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NCT05612100

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

Active, Not Recruiting
Not specifiedAges 18+Observational
Mayo Clinic
~169 participants
Updated 2026-07-21 on ClinicalTrials.gov
What's tested:Electronic Health Record ReviewQuestionnaire AdministrationSurvey Administration

At a glance

Recruiting sites
0 of 23 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Estimation and characterization of patient-reported treatment-emergent alopecia within and across the cohorts
Measured over Up to study completion; up to two years
+3 more outcomes measured

Conditions

Breast Carcinoma

Explore related trials

Breast Carcinoma

Where it's being run

23 sites across 1 states
Minnesota23

Study leadership

  • Elizabeth Cathcart-Rake, M.D. · PRINCIPAL_INVESTIGATOR · Mayo Clinic in Rochester

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Estimation and characterization of patient-reported treatment-emergent alopecia within and across the cohortsUp to study completion; up to two years

    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.

  • Overall impact on patient's quality of lifeUp to study completion; up to two years

    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.

  • Incidence rate of treatment-emergent alopeciaUp to study completion; up to two years

    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.

  • Risk of treatment-emergent alopeciaUp to study completion; up to two years

    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.