A Study of Low Dose Tamoxifen for Patients at High Risk for Breast Cancer
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 19-005289
- Jacksonville, Florida: 19-005289
Sponsor Protocol Number: 19-005289
About this study
The purpose of this study is to determine if counseling patients about low dose tamoxifen will influence the decision to take (or not take) preventive therapy among women at increased risk for breast cancer.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Women ≥ 35 years old and ≤ 75 years old.
- Women that meet at least one of the following:
- NCI-BCRAT 5-year risk (> 3%) or that shows at least moderate evidence of treatment benefit outweighing risk according to the US Preventative Services Task Force or IBIS (version 8) risk calculator (> 8% for the 10-year risk);
- History of atypical hyperplasia (30% lifetime risk for developing breast cancer);
- LCIS (approximately 20% lifetime risk for developing breast cancer);
- Status post-surgery (lumpectomy or unilateral mastectomy) for ER positive DCIS;
- Status post-surgery (lumpectomy or unilateral mastectomy) for pleomorphic LCIS.
Exclusion Criteria:
- Women whose BCRAT falls below the threshold moderate according to the US Preventative Task Force or IBIS (version 8) 10 year risk of < 8%; OR do not have a surgical finding that demonstrates increased risk of developing invasive breast cancer.
- Women with known BRCA1 and BRCA2 mutations.
- Women with known contraindications to tamoxifen, raloxifene, exemestane or anastrozole.
- Women unable to give informed consent.
- Prior history of invasive breast cancer.
- At-risk women due to prior radiation therapy to the chest.
- Prior use of preventive medications (tamoxifen, raloxifene, exemestane or anastrozole) for breast cancer prevention.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
Contact |
Rochester, Minn.
Mayo Clinic principal investigator Sandhya Pruthi, M.D. |
Closed for enrollment |
Contact information:
Cancer Center Clinical Trials Referral Office
(855) 776-0015
|
Jacksonville, Fla.
Mayo Clinic principal investigator Lauren Cornell, M.D. |
Closed for enrollment |
Contact information:
Cancer Center Clinical Trials Referral Office
(855) 776-0015
|
More information
Publications
Publications are currently not available