Endocrine Therapy-Induced Alopecia in Postmenopausal and Premenopausal Female Breast Cancer Patients

Launched by MAYO CLINIC · Nov 4, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at hair loss (called alopecia) that some women experience while undergoing endocrine therapy for breast cancer. Endocrine therapy is a type of treatment that helps block hormones that can fuel the growth of certain breast cancers. While many people know that chemotherapy can cause hair loss, this study aims to better understand how often and how severely hair loss occurs with endocrine therapy. By speaking with both postmenopausal and premenopausal women about their hair loss experiences during treatment, researchers hope to gather important information on when hair loss happens, how long it lasts, and if different types of endocrine therapy cause more or less hair loss.

To participate in this trial, women must be at least 18 years old and have been diagnosed with breast cancer, currently undergoing treatment aimed at curing their cancer. They should also be willing to fill out questionnaires about their hair loss every three months. However, women who already have significant hair loss before starting treatment or those who have received chemotherapy recently cannot join. Participants will complete their first questionnaire within two weeks of starting therapy. This trial is currently recruiting, and it’s an important opportunity for women to share their experiences and help improve understanding of this distressing side effect of treatment.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Age \>= 18 years
• • Women with a diagnosis of breast cancer who are being treated with curative intent, with the one exception being women who are receiving CDK4/6 inhibitors (these patients being allowed to have more advanced disease)
• • Provide informed consent
• • Ability to complete questionnaire(s) by themselves or with assistance
• • Filling into one of the 5 groups (understanding that groups will close once they complete their accrual goals of 30 patients)
• • Willingness to complete questionnaires every 3 months
• • Ability to complete the first questionnaire within 2 weeks of therapy initiation (for the four arms that are receiving adjuvant hormonal therapy)
• • For patients starting tamoxifen or an aromatase inhibitor: within 2 weeks of starting tamoxifen or aromatase inhibitor
• • For patients starting a CDK 4/6 inhibitor: within 2 weeks of starting the CDK 4/6 inhibitor (patients may have started an aromatase inhibitor at any time prior to initiation of CDK 4/6 inhibitor).
• Exclusion Criteria:
• • Verbal baseline alopecia \>= 2 on an 11 point scale (from none = 0 to severe = 10). The question to use for this item is: Please rate your hair thinning or loss on a scale from 0 to 10, with 0 being no hair loss and 10 being complete hair loss
• • Planned receipt of chemotherapy or another cancer-directed therapy concurrently (e.g., everolimus, etc.; note that a CDK4/6 inhibitor is allowed within cohort 3)
• • Prior use of endocrine therapy for breast cancer
• • Receipt of chemotherapy over the previous 6 months