Breast Cancer Treated by Neoadjuvant Chemotherapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

264 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2014-08-31

Brief Summary

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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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Detailed Description

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Conditions

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Individualized Chemotherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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standard (A)

3 FEC100 followed 3 Taxotere

Group Type NO_INTERVENTION

No interventions assigned to this group

Modulated (B)

possibility treatments receive: 2 FEC100 followed by 4 Taxotere 4 FEC100 followed by 2 Taxotere 6 FEC 100

Group Type EXPERIMENTAL

Taxotere

Intervention Type DRUG

5-Fluorouracil

Intervention Type DRUG

Epirubicin

Intervention Type DRUG

Cyclophosphamide

Intervention Type DRUG

Interventions

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Taxotere

Intervention Type DRUG

5-Fluorouracil

Intervention Type DRUG

Epirubicin

Intervention Type DRUG

Cyclophosphamide

Intervention Type DRUG

Other Intervention Names

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Docetaxel

Eligibility Criteria

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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

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No