EUCTR2009-012853-39-FR
Active, not recruiting
Not Applicable
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
Centre Jean Perrin0 sitesJuly 2, 2009
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- RH- and Her2- operable breast cancer, in neoadjuvant situation
- Sponsor
- Centre Jean Perrin
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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.
Outcomes
Primary Outcomes
Not specified
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