Combination Chemotherapy With or Without Fluorouracil and/or Pegfilgrastim in Treating Women With Node-Positive Breast Cancer - Full Text View

Sponsored by:	Gruppo Italiano Mammella
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00433420

Purpose

RATIONALE: Drugs used in chemotherapy, such as epirubicin, cyclophosphamide, paclitaxel, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Colony-stimulating factors, such as pegfilgrastim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Giving combination chemotherapy and pegfilgrastim after surgery may kill any tumor cells that remain after surgery. It is not yet known whether combination chemotherapy is more effective with or without fluorouracil and/or pegfilgrastim in treating breast cancer.

PURPOSE: This randomized phase III trial is studying combination chemotherapy to compare how well it works when given with or without fluorouracil and/or pegfilgrastim in treating women with node-positive breast cancer.

Condition	Intervention	Phase
Breast Cancer	Drug: cyclophosphamide Drug: epirubicin hydrochloride Drug: fluorouracil Drug: paclitaxel Drug: pegfilgrastim Procedure: adjuvant therapy	Phase III

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Cyclophosphamide Paclitaxel Fluorouracil Epirubicin hydrochloride Epirubicin Pegfilgrastim

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized
Official Title:	A Phase III Randomized Study of EC Followed by Paclitaxel Versus FEC Followed by Paclitaxel, All Given Either Every 3 Weeks or 2 Weeks Supported by Pegfilgrastim, for Node Positive Breast Cancer Patients

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

Primary Outcome Measures:

Disease-free survival [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall survival [ Designated as safety issue: No ]
Toxicity [ Designated as safety issue: Yes ]

Estimated Enrollment:	2000
Study Start Date:	April 2003

Detailed Description:

OBJECTIVES:

Primary

Compare the efficacy of adjuvant therapy comprising epirubicin hydrochloride, cyclophosphamide, and paclitaxel with vs without fluorouracil and/or pegfilgrastim in women with node-positive breast cancer.

Secondary

Compare the overall survival of patients treated with these regimens.
Compare the safety of these regimens in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 4 treatment arms.

Arm I: Patients receive epirubicin hydrochloride IV and cyclophosphamide IV on day 1. Treatment repeats every 3 weeks for 4 courses. Patients then receive paclitaxel IV over 3 hours on day 1. Treatment with paclitaxel repeats every 3 weeks for 4 courses.
Arm II: Patients receive fluorouracil IV, epirubicin hydrochloride IV, and cyclophosphamide IV on day 1. Treatment repeats every 3 weeks for 4 courses. Patients then receive paclitaxel as in arm I.
Arm III: Patients receive epirubicin hydrochloride IV and cyclophosphamide IV on day 1 and pegfilgrastim subcutaneously (SC) on day 4. Treatment repeats every 2 weeks for 4 courses. Patients then receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim subcutaneously (SC) on day 4. Treatment with paclitaxel and pegfilgrastim repeats every 2 weeks for 4 courses.
Arm IV: Patients receive fluorouracil IV, epirubicin hydrochloride IV, and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 4. Treatment repeats every 2 weeks for 4 courses. Patients then receive paclitaxel and pegfilgrastim as in arm III.

In all arms, treatment continues in the absence of disease progression or unacceptable toxicity. After completion of chemotherapy with or without pegfilgrastim, patients may undergo external-beam radiation therapy at the discretion of treating center. Patients with positive estrogen and/or progesterone receptor tumor receive tamoxifen for 5 years.

After completion of study treatment, patients are followed periodically for 5 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 2,000 patients will be accrued for this study.

Eligibility

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

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed primary breast cancer
- No histology other than carcinoma
Node-positive disease
- Must have at least 1 involved axillary node or internal mammary node
Previously resected disease
- Has undergone radical surgery (i.e., mastectomy or conservative surgery) with axillary node dissection within the past 7 weeks
No inflammatory carcinoma
No prior or concurrent ipsilateral or contralateral invasive breast carcinoma
No metastatic disease, including metastasis in the ipsilateral supraclavicular lymph nodes
Hormone receptor status not specified

PATIENT CHARACTERISTICS:

Female
Menopausal status not specified
ECOG performance status 0-1
Absolute neutrophil count ≥ 1,500/mm³
WBC ≥ 4,000/mm³
Platelet count ≥ 100,000/mm³
Hemoglobin ≥ 9 g/dL
Bilirubin ≤ 1.5 times upper limit of normal (ULN)
Creatinine ≤ 1.5 times ULN
AST and ALT ≤ 2.5 times ULN
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No chronic liver or renal disease
No other serious medical illness requiring medication
No other malignancy except adequately treated, cone-biopsied in situ carcinoma of the cervix or basal cell or squamous cell carcinoma of the skin
No symptomatic peripheral neuropathy > grade 2
No hypersensitivity to study drugs or their components
No recent myocardial infarction, congestive heart failure, or serious arrhythmia

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
No prior chemotherapy
No prior cytotoxic regimens
No prior radiation therapy, except for intraoperative radiation therapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00433420

Sponsors and Collaborators

Gruppo Italiano Mammella

Investigators

Study Chair:

Marco Venturini, MD

Istituto Nazionale per la Ricerca sul Cancro

More Information

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

Study ID Numbers:	CDR0000528056, GIM-2, EU-20681
Study First Received:	February 8, 2007
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00433420
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer

Study placed in the following topic categories:

Skin Diseases
Paclitaxel
Fluorouracil
Breast Neoplasms

Cyclophosphamide
Epirubicin
Breast Diseases

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Mitosis Modulators
Physiological Effects of Drugs
Antimitotic Agents
Antibiotics, Antineoplastic
Immunosuppressive Agents

Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Tubulin Modulators
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Alkylating Agents

ClinicalTrials.gov processed this record on January 16, 2009