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
- 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
- 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
- ALAT ≤ 2.5xUNL in absence of liver metastases, or ≤5xUNL in presence of liver
- 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 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.
- 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
- 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
- Subject unwilling or unable to comply with study requirements.