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A Pilot Trial Comparing Doxorubicin and Paclitaxel Induced Apoptosis in Locally Advanced Breast Cancer


Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Cancer

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Trial Information

A Pilot Trial Comparing Doxorubicin and Paclitaxel Induced Apoptosis in Locally Advanced Breast Cancer


OBJECTIVES: I. Assess the feasibility of obtaining serial biopsies in patients receiving
neoadjuvant chemotherapy for locally advanced breast cancer. II. Assess the feasibility of
performing assays of apoptosis and of markers that predict response on specimens obtained in
these patients. III. Correlate the results of the assays with clinical and pathologic
response rates. IV. Establish a baseline of change in apoptosis rates for future studies. V.
Obtain serial blood samples and tumor tissue for future biological studies.

OUTLINE: This is a randomized study. Patients are stratified by pre or postmenopausal state
and T3 or T4 lesions. Arm I: Patients receive single agent doxorubicin by bolus infusion on
day 1. Dose repeats every 14 days for a total of four courses, provided absolute neutrophil
count (ANC) and platelet count remain in the appropriate range. Patients then receive
paclitaxel IV administered over 3 hours once every 14 days for a total of four courses,
provided ANC and platelet count remain in the appropriate range. Filgrastim (G-CSF)
subcutaneous treatment is started on day 3 of each course, and continued for 7 days, or
until ANC is greater than 10,000/mm3. Patients undergo serial core-needle breast biopsies or
fine needle aspirations prior to starting therapy and on day one of each course. Arm II:
Patients receive four courses of paclitaxel given once every 14 days. Patients then receive
four courses of doxorubicin given on day 1 every 14 days, provided ANC and platelet count
are in the appropriate range. G-CSF subcutaneous treatment is started on day 3 of each
course, as in Arm I. Patients undergo serial core-needle breast biopsies or fine needle
aspirations prior to starting and on day one of each course. Arm I and II: Upon completion
of eight courses of chemotherapy, patients undergo a surgical procedure to evaluate the
extent of residual disease and number of lymph nodes involved, and to achieve local control.
Following surgery, patients receive additional treatment at the discretion of the treating
oncologist. Eligible patients undergo further high dose chemotherapy with peripheral blood
stem cell rescue; other patients receive cyclophosphamide therapy. Patients receiving
lumpectomies receive breast irradiation. Patients receiving mastectomies might receive chest
wall irradiation. Following radiotherapy, hormone receptor positive patients may start
tamoxifen therapy for 5 years.

PROJECTED ACCRUAL: An estimated 40 patients (20 per treatment arm) will be accrued for this
study.

Inclusion 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)

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Vered Stearns, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Michigan Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000065642

NCT ID:

NCT00003035

Start Date:

March 1997

Completion Date:

June 2001

Related Keywords:

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

Name

Location

Lombardi Cancer CenterWashington, District of Columbia  20007