NCT05612100

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

Endocrine Therapy-Induced Alopecia Natural History Evaluation Among Female Breast Cancer Survivors

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 170 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates endocrine therapy-induced alopecia among postmenopausal and premenopausal female patients with breast cancer. Alopecia is one of the most feared side effects of cancer-directed therapy, causing distress in women starting treatment for breast cancer. While alopecia is a well-known side effect of many chemotherapy drugs, it has also been reported by women undergoing endocrine therapy. Despite the frequent reports of alopecia related to endocrine therapy, hair loss is rarely reported as a side effect of endocrine therapy and the exact characterization of alopecia is not well understood. By having postmenopausal and premenopausal breast cancer patients describe their hair loss symptoms experienced while undergoing endocrine therapy, researchers may be able to better characterize the incidence, timing, duration, and severity of alopecia and whether the different types of endocrine therapy cause more or less trouble in this regard.

Detailed description

PRIMARY OBJECTIVE: I. To describe the incidence, characteristics, and severity of alopecia related to endocrine therapy in four cohorts of postmenopausal women who have had a diagnosis of breast cancer: patients undergoing endocrine therapy with tamoxifen, patients undergoing endocrine therapy with an aromatase inhibitor, patients undergoing therapy with an aromatase inhibitor in addition to a CDK4/6 inhibitor, and patients not receiving endocrine therapy. A fifth cohort has met the accrual goal and is no longer enrolling: premenopausal women receiving any type of endocrine therapy. SECONDARY OBJECTIVE: I. To investigate the difference in incidence, characteristics, and severity of alopecia between the aforementioned five cohorts of patients. OUTLINE: This is an observational study. Patients complete alopecia questionnaires and surveys and have medical records reviewed on study.

Conditions

• Breast Carcinoma

Interventions

Type	Name	Description
OTHER	Electronic Health Record Review	Ancillary studies
OTHER	Questionnaire Administration	Complete alopecia questionnaires
OTHER	Survey Administration	Complete alopecia surveys

Timeline

• Start date: 2022-07-06
• Primary completion: 2028-06-30
• Completion: 2028-06-30
• First posted: 2022-11-10
• Last updated: 2025-12-17

Locations

23 sites across 1 country: United States