ATAC - Arimidex, Tamoxifen Alone or in Combination

June 5, 2012 updated by: AstraZeneca

A Randomised, Double Blind Trial Comparing Arimidex Alone With Nolvadex Alone With Arimidex and Nolvadex in Combination, as Adjuvant Treatment in Post-Menopausal Women With Breast Cancer

The aim of this study is to test whether Arimidex alone or in combination with Tamoxifen is beneficial in the treatment of breast cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

9358

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patients with histologically proven operable invasive breast cancer
  • Patients who have completed all primary surgery and chemotherapy (if given), and are candidates to receive hormonal adjuvant therapy
  • Women defined as post-menopausal

Exclusion Criteria:

  • Patients in whom there is any clinical evidence of metastatic disease
  • Patients who, for whatever reason (e.g. confusion, infirmity, alcoholism), are unlikely to comply with trial requirements
  • Patients whose chemotherapy was started more than 8 weeks (ie 56 days) after completion of primary surgery or whose chemotherapy was completed more than 8 weeks (ie 56 days) before starting randomised treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 1
Arimidex 1mg + Nolvadex placebo
Drug: Anastozole (Arimidex)
1mg, orally, once daily
Other Names:
  • Arimidex
Drug: Tamoxifen (Nolvadex) placebo
20mg, orally, once daily
ACTIVE_COMPARATOR: 2
Arimidex placebo + Nolvadex 20mg
Drug: Tamoxifen (Nolvadex)
20mg, orally, once daily
Other Names:
  • Nolvadex
Drug: Anastozole (Arimidex) placebo
1mg, orally, once daily
ACTIVE_COMPARATOR: 3
Arimidex 1mg + Nolvadex 20mg
Drug: Anastozole (Arimidex)
1mg, orally, once daily
Other Names:
  • Arimidex
Drug: Tamoxifen (Nolvadex)
20mg, orally, once daily
Other Names:
  • Nolvadex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to recurrence of breast cancer
Time Frame: Earliest of local or distant recurrence, new primary breast cancer, or death
Earliest of local or distant recurrence, new primary breast cancer, or death
Safety and side effects
Time Frame: Earliest of local or distant recurrence, new primary breast cancer, or death
Earliest of local or distant recurrence, new primary breast cancer, or death

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to distant recurrence
Time Frame: Earliest of local or distant recurrence, new primary breast cancer, or death
Earliest of local or distant recurrence, new primary breast cancer, or death
Survival
Time Frame: Earliest of local or distant recurrence, new primary breast cancer, or death
Earliest of local or distant recurrence, new primary breast cancer, or death
New breast primaries
Time Frame: Earliest of local or distant recurrence, new primary breast cancer, or death
Earliest of local or distant recurrence, new primary breast cancer, or death

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 1996

Primary Completion (ACTUAL)

June 1, 2001

Study Completion (ACTUAL)

April 1, 2010

Study Registration Dates

First Submitted

February 20, 2009

First Submitted That Met QC Criteria

February 20, 2009

First Posted (ESTIMATE)

February 23, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

June 6, 2012

Last Update Submitted That Met QC Criteria

June 5, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1033IL/0029
  • D5392C00029

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer

Clinical Trials on Anastozole (Arimidex)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Taiwan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe