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Long-term Anastrozole Versus Tamoxifen Treatment Effects (LATTE)

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ClinicalTrials.gov Identifier: NCT01745289
Recruitment Status : Completed
First Posted : December 10, 2012
Last Update Posted : June 2, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:

The LATTE study is an extension study to the now closed Arimidex, Tamoxifen Alone or in combination (ATAC) trail that took place 10 years ago. LATTE aims to collect long term follow-up information since the conclusion of ATAC, and for at least another 5 years, regarding: Additional efficacy data (first local recurrence, first distant recurrence), Additional safety data (ischaemic cardiac and cerebrovascular event, fractures), and Cause specific mortality and new primary cancers.

The LATTE study will pick up where ATAC left off to follow a number of post-menopausal women with breast cancer who were randomised to receive either anastrozole or tamoxifen in the ATAC Trial and not known to have died or withdrawn consent before April 1st 2009. Since ATAC was a nationwide study, the women of LATTE will also reside and receive their follow-up care in various areas of the country. There will not be any vulnerable groups participating in this study.

Patient interaction will consist on in person interviews at designated follow-up times and/or telephone interviews. Data will be collected at point of contact, whether that is in person at the clinic site or over the telephone. Telephone interviews will be completed in LATTE study offices. Topics of focus for data collection consists of: whether or not there is a suspected recurrence, new breast primary tumour, new other primary tumour, ischaemic cardiac event, cerebrovascular event, or a serious fracture. Since the follow-up questions are short in detail, respondent burden time should be less than 1 hour in most cases.


Condition or disease
Breast Cancer

Study Design

Study Type : Observational
Actual Enrollment : 78 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Long-term Anastrozole Versus Tamoxifen Treatment Effects (LATTE)
Study Start Date : October 2010
Primary Completion Date : May 2017
Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. Time to recurrence [ Time Frame: LATTE particpants who are 10 years post treatment will be followed for 5 years for the purpose of this study. ]
    Time to recurrence of breast cancer in the post 10 year period (defined as the earliest of local or distant recurrence, new primary breast cancer, or death)


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Post-menopausal women with breast cancer who were randomised to receive either anastrozole or tamoxifen in the ATAC Trial and not known to have died or withdrawn consent before April 1st 2009 over the age of 18, living in the United States are eligible for LATTE.
Criteria

Inclusion Criteria:

  • patients randomised to one of the monotherapy arms in the ATAC Trial
  • alive at 10 years follow-up

Exclusion Criteria:

  • patients who have withdrawn consent to participate in the ATAC Trial or this study
  • where the LATTE Executive Committee determines that there is no possibility of obtaining follow-up
Contacts and Locations

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): NCT01745289


Sponsors and Collaborators
American Cancer Society, Inc.
Queen Mary University of London
Investigators
Principal Investigator: Robert Smith, PhD American Cancer Society, Inc.
Principal Investigator: Aman Buzdar, MD M.D. Anderson Cancer Center
More Information

Responsible Party: American Cancer Society, Inc.
ClinicalTrials.gov Identifier: NCT01745289     History of Changes
Other Study ID Numbers: IRB00050408
First Posted: December 10, 2012    Key Record Dates
Last Update Posted: June 2, 2017
Last Verified: June 2017

Keywords provided by American Cancer Society, Inc.:
Breast Cancer
Survival
Recurrence

Additional relevant MeSH terms:
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