ATAC - Endometrial Sub-Protocol

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Breast Cancer

Treatments: Drug: Nolvadex placebo; Drug: Tamoxifen (Nolvadex); Drug: Arimidex placebo; Drug: Anastrozole (Arimidex)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00814125

1033IC/0029

D5392C06736

Details and patient eligibility

About

To compare the difference between the ARIMIDEX group and the tamoxifen group in the incidence of abnormal endometrial histological findings arising after treatment has commenced.

Enrollment: 285 patients

Sex: Female

Ages: 45+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients eligible for entry into the main ATAC trial (1033IL/0029)
• Not received any previous tamoxifen, for whatever reason
• Not undergone a hysterectomy and do not have a hysterectomy planned within the next 6 years
• No previous endometrial ablation

Exclusion criteria

• Excluded from entry into the main ATAC trial (1033IL/0029). As detailed in Section 4.4 of the main ATAC trial (1033IL/0029)

Trial design

285 participants in 3 patient groups

1

Active Comparator group

Description:

Arimidex 1mg + Nolvadex placebo

Treatment:

Drug: Anastrozole (Arimidex)

Drug: Nolvadex placebo

2

Active Comparator group

Description:

Arimidex placebo + Nolvadex 20mg

Treatment:

Drug: Arimidex placebo

Drug: Tamoxifen (Nolvadex)

3

Active Comparator group

Description:

Arimidex 1mg + Nolvadex 20mg

Treatment:

Drug: Anastrozole (Arimidex)

Drug: Tamoxifen (Nolvadex)