TVA: Assessment of the Efficacy of the Neoadjuvant Combination: "Chemotherapy-Targeted Therapy" in Breast Cancer.

Sponsor

Centre Jean Perrin (Other)

Overall Status

Completed

CT.gov ID

NCT00933517

Collaborator

(none)

Enrollment

Locations

Duration (Months)

5.2

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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".

Condition or Disease	Intervention/Treatment	Phase
Pathological Response Rate	Drug: vectibix Drug: fluorouracile Drug: Epirubicine Drug: cyclophosphamide Drug: docetaxel	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

62 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2009

Actual Primary Completion Date :

Oct 1, 2011

Actual Study Completion Date :

Oct 1, 2011

Outcome Measures

Primary Outcome Measures

To assess the rate of complete histological response, according to Chevallier's classification [after 24 weeks of treatment]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.
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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Centre Jean Perrin	Clermont-Ferrand	France	63011
2	Pole Santé République	Clermont-Ferrand	France	63100
3	Centre Georges François Leclerc	Dijon	France	21079
4	Centre Oscar Lambret	Lille	France	59020
5	CHU Dupuytren	Limoges	France	87042
6	Centre Léon Bérard	Lyon	France	69373
7	Centre Hospitalier	Montluçon	France	03113
8	Hôpital Tenon	Paris	France	75970
9	Institut Jean Godinot	Reims	France	51056
10	Institut de Cancérologie de la Loire	Saint Priest en Jarez	France	42270
11	Centre Paul Strauss	Strasbourg	France	67065
12	Centre Alexis Vautrin	Vandoeuvre les Nancy	France	54511