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

Breast Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05612100
• Other study ID #: MC220902
• Secondary ID: NCI-2022-0568622
• Status: Recruiting
• Start date: July 6, 2022
• Est. completion date: August 1, 2025

Study information

• Verified date: June 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 of patients will also be included, consisting of 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 on study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 170
• Est. completion date: August 1, 2025
• Est. primary completion date: August 1, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alopecia
• Breast Carcinoma
• Breast Neoplasms

Intervention

Other:
• Electronic Health Record Review
Ancillary studies
• Questionnaire Administration
Complete alopecia questionnaires
• Survey Administration
Complete alopecia surveys

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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

External Links

•   Mayo Clinic Clinical Trials