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

Running, not enrolling

Conditions studied: Breast Carcinoma

In brief

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.

Key facts

Study ID

NCT05612100

Run by

Mayo Clinic

People needed

169

Starts

2022-07-06

Expected to finish

2028-07-09

Last updated by the study team

2026-07-21

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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

Where it is running

• Mayo Clinic Health System in Albert Lea — Albert Lea, Minnesota, United States
• Essentia Health Baxter Clinic — Baxter, Minnesota, United States
• Sanford Joe Lueken Cancer Center — Bemidji, Minnesota, United States
• Essentia Health Saint Joseph's Medical Center — Brainerd, Minnesota, United States
• Essentia Health - Deer River Clinic — Deer River, Minnesota, United States
• Essentia Health Saint Mary's - Detroit Lakes Clinic — Detroit Lakes, Minnesota, United States
• Essentia Health Cancer Center — Duluth, Minnesota, United States
• Essentia Health Ely Clinic — Ely, Minnesota, United States
• Essentia Health - Fosston — Fosston, Minnesota, United States
• Fairview Grand Itasca Clinic & Hospital — Grand Rapids, Minnesota, United States
• Essentia Health Hibbing Clinic — Hibbing, Minnesota, United States
• Fairview Range Medical Center — Hibbing, Minnesota, United States
• Essentia Health - International Falls Clinic — International Falls, Minnesota, United States
• Mayo Clinic Health Systems-Mankato — Mankato, Minnesota, United States
• MMCORC CentraCare Monticello Cancer Center — Monticello, Minnesota, United States
• Essentia Health Moose Lake — Moose Lake, Minnesota, United States
• Essentia Health - Park Rapids — Park Rapids, Minnesota, United States
• Fairview Northland Medical Center — Princeton, Minnesota, United States
• Mayo Clinic in Rochester — Rochester, Minnesota, United States
• Essentia Health Sandstone — Sandstone, Minnesota, United States
• Sanford Health Thief River Falls — Thief River Falls, Minnesota, United States
• Essentia Health Virginia Clinic — Virginia, Minnesota, United States
• Sanford Health Worthington — Worthington, Minnesota, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.