Breast Cancer Treated by Neoadjuvant Chemotherapy

NCT00425516 | Completed Phase 2

• 1 other identifier: CJP AU651/Afssaps060744
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Individualized Chemotherapy

Keywords

neoadjuvant chemotherapy; breast cancer; sequential treatment

Outcome Measures

Primary Outcomes (1)

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

  after 6 cycles of chemotherapy

Secondary Outcomes (5)

• Tolerance according to NCI-CTC criteria

  after each cycle of chemotherapy

• Objective clinical, echographic, mammographic responses after 6 cycles

  after every 2 cycles of chemotherapy treatment

• Breast conservation rate

  at surgery

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

  before receive chemotherapy

• Overall and relapse-free survivals

  5 years after diagnosis

Study Arms (2)

standard (A)

NO INTERVENTION

3 FEC100 followed 3 Taxotere

Modulated (B)

EXPERIMENTAL

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

Drug: Taxotere; Drug: 5-Fluorouracil; Drug: Epirubicin; Drug: Cyclophosphamide

Interventions

Taxotere DRUG

Also known as: Docetaxel

Modulated (B)

5-Fluorouracil DRUG

Modulated (B)

Epirubicin DRUG

Modulated (B)

Cyclophosphamide DRUG

Modulated (B)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 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

Sponsors & Collaborators

• Centre Jean Perrin: lead

Study Sites (6)

Hospital center

Brive-la-Gaillarde, 19100, France

Location

Centre Jean Perrin

Clermont-Ferrand, 63011, France

Location

University Hospital La Tronche

Grenoble, 38043, France

Location

Edouard Herriot University Hospital

Lyon, 69000, France

Location

Institut Jean Godinot

Reims, 51056, France

Location

Institut de Cancérologie de la Loire

Saint-Priest-en-Jarez, 42270, France

Location

Related Publications (3)

• Roché H, Fumoleau P, Spielman M et al. Breast Cancer Res Treat. 2004;88(suppl1):S16. Abstract 27

  BACKGROUND

• Mouret-Reynier MA, Abrial CJ, Ferriere JP, Amat S, Cure HD, Kwiatkowski FG, Feillel VA, Lebouedec G, Penault-Llorca FM, Chollet PJ. Neoadjuvant FEC 100 for operable breast cancer: eight-year experience at Centre Jean Perrin. Clin Breast Cancer. 2004 Oct;5(4):303-7. doi: 10.3816/cbc.2004.n.035.

  PMID: 15507178 BACKGROUND

• Wang-Lopez Q, Mouret-Reynier MA, Savoye AM, Abrial C, Kwiatkowski F, Garbar C, DuBray-Longeras P, Eymard JC, Lebouedec G, Vanpraagh I, Penault-Llorca F, Chollet P, Cure H. Is it important to adapt neoadjuvant chemotherapy to the visible clinical response? An open randomized phase II study comparing response-guided and standard treatments in HER2-negative operable breast cancer. Oncologist. 2015 Mar;20(3):243-4. doi: 10.1634/theoncologist.2014-0400. Epub 2015 Jan 30.

  PMID: 25637380 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Docetaxel; Fluorouracil; Epirubicin; Cyclophosphamide

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds

Study Officials

• Philippe Chollet, Pr

  Centre Jean Perrin

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2007
• First Posted: January 23, 2007
• Study Start: January 1, 2007
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: October 1, 2014

Record last verified: 2007-02

Locations

FR (6)