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Weekly Paclitaxel During Radiation Therapy for Locally Advanced Breat Cancer

Phase 2
18 Years
Not Enrolling
Breast Cancer

Thank you

Trial Information

Weekly Paclitaxel During Radiation Therapy for Locally Advanced Breat Cancer

OBJECTIVES: I. Evaluate the safety and feasibility of twice a week paclitaxel and radiation
therapy in patients with locally advanced breast cancer. II. Determine the pathological
effects of paclitaxel and radiation in locally advanced breast cancer.

OUTLINE: This is a nonrandomized, dual institution study. Patients receive paclitaxel IV
over 1 hour twice a week for a total of 8 weeks. This is started within 1 week of a tumor
biopsy. Patients receive radiotherapy 5 days/week for 5.0 weeks within 1 week of the first
paclitaxel dose. Operable patients who have progressive disease with the above therapy
undergo a modified radical mastectomy (MRM), then receive 4 courses of doxorubicin IV and
cyclophosphamide IV, administered once every 21 days. Inoperable patients receive this same
chemotherapy regimen, then are reevaluated for surgery. Patients who have stable disease or
who respond to the paclitaxel/radiation regimen undergo a MRM, then receive 4 courses of
doxorubicin IV and paclitaxel IV (over 3 hours) once every 21 days. All patients with
hormone receptor positive tumors receive tamoxifen for 5 years after all other therapy is

PROJECTED ACCRUAL: A total of 40 patients (20 patients per institution) will be accrued over
18- 24 months.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically proven, untreated, locally advanced breast cancer;
stage IIB (T3 N0), IIIA, or IIIB Measurable disease Not inflammatory breast cancer or
other stage IIB (T2 N1) No distant metastases except for positive ipsilateral
supraclavicular nodes

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: ECOG 0-1 Life expectancy: Not
specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other:
Not pregnant Fertile patients must use effective contraception during and 6 months after
treatment Medically and psychologically stable

PRIOR CONCURRENT THERAPY: No prior therapy of any type

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Darcy V. Spicer, MD

Investigator Role:

Study Chair

Investigator Affiliation:

USC/Norris Comprehensive Cancer Center


United States: Federal Government

Study ID:

CDR0000065692 (1B-97-2)



Start Date:

April 1997

Completion Date:

March 2000

Related Keywords:

  • Breast Cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • Breast Neoplasms



USC/Norris Comprehensive Cancer Center Los Angeles, California  90033-0800
Mayo Clinic Jacksonville Jacksonville, Florida  32224