Recruiting

Aromatase Inhibitor Therapy

Sponsor:

Mayo Clinic

Code:

NCT06401889

Conditions

Anatomic Stage 0 Breast Cancer AJCC v8

Anatomic Stage I Breast Cancer AJCC v8

Anatomic Stage II Breast Cancer AJCC v8

Anatomic Stage III Breast Cancer AJCC v8

Breast Adenocarcinoma

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Non-Interventional Study

Study Details

Brief summary:

This study evaluates changes in skin quality and self-esteem among breast cancer patients who are initiating aromatase inhibitor therapy.

Conditions

Anatomic Stage 0 Breast Cancer AJCC v8

Anatomic Stage I Breast Cancer AJCC v8

Anatomic Stage II Breast Cancer AJCC v8

Anatomic Stage III Breast Cancer AJCC v8

Breast Adenocarcinoma

Study ID

NCT06401889

Start date

Jul 19, 2024

Status verified date

May, 2026

Completion date

Jul 19, 2027

Anticipated

Primary completion date

Jul 19, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • \* Female ≥ 18 years

  • Postmenopausal women suitable to receive aromatase inhibitor as per physician's discretion
  • Histologically confirmed adenocarcinoma of the breast stage 0-III with estrogen receptor (ER) and/or progesterone receptor (PR) positive per American Society of Clinical Oncology (ASCO)/ College of American Pathologists (CAP) guideline and any human epidermal growth factor receptor 2 (HER2)
  • Patients must not have received any prior chemotherapy or endocrine therapy for their current breast cancer. Patients who received tamoxifen or raloxifene or another agent for prevention of breast cancer may be included
  • Patients willing to avoid any facial procedures including facials, neurotoxin injections, fillers, or lasers during study period
  • Willing and able to provide consent

Exclusion Criteria:

  • \* Patients who have previously taken AIs

  • Patients using prescription tretinoin, neurotoxin injections, fillers, facial lasers, microneedling, or facials within 6 months of study consent

Study Design

Enrollment

35 participants

Anticipated

Interventions and Outcome Measures

Arms

Observational

Patients complete surveys/questionnaires, undergo skin measurement with the VISIA CA device, undergo facial skin photography, and attend consultations with an aesthetician on study.

Interventions

Non-Interventional Study

Non-interventional study

Primary outcome measure

  • Changes in skin quality [ Time Frame: Up to 6 months ]

Central Contacts and Locations

Central contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Locations

Mayo Clinic in Florida

Recruiting

Jacksonville, Florida, United States, 32224-9980

Contacts

Clinical Trials Referral Office, M.D.

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

Leila M. Tolaymat, M.D.

More Information

Sponsor

Mayo Clinic

Last update posted

May 19, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-05-19.