PROTOCOL ID: E-1199

PROJECTED ACCRUAL: A total of 5,000 patients will be accrued within 1.27 years.

OBJECTIVES

1. Compare the disease-free survival and overall survival in patients with node-positive or high-risk node-negative operable stage II or IIIA breast cancer treated with docetaxel or paclitaxel after AC.
2. Determine whether the weekly administration of paclitaxel or docetaxel for 12 weeks improves disease-free survival and overall survival when compared with the conventional schedule of every 3 weeks for 4 courses after AC.
3. Compare the toxic effects of docetaxel and paclitaxel when administered weekly for 12 weeks versus every 3 weeks for 4 courses in these patients.
4. Compare the toxicity of paclitaxel administered every 3 weeks for 4 courses or weekly for 12 weeks to that of docetaxel administered on the same schedules in these patients.

PARTICIPATION CRITERIA

• 18 and over, any hormone receptor status
• Histologically confirmed operable stage IIA, IIB or IIIA adenocarcinoma of the breast with histologically involved lymph nodes OR high-risk node-negative disease
• Tumor at least 2.1 cm in diameter for node-negative disease
• Bilateral breast disease allowed if at least 1 primary tumor meets the criteria above
• Must have had at least 6 axillary lymph nodes removed at dissection and at least one node positive OR sentinel node biopsy negative for metastasis (SNLB+ allowed if enrolled on American College of Surgery Trial Z0011 and have been randomized to receive no axillary dissection)
• Tumor-free margins at least 1 mm for both invasive and noninvasive carcinoma except for LCIS (< 1 mm allowed)
• Concurrent enrollment on ACS Z0010, Z0011 or NSABP B-32 allowed

STUDY CONTACT

Joseph A Sparano, Chair, Ph: 718-904-2555 Eastern Cooperative Oncology Group Edith A Perez, Chair, Ph: 904-953-7283 North Central Cancer Treatment Group Silvana Martino, Chair, Ph: 310-998-3961 Southwest Oncology Group Vicky Eileen Jones, Chair, Ph: 858-657-8710 Cancer and Leukemia Group B

PROTOCOL IDS: UCLA-0011004, NCI-G01-2002, ORTHO-PR-00-27-012, ORTHO-PR-01-27-003

PROJECTED ACCRUAL: A maximum of 2,500 patients will be accrued for this study.

1. Determine the effectiveness and safety of epoetin alfa in patients receiving adjuvant chemotherapy for stage I, II or III breast cancer.
2. Determine the clinical outcomes in these patients receiving this drug.

PARTICIPATION CRITERIA

• Age: 18 and over
• Histologically or cytologically confirmed stage I, II or III breast cancer
• Planned adjuvant anthracycline-based chemotherapy with or without a taxane for 3-6 months
• Hemoglobin 10-14 g/dL (independent of transfusion)
• No anemia due to factors other than cancer/chemotherapy (i.e., iron, cyanocobalamin or folate deficiency; hemolysis; gastrointestinal bleeding; or myelodysplastic syndrome)
• At least 6 months since prior epoetin alfa or any investigational forms of erythropoietin (e.g., gene-activated erythropoietin or novel erythropoiesis-stimulating protein)

PROTOCOL

Patients receive epoetin alfa subcutaneously once weekly for up to 24 weeks in the absence of unacceptable toxicity.

STUDY CONTACT

John A Glaspy, Chair Ph: 310-794-1274 Jonsson Comprehensive Cancer Center, UCLA

PROTOCOL IDS: NSABP B-30; CTSU

PROJECTED ACCRUAL: A total of 4,000 patients will be accrued within 3 years.

OBJECTIVES

1. Compare the efficacy of adjuvant AC and docetaxel given concurrently versus adjuvant AC followed by docetaxel, in terms of overall survival and disease-free survival of women with breast cancer and positive axillary lymph nodes.
2. Compare the efficacy of adjuvant doxorubicin and docetaxel versus regimens containing cyclophosphamide.
3. Compare the toxic effects of these regimens.
4. Compare the quality of life of these patients.
5. Compare the differences in amenorrhea in premenopausal women in each treatment arm and its relationship to symptoms, quality of life, disease-free survival and overall survival.

