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

Last updated: June 27, 2024
Sponsor: Mayo Clinic
Overall Status: Active - Recruiting

Phase

N/A

Condition

Carcinoma

Hair Loss

Cancer/tumors

Treatment

Electronic Health Record Review

Questionnaire Administration

Survey Administration

Clinical Study ID

NCT05612100
MC220902
MNCCTN013
22-004341
NCI-2022-05686
  • Ages > 18
  • Female

Study 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.

Eligibility Criteria

Inclusion

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 (thesepatients 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 theycomplete 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 ofstarting 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 timeprior to initiation of CDK 4/6 inhibitor).

Exclusion

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 ascale 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

Study Design

Total Participants: 170
Treatment Group(s): 3
Primary Treatment: Electronic Health Record Review
Phase:
Study Start date:
July 06, 2022
Estimated Completion Date:
August 01, 2025

Study 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 and have medical records reviewed on study.

Connect with a study center

  • Mayo Clinic Health System in Albert Lea

    Albert Lea, Minnesota 56007
    United States

    Active - Recruiting

  • Essentia Health Baxter Clinic

    Baxter, Minnesota 56425
    United States

    Active - Recruiting

  • Sanford Joe Lueken Cancer Center

    Bemidji, Minnesota 56601
    United States

    Active - Recruiting

  • Essentia Health Saint Joseph's Medical Center

    Brainerd, Minnesota 56401
    United States

    Active - Recruiting

  • Essentia Health - Deer River Clinic

    Deer River, Minnesota 56636
    United States

    Active - Recruiting

  • Essentia Health Saint Mary's - Detroit Lakes Clinic

    Detroit Lakes, Minnesota 56501
    United States

    Active - Recruiting

  • Essentia Health Cancer Center

    Duluth, Minnesota 55805
    United States

    Active - Recruiting

  • Essentia Health Ely Clinic

    Ely, Minnesota 55731
    United States

    Active - Recruiting

  • Essentia Health - Fosston

    Fosston, Minnesota 56542
    United States

    Active - Recruiting

  • Fairview Grand Itasca Clinic & Hospital

    Grand Rapids, Minnesota 55744
    United States

    Active - Recruiting

  • Essentia Health Hibbing Clinic

    Hibbing, Minnesota 55746
    United States

    Active - Recruiting

  • Fairview Range Medical Center

    Hibbing, Minnesota 55746
    United States

    Active - Recruiting

  • Essentia Health - International Falls Clinic

    International Falls, Minnesota 56649
    United States

    Active - Recruiting

  • Mayo Clinic Health Systems-Mankato

    Mankato, Minnesota 56001
    United States

    Active - Recruiting

  • MMCORC CentraCare Monticello Cancer Center

    Monticello, Minnesota 55362
    United States

    Active - Recruiting

  • Essentia Health Moose Lake

    Moose Lake, Minnesota 55767
    United States

    Active - Recruiting

  • Essentia Health - Park Rapids

    Park Rapids, Minnesota 56470
    United States

    Active - Recruiting

  • Fairview Northland Medical Center

    Princeton, Minnesota 55731
    United States

    Active - Recruiting

  • Mayo Clinic in Rochester

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • Essentia Health Sandstone

    Sandstone, Minnesota 55072
    United States

    Active - Recruiting

  • Sanford Health Thief River Falls

    Thief River Falls, Minnesota 56701
    United States

    Active - Recruiting

  • Essentia Health Virginia Clinic

    Virginia, Minnesota 55792
    United States

    Active - Recruiting

  • Sanford Health Worthington

    Worthington, Minnesota 56187
    United States

    Active - Recruiting

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