Combination Chemotherapy in Treating Women With Stage I Breast Cancer - Full Text View

Sponsored by:	Federation Nationale des Centres de Lutte Contre le Cancer
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00055679

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 may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating early breast cancer.

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

Condition	Intervention	Phase
Breast Cancer	Drug: cyclophosphamide Drug: epirubicin hydrochloride Drug: fluorouracil Drug: tamoxifen citrate Procedure: adjuvant therapy Radiation: radiation therapy	Phase III

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Radiation Therapy

Drug Information available for: Cyclophosphamide Fluorouracil Tamoxifen Tamoxifen citrate Epirubicin hydrochloride Epirubicin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control
Official Title:	Phase III Randomized Study Of Adjuvant Fluourouracil, Epirubicin And Cyclophosphamide, In Women With Stage I Breast Cancer

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

Primary Outcome Measures:

Efficacy, in terms of 5-year survival [ Designated as safety issue: No ]
Toxicity [ Designated as safety issue: Yes ]
Length of survival with biological factors [ Designated as safety issue: No ]
Biological factors significant for prognosis and prediction of survival [ Designated as safety issue: No ]
Overall survival [ Designated as safety issue: No ]

Estimated Enrollment:	1512
Study Start Date:	August 2002

Detailed Description:

OBJECTIVES:

Compare the efficacy of 4 vs 6 courses of adjuvant fluorouracil, epirubicin, and cyclophosphamide, in terms of 5-year survival, in women with stage I breast cancer.
Compare the toxicity of these regimens in these patients.
Determine the correlation of length of survival with biological factors in patients treated with these regimens.
Determine biological factors significant for prognosis and prediction of survival of patients treated with these regimens.
Determine the overall survival of patients treated with these regimens.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive fluorouracil IV, epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Arm II: Patients receive the same regimen as in arm I for up to 4 courses. After completion of chemotherapy, patients undergo radiotherapy 5 days a week for 6 weeks. Patients who are estrogen or progesterone receptor positive also receive oral tamoxifen daily for 5 years, beginning after completion of chemotherapy.

Patients are followed every 6 months for 5 years.

PROJECTED ACCRUAL: A total of 1,512 patients (756 per treatment arm) will be accrued for this study within 3 years.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed nonmetastatic, unilateral adenocarcinoma of the breast
- Stage I
- No clinically or radiologically suspicious metastases
- No positive sentinel lymph nodes by immunohistochemistry for tumors less than 2 cm
- No clinically proven positive axillary lymph nodes
  - Tumor cells found on immunohistochemistry only allowed
- No clinically or radiologically contralateral suspicious lesions
No deeply adherent disease
No cutaneous invasion
No inflammatory disease
Complete surgical resection within the past 42 days
- At least 8 lymph nodes removed
Tumor at least 1 cm with no residual disease
Presenting with at least 1 of the following factors of a poor prognosis:
- Tumor greater than 2 cm
- Hormone receptor negative tumor
- Grade II or III
- 35 years old or under
Hormone receptor status:
- Positive or negative

PATIENT CHARACTERISTICS:

Age

18 to 65

Sex

Female

Menopausal status

Not specified

Performance status

WHO 0-1

Life expectancy

Not specified

Hematopoietic

WBC at least 2,000/mm^3
Platelet count at least 100,000/mm^3

Hepatic

Bilirubin no greater than 1.25 times upper limit of normal (ULN)
AST and ALT no greater than 1.25 times ULN
Alkaline phosphatase no greater than 2.5 times ULN
No chronic hepatitis B
No active hepatitis C

Renal

Creatinine no greater than 1.25 times ULN

Pulmonary

FEV normal

Other

Not pregnant or nursing
HIV negative
No prior breast cancer or other malignancy
No familial, social, or geographical reason that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

No prior chemotherapy

Endocrine therapy

No prior anticancer hormone therapy

Radiotherapy

No prior radiotherapy

Surgery

See Disease Characteristics

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00055679

Show 72 Study Locations

Sponsors and Collaborators

Federation Nationale des Centres de Lutte Contre le Cancer

Investigators

Study Chair:

Pierre Kerbrat, MD, PhD

Centre Eugene Marquis

More Information

Additional Information:

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

No publications provided

Study ID Numbers:	CDR0000270763, FRE-FNCLCC-PACS-05/0106, EU-20239
Study First Received:	March 6, 2003
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00055679 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage I breast cancer

Study placed in the following topic categories:

Antimetabolites
Immunologic Factors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Bone Density Conservation Agents
Cyclophosphamide
Selective Estrogen Receptor Modulators
Hormones
Anti-Bacterial Agents
Estrogen Receptor Modulators
Alkylating Agents
Breast Diseases
Estrogens

Estrogen Antagonists
Skin Diseases
Antineoplastic Agents, Hormonal
Citric Acid
Adjuvants, Immunologic
Breast Neoplasms
Immunosuppressive Agents
Tamoxifen
Epirubicin
Fluorouracil
Antineoplastic Agents, Alkylating
Antirheumatic Agents

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
Cyclophosphamide
Antibiotics, Antineoplastic
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Neoplasms by Site
Therapeutic Uses

Alkylating Agents
Breast Diseases
Estrogen Antagonists
Skin Diseases
Antineoplastic Agents, Hormonal
Breast Neoplasms
Immunosuppressive Agents
Tamoxifen
Epirubicin
Pharmacologic Actions
Neoplasms
Fluorouracil
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 07, 2009