Long-term Anastrozole Versus Tamoxifen Treatment Effects (LATTE)

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Queen Mary University of London
Information provided by (Responsible Party):
American Cancer Society, Inc.
ClinicalTrials.gov Identifier:
NCT01745289
First received: December 5, 2012
Last updated: November 4, 2013
Last verified: November 2013
  Purpose

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cancer who were randomised to receive either anastrozole or tamoxifen in the ATAC Trial and not known to have died or withdrawn consent before April 1st 2009.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
Breast Cancer

Study Type: Observational
Official Title: Long-term Anastrozole Versus Tamoxifen Treatment Effects (LATTE)

Resource links provided by NLM:


Further study details as provided by American Cancer Society, Inc.:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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)


Estimated Enrollment: 4337
Study Start Date: February 2013
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
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: 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

No publications provided

Responsible Party: American Cancer Society, Inc.
ClinicalTrials.gov Identifier: NCT01745289     History of Changes
Other Study ID Numbers: IRB00050408
Study First Received: December 5, 2012
Last Updated: November 4, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Anastrozole
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 30, 2014