8. Post-tamoxifen Adjuvant Endocrine Therapy

8.1 Phase III Study of Prolonged Adjuvant Tamoxifen for Breast Cancer

Objectives

Assess the balance of risks and benefits in prolonging the duration of adjuvant tamoxifen by at least five years in patients who have had a breast tumor removed.

Participation Criteria

• Age: Any age. n Curatively treated carcinoma of the breast.
  
  
• Prior biologic therapy allowed.
  
  
• Prior chemotherapy allowed.
  
  
• Currently taking adjuvant tamoxifen.
  
  
• Prior radiotherapy allowed.
  
  
• Prior surgery allowed.

Randomization

Christopher J. Williams, Chair
Principal Investigator Ph: +44-1865-226628 United Kingdom Coordinating Committee on Cancer Research Cochrane Cancer Network Oxford, England, United Kingdom

8.2 Phase III Randomized Adjuvant Study of Tamoxifen in Women with Early Breast Cancer

Objectives

Compare the disease-free and overall survival of women with early breast cancer who are randomized to stop adjuvant tamoxifen with those randomized to continue for at least 5 extra years.

Participation Criteria

• Menopausal status: Any status allowed.
  
  
• Hormone receptor status: Any status allowed.
  
  
• Histologically confirmed breast carcinoma that has been completely excised.
  
  
• Clinically relapse-free.
  
  
• Must have completed at least two years of adjuvant therapy with tamoxifen for early breast cancer AND no clear indication for or against receiving further tamoxifen.
  
  
• No significant endometrial hyperplasia.
  
  
• No patients with negligibly low risk of breast cancer death.
  
  
• At least 2 years of adjuvant tamoxifen.

Randomization

David J. Kerr, Chair
Principal Investigator Ph: 0121-414-3802 Cancer Research Campaign Clinical Trials Unit- Birmingham (CRCTU) University Birmingham Birmingham, England, United Kingdom

8.3 Phase III Randomized Study of Letrozole Versus Placebo in Women with Resected Breast Cancer after Completion of Treatment with Adjuvant Tamoxifen

Objectives

I. Determine the disease-free survival and overall survival for women who have previously received adjuvant tamoxifen who are randomized to receive either letrozole or placebo daily for 5 years.

II. Evaluate the incidence of contralateral breast cancer in this patient population.

Participation Criteria

• Age: Postmenopausal.
  
  
• Menopausal status: 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.
  
  
• Other 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 and idoxifene.
  
  
• No concurrent use of other aromatase inhibitors.
  
  
• Prior radiation therapy allowed.

Randomization

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