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

Mayo Clinic

Status

Enrolling

Conditions

Breast Carcinoma

Treatments

Other: Survey Administration

Other: Electronic Health Record Review

Other: Questionnaire Administration

Study type

Observational

Funder types

Other

NIH

Identifiers

NCT05612100

MNCCTN013 (Other Identifier)

MC220902 (Other Identifier)

22-004341 (Other Identifier)

NCI-2022-05686 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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 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.

Enrollment

170 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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