Overview

Doxorubicin and Paclitaxel in Treating Women With Locally Advanced Breast Cancer

Status:
Completed
Trial end date:
2001-06-01
Target enrollment:
0
Participant gender:
Female
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 and giving the drugs in different ways may kill more tumor cells. PURPOSE: Randomized phase II trial to compare the effectiveness of doxorubicin with paclitaxel in treating women who have locally advanced breast cancer.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Georgetown University
Collaborator:
National Cancer Institute (NCI)
Treatments:
Albumin-Bound Paclitaxel
Doxorubicin
Liposomal doxorubicin
Paclitaxel
Tamoxifen
Criteria
DISEASE CHARACTERISTICS: Histologically proven locally advanced breast cancer Unresected T3
or T4 lesion, OR Unresected T2 lesion if patient considered appropriate candidate for
neoadjuvant chemotherapy to enhance breast conservation Hormone receptor status: Not
specified

PATIENT CHARACTERISTICS: Age: 18 and over Sex: Female Menopausal status: Not specified
Performance status: ECOG 0-2 Hematopoietic: WBC at least 3,500/mm3 Platelet count at least
100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times normal Renal: Creatinine no
greater than 1.5 times normal Cardiovascular: LVEF at least 50% (baseline MUGA) No history
of uncontrolled congestive heart failure At least 6 months since prior myocardial
infarction No unstable angina No uncontrolled hypertension Neurologic: No peripheral
neuropathy Other: Not pregnant or nursing No psychosis

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior cytotoxic
therapy Endocrine therapy: No prior hormonal therapy for breast cancer Prior estrogen
replacement therapy allowed No concurrent steroid therapy Radiotherapy: Not specified
Surgery: See Disease Characteristics Other: No concurrent treatment for serious infection
(bacterial, viral, or fungal)