PARTICIPATION CRITERIA

• Age unspecified, hormone receptor status known
• Histologically proven invasive adenocarcinoma of the breast confined to the breast and ipsilateral axilla on clinical exam
• Stage I, II or IIIA (T1-3, N0-1, M0)
• At least one axillary lymph node with tumor on histologic exam
• Sentinel node biopsy allowed if followed by axillary dissection
• No suspicious palpable nodes in the contralateral axilla or palpable supraclavicular or infraclavicular nodes, unless proven on biopsy to not be involved with tumor
• No bilateral malignancy or mass in the opposite breast, unless mass is histologically proven to be benign
• Must have undergone either a prior total mastectomy and axillary dissection (modified radical mastectomy) OR prior lumpectomy and axillary dissection
• Patients must receive radiotherapy after randomization
• Margins must be clear
• No N2 disease and/or any positive nonaxillary lymph nodes
• No metastatic disease by X-ray, MRI or biopsy
• Skeletal pain allowed if bone scan negative for metastases

STUDY CONTACT

Sandra M Swain, Chair, Ph: 301-496-4916 National Surgical Adjuvant Breast and Bowel Project

PROTOCOL IDS: ICCG-C/14/96, EU-20040

PROJECTED ACCRUAL: A total of 800 patients will be accrued for this study.

OBJECTIVES

1. Compare the impact of adjuvant epirubicin with or without docetaxel and concurrent or sequential tamoxifen on time to relapse and overall survival in postmenopausal women with node-positive breast cancer.
2. Compare the toxic effects of these regimens in this patient population.
3. Compare the quality of life in terms of shift in long-term toxicity and differences in recuperation.
4. Compare the incidence of thromboembolic events during the first 9 months of study and the influence of such events on compliance in women treated with these regimens.

PARTICIPATION CRITERIA

• Histologically proven node-positive breast cancer
• Postmenopausal
• No distant metastases

STUDY CONTACT

Raoul C Coombes, Chair, Ph: +44 (0)20 8846 14 18 International Collaborative Cancer Group Charing Cross Hospital London, England, United Kingdom

PROTOCOL IDS: CAN-NCIC-MA21, AMGEN-CAN-NCIC-MA21, BMS-CAN-NCIC-MA21, JANSSEN-CAN-NCIC-MA21, P-UPJOHN-CAN-NCIC-MA21

PROJECTED ACCRUAL: A total of 1,500 patients (500 per treatment arm) will be accrued for this study within 3 years.

OBJECTIVES

1. Compare the disease-free survival and overall survival of premenopausal or early postmenopausal women with previously resected node-positive or high-risk node-negative stage I-IIIA breast cancer treated with cyclophosphamide, epirubicin and fluorouracil vs cyclophosphamide, epirubicin, filgrastim (G-CSF) and epoetin alfa followed by paclitaxel vs cyclophosphamide and doxorubicin followed by paclitaxel.
2. Compare the rate of toxic effects of these regimens.
3. Compare the quality of life of patients treated with these regimens.

PARTICIPATION CRITERIA

• Age: 60 and under
• Histologically confirmed adenocarcinoma of the breast that is potentially curable
• Stage I-IIIA (T0-4 (dermal involvement only), N0-2, M0)
• Axillary node-positive or high-risk node-negative
• Previously treated with total mastectomy and axillary node dissection or partial mastectomy and axillary node dissection with planned breast radiotherapy after completion of study or sentinel node biopsy (if node-positive, must undergo axillary node dissection)
• No prior immunotherapy, chemotherapy, radiotherapy or hormonal therapy for breast cancer

STUDY CONTACT

Margot J Burnell, Chair, Ph: 506-648-6884 NCIC-Clinical Trials Group

PROTOCOL IDS: IBCSG-22-00, EU-20119

PROJECTED ACCRUAL: Approximately 1,330 patients will be accrued for this study within 5 years.

OBJECTIVES

1. Determine the efficacy of adjuvant induction chemotherapy with or without cyclophosphamide and methotrexate as maintenance chemotherapy in patients with stage I, II or III breast cancer.
2. Compare the disease-free, overall and systemic disease-free survival of patients treated with these regimens.
3. Compare the toxic effects of these regimens in these patients.
4. Compare the quality of life of patients treated with these regimens.

PARTICIPATION CRITERIA

• Pre-or postmenopausal
• Histologically confirmed stage I, II or III breast cancer (T1-3, N0-1, M0. T4 disease with minimal dermal invasion allowed)
• No distant metastases
• Prior mastectomy OR BCT within past 6 weeks
• Estrogen and progesterone receptor-negative
• No prior radiotherapy for breast cancer

STUDY CONTACT

Marco Colleoni, Chair, Ph: 039-2-57489439 International Breast Cancer Study Group

PROTOCOL ID: : SWOG-9342

PROJECTED ACCRUAL: A total of 420 patients will be accrued for this study. After initial accrual is completed, approximately 50 additional patients will be accrued at 10 years.

