Evaluating hair loss in women with breast cancer undergoing endocrine therapy

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

This study is trying to see how different hormone treatments for breast cancer affect hair loss in women, so they can better understand this common concern.

Quick facts

• Study type: Observational
• Enrollment: 170 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Mayo Clinic (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 23 sites (Albert Lea, Minnesota and 22 other locations)
• Trial ID: NCT05612100 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the incidence, characteristics, and severity of alopecia in postmenopausal and premenopausal women diagnosed with breast cancer who are undergoing various forms of endocrine therapy. Participants will be grouped based on their treatment type, including those receiving tamoxifen, aromatase inhibitors, or a combination with CDK4/6 inhibitors. Patients will complete questionnaires and surveys regarding their hair loss experiences, and their medical records will be reviewed to gather comprehensive data. The study seeks to better understand how different endocrine therapies impact hair loss, which is often underreported despite being a significant concern for patients.

Who should consider this trial

Good fit: Ideal candidates include postmenopausal and premenopausal women diagnosed with breast cancer who are receiving endocrine therapy.

Not a fit: Patients who are not undergoing endocrine therapy or those with non-curative treatment intentions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into managing and mitigating hair loss for women undergoing endocrine therapy for breast cancer.

How similar studies have performed: While alopecia is a known side effect of chemotherapy, this study's focus on endocrine therapy-induced alopecia is less explored, making it a novel approach.

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

Where this trial is running

Albert Lea, Minnesota and 22 other locations

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

Study contacts

• Principal investigator: Elizabeth Cathcart-Rake, M.D. — Mayo Clinic in Rochester

Conditions Breast Carcinoma