Status:
COMPLETED
Assessment of the Efficacy of the Neoadjuvant Combination: "Chemotherapy-Targeted Therapy" in Breast Cancer.
Lead Sponsor:
Centre Jean Perrin
Conditions:
Pathological Response Rate
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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".
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT00933517
Start Date
September 1 2009
End Date
October 1 2011
Last Update
March 21 2014
Active Locations (12)
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1
Centre Jean Perrin
Clermont-Ferrand, Clermont-Ferrand, France, 63011
2
Centre Paul Strauss
Strasbourg, Strasbourg, France, 67065
3
Pole Santé République
Clermont-Ferrand, France, 63100
4
Centre Georges François Leclerc
Dijon, France, 21079