Neoadjuvant Endocrine Therapy Tolerance in Geriatric Early Stage ER+ Breast Cancer

  • STATUS
    Recruiting
  • days left to enroll
    32
  • participants needed
    83
  • sponsor
    Shayna Showalter, MD
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Updated on 16 February 2024
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cancer
breast cancer
aromatase inhibitor
hormone therapy
tamoxifen
endocrine therapy
invasive breast cancer
letrozole
anastrozole
adjuvant
HER2
estrogen receptor positive breast cancer

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 IdentifierNCT04272801
SponsorShayna Showalter, MD
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

ECOG performance status 0-2
Diagnosed with anatomic stage I, ER positive, PR positive or negative, and HER2 non amplified invasive breast cancer and clinically negative nodes; any invasive breast cancer histologic subtype may be enrolled
Tumor size 2 cm
Patient has elected BCS as surgical choice
Eligible to receive tamoxifen or an aromatase inhibitor
Ability to take oral medication and be willing to adhere to the endocrine therapy for the 3 month period prior to BCS

Exclusion Criteria

Prior or current use of endocrine therapy for breast cancer
History of ipsilateral breast radiation
Pregnancy or lactation
Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer
Current or planned use of a strong CYP2D6 inhibitor (e.g. Fluoxetine, Paroxetine) and is not able to receive an endocrine therapy agent that does not use the CYP2D6 pathway
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cancer
breast cancer
aromatase inhibitor
hormone therapy
tamoxifen
endocrine therapy
invasive breast cancer
letrozole
anastrozole
adjuvant
HER2
estrogen receptor positive breast cancer

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