Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
No phase specified	Treatment	Closed	no age specified		MDA-MBDT-8081

Objectives

I.  Determine whether the administration of adriamycin by continuous infusion 
decreases cardiotoxicity and therefore can allow continued administration for 
a longer period.
II.  Determine whether continuous-infusion adriamycin can increase the 
response rate from the combination chemotherapy regimen FAC:  
5-fluorouracil/adriamycin/cyclophosphamide.
III.  Determine whether continuing adriamycin as part of the FAC regimen 
prolongs the remission and survival durations of patients with metastatic 
breast cancer.
IV.  Determine the qualitative and quantitative toxicity of this combination.
V.  Determine whether early changes in systemic therapy in patients with 
stable and progressive disease prolongs the duration of survival of these two 
subgroups of patients.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients with histologically 
diagnosed, measurable or evaluable metastatic breast cancer with evidence of 
progression.  Patients showing evidence of resistance to the study agents and 
those with abnormal electrocardiogram may be excluded.  Patients with 
uncompensated congestive heart failure or uncompensated severe hypertension 
are excluded.  Patients must be ineligible for protocols of higher priority 
and have adequate bone marrow function.

Expected Enrollment

60 patients will be required.  Protocol closed.

Outline

Nonrandomized study.  ER-positive or unknown patients enter Regimen A, then 
switch to Regimen B if disease progresses, or follow Regimen A with Regimen B 
if disease stabilizes or improves.  Patients receive Regimens A and B 
simultaneously in the presence of life-threatening disease or liver and 
lymphangitic lung metastases at study entry.
Regimen A:  Single-agent Antiestrogen Therapy.  Tamoxifen, TMX, NSC-180973.
Regimen B:  Induction:  3-Drug Combination Chemotherapy.  FAC:  
5-Fluorouracil, 5-FU, NSC-19893; Adriamycin, Doxorubicin, ADR, NSC-123127; 
Cyclophosphamide, Cytoxan, CTX, NSC-26271.  Substitute alternate drug for CTX 
if hemorrhagic cystitis develops:  Melphalan, L-PAM, NSC-8806.
Patients enter Regimen C if there is disease progression after 2 courses (or 
no improvement after 6 courses) of Regimen B.
Regimen C:  Single-agent Chemotherapy.  Vinblastine, VBL, NSC-49842.
Patients enter Regimen D upon evidence of cardiac toxicity while responding to 
therapy.
Regimen D:  Maintenance:  3-Drug Combination Chemotherapy.  CMF:  CTX; 5-FU; 
Methotrexate, MTX, NSC-740.
Patients are restaged after 6 courses of Regimen B, and receive debulking 
surgery concomitant with systemic therapy.  Patients achieving CR, or PR in 
excess of 75 percent, after systemic therapy and/or debulking enter Regimen E 
concomitantly.
Regimen E:  Local Consolidation:  Radiotherapy, local and involved fields.

Trial Contact Information

Trial Lead Organizations

M. D. Anderson Cancer Center at University of Texas

Eugene M. McKelvey, MD, Protocol chair		Ph: 713-792-2570; 800-392-1611