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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00933517
Recruitment Status : Completed
First Posted : July 7, 2009
Last Update Posted : March 21, 2014
Information provided by (Responsible Party):
Centre Jean Perrin

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
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 : September 2009
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Intervention Details:
    Drug: vectibix
    9mg/kg at D1 of each 21-days cycle
    Drug: fluorouracile
    500 mg/m2 at D1 of each 21-days cycle
    Drug: Epirubicine
    100 mg/m2 at D1 of each 21-days cycle
    Drug: cyclophosphamide
    500 mg/m2 at D1 of each 21 dyas cycle
    Drug: docetaxel
    100 mg/m2 at D1 of each 21 days cycle

Primary Outcome Measures :
  1. To assess the rate of complete histological response, according to Chevallier's classification [ Time Frame: after 24 weeks of treatment ]

Secondary Outcome Measures :
  1. 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. [ Time Frame: After 24 weeks of treatment, at surgery and at five years ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00933517

Centre Jean Perrin
Clermont-Ferrand, France, 63011
Pole Santé République
Clermont-Ferrand, France, 63100
Centre Georges François Leclerc
Dijon, France, 21079
Centre Oscar Lambret
Lille, France, 59020
CHU Dupuytren
Limoges, France, 87042
Centre Léon Bérard
Lyon, France, 69373
Centre Hospitalier
Montluçon, France, 03113
Hôpital Tenon
Paris, France, 75970
Institut Jean Godinot
Reims, France, 51056
Institut de Cancérologie de la Loire
Saint Priest en Jarez, France, 42270
Centre Paul Strauss
Strasbourg, France, 67065
Centre Alexis Vautrin
Vandoeuvre les Nancy, France, 54511
Sponsors and Collaborators
Centre Jean Perrin

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Centre Jean Perrin Identifier: NCT00933517     History of Changes
Other Study ID Numbers: Getna7/CJP1.0
First Posted: July 7, 2009    Key Record Dates
Last Update Posted: March 21, 2014
Last Verified: March 2014

Keywords provided by Centre Jean Perrin:
breast cancer, neoadjuvant therapies, chemotherapy, targeted therapy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators