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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centre Jean Perrin
ClinicalTrials.gov Identifier:
NCT00933517
First received: July 3, 2009
Last updated: March 20, 2014
Last verified: March 2014
  Purpose

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 Intervention Phase
Pathological Response Rate
Drug: vectibix
Drug: fluorouracile
Drug: Epirubicine
Drug: cyclophosphamide
Drug: docetaxel
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Centre Jean Perrin:

Primary Outcome Measures:
  • To assess the rate of complete histological response, according to Chevallier's classification [ Time Frame: after 24 weeks of treatment ] [ Designated as safety issue: No ]

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. [ Time Frame: After 24 weeks of treatment, at surgery and at five years ] [ Designated as safety issue: Yes ]

Enrollment: 62
Study Start Date: September 2009
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00933517

Locations
France
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
  More Information

No publications provided by Centre Jean Perrin

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Centre Jean Perrin
ClinicalTrials.gov Identifier: NCT00933517     History of Changes
Other Study ID Numbers: Getna7/CJP1.0
Study First Received: July 3, 2009
Last Updated: March 20, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Committee for the Protection of Personnes

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

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

ClinicalTrials.gov processed this record on September 18, 2014