Study of Docetaxel in Breast Cancer Patients

NCT00174707 | Completed Phase 3

• 2 other identifiers: TAX_IT1_302TAX_IT_216
• Study Type: interventional
• Target: 998
• Locations: 1 country
• Sites: 1

Brief Summary

Primary objectives:

• To compare the disease free survival (DFS) in patients treated with the sequential epidoxorubicin, cyclophosphamide, methotrexate, and fluorouracil (CMF) regimen to that in patients treated with the same treatment plus docetaxel given sequentially after epidoxorubicin Secondary objectives:
• To compare the DFS in patients treated with the sequential epidoxorubicin, docetaxel and CMF (only patients with \> or = 4 lymph nodes) regimen to that in patients treated with sequential intensified epidoxorubicin/docetaxel/high dose (HD) cyclophosphamide regimen
• To evaluate the overall survival in each arm
• To evaluate the tolerability of a sequential intensified epidoxorubicin/docetaxel/HD-cyclophosphamide (arm C)
• To compare the safety of a sequential epidoxorubicin/docetaxel/CMF (arm B) regimen versus a standard sequential epidoxorubicin/CMF regimen (arm A)

Conditions

Breast Neoplasms

Outcome Measures

Primary Outcomes (1)

• Invasive Disease-Free Survival (IDFS) - with exclusion of ductal carcinoma in situ- DCIS- either collateral or ipsilateral, according to STEEP in adjuvant breast cancer trial: Standardized Definitions for Efficacy Endpoints

  Time between randomization date and date of local or distant recurrence or contralateral breast cancer or second primary (non breast) cancer or death from any cause, whichever occurs first

Secondary Outcomes (3)

• Recurrence-Free Survival (RFS)

  Time between the date of randomization and the date of local or distant recurrence or death from any cause, whichever occurs first, thus excluding contralateral breast cancer or second primary (non breast) cancers

• Overall Survival (OS)

  Time between the date of randomization and date of death

• Distant Disease-Free Survival (DDFS)

  Time betwen the date of randomization and the date of distant recurrence or death from any cause, whichever occurs first

Study Arms (3)

A

ACTIVE COMPARATOR

Sequential Epidoxorubicin followed by CMF: ciclophosphamide/Methotrexate/fluorouracile (±TAM: tamoxifen)

Drug: epidoxorubicine, ciclophosphamide, methotrexate, fluorouracile

B

EXPERIMENTAL

Sequential Epidoxorubicin followed by Docetaxel followed by ciclophosphamide/methotrexate/fluorouracile (± TAM)

Drug: epidoxorubicine, docetaxel, ciclophosphamide, methotrexate, fluorouracile

C

EXPERIMENTAL

Sequential Intensified Epidoxorubicin followed by Docetaxel followed by Cyclophosphamide (± TAM)

Drug: epidoxorubicine, docetaxel, cyclophosphamide

Interventions

epidoxorubicine, ciclophosphamide, methotrexate, fluorouracile DRUG

Sequential Epidoxorubicin followed by ciclophosphamide/Methotrexate/fluorouracile (±TAM)

A

epidoxorubicine, docetaxel, ciclophosphamide, methotrexate, fluorouracile DRUG

Sequential Epidoxorubicin followed by Docetaxel followed by ciclophosphamide/methotrexate/fluorouracile (± TAM)

B

epidoxorubicine, docetaxel, cyclophosphamide DRUG

Sequential Intensified Epidoxorubicin followed by Docetaxel followed by Cyclophosphamide (± TAM)

C

Eligibility Criteria

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

You may qualify if:

• Histologically proven breast cancer at the first diagnosis with \> or = 4 axillary nodes showing evidence of tumor among a minimum of 10 resected lymph nodes (American Joint Committee on Cancer 1992 pathologic staging pT1-4, pN1-2 \[at least 1/10\], M0)
• Ages ≥ 18 years and ≤ 70 years for patients who will be randomized to arm A and B. Ages ≥ 18 years and ≤ 65 years for patients who will be randomized to arm C
• World Health Organization performance status 0-1
• Definitive surgical treatment must be either mastectomy or breast conserving surgery, with axillary lymph node dissection for operable breast cancer (clinical T1-3, N1, M0). Margins of resected specimen from definitive surgery must be histologically free of invasive adenocarcinoma and ductal carcinoma in situ. Lobular carcinoma in situ does not count as a positive margin. Patients with histologically-documented infiltration of the skin (pT4a) will be also eligible
• Surgical procedures completed within 8 weeks from the randomization.
• Laboratory requirements:
• Hematology :
• Neutrophils ≥ 2 x 10\^9/L
• Platelets ≥ 100 x 10\^9/L
• Hemoglobin ≥ 10 g/DL
• Hepatic function:
• Total bilirubin ≤ 1 time the upper-normal limits of the institutional normal values.
• ASAT \& ALAT ≤ 2.5 UNL, alkaline phosphatase ≤ 5 UNL. Patients with ASAT \&/or ALAT \> 1.5 x UNL associated with alkaline phosphatase \> 2.5 x UNL are not eligible for the study
• Renal function :
• Creatinine ≤ 140 µmol/L (1.6 mg/DL); if limit values, the creatinine clearance should be performed and should be ≥ 60 ml/min

You may not qualify if:

• Axillary lymph nodes free of involvement
• Primary breast cancer with histology other than adenocarcinoma
• Inflammatory carcinoma
• Any locally advanced (T4 and/or N2-known N3) or metastatic (M1) breast cancer
• Histologically positive resection margins. Patients undergoing conservative resection margins can be considered eligible if radically resected within 4 weeks from randomization
• Pregnant or lactating women or women of childbearing potential (e.g. not using adequate contraception)
• History of prior or concomitant malignancies other than curatively treated basal cell skin cancer or excised cervical carcinoma in situ
• Symptomatic peripheral neuropathy \> grade 2 according to the National Cancer Institute Common Toxicity Criteria
• Other serious illnesses or medical conditions:
• Congestive heart failure or angina pectoris even if it is medically controlled. Previous history of myocardial infarction within 1 year from study entry, uncontrolled high risk hypertension or arrhythmias
• History of significant neurologic or psychiatric disorders including dementia or seizures
• Active infection
• Peptic ulcer, unstable diabetes mellitus or other contraindications for the use of dexamethasone
• Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational regimen within 30 days prior to study entry
• Concurrent treatment with any other anti-cancer therapy

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis Administrative Office

Milan, Italy

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Methotrexate; Docetaxel; Cyclophosphamide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds

Study Officials

• Georges Paizis, MD

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 15, 2005
• Study Start: December 1, 1997
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: December 7, 2009

Record last verified: 2009-12

Locations

IT (1)