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Multi-Cycle High-Dose Chemotherapy Versus Optimized Conventionally-Dosed Chemotherapy in Patients With Metastatic Breast Cancer: A Phase II Prospective Randomized Trial


Phase 2
18 Years
59 Years
Open (Enrolling)
Female
Breast Cancer

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Trial Information

Multi-Cycle High-Dose Chemotherapy Versus Optimized Conventionally-Dosed Chemotherapy in Patients With Metastatic Breast Cancer: A Phase II Prospective Randomized Trial


OBJECTIVES: I. Compare the efficacy of multi-course high-dose chemotherapy with autologous
peripheral blood stem cell transplantation versus standard-dose chemotherapy in women with
metastatic breast cancer. II. Compare the five year event-free survival, in terms of time to
progression or time to death due to toxic effects, in patients treated with these regimens.
III. Compare the response rate and overall survival of patients treated with these regimens.
IV. Compare the toxicity of these regimens in this patient population.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two
treatment arms. Arm I: Patients receive docetaxel and doxorubicin once followed by
filgrastim (G-CSF) daily for approximately 1 week. Treatment repeats approximately every 3
weeks for 4 courses. Patients then receive cyclophosphamide, methotrexate, and fluorouracil
on days 7 and 8 every 4 weeks for 4 courses. Arm II: Patients receive docetaxel,
doxorubicin, and G-CSF as in arm I for 3 courses. Patients undergo leukapheresis daily for 3
or 4 days. Patients then receive 1 course of ifosfamide, etoposide, and carboplatin daily
for 4 days when blood counts recover, followed by 1 course of cyclophosphamide and thiotepa
daily for 4 days. Patients undergo peripheral blood stem cell reinfusion following each
course.

PROJECTED ACCRUAL: A total of 264 patients (132 per arm) will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed stage IV breast carcinoma Bone
metastasis as only form of metastatic disease allowed No evidence of bone marrow
involvement by aspirate or biopsy No brain metastases Hormone receptor status: Not
specified

PATIENT CHARACTERISTICS: Age: 18 to 59 Sex: Female Menopausal status: Not specified
Performance status: Karnofsky 80-100% Life expectancy: More than 3 months Hematopoietic:
Absolute neutrophil count greater than 1,500/mm3 Platelet count greater than 100,000/mm3
Hemoglobin greater than 9 g/dL PT normal Activated PTT normal Hepatic: Bilirubin normal
(unless benign congenital hyperbilirubinemia is present) No AST/ALT greater than 1.5 times
upper limit of normal (ULN) together with alkaline phosphatase greater than 2.5 times ULN
No active hepatitis B or C Renal: Creatinine normal Cardiovascular: Ejection fraction
normal by MUGA or echocardiogram No active heart disease No prior myocardial infarction or
other manifestation of coronary artery disease Other: More than 1,000 calories/day oral
intake HIV negative No active serious medical or psychiatric disease No other prior or
concurrent malignancy except basal cell skin cancer or carcinoma in situ of the cervix No
allergy to polysorbate 80 or E. coli-derived products No peripheral neuropathy greater
than grade 2 Not pregnant Negative pregnancy test

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy for metastatic disease No prior mitomycin, nitrosoureas, or platinum
coordination complexes Prior adjuvant chemotherapy allowed if completed more than 6 months
prior to relapse with metastases No more than 300 mg/m2 prior doxorubicin or 450 mg/m2
prior epirubicin Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to
the brain or marrow-bearing pelvis Prior radiotherapy to lower pelvis allowed if the upper
border of the radiotherapy field is below the upper border of the acetabulum No other
prior radiotherapy to the pelvis Surgery: At least 2 weeks since prior major surgery
Other: No other concurrent anti-cancer therapy

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Linda T. Vahdat, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Herbert Irving Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000068504

NCT ID:

NCT00012311

Start Date:

January 2000

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage IV breast cancer
  • recurrent breast cancer
  • Breast Neoplasms

Name

Location
Herbert Irving Comprehensive Cancer Center New York, New York  10032