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Combination Chemotherapy in Treating Women With Resected Breast Cancer
This study is ongoing, but not recruiting participants.
First Received: April 9, 2002   Last Updated: February 6, 2009   History of Changes
Sponsored by: Institute of Cancer Research - London
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00033683
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them after surgery may kill any tumor cells remaining after surgery. It is not yet known which combination chemotherapy regimen is more effective in treating resected stage I or stage II breast cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of different combination chemotherapy regimens in treating women who have resected stage I or stage II breast cancer.


Condition Intervention Phase
Breast Cancer
 Drug: CMF regimen
Drug: cyclophosphamide
Drug: docetaxel
Drug: epirubicin hydrochloride
Drug: fluorouracil
Drug: methotrexate
Drug: tamoxifen citrate
Procedure: adjuvant therapy
Radiation: radiation therapy
 Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Active Control
Official Title: A Randomised Trial Of Standard Anthracycline-Based Chemotherapy With Fluorouracil, Epirubicin And Cyclophosphamide (FEC) Or Epirubicin And CMF (Epi-CMF) Versus FEC Followed By Sequential Docetaxel As Adjuvant Treatment For Women With Early Breast Cancer

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer Radiation Therapy
Drug Information available for: Cyclophosphamide Fluorouracil Methotrexate Tamoxifen Tamoxifen citrate Epirubicin hydrochloride Epirubicin Docetaxel
U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: February 2001
Detailed Description:

OBJECTIVES:

  • Compare the disease-free and overall survival of women with completely resected stage I or II breast cancer adjuvantly treated with fluorouracil, epirubicin, and cyclophosphamide (FEC) or epirubicin followed by cyclophosphamide, methotrexate, and fluorouracil (EPI-CMF) versus FEC followed by sequential docetaxel.
  • Compare the acute toxicity of these regimens in these patients.
  • Compare the quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, estrogen receptor status (positive vs negative), and nodal status. Within 8 weeks after definitive surgery, patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients are assigned to 1 of 2 standard adjuvant chemotherapy regimens.

    • Regimen A: Patients receive fluorouracil, epirubicin, and cyclophosphamide (FEC) IV on day 1. Treatment repeats every 3 weeks for 8 courses.
    • Regimen B: Patients receive epirubicin IV on day 1. Treatment repeats every 3 weeks for 4 courses. Patients then receive cyclophosphamide orally on days 1-14 or IV on days 1 and 8 and methotrexate IV and fluorouracil IV on days 1 and 8 (CMF). Treatment with CMF repeats every 4 weeks for 4 courses.
  • Arm II: Patients receive 4 courses of adjuvant chemotherapy with FEC as in arm I, regimen A. Patients then receive sequential docetaxel IV over 1 hour once every 3 weeks for 4 courses. Beginning within 4 weeks after completion of adjuvant chemotherapy, patients who are not concurrently enrolled in the Standardization of Breast Radiotherapy (START) trial receive localized radiotherapy once daily, 5 days a week, for 3-5 weeks, according to local practice.

Beginning within 4 weeks after completion of adjuvant chemotherapy, patients who are estrogen receptor and/or progesterone receptor positive receive oral tamoxifen once daily for at least 5 years.

Quality of life is assessed at baseline, before course 5, at 3-4 weeks after course 8, and then at 9, 12, 18, and 24 months after initiation of adjuvant chemotherapy.

Patients are followed every 3 months for 2 years and then every 6 months thereafter.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 3,340 patients (1,670 per treatment arm) will be accrued for this study within 2 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed completely resected, invasive breast cancer for which adjuvant chemotherapy is indicated
  • No clinical or radiological evidence of locoregional or metastatic disease

  • No locally advanced tumors at diagnosis, indicated by any of the following:

    • Fixed tumors
    • Peau d'orange skin changes
    • Skin ulceration
    • Inflammatory changes (T4 or T3b, N2 disease)
  • No male breast cancer
  • No prior invasive breast cancer or bilateral breast cancer
  • Prior ductal carcinoma in situ or lobular carcinoma in situ is allowed
  • Must begin study chemotherapy within 8 weeks after definitive surgery

  • Hormone receptor status:

    • Estrogen receptor and progesterone receptor status known

PATIENT CHARACTERISTICS:

Age:

  • Over 18

Sex:

  • Female

Menopausal status:

  • Not specified

Performance status:

  • WHO 0-1

Life expectancy:

  • At least 2 years

Hematopoietic:

  • WBC at least 3,000/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 9 g/dL

Hepatic:

  • Bilirubin normal
  • AST no greater than 1.5 times normal
  • Alkaline phosphatase no greater than 1.5 times normal

Renal:

  • Creatinine no greater than 1.5 times normal

Cardiovascular:

  • No myocardial infarction within the past 6 months
  • No congestive heart failure

Other:

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No other invasive malignancy within the past 10 years except surgically cured nonmelanoma skin cancer or carcinoma in situ of the cervix
  • No other serious medical illness that would limit life expectancy
  • No psychiatric condition that would preclude informed consent
  • No active uncontrolled bacterial, viral, or fungal infection

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior biologic therapy

Chemotherapy:

  • See Disease Characteristics
  • No prior cytotoxic chemotherapy

Endocrine therapy:

  • No concurrent hormonal therapy (e.g., tamoxifen) during study chemotherapy
  • No concurrent hormone replacement therapy

Radiotherapy:

  • No prior radiotherapy

Surgery:

  • See Disease Characteristics

Other:

  • At least 4 weeks since any prior unlicensed drugs
  • No other concurrent experimental drugs
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00033683

  Show 69 Study Locations
Sponsors and Collaborators
Institute of Cancer Research - London
Investigators
Study Chair: Jane Banerji Institute of Cancer Research, United Kingdom
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications:
Hopwood P, Ellis P, Barrett-Lee P, et al.: Impact on quality of life (QL) during chemotherapy (CT) of FEC-T compared to FEC or E-CMF: results from the UK NCRI taxotere as adjuvant chemotherapy trial (TACT). [Abstract] J Clin Oncol 23 (Suppl 16): A-661, 43s, 2005.

Study ID Numbers: CDR0000069311, ICR-TACT, EU-20109
Study First Received: April 9, 2002
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00033683     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I breast cancer
stage II breast cancer

Study placed in the following topic categories:
Antimetabolites
Immunologic Factors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Folate
Bone Density Conservation Agents
Cyclophosphamide
Selective Estrogen Receptor Modulators
Hormones
Vitamin B9
Docetaxel
Anti-Bacterial Agents
Estrogen Receptor Modulators
Methotrexate
Alkylating Agents
 Breast Diseases
Estrogen Antagonists
Estrogens
Skin Diseases
Antineoplastic Agents, Hormonal
Citric Acid
Adjuvants, Immunologic
Breast Neoplasms
Folinic Acid
Folic Acid Antagonists
Immunosuppressive Agents
Tamoxifen
Epirubicin
Folic Acid
Fluorouracil

Additional relevant MeSH terms:
Antimetabolites
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Bone Density Conservation Agents
Reproductive Control Agents
Cyclophosphamide
Selective Estrogen Receptor Modulators
Antibiotics, Antineoplastic
Docetaxel
Estrogen Receptor Modulators
 Neoplasms by Site
Therapeutic Uses
Abortifacient Agents
Methotrexate
Dermatologic Agents
Alkylating Agents
Nucleic Acid Synthesis Inhibitors
Breast Diseases
Estrogen Antagonists
Antineoplastic Agents, Hormonal
Skin Diseases
Breast Neoplasms
Enzyme Inhibitors
Folic Acid Antagonists
Abortifacient Agents, Nonsteroidal

ClinicalTrials.gov processed this record on July 02, 2009



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