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NCT Number: NCT00425516

Breast Cancer Treated by Neoadjuvant Chemotherapy

Neoadjuvant chemotherapy, known as "first" or "induction chemotherapy" in the therapeutic assumption of breast cancer is based on the narrow dependence preclinically revealed between primary tumour, tumoral angiogenesis and growth of distant metastases.

The results of the Aberdeen Group (Smith et al, 2002 ; Hutcheon et al, 2003), of the NSABP B27 trial (Bear et al, 2003) and of the Gepar-Duo Group (Von Minckwitz et al, 2002) have shown that a sequential protocol, using docetaxel after an anthracycline-based combination, allowed a better clinical response leading to more frequent conservative surgeries and, more importantly, to an increase in the rate of complete pathological response, assessing a better efficacy.

The use of a reference adjuvant protocol as a neo-adjuvant treatment is fully admissible because 7 randomized trials have shown a perfect equivalence between an adjuvant protocol and the same chemotherapy given as an induction treatment Even keeping the principle of a sequential treatment, a crucial question is to know if this sequential treatment should be the same for all patients, or if the oncologist could get a better complete pathological response, disease-free or overall survival rates by an adaptation of treatment to the objective result beginning after 2 FEC 100 courses by modulation of the following courses.

We will use as a primary regimen 3 FEC cycles + 3 TAXOTERE cycles, a standard adjuvant regimen (noted in the Temporary Protocol of Treatment of the Inca page 5 (October 2005) as well as in Saint Paul de Vence 2005 recommendations for adjuvant chemotherapy (Oncologie -- volume 7 - N°5, August 2005, p 370). This standard treatment will be compared to the same chemotherapy modulated in its repartition according to results obtained by subsequent tumor evaluations during induction therapy.

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Key information

Conditions

Individualized Chemotherapy Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Hospital center, Brive-la-Gaillarde, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient with histological proof of non metastatic breast cancer, whose clinical tumor diameter is > 2 cm, or < 2 cm, but situated in areolar area of the nipple.
  • T2-T3, N0-N1 tumor, non-inflammatory, unilateral, non-metastatic, grade II - III, HER2-neu negative, without extension beyond the breast and axillar area.
  • Performance Status = 0-1 WHO.
  • Patient non pretreated for breast cancer.
  • Patient without cardiac pathology and without anthracyclines contra-indication (assessed by normal ejection fraction).
  • Normal haematological, renal and hepatic functions : PNN > 2.109 /l, platelets > 100. 109 /l, Hb > 10 g/dl, normal bilirubin serum , ASAT and ALAT < 2,5 ULN, alkaline phosphatases < 2,5 ULN, creatinin < 140 µmol/l or creatinin clearance > 60 ml/min
  • Written informed consent dated and signed by the patient

Exclusion criteria

  • All other breast cancers than those described in inclusion criteria, in particular inflammatory and/or neglected (T4b or T4d) forms.
  • Patient presenting with plurifocal tumors, multicentric tumor, bilateral tumor.
  • Grade I well differentiated tumor.
  • HER2 neu 3 + (ICH or FISH or CISH) tumor.
  • Non measurable lesion, in the two diameters, whatever radiological methods used.
  • Patient presenting microcalcifications for which breast conservation is not possible.
  • Patient already operated for breast cancer or having had primary axillar node dissection.
  • Patient having antecedent of other cancer, exception for in situ uterine cervix or basocellular skin cancer, considered as healed.
  • Patient presenting another pathology considered as incompatible with patient inclusion in the study
  • Patient should not receive treatment with any other investigational drug and should not participate to another clinical study in a delay < 30 days or should not be pre-treated by cytostatic chemotherapy.
  • Antecedents of allergy to polysorbate 80.
  • Patient who is pregnant or lactating and not using effective contraceptive method.
  • Any psychological, familial, sociological or geographical condition that may potentially hamper compliance with the study protocol and follow up schedule, assessed with the patient prior to registration in the trial

Treatment and study plan

Taxotere

Drug

Other names: Docetaxel

5-fluorouracil

Drug

Epirubicin

Drug

Cyclophosphamide

Drug

Primary outcomes

  1. Improvement of complete pathological response rate at surgery after 6 chemotherapy cycles

    Time frame: after 6 cycles of chemotherapy

Secondary outcomes

  1. Tolerance according to NCI-CTC criteria

    Time frame: after each cycle of chemotherapy

  2. Objective clinical, echographic, mammographic responses after 6 cycles

    Time frame: after every 2 cycles of chemotherapy treatment

  3. Breast conservation rate

    Time frame: at surgery

  4. Study of biological predictive factors of chemosensitivity and resistance by immunological and molecular biology techniques)

    Time frame: before receive chemotherapy

  5. Overall and relapse-free survivals

    Time frame: 5 years after diagnosis

Sponsors and collaborators

Lead sponsor

Centre Jean Perrin

Other

Registry information

Official study title

Clinical Trial of the Neoadjuvant Standard Chemotherapy 3 FEC 100 + 3 TAXOTERE Protocol Versus the Same Protocol Adapted as a Function of Clinical Response

Important dates

Study start
2007
Primary completion
2014
Study completion
2014
First posted
Jan 23, 2007
Registry last updated
Oct 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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