Endocrine Therapy-Induced Alopecia in Postmenopausal and Premenopausal Female Breast Cancer Patients
NCT ID: NCT05612100
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
170 participants
OBSERVATIONAL
2022-07-06
2028-06-30
Brief Summary
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Detailed Description
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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 has met the accrual goal and is no longer enrolling: 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 and have medical records reviewed on study.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Observational (alopecia questionnaires and surveys)
Patients complete alopecia questionnaires and surveys and have medical records reviewed on study.
Electronic Health Record Review
Ancillary studies
Questionnaire Administration
Complete alopecia questionnaires
Survey Administration
Complete alopecia surveys
Interventions
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Electronic Health Record Review
Ancillary studies
Questionnaire Administration
Complete alopecia questionnaires
Survey Administration
Complete alopecia surveys
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Principal Investigators
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Elizabeth Cathcart-Rake, M.D.
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic in Rochester
Locations
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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, United States
Countries
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Facility Contacts
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Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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NCI-2022-05686
Identifier Type: REGISTRY
Identifier Source: secondary_id
22-004341
Identifier Type: OTHER
Identifier Source: secondary_id
MNCCTN013
Identifier Type: OTHER
Identifier Source: secondary_id
MC220902
Identifier Type: -
Identifier Source: org_study_id