Breast CarcinomaNCT05612100
Endocrine Therapy-Induced Alopecia in Postmenopausal and Premenopausal Female Breast Cancer Patients
An observational study of Breast Carcinoma, run by Mayo Clinic at 23 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Carcinoma
- What is being tested?
- Electronic Health Record Review, Questionnaire Administration and Survey Administration
- How many people
- 169 participants
- Where
- 23 sitesUnited States
- Study dates
- 6 Jul 2022to 9 Jul 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Postmenopausal and premenopausal women with a diagnosis of breast cancer.
Who may be able to join
- 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
Show all 9Show fewer
- 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).
Who cannot join
- 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
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
Mayo Clinic Health System in Albert Lea
Albert Lea, Minnesota, 56007
Essentia Health Baxter Clinic
Baxter, Minnesota, 56425
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, 56601
Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota, 56401
Essentia Health - Deer River Clinic
Deer River, Minnesota, 56636
Essentia Health Saint Mary's - Detroit Lakes Clinic
Detroit Lakes, Minnesota, 56501
Essentia Health Cancer Center
Duluth, Minnesota, 55805
Essentia Health Ely Clinic
Ely, Minnesota, 55731
Essentia Health - Fosston
Fosston, Minnesota, 56542
Fairview Grand Itasca Clinic & Hospital
Grand Rapids, Minnesota, 55744
Essentia Health Hibbing Clinic
Hibbing, Minnesota, 55746
Fairview Range Medical Center
Hibbing, Minnesota, 55746
Essentia Health - International Falls Clinic
International Falls, Minnesota, 56649
Mayo Clinic Health Systems-Mankato
Mankato, Minnesota, 56001
MMCORC CentraCare Monticello Cancer Center
Monticello, Minnesota, 55362
Essentia Health Moose Lake
Moose Lake, Minnesota, 55767
Essentia Health - Park Rapids
Park Rapids, Minnesota, 56470
Fairview Northland Medical Center
Princeton, Minnesota, 55731
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Essentia Health Sandstone
Sandstone, Minnesota, 55072
Sanford Health Thief River Falls
Thief River Falls, Minnesota, 56701
Essentia Health Virginia Clinic
Virginia, Minnesota, 55792
Sanford Health Worthington
Worthington, Minnesota, 56187
About this study
Official title: Endocrine Therapy-Induced Alopecia Natural History Evaluation Among Female Breast Cancer Survivors
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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 has met the accrual goal and is no longer enrolling: premenopausal women receiving any type of endocrine therapy.
SECONDARY OBJECTIVE:
- 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 and have medical records reviewed on study.
- Conditions
- Breast Carcinoma
- Being tested
- Electronic Health Record Review, Questionnaire Administration, Survey Administration
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic Health Record ReviewOther
Ancillary studies
Questionnaire AdministrationOther
Complete alopecia questionnaires
Survey AdministrationOther
Complete alopecia surveys
| Study group | Role | What they receive |
|---|---|---|
| Observational (alopecia questionnaires and surveys) | Patients complete alopecia questionnaires and surveys and have medical records reviewed on study. Receives: Other: Electronic Health Record Review; Other: Questionnaire Administration; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to study completion; up to two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2022
- Study start6 Jul 2022
- Primary completion9 Jul 2028 (estimated)
- Study completion9 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CarcinomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 169 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elizabeth Cathcart-Rake, M.D., Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05612100
- Sponsor's protocol ID
- MC220902
- Other IDs
- 22-004341, MNCCTN013
- Status last verified
- Jul 2026
- First submitted
- 27 Oct 2022
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endocrine Therapy-Induced Alopecia Natural History Evaluation Among Female Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT05612100
- Acronym / sponsor ID
- MC220902
- Conditions
- Breast Carcinoma
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 169 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 6 Jul 2022 (actual)
- Primary completion
- 9 Jul 2028 (estimated)
- Study completion
- 9 Jul 2028 (estimated)
- First posted
- 10 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVE:
- 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 has met the accrual goal and is no longer enrolling: premenopausal women receiving any type of endocrine therapy.
SECONDARY OBJECTIVE:
- 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 and have medical records reviewed on study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (alopecia questionnaires and surveys) | – | Other: Electronic Health Record Review, Other: Questionnaire Administration, Other: Survey AdministrationPatients complete alopecia questionnaires and surveys and have medical records reviewed on study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Postmenopausal and premenopausal women with a diagnosis of breast cancer.
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electronic Health Record ReviewAncillary studies | Other | Observational (alopecia questionnaires and surveys) |
| Questionnaire AdministrationComplete alopecia questionnaires | Other | Observational (alopecia questionnaires and surveys) |
| Survey AdministrationComplete alopecia surveys | Other | Observational (alopecia questionnaires and surveys) |
Primary outcome
Estimation and characterization of patient-reported treatment-emergent alopecia within and across the cohorts
Time frame: Up 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 life
Time frame: Up 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 alopecia
Time frame: Up 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 alopecia
Time frame: Up 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Cathcart-Rake, M.D. principal investigator
Mayo Clinic in Rochester
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Carcinoma, run by Mayo Clinic at 23 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimation and characterization of patient-reported treatment-emergent alopecia within and across the cohorts (time frame: Up to study completion; up to two years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.