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

Centre Jean Perrin12 sites in 1 country62 target enrollmentSeptember 2009

ConditionsPathological Response Rate

Drugsvectibix fluorouracile Epirubicine cyclophosphamide docetaxel

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Pathological Response Rate
Sponsor: Centre Jean Perrin
Enrollment: 62
Locations: 12
Primary Endpoint: To assess the rate of complete histological response, according to Chevallier's classification
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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".

Registry

clinicaltrials.gov

Start Date

September 2009

End Date

October 2011

Last Updated

12 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Centre Jean Perrin

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

To assess the rate of complete histological response, according to Chevallier's classification

Time Frame: after 24 weeks of treatment

Secondary Outcomes

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)