A RANDOMIZED, MULTI-CENTRE PHASE III TRIAL TO EVALUATE THE ROLE OF INTENSIFIED THERAPY WITH AUTOLOGOUS TRANSPLANTATION OF HEMATOPOIETIC STEM CELLS IN ADVANCED OR METASTATIC BREAST CANCER RESPONDING TO INDUCTION CHEMOTHERAPY
N/A
59 Years
Female
Breast Cancer
Trial Information
A RANDOMIZED, MULTI-CENTRE PHASE III TRIAL TO EVALUATE THE ROLE OF INTENSIFIED THERAPY WITH AUTOLOGOUS TRANSPLANTATION OF HEMATOPOIETIC STEM CELLS IN ADVANCED OR METASTATIC BREAST CANCER RESPONDING TO INDUCTION CHEMOTHERAPY
OBJECTIVES: I. Evaluate the effect on 3-year survival of intensive chemotherapy with
cyclophosphamide/thiotepa with peripheral blood stem cell rescue in women with locally
recurrent or metastatic breast cancer who respond to induction therapy with
epirubicin/fluorouracil/cyclophosphamide. II. Evaluate the effects of this intensive
treatment on patient quality of life. III. Evaluate tumor response and progression-free
survival after intensification.
OUTLINE: This is a randomized study. Patients are stratified by clinical/therapeutic hormone
sensitivity and participating institution. All patients receive induction therapy with
epirubicin, fluorouracil, and cyclophosphamide (FEC 100) every 3 weeks for up to 4 courses,
with response evaluated after at least 2 courses. Patients with a complete response or at
least a 50% partial response are randomized either to no further therapy or to receive
intensification chemotherapy. Patients randomized to intensification undergo peripheral
blood stem cell (PBSC) harvest with G-CSF mobilization after the third or fourth induction
course. Three to 6 weeks after induction, patients receive intensification chemotherapy with
cyclophosphamide/thiotepa followed by PBSC. Post-transplant G-CSF is given for hematopoietic
support. No concurrent hormonal therapy is permitted during induction; local irradiation of
multifocal tumors is allowed provided response is still evaluable. Local therapy (excision
of single metastasis, radiotherapy to metastatic site) is permitted after completion of
protocol therapy. Treatment of relapsed disease is at the discretion of the investigator.
Patients are followed every 3 months for 3 years or until relapse, then every 6 months.
PROJECTED ACCRUAL: A total of 180 patients will be accrued over 3 years in this multicenter
study.
Inclusion Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically proven glandular breast cancer
Metastatic or locoregionally relapsed disease for which curative surgery and/or
radiotherapy is not feasible Histologic/cytologic confirmation of metastasis as feasible
Progression required within the month prior to entry, whether or not it occurs on hormonal
therapy No clinically detectable cerebral or meningeal involvement Measurable lesion
required, including soft tissue site, lymphadenopathy, or visceral site The following are
not considered measurable: Bony sites of involvement Ascites Pulmonary lymphangitic
carcinomatosis Skin lesions Pathologic CEA or CA 15.3 levels Laboratory changes Pleural
effusion Hormone receptor status: Not specified
PATIENT CHARACTERISTICS: Age: Under 60 Sex: Women only Menopausal status: Not specified
Performance status: WHO 0-2 Life expectancy: Greater than 3 months Hematopoietic: ANC at
least 2,000 Platelets at least 100,000 Hepatic: Bilirubin no greater than 2.0 mg/dL (35
micromoles/L) Renal: Creatinine no greater than 1.3 mg/dL (130 micromoles/L)
Cardiovascular: No congestive heart failure, even if stable No coronary artery disease No
myocardial infarction within 6 months Ventricular ejection fraction (resting) normal by
isotopic scan or echocardiogram No evidence of cardiac disease on EKG Other: No active
infection No second malignancy except: In situ cervical carcinoma Basal cell skin
carcinoma No pregnant women No psychological, familial, social, or geographical
contraindication to regular follow-up
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
palliative chemotherapy At least 1 year since adjuvant chemotherapy Maximum prior
cumulative anthracycline doses as follows: Epirubicin no greater than 450 mg per square
meter Doxorubicin no greater than 300 mg per square meter Pirarubicin no greater than 300
mg per square meter Mitoxantrone no greater than 60 mg per square meter Endocrine therapy:
Prior hormonal therapy allowed See Disease Characteristics Radiotherapy: At least 6 weeks
since radiotherapy to more than one third of hematopoietic regions Surgery: Not specified
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Principal Investigator
Pierre Biron, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Centre Leon Berard
Authority:
United States: Federal Government
Study ID:
CDR0000065151
NCT ID:
NCT00002870
Start Date:
December 1994
Completion Date:
Related Keywords:
- Breast Cancer
- stage IV breast cancer
- recurrent breast cancer
- Breast Neoplasms
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