Clinical trial NCT00002696: Combination Chemotherapy in Treating Women With Stage III Breast Cancer
Official title: MULTIMODALITY TREATMENT STRATEGY FOR STAGE III BREAST CANCER
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE3
Conditions: Breast Cancer
Keywords: stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2003-01-27
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: 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.

PURPOSE: Randomized phase III trial to compare cyclophosphamide, doxorubicin, and fluorouracil with cyclophosphamide, methotrexate, and fluorouracil in treating women with stage III breast cancer.

Detailed description: OBJECTIVES:

* Compare the response in women with stage III breast cancer treated with neoadjuvant fluorouracil, doxorubicin, and cyclophosphamide (FAC) vs cyclophosphamide, methotrexate, and fluorouracil (CMF).
* Compare the rates of conservative surgical resectability and locoregional control in patients treated with these neoadjuvant therapy regimens.
* Compare the disease-free and overall survival of patients treated with these regimens.
* Compare the toxic effects of these regimens in these patients.
* Compare the compliance of patients treated with these regimens.
* Assess the cosmetic results in patients treated with conservative surgery.
* 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.

* Arm I: Patients receive fluorouracil (5-FU) IV on days 1 and 8 and doxorubicin IV and cyclophosphamide (CTX) IV on day 1 (FAC). Treatment continues every 3 weeks for 3 courses in the absence of disease progression.
* Arm II: Patients receive CTX IV, methotrexate IV, and 5-FU IV on days 1 and 8 (CMF). Treatment continues every 4 weeks for 3 courses in the absence of disease progression.

Patients on both arms with resectable disease after the third course of chemotherapy undergo quadrantectomy with axillary node dissection (preferred) or modified radical mastectomy, followed by 6 additional courses of chemotherapy on the arm to which they were randomized initially. Those patients without distant metastasis undergo locoregional radiotherapy beginning concurrently with the initiation of postoperative chemotherapy. Patients on both arms with unresectable disease after the initial 3 courses of chemotherapy undergo locoregional radiotherapy and then surgical resection (if feasible).

Quality of life is assessed at baseline and then monthly thereafter.

Patients are followed every 3-4 months for 2 years, every 4-6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: Not specified

Eligibility criteria: DISEASE CHARACTERISTICS:

* Histologically confirmed stage III breast cancer
* Measurable disease
* No inflammatory breast cancer
* No synchronous bilateral breast cancer
* Hormone receptor status:

  * Not specified

PATIENT CHARACTERISTICS:

Age:

* 21 to 75

Sex:

* Female

Menopausal status:

* Not specified

Performance status:

* ECOG 0-1 OR
* Zubrod 0-1

Life expectancy:

* More than 12 weeks

Hematopoietic:

* WBC greater than 4,000/mm\^3
* Platelet count greater than 100,000/mm\^3

Hepatic:

* Bilirubin less than 1.25 times upper limit of normal (ULN)
* AST less than 1.25 times ULN

Renal:

* Creatinine clearance greater than 70 mL/min

Cardiovascular:

* No angina pectoris
* No significant arrhythmia requiring therapy
* No bilateral bundle branch block
* No congestive heart failure
* No myocardial infarction

Other:

* No medical or psychiatric disease that would preclude study therapy
* No other malignancy except adequately treated nonmelanomatous skin cancer or carcinoma in situ of the cervix
* Not pregnant

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* Not specified

Endocrine therapy:

* Not specified

Radiotherapy:

* No prior radiotherapy

Surgery:

* No prior surgery except incisional biopsy or fine-needle aspiration

Other:

* No prior systemic therapy
* No concurrent caffeine or alcohol

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bahia Blanca
country: Argentina
facility: Policlinica Privada Instituto De Medicina Nuclear
state: Buenos Aires
city: Mar del Plata
country: Argentina
facility: Consultorio Oncologico Privado
state: Buenos Aires
city: Santa Rosa
country: Argentina
facility: Centro De Oncologia y Terapia Radiante
state: La Pampa
city: Neuquen
country: Argentina
facility: Unidad Oncologica Del Comahue
city: Rio Gallegos
country: Argentina
facility: Consultorio Oncologico Privado
city: Santa Fe
country: Argentina
facility: Centro Oncologico Del Litoral
city: Tres Arroyos
country: Argentina
facility: Centro Oncologico Tres Arroyos
Study officials:
affiliation: Unidad Oncologica Del Neuquen
name: Bernardo A. Leone, MD
role: STUDY_CHAIR
References: