Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT00301457
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00301457
Recruitment Status : Active, not recruiting
First Posted : March 13, 2006
Last Update Posted : August 14, 2020
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center

Tracking Information
First Submitted Date  ICMJE March 9, 2006
First Posted Date  ICMJE March 13, 2006
Last Update Posted Date August 14, 2020
Study Start Date  ICMJE June 2006
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 22, 2017)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 9, 2006)
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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 22, 2017)
  • 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 ]
  • 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 ]
  • 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 ]
  • 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.
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 9, 2006)
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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Different Durations of Adjuvant Anastrozole Therapy After 2 to 3 Years Tamoxifen Therapy in Breast Cancer
Official Title  ICMJE 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.
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE Drug: Anastrozole
1 mg once daily oral dose
Other Names:
  • ARIMIDEX
  • ZD1033
Study Arms  ICMJE
  • Experimental: 1
    6 years adjuvant anastrozole therapy
    Intervention: Drug: Anastrozole
  • Experimental: 2
    3 years adjuvant anastrozole therapy
    Intervention: Drug: Anastrozole
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: May 12, 2016)
1914
Original Enrollment  ICMJE
 (submitted: March 9, 2006)
1900
Estimated Study Completion Date  ICMJE April 2022
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 45 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00301457
Other Study ID Numbers  ICMJE D5392NL003
EUDRAct No: 2005-006167-31
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Maastricht University Medical Center
Study Sponsor  ICMJE Maastricht University Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: AstraZeneca Netherlands Medical Director, MD AstraZeneca
PRS Account Maastricht University Medical Center
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP