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Study of Docetaxel in Breast Cancer Patients

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00174707
First received: September 12, 2005
Last updated: December 4, 2009
Last verified: December 2009
  Purpose

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)

Condition Intervention Phase
Breast Neoplasms
Drug: epidoxorubicine, ciclophosphamide, methotrexate, fluorouracile
Drug: epidoxorubicine, docetaxel, ciclophosphamide, methotrexate, fluorouracile
Drug: epidoxorubicine, docetaxel, cyclophosphamide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III Randomized Study of Sequential Epidoxorubicin Followed By CMF: Cyclophosphamide+Methotrexate+Fluorouracil (Arm A) Versus Sequential Epidoxorubicin Followed By Docetaxel Followed By CMF (Arm B) Versus Sequential Intensified Epidoxorubicin Followed By Docetaxel Followed By High-Dose Cyclophosphamide (Arm C) in Early Breast Cancer Patients With Positive Axillary Lymph Nodes

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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 Frame: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Recurrence-Free Survival (RFS) [ Time Frame: 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 ] [ Designated as safety issue: No ]
  • Overall Survival (OS) [ Time Frame: Time between the date of randomization and date of death ] [ Designated as safety issue: No ]
  • Distant Disease-Free Survival (DDFS) [ Time Frame: Time betwen the date of randomization and the date of distant recurrence or death from any cause, whichever occurs first ] [ Designated as safety issue: No ]

Enrollment: 998
Study Start Date: December 1997
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Sequential Epidoxorubicin followed by CMF: ciclophosphamide/Methotrexate/fluorouracile (±TAM: tamoxifen)
Drug: epidoxorubicine, ciclophosphamide, methotrexate, fluorouracile
Sequential Epidoxorubicin followed by ciclophosphamide/Methotrexate/fluorouracile (±TAM)
Experimental: B
Sequential Epidoxorubicin followed by Docetaxel followed by ciclophosphamide/methotrexate/fluorouracile (± TAM)
Drug: epidoxorubicine, docetaxel, ciclophosphamide, methotrexate, fluorouracile
Sequential Epidoxorubicin followed by Docetaxel followed by ciclophosphamide/methotrexate/fluorouracile (± TAM)
Experimental: C
Sequential Intensified Epidoxorubicin followed by Docetaxel followed by Cyclophosphamide (± TAM)
Drug: epidoxorubicine, docetaxel, cyclophosphamide
Sequential Intensified Epidoxorubicin followed by Docetaxel followed by Cyclophosphamide (± TAM)

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • 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
  • Normal left ventricular ejection fraction or superior to the lower limits of the institution
  • Patients must be accessible for treatment and follow-up. Patients registered on this trial must be treated and followed at the participating center
  • Complete work-up within 3 months prior to randomization. All patients will have bilateral mammography, chest X rays (posteroanterior [PA] and lateral), abdominal ultrasound and/or computed tomography scan, & bone scan

Exclusion criteria:

  • 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
  • Past or current history of ipsilateral or contralateral invasive or contralateral ductal in situ breast carcinoma. A past or current history of ipsilateral ductal in situ or lobular in situ (ipsilateral or contralateral) breast carcinoma is not an exclusion criterion
  • 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
  • Concurrent treatment with ovarian hormonal replacement therapy. Prior treatment should be stopped before study entry
  • Prior systemic anticancer therapy for breast cancer (chemotherapy, hormonal therapy, immunotherapy, etc.) as adjuvant and/or neo-adjuvant therapy
  • Concomitant treatment with corticosteroids used for reasons other than premedication; however, patients receiving chronic treatment with corticosteroids (>6 months) at low dose (≤ 20 mg of methylprednisolone or equivalent dose of other corticosteroids) for whichever reason are eligible
  • Definite contraindications for the use of corticosteroids as premedication
  • Prior radiation therapy

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00174707

Locations
Italy
Sanofi-Aventis Administrative Office
Milan, Italy
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Georges Paizis, MD Sanofi
  More Information

No publications provided

Responsible Party: Medical Affairs Medical Director, Sanofi-aventis aministrative office
ClinicalTrials.gov Identifier: NCT00174707     History of Changes
Other Study ID Numbers: TAX_IT1_302, TAX_IT_216
Study First Received: September 12, 2005
Last Updated: December 4, 2009
Health Authority: Italy: The Italian Medicines Agency

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Cyclophosphamide
Docetaxel
Epirubicin
Methotrexate
Abortifacient Agents
Abortifacient Agents, Nonsteroidal
Alkylating Agents
Antibiotics, Antineoplastic
Antimetabolites
Antimetabolites, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunologic Factors
Immunosuppressive Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 27, 2014