any other investigational drugs within 30 days of initiation of treatment and/or during the study; 15) Must not have had a major surgical procedure within 30 days of initiation of treatment; 16) Pregnant women, women who are likely to become pregnant or are breast-feeding; 17) Patients with any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial; 18) Patients with history of non compliance to medical regimens or unwilling or unable to comply with the protocol; 19) Individual deprived of liberty or placed under the authority of a tutor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: - To investigate predictive factors of response to both treatment regimens (anthracycline-based and non anthracycline-based regimens). - To assess the pathological complete response (pCR), according to Sataloff’s classification. - To assess the clinical and radiological response, according to the WHO criteria. - To assess FDG-PET early response to both treatment regimens. - To evaluate the rate of breast conservative surgery. - To evaluate safety and tolerability. - To evaluate benefice on Progression-free survival (PFS) and Overall survival (OS).;Primary end point(s): Pathological complete response, using Chevallier classification (on surgical specimen and lymph nodes at the time of the surgery).;Timepoint(s) of evaluation of this end point: not applicable;Main Objective: To assess the pathological complete response (pCR), according to Chevallier classification. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Pathological complete response, using Sataloff’s classification (on surgical specimen and lymph nodes at the time of the surgery). - The radiological response will be assessed on mammogram and ultrasound (and/or MRI), according to the WHO criteria (Before treatment, during treatment and before surgery). - Toxicity will be assessed according to NCI CTC-AE v4.0 criteria - Progression-free survival (PFS) The PFS is defined as the time from the first administration of treatment to progression or death of any cause, if progression has not been documented. - Overall survival (OS) with 5 years of follow-up (ie median follow-up = 5 years) The OS is defined as the time from the first administration of treatment to death from any cause. ;Timepoint(s) of evaluation of this end point: not applicable | — |
Countries
France
Contacts
Public ContactChristine ORSINI, Project manager
UNICANCER
Outcome results
None listed