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A Comparison of Intensive Sequential Chemotherapy Using Doxorubicin Plus Paclitaxel Plus Cyclophosphamide With High Dose Chemotherapy and Autologous Hematopoietic Progenitor Cell Support for Primary Breast Cancer in Women With 4-9 Involved Axillary Lymph Nodes


Phase 3
18 Years
N/A
Not Enrolling
Female
Breast Cancer

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Trial Information

A Comparison of Intensive Sequential Chemotherapy Using Doxorubicin Plus Paclitaxel Plus Cyclophosphamide With High Dose Chemotherapy and Autologous Hematopoietic Progenitor Cell Support for Primary Breast Cancer in Women With 4-9 Involved Axillary Lymph Nodes


OBJECTIVES: I. Compare disease free survival and overall survival in women with operable
breast cancer and at least 4 positive axillary lymph nodes treated with intensive sequential
chemotherapy with doxorubicin, paclitaxel, and cyclophosphamide versus standard dose
doxorubicin and cyclophosphamide followed by high dose STAMP I (cyclophosphamide, cisplatin,
and carmustine) or STAMP V (cyclophosphamide, carboplatin, and thiotepa) and autologous stem
cell rescue. II. Compare the toxic effects of these regimens in this patient population.
III. Measure the breast cancer cell content of the peripheral blood progenitor cell (PBPC)
fractions from patients randomized to the PBPC supported arm and correlate the results with
the disease free survival, survival, and pattern of relapse in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified by center, primary
treatment (mastectomy alone vs mastectomy plus radiotherapy following chemotherapy vs breast
conserving surgery plus radiotherapy following chemotherapy), menopausal status
(premenopausal vs postmenopausal), estrogen and/or progesterone receptor status (positive vs
negative vs unknown), N2 disease (yes vs no), T3 disease (yes vs no), myeloablative
chemotherapy regimen (STAMP I vs STAMP V), and source of progenitor cells (marrow vs
peripheral blood vs both). Patients are randomized to 1 of 2 treatment arms: Arm I: Patients
receive doxorubicin IV over 1 hour on days 1, 15, and 29, paclitaxel IV over 24 hours on
days 43, 57, and 71, and cyclophosphamide IV over 1 hour on days 85, 99, and 113. Patients
receive filgrastim (G-CSF) subcutaneously on days 3-10, 17-24, 31-38, 45-52, 59-66, 73-80,
87-94, 101-108, and 115-122. Arm II: Mobilization chemotherapy: Patients receive doxorubicin
IV over 1 hour and cyclophosphamide IV over 1 hour on days 1, 22, 43, and 64. Harvest:
Patients undergo harvest of autologous bone marrow and/or peripheral blood stem cells
(PBSC). Patients who undergo harvest of PBSC alone do not receive mobilization chemotherapy
but receive hematopoietic growth factors prior to harvest. High dose myeloablative
chemotherapy: Patients receive STAMP I OR STAMP V: STAMP I: Patients receive
cyclophosphamide IV over 1 hour and cisplatin IV over 24 hours on days -6 to -4 and
carmustine IV over 2 hour on day -3. STAMP V: Patients receive cyclophosphamide IV over 24
hours, carboplatin IV over 24 hours, and thiotepa IV over 24 hours on days -7 to -4.
Transplantation: Autologous bone marrow and/or PBSC are reinfused on day 0. Both arms:
Patients who are postmenopausal or who have hormone receptor positive disease receive oral
tamoxifen daily beginning 4 weeks after the completion of chemotherapy and continuing for 5
years. Patients who underwent breast conserving surgery receive locoregional radiotherapy 5
days a week for 4.5-5.5 weeks beginning 4-6 weeks after the completion of chemotherapy.
Patients who underwent modified radical mastectomy may receive locoregional radiotherapy 5
days a week for 5 weeks at the discretion of their physician. Patients are followed every 4
months for 3 years, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 1,000 patients (500 per arm) will be accrued for this study
within 5 years.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically proven adenocarcinoma of the breast with at least
4 involved axillary and/or intramammary lymph nodes No known T4, N3, or M1 disease Dermal
lymphatic involvement without clinical inflammatory changes (edema, peau d'orange,
erythema) allowed Must have undergone breast conserving surgery or modified radical
mastectomy plus axillary lymph node dissection Surgical margins negative for invasive or
noninvasive ductal carcinoma At least 10 nodes sampled No more than 12 weeks since
definitive surgery Synchronous bilateral breast carcinoma allowed if: Diagnosed within 4
weeks of initial histologic diagnosis One breast meets the eligibility criteria Other
breast has fewer than 10 involved nodes and is not N3 or T4 Both breasts treated by
modified radical mastectomy or breast conserving surgery with axillary node dissection
Concurrent registration on S9719 Hormone receptor status: Not specified

PATIENT CHARACTERISTICS: Age: Adult Sex: Female Menopausal status: Any status Performance
status: SWOG 0 or 1 Hematopoietic: WBC at least 3,000/mm3 Absolute neutrophil count at
least 1,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5
times upper limit of normal (ULN) SGOT no greater than 1.5 times ULN Hepatitis C status
required Renal: Creatinine clearance at least 60 mL/min Cardiovascular: Left ventricular
ejection fraction at rest at least 45% by MUGA No EKG abnormalities unless cleared by a
cardiologist No uncontrolled or significant cardiac disease No congestive heart failure No
second or third degree heart block or other serious cardiac conduction abnormality No
atrial or ventricular arrhythmia No requirement for medication known to affect cardiac
conduction unless: Given for reasons other than heart failure or arrhythmia Cleared by a
cardiologist Pulmonary: FVC and FEV1 at least 60% predicted DLCO at least 60% predicted
Other: HIV negative Hepatitis B surface antigen status required No serious medical or
psychiatric illness that would preclude informed consent or study participation No second
malignancy within the past 5 years except adequately treated basal cell or squamous cell
skin cancer, carcinoma in situ of the cervix, or intraductal or lobular carcinoma of the
breast (diagnosed at any time) Not pregnant or nursing Fertile patients must use effective
contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy Endocrine therapy: No prior hormonal therapy for breast cancer Radiotherapy:
No prior radiotherapy to the breast Surgery: See Disease Characteristics

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Scott I. Bearman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Colorado, Denver

Authority:

United States: Federal Government

Study ID:

CDR0000064747

NCT ID:

NCT00002772

Start Date:

July 1996

Completion Date:

February 2004

Related Keywords:

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

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021