1. Compare the frequency of subclinical congestive heart failure by measuring resting MUGA at 5-8 and 10-11 years after randomization in women receiving adjuvant chemotherapy with cyclophosphamide, methotrexate and fluorouracil or cyclophosphamide, doxorubicin and fluorouracil on protocol SWOG-8897.
2. Estimate the frequency of late cardiac effects (congestive heart failure, cardiac ischemic events and clinical symptoms) in these patients treated with these regimens.
3. Monitor prospectively the incidence of annual cardiac events between the fifth and tenth year after randomization of these patients to these regimens.

PARTICIPATION CRITERIA

• Age: 18 and over
• Women registered on Arm I, II, III or IV of protocol SWOG-8897 who have completed at least 1 course of assigned chemotherapy
• Completion of tamoxifen therapy not required
• Registration to current study required between 5.25-8 years or 10-11 years after randomization to protocol SWOG-8897
• Patients must be diagnosed disease-free with no prior recurrence after registration on protocol SWOG-8897

PROTOCOL

The treating physician completes patient cardiovascular and routine history and physical examination questionnaires at baseline and yearly. Patients undergo resting MUGA scans at 5-8 and 10-11 years after registration on protocol SWOG-8897. The first scan must be performed within 3 months prior to enrollment or within 1 month after registration on the current study, and the second scan must be done in the tenth year of follow-up and within 3 months prior to enrollment or 1 month from the anniversary of registration on the current study.

STUDY CONTACT

Patricia A Ganz, Chair, Ph: 310-206-1404 Southwest Oncology Group

PROTOCOL IDS: NCI-99-C-0026, NCI-99-C-0020

PROJECTED ACCRUAL: A total of 140 patients will be accrued for this study within 1-2 years.

I. Evaluate the relative contributions of factors that may lead to weight gain in breast cancer patients receiving adjuvant chemotherapy. Factors examined include:

• Hormonal and growth factor status (follicle stimulating hormone; total, bound and free estradiol; androgens; sex hormone-binding globulin; thyroid hormones; prolactin; insulin-like growth factors I and II; and plasma leptin).
• Factors affecting energy intake or expenditure (oral intake, physical activity and resting metabolic rate).
• Psychological factors (depression and quality of life).

II. Evaluate the effect of chemotherapy on hormonal and growth factor status in these patients.

III. Assess the impact of chemotherapy on bone marrow density in these patients.

PARTICIPATION CRITERIA

• Age: 18 to 80
• Menopausal status: Premenopausal or postmenopausal
• Histologically proven newly diagnosed stage I, II or resectable IIIA primary breast cancer
• Scheduled to receive chemotherapy
• No prior oophorectomy

PROTOCOL

Data is collected from women diagnosed with primary breast cancer at 3 points (5 visits): (I) after breast cancer surgery, but before chemotherapy begins (2 visits to NIH day hospital 1 week apart); (II) 2-3 weeks after chemotherapy has ended (2 visits, 1 week apart); and (III) 6 months after chemotherapy has ended (1 visit). Tests conducted during these visits include evaluation of blood for hormones, growth factors, and leptin; body composition by DXA; visceral and subcutaneous abdominal adipose tissue by an axial CT scan; and evaluation of resting metabolic rate and daily energy expenditure by a single administration of doubly labeled water at visits "a" and "b" during data collection timepoints 1 and 2. Questionnaires assessing epidemiologic risk factors for breast cancer, dietary intake, physical activity, depression, and quality of life are also administered at the three timepoints.

STUDY CONTACT

Noreen Aziz, Ph: 301-496-0598 Cancer Prevention Studies Branch Bethesda, Maryland

PROTOCOL IDS: CLB-49907, CTSU

PROJECTED ACCRUAL: A total of 600-1,800 patients (300-900 per treatment arm) will be accrued for this study within 2-6 years.

OBJECTIVES

1. Compare the effectiveness of adjuvant chemotherapy using standard CMF or AC vs oral capecitabine in terms of disease-free and overall survival in elderly women with operable adenocarcinoma of the breast.
2. Compare the quality of life and physical functioning of patients treated with these regimens.
3. Compare the toxicity of these regimens in these patients.
4. Evaluate the adherence of older patients to an oral chemotherapy regimen.

ELIGIBILITY

• Postmenopausal women age 65 and over
• Histologically proven operable adenocarcinoma of the breast
• Stage IIA or IIIA disease ( T1-3, N1, M0 or T2, N0, M0 if primary lesion at least 3 cm)
• Hormone receptor status not specified
• Must have undergone 1 of the following within the past 12 weeks: Modified radical mastectomy OR lumpectomy with axillary lymph node dissection or sentinel node biopsy. Prior full axillary dissection required if positive sentinel node(s)
• Any number of previously excised nodes allowed
• No prior chemotherapy for breast cancer
• No other concurrent chemotherapy or hormonal therapy

STUDY CONTACT

Richard L. Schilsky, Chair Ph: 773-834-3914 Cancer and Leukemia Group B