170 Participants Needed

Endocrine Therapy for Hair Loss in Breast Cancer

Recruiting at 22 trial locations
CT
AG
Overseen ByAngela Gosch
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Mayo Clinic
Must be taking: Endocrine therapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 6 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates hair loss (alopecia) caused by endocrine therapy in women with breast cancer. Researchers aim to determine the frequency and severity of this hair loss and whether different endocrine treatments affect this side effect differently. Women with breast cancer who are beginning endocrine therapy, such as tamoxifen or aromatase inhibitors, may qualify. Participants will complete questionnaires about their hair loss experience every three months. This information will enhance understanding and management of this side effect for future patients. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to important findings.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop your current medications. However, you cannot participate if you are planning to receive chemotherapy or other cancer-directed therapies at the same time, except for certain allowed medications like CDK4/6 inhibitors.

What is the safety track record for endocrine therapy?

Research has shown that treatments for breast cancer, such as endocrine therapy, can lead to hair loss. This hair loss, known as alopecia, often links to common medications like aromatase inhibitors and tamoxifen. One study found that most patients experienced only mild hair thinning, classified as grade 1. About 43–58% of patients noticed hair loss within a year of starting treatment.

These findings indicate that hair loss is a common side effect, but it is usually not severe. However, patients should be aware that this might occur.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it seeks to better understand endocrine therapy-induced alopecia in female breast cancer patients, a side effect that can significantly impact quality of life. Unlike typical approaches focusing on treating hair loss after it occurs, this observational study aims to gather detailed patient experiences and medical records to uncover patterns and potential predictive factors. This data-driven approach could lead to more personalized treatment plans, helping to prevent or mitigate hair loss for patients undergoing endocrine therapy in the future.

What evidence suggests that endocrine therapy might be an effective treatment for hair loss in breast cancer?

Research has shown that hair loss can be a noticeable side effect of hormone therapy used in breast cancer treatment. In one study, 67% of patients taking aromatase inhibitors and 33% taking tamoxifen experienced some hair loss. Most cases were mild, with 92% of patients reporting only the least severe level of hair loss. Another study found that 18% of patients on hormone therapy alone felt moderate to extreme concern about their hair loss. Overall, hair loss from hormone therapy is less common than with chemotherapy, but it still affects many patients. Participants in this trial will complete alopecia questionnaires and surveys to further understand the impact of endocrine therapy on hair loss.13678

Who Is on the Research Team?

EC

Elizabeth Cathcart-Rake, M.D.

Principal Investigator

Mayo Clinic in Rochester

Are You a Good Fit for This Trial?

Inclusion Criteria

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)
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)
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Observational

Participants complete alopecia questionnaires and surveys and have medical records reviewed

Up to 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Endocrine Therapy

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Observational (alopecia questionnaires and surveys)Experimental Treatment3 Interventions

Endocrine Therapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

🇪🇺
Approved in European Union as Hormone Therapy for:
🇺🇸
Approved in United States as Hormone Therapy for:
🇨🇦
Approved in Canada as Hormone Therapy for:
🇯🇵
Approved in Japan as Hormone Therapy for:
🇨🇳
Approved in China as Hormone Therapy for:
🇨🇭
Approved in Switzerland as Hormone Therapy for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials
3,427
Recruited
3,221,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Citations

Endocrine Therapy–Induced Alopecia in Patients With ...

Alopecia was attributed to aromatase inhibitors in 75 patients (67%) and tamoxifen in 37 (33%). Severity was grade 1 in 96 of 104 patients (92%) ...

Perceptions of Delayed Alopecia Among Breast Cancer ...

Moderate to extreme bother from hair loss was reported by 27% of chemotherapy recipients, by 18% of endocrine therapy only recipients, and by 14% of patients ...

Endocrine Therapy-Induced Alopecia in Postmenopausal ...

This study evaluates endocrine therapy-induced alopecia among postmenopausal and premenopausal female patients with breast cancer. Alopecia is one of the ...

Natural History Evaluation Among Female Breast Cancer ...

Natural History Evaluation Among Female Breast Cancer Survivors with Endocrine Therapy-Induced Alopecia.

Endocrine Therapy–Induced Alopecia in Patients With ...

5 An alopecia meta-analysis of 13 415 patients in 35 clinical trials revealed an overall incidence of alopecia of 4.4%, with the highest ...

Hair regrowth in endocrine therapy alopecia with ...

There is a great need to find safe and effective treatments for endocrine therapy alopecia in women undergoing estrogen-inhibiting therapies for breast cancer.

Hair loss: alopecia fears and realities for survivors of breast ...

Within 12 months of the initiation of an endocrine therapy, 43–58% of patients reported noticing significant alopecia (6,8). A striking 8.3% of patients ...

Cancer-Related Alopecia Risk and Treatment

Endocrine therapy-induced alopecia (EIA) is a recognized side effect of hormone-targeting treatments used to treat breast, prostate, ovarian, ...