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

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ClinicalTrials.gov Identifier: NCT00301457
Recruitment Status : Completed
First Posted : March 13, 2006
Last Update Posted : February 21, 2023
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Breast Cancer Drug: Anastrozole Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1914 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Actual Study Start Date : June 2006
Actual Primary Completion Date : April 2022
Actual Study Completion Date : April 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Anastrozole

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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: After 9 years for the group with 6 years of adjuvant anastrozol, subsequent to 2 to 3 years of adjuvant tamoxifen or after 6 years for the group with 3 years of adjuvant anastrozole subsequent to 2 to 3 years of adjuvant tamoxifen ]

Secondary Outcome Measures :
  1. To compare the incidence of contralateral breast cancer after 6 years versus 3 years adjuvant anastrozole, subsequent to 2 to 3 years of tamoxifen [ Time Frame: After 9 years for the group with 6 years of adjuvant anastrozol, subsequent to 2 to 3 years of adjuvant tamoxifen or after 6 years for the group with 3 years of adjuvant anastrozole subsequent to 2 to 3 years of adjuvant tamoxifen ]
  2. To compare the overall survival after 6 years versus 3 years adjuvant anastrozole, subsequent to 2 to 3 years of tamoxifen [ Time Frame: After 9 years for the group with 6 years of adjuvant anastrozol, subsequent to 2 to 3 years of adjuvant tamoxifen or after 6 years for the group with 3 years of adjuvant anastrozole subsequent to 2 to 3 years of adjuvant tamoxifen ]
  3. To compare toxicity of 6 years versus 3 years of adjuvant anastrozole in postmenopausal hormone sensitive breast cancer patients, subsequent to 2 to 3 years of tamoxifen [ Time Frame: After 9 years for the group with 6 years of adjuvant anastrozol, subsequent to 2 to 3 years of adjuvant tamoxifen or after 6 years for the group with 3 years of adjuvant anastrozole subsequent to 2 to 3 years of adjuvant tamoxifen ]
  4. To determine regional differences in the initial treatment of breast cancer retrospectively by collecting baseline information on initial therapies. [ Time Frame: After 9 years ]
    Aspects of the initial treatment that will be investigated are e.g. the kind of surgery performed (breast saving or mastectomy) and whether or not chemotherapy is given and which chemotherapy was used in postmenopausal patients in relation to the primary tumour and patient characteristics.

  5. To compare the cost effectiveness of 3 years versus 6 years adjuvant anastrozole therapy, after subsequent 2 to 3 years of adjuvant tamoxifen treatment. [ Time Frame: After 9 years for the group with 6 years of adjuvant anastrozol, subsequent to 2 to 3 years of adjuvant tamoxifen or after 6 years for the group with 3 years of adjuvant anastrozole subsequent to 2 to 3 years of adjuvant tamoxifen ]
  6. To assess patterns of care in The Netherlands in prevention, detection and treatment of osteoporosis in postmenopausal women with breast cancer treated with adjuvant anastrozole. [ Time Frame: After 9 years ]
  7. To relate the number of osteoporotic fractures during and following treatment with adjuvant anastrozole with the compliance to osteoporotic guidelines. [ Time Frame: After 9 years ]
  8. To analyse occurrence of distant (bone) metastases in relation to occurrence of osteopenia and osteoporosis, and in relation to use of supplements and therapy for reduced BMD. [ Time Frame: After 9 years ]

Eligibility Criteria
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Ages Eligible for Study:   45 Years to 99 Years   (Adult, Older Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00301457


Locations
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Sponsors and Collaborators
Maastricht University Medical Center
Investigators
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Study Director: AstraZeneca Netherlands Medical Director, MD AstraZeneca
  Study Documents (Full-Text)

Documents provided by Maastricht University Medical Center:
Study Protocol  [PDF] October 31, 2016

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT00301457    
Other Study ID Numbers: D5392NL003
EUDRAct No: 2005-006167-31
First Posted: March 13, 2006    Key Record Dates
Last Update Posted: February 21, 2023
Last Verified: February 2023
Keywords provided by Maastricht University Medical Center:
Hormone Sensitive Primary Breast Cancer
Adjuvant Treatment
Aromatase Inhibitor
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Anastrozole
Antineoplastic Agents, Hormonal
Antineoplastic Agents
 Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs