Endocrine Therapy-Induced Alopecia in Postmenopausal and Premenopausal Female Breast Cancer Patients
3 other identifiers
observational
170
1 country
23
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2022
Longer than P75 for all trials
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 6, 2022
CompletedFirst Submitted
Initial submission to the registry
October 27, 2022
CompletedFirst Posted
Study publicly available on registry
November 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2028
April 30, 2026
April 1, 2026
6 years
October 27, 2022
April 28, 2026
Conditions
Outcome Measures
Primary Outcomes (4)
Estimation and characterization of patient-reported treatment-emergent alopecia within and across the cohorts
Exact 95% confidence intervals will be created within each cohort and compared graphically using forest plots. Plots of alopecia incidence rates and severity will be plotted over time by cohort.
Up to study completion; up to two years
Overall impact on patient's quality of life
Descriptive summaries of all the questions on the baseline and follow-up questionnaires will be tabulated to facilitate our understanding of patient-experienced alopecia and to provide a comprehensive picture of how alopecia is treated, as well as to quantify the overall impact on patient's quality of life. Standardized differences will be computed in order to give a common metric for all variables. The largest standardized difference between the pairwise cohorts will be reported.
Up to study completion; up to two years
Incidence rate of treatment-emergent alopecia
A cumulative incidence function will be estimated in order to calculate the cumulative incidence rate (i.e. time to initial onset) of treatment-emergent alopecia, treating death and disease progression as competing risks for each cohort. Cox proportional hazards models will be used to compare differences between treatment-emergent alopecia risk between the control cohort (n=20) and the combined treatment cohorts (n = 80). The covariates included in the regression model will include age (years) and alopecia scores at baseline.
Up to study completion; up to two years
Risk of treatment-emergent alopecia
A longitudinal analysis will be used for the binary response of whether the patient experiences treatment-emergent alopecia; this mixed model will contain an interaction between control versus treatment cohort and time, both as categorical variables, and a random intercept and slope by patient. The above covariates will also be adjusted for and piecewise splices will be used to account for any nonlinearity. The goal of the longitudinal analysis is to explore whether the risk of treatment-emergent alopecia increases with endocrine therapy exposure over time and whether this risk differs between cohorts.
Up to study completion; up to two years
Study Arms (1)
Observational (alopecia questionnaires and surveys)
Patients complete alopecia questionnaires and surveys and have medical records reviewed on study.
Interventions
Ancillary studies
Complete alopecia questionnaires
Complete alopecia surveys
Eligibility Criteria
Postmenopausal and premenopausal women with a diagnosis of breast cancer.
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (23)
Mayo Clinic Health System in Albert Lea
Albert Lea, Minnesota, 56007, United States
Essentia Health Baxter Clinic
Baxter, Minnesota, 56425, United States
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, 56601, United States
Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota, 56401, United States
Essentia Health - Deer River Clinic
Deer River, Minnesota, 56636, United States
Essentia Health Saint Mary's - Detroit Lakes Clinic
Detroit Lakes, Minnesota, 56501, United States
Essentia Health Cancer Center
Duluth, Minnesota, 55805, United States
Essentia Health Ely Clinic
Ely, Minnesota, 55731, United States
Essentia Health - Fosston
Fosston, Minnesota, 56542, United States
Fairview Grand Itasca Clinic & Hospital
Grand Rapids, Minnesota, 55744, United States
Essentia Health Hibbing Clinic
Hibbing, Minnesota, 55746, United States
Fairview Range Medical Center
Hibbing, Minnesota, 55746, United States
Essentia Health - International Falls Clinic
International Falls, Minnesota, 56649, United States
Mayo Clinic Health Systems-Mankato
Mankato, Minnesota, 56001, United States
MMCORC CentraCare Monticello Cancer Center
Monticello, Minnesota, 55362, United States
Essentia Health Moose Lake
Moose Lake, Minnesota, 55767, United States
Essentia Health - Park Rapids
Park Rapids, Minnesota, 56470, United States
Fairview Northland Medical Center
Princeton, Minnesota, 55731, United States
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Essentia Health Sandstone
Sandstone, Minnesota, 55072, United States
Sanford Health Thief River Falls
Thief River Falls, Minnesota, 56701, United States
Essentia Health Virginia Clinic
Virginia, Minnesota, 55792, United States
Sanford Health Worthington
Worthington, Minnesota, 56187, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Elizabeth Cathcart-Rake, M.D.
Mayo Clinic in Rochester
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 27, 2022
First Posted
November 10, 2022
Study Start
July 6, 2022
Primary Completion (Estimated)
June 30, 2028
Study Completion (Estimated)
June 30, 2028
Last Updated
April 30, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share