- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00933517
Assessment of the Efficacy of the Neoadjuvant Combination: "Chemotherapy-Targeted Therapy" in Breast Cancer. (TVA)
March 20, 2014 updated by: Centre Jean Perrin
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
The purpose of this study is to assess the pathological response rate in operable breast cancer patients treated by neoadjuvant combination: "FEC-Taxotere/Vectibix".
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
62
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Clermont-Ferrand, France, 63011
- Centre Jean Perrin
-
Clermont-Ferrand, France, 63100
- Pôle Santé République
-
Dijon, France, 21079
- Centre Georges François Leclerc
-
Lille, France, 59020
- Centre Oscar Lambret
-
Limoges, France, 87042
- Chu Dupuytren
-
Lyon, France, 69373
- Centre Leon Berard
-
Montluçon, France, 03113
- Centre Hospitalier
-
Paris, France, 75970
- Hopital Tenon
-
Reims, France, 51056
- Institut Jean Godinot
-
Saint Priest en Jarez, France, 42270
- Institut de Cancerologie de La Loire
-
Strasbourg, France, 67065
- Centre Paul Strauss
-
Vandoeuvre les Nancy, France, 54511
- Centre Alexis Vautrin
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To assess the rate of complete histological response, according to Chevallier's classification
Time Frame: after 24 weeks of treatment
|
after 24 weeks of treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
After 24 weeks of treatment, at surgery and at five years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2009
Primary Completion (Actual)
October 1, 2011
Study Completion (Actual)
October 1, 2011
Study Registration Dates
First Submitted
July 3, 2009
First Submitted That Met QC Criteria
July 6, 2009
First Posted (Estimate)
July 7, 2009
Study Record Updates
Last Update Posted (Estimate)
March 21, 2014
Last Update Submitted That Met QC Criteria
March 20, 2014
Last Verified
March 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antirheumatic Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antineoplastic Agents, Immunological
- Antibiotics, Antineoplastic
- Docetaxel
- Cyclophosphamide
- Epirubicin
- Panitumumab
Other Study ID Numbers
- Getna7/CJP1.0
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pathological Response Rate
-
University of Southern DenmarkCompleted
-
Shanghai Jiao Tong University School of MedicineCompleted
-
Peking Union Medical College HospitalOrigiMedRecruitingQuality of Life | Objective Response Rate | Overall Survival | Progression-free Survival | Disease Control Rate | Duration of Response | Five-year Survival RateChina
-
Leiden University Medical CenterThe Netherlands Cancer Institute; Borstkanker Onderzoek Groep; Comprehensive... and other collaboratorsSuspendedHER2-negative Breast Cancer | Hormone Receptor-positive Breast Cancer | Neoadjuvant Chemotherapy | Fasting Mimicking Diet | Pathological Complete Response | Objective Response RateNetherlands
-
Erasmus Medical CenterNot yet recruitingPathological Response Rate, Circulating Tumour DNA
-
Shanghai CP Guojian Pharmaceutical Co., Ltd.CompletedAdverse Events | Progress-free Survival | Overall Response Rate
-
InCor Heart InstituteConselho Nacional de Desenvolvimento Científico e TecnológicoCompletedOxidative Stress | Heart Rate Variability | Systemic Inflammatory Response | Lung FunctionBrazil
-
Second Affiliated Hospital, School of Medicine,...RecruitingObjective Response RateChina
-
Mayo ClinicNational Heart, Lung, and Blood Institute (NHLBI)CompletedHeart Rate Variability | Blood Pressure Variability | Pressor Response | Baroreflex Sensitivity | Arterial CatecholaminesUnited States
-
The University of Hong KongCompletedTo Test the Effectiveness of Different Incentive Models for Increasing the Follow-up Response Rate in the Current Smoker SubjectHong Kong
Clinical Trials on vectibix
-
Fondazione del Piemonte per l'OncologiaCompleted
-
AmgenCompletedCarcinoma | Cancer | Head and Neck Cancer | Metastatic Cancer | Oncology | Tumors | Metastatic or Recurrent Squamous Cell Carcinoma of Head and Neck | Squamous Cell Carcinoma | Metastases
-
M.D. Anderson Cancer CenterAmgenCompletedGastrointestinal CancerUnited States
-
Cliniques universitaires Saint-Luc- Université...Terminated
-
National Center for Tumor Diseases, HeidelbergCompleted
-
Boston Medical CenterAmgenWithdrawn
-
Qilu Pharmaceutical Co., Ltd.Unknown
-
AmgenCompletedMetastatic Colorectal Cancer
-
AmgenCompleted
-
John Strickler, M.D.ExelixisCompletedColorectal CancerUnited States