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New study aims to uncover hidden hair loss side effect of breast cancer hormone pills

NCT ID NCT05612100

Knowledge-focused Sponsor: Mayo Clinic Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jul 22, 2026 · Updated 5 times

Summary

This study tracks hair loss in 170 women with breast cancer who are taking hormone therapy. Researchers want to learn how common hair loss is, when it starts, how long it lasts, and how severe it gets. Participants will fill out questionnaires about their hair loss and quality of life. The goal is to better understand this side effect so doctors can help women manage it.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could help doctors better predict and manage hair loss from hormone therapy, improving quality of life for breast cancer survivors.
What could go wrong
This is an observational study, not a treatment trial. It will not test any new drug or intervention, so it cannot directly lead to a cure or new therapy.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

169 people

The number who actually took part.

Started

Jul 2022

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Postmenopausal and premenopausal women with a diagnosis of breast cancer.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

breast cancer breast carcinoma breast neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast carcinoma

Contacts and locations

Locations

  • Essentia Health - Deer River Clinic

    Deer River, Minnesota, 56636, United States

  • Essentia Health - Fosston

    Fosston, Minnesota, 56542, United States

  • Essentia Health - International Falls Clinic

    International Falls, Minnesota, 56649, United States

  • Essentia Health - Park Rapids

    Park Rapids, Minnesota, 56470, United States

  • Essentia Health Baxter Clinic

    Baxter, Minnesota, 56425, United States

  • Essentia Health Cancer Center

    Duluth, Minnesota, 55805, United States

  • Essentia Health Ely Clinic

    Ely, Minnesota, 55731, United States

  • Essentia Health Hibbing Clinic

    Hibbing, Minnesota, 55746, United States

  • Essentia Health Moose Lake

    Moose Lake, Minnesota, 55767, United States

  • Essentia Health Saint Joseph's Medical Center

    Brainerd, Minnesota, 56401, United States

  • Essentia Health Saint Mary's - Detroit Lakes Clinic

    Detroit Lakes, Minnesota, 56501, United States

  • Essentia Health Sandstone

    Sandstone, Minnesota, 55072, United States

  • Essentia Health Virginia Clinic

    Virginia, Minnesota, 55792, United States

  • Fairview Grand Itasca Clinic & Hospital

    Grand Rapids, Minnesota, 55744, United States

  • Fairview Northland Medical Center

    Princeton, Minnesota, 55731, United States

  • Fairview Range Medical Center

    Hibbing, Minnesota, 55746, United States

  • MMCORC CentraCare Monticello Cancer Center

    Monticello, Minnesota, 55362, United States

  • Mayo Clinic Health System in Albert Lea

    Albert Lea, Minnesota, 56007, United States

  • Mayo Clinic Health Systems-Mankato

    Mankato, Minnesota, 56001, United States

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905, United States

  • Sanford Health Thief River Falls

    Thief River Falls, Minnesota, 56701, United States

  • Sanford Health Worthington

    Worthington, Minnesota, 56187, United States

  • Sanford Joe Lueken Cancer Center

    Bemidji, Minnesota, 56601, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.