PROTOCOL IDS: CAN-NCIC-MA17, EORTC-10983, JRF-Vor-Int-10, NCCTG-CAN-MA17, SWOG-CAN-MA17, CLB-49805

PROJECTED ACCRUAL: Approximately 4,800 patients will be accrued for this study within 4 years.

OBJECTIVES

1. Determine the disease-free survival and overall survival for women who have previously received at least five years of adjuvant tamoxifen who are randomized to receive either letrozole or placebo.
2. Evaluate the incidence of contralateral breast cancer in this patient population.

PARTICIPATION CRITERIA

• Postmenopausal
• Hormone receptor status: Positive or unknown (providing an effort has been made to determine receptor status by immunocytochemistry)
• Histologically or cytologically confirmed breast carcinoma resected at time of original diagnosis
• No evidence of metastases
• No localized or distant breast cancer recurrence. Not registered on protocol NCCTG 89-30-52, any other IBCSG protocol or any other SWOG adjuvant breast cancer protocol
• Prior adjuvant chemotherapy allowed
• No other concurrent chemotherapy
• Completed at least 4.5 but no more than 6 years of adjuvant tamoxifen after resection
• No more than 3 months since prior adjuvant tamoxifen
• No concurrent hormone replacement therapy including raloxifene, idoxifene or megestrol
• No concurrent use of other aromatase inhibitors
• Prior radiation therapy allowed

STUDY CONTACTS

Paul Edward Goss, Ph: 416-946-4534
NCIC-Clinical Trials Group
Princess Margaret Hospital
Toronto, Ontario, Canada

James N. Ingle, Chair PH: 507-284-8432
North Central Cancer Treatment Group

Monica Castiglione-Gertsch, Chair PH: 41-31-389-91-91
International Breast Cancer Study Group

Nicholas J. Robert, Chair PH: 703-280-5390
Eastern Cooperative Oncology Group

Silvana Martino, Chair PH: 310-998-3961
Southwest Oncology Group

Hyman Bernard Muss, Chair PH: 802-847-3827
Cancer and Leukemia Group B

Martine J. Piccart-Gebhart, Chair Ph: 32-2-5413206
EORTC Breast Cancer Group

PROTOCOL ID: AU01

PROJECTED ACCRUAL: Approximately 1,700 patients will be accrued.

OBJECTIVES

1. Evaluate the effect of continued adjuvant Arimidex compared to no further treatment in women who have previously received five years of tamoxifen or tamoxifen plus aminoglutethimide.
2. Evaluate the tolerability of this regimen.

PARTICIPATION CRITERIA

• Postmenopausal women
• Node-positive breast cancer
• Estrogen and/or progesterone receptor-positive
• Prior adjuvant treatment with tamoxifen x 5 years or tamoxifen plus aminoglutethimide

STUDY CONTACTS

Raimund Jakesz, MD, Chair
Austrian Breast & Colorectal Cancer Study Group
Vienna, Austria

PROTOCOL IDS: NSABP B-33, CTSU

PROJECTED ACCRUAL: A total of 3,000 patients will be accrued for this study within 3 years and 4 months.

OBJECTIVES

1. Determine whether exemestane following 5 years of tamoxifen therapy is more effective than 5 years of prior tamoxifen therapy alone in prolonging disease-free survival, overall survival and time to treatment failure in postmenopausal women with resected stage I, II or IIIA breast cancer.
2. Determine the effect of tamoxifen withdrawal on bone in terms of height, fractures, total alkaline phosphatase, bone mineral density and biochemical markers in these patients.
3. Determine the effect of exemestane on bone after tamoxifen withdrawal in these patients.
4. Evaluate the quality of life of a subset of these patients.

PARTICIPATION CRITERIA

• Postmenopausal
• Histologically confirmed invasive stage I-IIIA adenocarcinoma of the breast (T1-3, N0-1, M0)
• Prior surgical resection
• Currently disease-free
• Primary tumor ER+ and/or PR+
• Borderline ER+ tumors allowed if previously treated with tamoxifen
• Previously treated with tamoxifen for 57-66 months
• Completed tamoxifen within the past 180 days
• No advanced disease at time of original diagnosis

STUDY CONTACTS

Terry Mamounas, Chair, Ph: 330-363-6281
National Surgical Adjuvant Breast and Bowel Project

PROTOCOL IDS: ICCG-96OEXE031-C1396-BIG9702, EU-20013, EU-99002, ICCG-BIG-97/02

PROJECTED ACCRUAL: Approximately 4,400 patients (2,200 patients in each arm) will be accrued for this study.

OBJECTIVES

1. Compare, in terms of disease-free and overall survival, the sequential administration of exemestane with administration of further tamoxifen until 5 years of therapy is achieved in postmenopausal women with operable breast cancer who have already received 2-3 years of adjuvant tamoxifen.
2. Compare the regimens in terms of the incidence of contralateral breast cancer and long-term tolerability of the regimens.
3. Determine the tolerability in terms of endometrial status, bone metabolism, lipid profile and coagulation profile.
4. Assess quality of life in these patients treated with these regimens.

PARTICIPATION CRITERIA

• Postmenopausal
• Histologically confirmed unilateral adenocarcinoma of the breast that was considered operable
• Estrogen receptor positive or unknown
• Must have had adequate therapy for primary disease
• Must have remained disease-free after therapy for primary disease
• Must have been receiving tamoxifen for minimum of 2 years and maximum of 3 years 1 month with no more than 1 month break at any one time
• PNo evidence of local relapse or distant metastasis at any time

STUDY CONTACTS

Raoul C Coombes, Chair, Ph: +44 (0)20 8846 14 18
International Collaborative Cancer Group

Robert Paridaens, Chair, Ph: 32-16-346902
EORTC Breast Cancer Group

Moise Namer, Chair, Ph: 33 4 92031000
Federation Nationale des Centres de Lutte Contre le Cancer