Clinical trial · Interventional
Assessment of the Efficacy of the Neoadjuvant Combination: "Chemotherapy-Targeted Therapy" in Breast Cancer.
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
NCT00933517CI-TRIAL-00014081TVAcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to assess the pathological response rate in operable breast cancer patients treated by neoadjuvant combination: "FEC-Taxotere/Vectibix".
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pathological Response Rate | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| docetaxel | Drug | Docetaxel | ALIAS |
| Epirubicine | Drug | Epirubicin | ALIAS |
| fluorouracile | Drug | — | UNRESOLVED |
| vectibix | Drug | Panitumumab | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To assess the rate of complete histological response, according to Chevallier's classification
- timeFrame
- after 24 weeks of treatment
Secondary outcomes (1)
- measure
- 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.
- timeFrame
- After 24 weeks of treatment, at surgery and at five years
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDNabholtz 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 24827135