Neoadjuvant Endocrine Therapy Tolerance in Geriatric Early Stage ER+ Breast Cancer
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- STATUS
- Recruiting
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- days left to enroll
- 30
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- participants needed
- 83
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- sponsor
- Shayna Showalter, MD
Summary
This single arm pilot study evaluates the use of neoadjuvant endocrine therapy in women with early stage ER+ breast cancer who are 70 years or older and are scheduled to have breast conservation surgery (BCS). The purpose of this study is to see if tolerance of neoadjuvant endocrine therapy helps inform decisions on whether or not to omit radiation. Participants will be treated with the novel approach of 3 months of neoadjuvant endocrine therapy, so that the participants and providers will have some indication of tolerance prior to making a decision about radiation omission. Tolerance of the endocrine therapy will be assessed by patient reported outcome (PRO) measures during neoadjuvant and adjuvant endocrine therapy treatment periods. Breast cancer participants and their surgical oncologists will be asked their preference regarding radiation therapy before starting endocrine therapy and again post-operatively. They will make a determination regarding radiation therapy as per standard care. The hypothesis is that knowledge of tolerance of endocrine therapy will influence the decision by the patient and the surgical oncologist whether or not to elect radiation omission.
Details
| Condition | Breast Cancer Female |
|---|---|
| Age | 70years - 100years |
| Treatment | tamoxifen, letrozole, anastrozole, or exemestane, Patient reported outcomes |
| Clinical Study Identifier | NCT04272801 |
| Sponsor | Shayna Showalter, MD |
| Last Modified on | 19 February 2024 |
How to participate?
Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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