ATAC - Arimidex, Tamoxifen Alone or in Combination

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00849030
First received: February 20, 2009
Last updated: June 5, 2012
Last verified: June 2012
  Purpose

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


Condition Intervention Phase
Breast Cancer
Drug: Anastozole (Arimidex)
Drug: Tamoxifen (Nolvadex)
Drug: Anastozole (Arimidex) placebo
Drug: Tamoxifen (Nolvadex) placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Time to recurrence of breast cancer [ Time Frame: Earliest of local or distant recurrence, new primary breast cancer, or death ] [ Designated as safety issue: No ]
  • Safety and side effects [ Time Frame: Earliest of local or distant recurrence, new primary breast cancer, or death ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Time to distant recurrence [ Time Frame: Earliest of local or distant recurrence, new primary breast cancer, or death ] [ Designated as safety issue: No ]
  • Survival [ Time Frame: Earliest of local or distant recurrence, new primary breast cancer, or death ] [ Designated as safety issue: No ]
  • New breast primaries [ Time Frame: Earliest of local or distant recurrence, new primary breast cancer, or death ] [ Designated as safety issue: No ]

Enrollment: 9358
Study Start Date: July 1996
Study Completion Date: April 2010
Primary Completion Date: June 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Arimidex 1mg + Nolvadex placebo
Drug: Anastozole (Arimidex)
1mg, orally, once daily
Other Name: Arimidex
Drug: Tamoxifen (Nolvadex) placebo
20mg, orally, once daily
Active Comparator: 2
Arimidex placebo + Nolvadex 20mg
Drug: Tamoxifen (Nolvadex)
20mg, orally, once daily
Other Name: Nolvadex
Drug: Anastozole (Arimidex) placebo
1mg, orally, once daily
Active Comparator: 3
Arimidex 1mg + Nolvadex 20mg
Drug: Anastozole (Arimidex)
1mg, orally, once daily
Other Name: Arimidex
Drug: Tamoxifen (Nolvadex)
20mg, orally, once daily
Other Name: Nolvadex

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00849030     History of Changes
Other Study ID Numbers: 1033IL/0029, D5392C00029
Study First Received: February 20, 2009
Last Updated: June 5, 2012
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Argentina: Human Research Bioethics Committee
Australia: Department of Health and Ageing Therapeutic Goods Administration
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Netherlands: Medical Ethics Review Committee (METC)
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United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Tamoxifen
Anastrozole
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Selective Estrogen Receptor Modulators
Bone Density Conservation Agents
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 20, 2014