Long-term Anastrozole Versus Tamoxifen Treatment Effects (LATTE)
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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cancer who were randomised to receive either anastrozole or tamoxifen in the ATAC Trial and not known to have died or withdrawn consent before April 1st 2009.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) |
- 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 |
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.
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| Contact: Samaha Hodges, MPH | 404.327.6428 | samaha.hodges@cancer.org |
| 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: | January 10, 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 Tamoxifen Anastrozole Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
Selective Estrogen Receptor Modulators Estrogen Receptor Modulators Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Bone Density Conservation Agents Estrogen Antagonists Aromatase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013