Phase II trial assessing neoadjuvant therapy with FEC 100 followed by Taxotere® (docetaxel) plus Vectibix® (panitumumab) in patients with operable, HR and Her-2 negative breast cancer. TVA study. - TVA study

• Conditions: RH- and Her2- operable breast cancer, in neoadjuvant situation; MedDRA version: 9.1Level: LLTClassification code 10022882Term: Invasive ductal breast cancer

• Registration Number: EUCTR2009-012853-39-FR
• Lead Sponsor: Centre Jean Perrin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07-02
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: Not specified

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

-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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified