NCT00933517

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".

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2009

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 3, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 7, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

March 21, 2014

Status Verified

March 1, 2014

Enrollment Period

2.1 years

First QC Date

July 3, 2009

Last Update Submit

March 20, 2014

Conditions

Pathological Response Rate

Keywords

breast cancer, neoadjuvant therapies, chemotherapy, targeted therapy

Outcome Measures

Primary Outcomes (1)

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

    after 24 weeks of treatment

Secondary Outcomes (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.

    After 24 weeks of treatment, at surgery and at five years

Interventions

vectibixDRUG

9mg/kg at D1 of each 21-days cycle

fluorouracileDRUG

500 mg/m2 at D1 of each 21-days cycle

EpirubicineDRUG

100 mg/m2 at D1 of each 21-days cycle

cyclophosphamideDRUG

500 mg/m2 at D1 of each 21 dyas cycle

docetaxelDRUG

100 mg/m2 at D1 of each 21 days cycle

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).
  • Member of a Social Security scheme (or a beneficiary of such a scheme) according to the provisions of the law of 9 August 2004.

You may not qualify if:

  • 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.
  • 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.
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Centre Jean Perrin

Clermont-Ferrand, Clermont-Ferrand, 63011, France

Location

Centre Paul Strauss

Strasbourg, Strasbourg, 67065, France

Location

Pole Santé République

Clermont-Ferrand, 63100, France

Location

Centre Georges François Leclerc

Dijon, 21079, France

Location

Centre Oscar Lambret

Lille, 59020, France

Location

CHU Dupuytren

Limoges, 87042, France

Location

Centre Léon Bérard

Lyon, 69373, France

Location

Centre Hospitalier

Montluçon, 03113, France

Location

Hôpital Tenon

Paris, 75970, France

Location

Institut Jean Godinot

Reims, 51056, France

Location

Institut de Cancérologie de la Loire

Saint-Priest-en-Jarez, 42270, France

Location

Centre Alexis Vautrin

Vandœuvre-lès-Nancy, 54511, France

Location

Related Publications (1)

  • Nabholtz JM, Abrial C, Mouret-Reynier MA, Dauplat MM, Weber B, Gligorov J, Forest AM, Tredan O, Vanlemmens L, Petit T, Guiu S, Van Praagh I, Jouannaud C, Dubray-Longeras P, Tubiana-Mathieu N, Benmammar KE, Kullab S, Bahadoor MR, Radosevic-Robin N, Kwiatkowski F, Desrichard A, Cayre A, Uhrhammer N, Chalabi N, Chollet P, Penault-Llorca F. Multicentric neoadjuvant phase II study of panitumumab combined with an anthracycline/taxane-based chemotherapy in operable triple-negative breast cancer: identification of biologically defined signatures predicting treatment impact. Ann Oncol. 2014 Aug;25(8):1570-7. doi: 10.1093/annonc/mdu183. Epub 2014 May 14.

    PMID: 24827135DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

PanitumumabFluorouracilEpirubicinCyclophosphamideDocetaxel

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDoxorubicinDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedPhosphoramidesOrganophosphorus CompoundsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicDiterpenesTerpenes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2009

First Posted

July 7, 2009

Study Start

September 1, 2009

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

March 21, 2014

Record last verified: 2014-03

Locations

FR(12)