Adjuvant Tamoxifen Compared With Anastrozole in Treating Postmenopausal Women With Ductal Carcinoma In Situ
Condition: Breast Cancer
MeSH terms: Breast Neoplasms; Carcinoma in Situ
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using
      either tamoxifen or anastrozole may fight breast cancer by blocking the use of estrogen. It
      is not yet known whether tamoxifen is more effective than anastrozole in preventing breast
      cancer after surgery for ductal carcinoma in situ.

      PURPOSE: This randomized phase III trial is studying how well adjuvant tamoxifen works
      compared to anastrozole in treating postmenopausal women who have undergone surgery to remove
      ductal carcinoma in situ.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Compare the efficacy of adjuvant tamoxifen vs anastrozole, in terms of local control and
           prevention of contralateral disease, in postmenopausal women with locally excised ductal
           carcinoma in situ.

        -  Compare side effect profiles of these drugs in these patients.

      Secondary

        -  Compare the efficacy of these drugs, according to the receptor status of the primary or
           recurrent cancer in these patients.

        -  Compare the rate of breast cancer recurrence and growth of new contralateral tumors
           after cessation of treatment with these drugs in these patients.

        -  Compare breast cancer mortality in patients treated with these drugs.

        -  Compare the effect of these drugs on other cancers, cardiovascular disease, fracture
           rates, and non-breast cancer deaths in these patients.

        -  Compare the tolerability and acceptability of side effects experienced by patients
           treated with these drugs.

      OUTLINE: This is a randomized, double-blind, multicentre study. Patients are stratified
      according to participating centre. Patients are randomized to 1 of 2 treatment arms.

        -  Arm I: Patients receive oral tamoxifen and oral placebo once daily.

        -  Arm II: Patients receive oral anastrozole and oral placebo once daily. In both arms,
           treatment continues for 5 years in the absence of disease recurrence or unacceptable
           toxicity.

      Patients are followed annually for 5 years and a further 5 years (minimum) off treatment.

      Peer Reviewed and Funded by Cancer Research UK. Sponsored by Queen Mary University of London

      ACTUAL ACCRUAL: A total of 2,980 patients were accrued for this study over 9 years.
    

Intervention name(s): tamoxifen citrate; Anastrozole
Intervention type(s): Drug; Drug
Intervention description(s): Tamoxifen 20mg + Anastrozole placebo; Anastrozole 1mg + Tamoxifen placebo
Other intervention name(s): Nolvadex; Arimidex
Intervention MeSH terms: Tamoxifen; Anastrozole
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ductal breast carcinoma in situ; breast cancer in situ