Assessment of the Efficacy of the Neoadjuvant Combination: "Chemotherapy-Targeted Therapy" in Breast Cancer.
Phase 2
Completed
- Conditions
- Pathological Response Rate
- Registration Number
- NCT00933517
- Lead Sponsor
- Centre Jean Perrin
- Brief Summary
The purpose of this study is to assess the pathological response rate in operable breast cancer patients treated by neoadjuvant combination: "FEC-Taxotere/Vectibix".
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 62
Inclusion Criteria
- Age ³ 18.- Performance status £ 2 (according to WHO criteria).
- Patient has histologically confirmed, non-metastatic breast cancer, with a clinical tumour diameter of ³ 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: o Neutrophil count ≥1.5x109/Lo Platelet count ≥100x109/Lo Leucocyte count > 3,000/mmo Hb> 9g/dl· Hepatic Function:o Total bilirubin ≤ 1.5 time the upper normal limit (UNL)o 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 o Magnesium ≥ lower limit of normal. o Calcium ≥ lower limit of normal.
- Patient with no progressive heart disease, and for whom anthracyclines 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.
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) £ 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method To assess the rate of complete histological response, according to Chevallier's classification after 24 weeks of treatment
- Secondary Outcome Measures
Name Time Method the rate of complete histological response, according to Sataloff's classification; the rate of clinical, ultrasound, mammogram response, according to the WHO criteria; progression-free and overall survival; the tolerance. After 24 weeks of treatment, at surgery and at five years
Trial Locations
- Locations (12)
Centre Léon Bérard
🇫🇷Lyon, France
Centre Jean Perrin
🇫🇷Clermont-Ferrand, France
Institut de Cancérologie de la Loire
🇫🇷Saint Priest en Jarez, France
Pole Santé République
🇫🇷Clermont-Ferrand, France
Centre Georges François Leclerc
🇫🇷Dijon, France
Centre Oscar Lambret
🇫🇷Lille, France
CHU Dupuytren
🇫🇷Limoges, France
Centre Hospitalier
🇫🇷Montluçon, France
Hôpital Tenon
🇫🇷Paris, France
Institut Jean Godinot
🇫🇷Reims, France
Centre Paul Strauss
🇫🇷Strasbourg, France
Centre Alexis Vautrin
🇫🇷Vandoeuvre les Nancy, France