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Different Durations of Adjuvant Anastrozole Therapy After 2 to 3 Years Tamoxifen Therapy in Breast Cancer (DATA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00301457
First received: March 9, 2006
Last updated: May 12, 2016
Last verified: May 2016
  Purpose
The purpose of this study is to determine whether 6 years adjuvant anastrozole will improve the disease free survival compared to 3 years adjuvant anastrozole in postmenopausal hormone sensitive breast cancer patients, subsequent to 2-3 years tamoxifen

Condition Intervention Phase
Breast Cancer
Drug: Anastrozole
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Randomised, Open, Multicentre, Phase III Study to Assess Different Durations of Anastrozole Therapy After 2 to 3 Years Tamoxifen as Adjuvant Therapy in Postmenopausal Women With Breast Cancer.

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • To assess the disease free survival (DFS) with 6 years of adjuvant anastrozole compared with 3 years of adjuvant anastrozole in postmenopausal hormone sensitive breast cancer patients, subsequent to 2 to 3 years of adjuvant tamoxifen [ Time Frame: Assessed after 3 years and 6 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To compare the incidence of contralateral breast cancer, overall survival and toxicity after 6 years versus 3 years adjuvant anastrozole, subsequent to 2 to 3 years of tamoxifen [ Time Frame: Assessed after 3 years and 6 years ] [ Designated as safety issue: No ]

Enrollment: 1914
Study Start Date: June 2006
Study Completion Date: April 2016
Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
6 years adjuvant anastrozole therapy
Drug: Anastrozole
1 mg once daily oral dose
Other Names:
  • ARIMIDEX
  • ZD1033
Experimental: 2
3 years adjuvant anastrozole therapy
Drug: Anastrozole
1 mg once daily oral dose
Other Names:
  • ARIMIDEX
  • ZD1033

  Eligibility

Ages Eligible for Study:   45 Years to 99 Years   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • postmenopausal patients with hormone receptor positive breast cancer who have already received 2 to 3 years of adjuvant tamoxifen, and who never had signs of loco-regional recurrences or distant metastasis

Exclusion Criteria:

  • Previous hormonal therapy as adjuvant breast cancer treatment besides tamoxifen.
  • Previous history of invasive breast cancer within the last 10 years, other then the breast cancer that is currently treated with tamoxifen
  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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00301457

  Show 67 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca Netherlands Medical Director, MD AstraZeneca
  More Information

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00301457     History of Changes
Other Study ID Numbers: D5392NL003  EUDRAct No: 2005-006167-31 
Study First Received: March 9, 2006
Last Updated: May 12, 2016
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by AstraZeneca:
Hormone Sensitive Primary Breast Cancer
Adjuvant Treatment
Aromatase Inhibitor

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

ClinicalTrials.gov processed this record on December 02, 2016