Recruiting

Hormone Directed Treatment

Sponsor:

Mayo Clinic

Code:

NCT06557057

Conditions

HER2-Positive Breast Carcinoma

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Accepted

Interventions

Non-Interventional Study

Study Details

Brief summary:

This study assesses the effect of hormone directed treatment for breast cancer on glucose metabolism.

Conditions

HER2-Positive Breast Carcinoma

Study ID

NCT06557057

Start date

Nov 16, 2023

Status verified date

Sep, 2026

Completion date

Dec 1, 2026

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Post-menopausal women with hormone receptor positive breast cancer, ductal carcinoma in situ (DCIS), or with other high risk breast conditions. Post-menopause will be defined as women who experience 12 months of amenorrhea or have undergone bilateral salpingo-oophorectomy.

  • 25 women who are planning to start or are within 6 months of starting treatment with aromatase inhibitors, after consultation in breast clinic and cancer center.
  • 25 women who will be starting Tamoxifen (comparative group)
  • 25 healthy post menopausal women will also be recruited.

Exclusion Criteria:

  • Established diagnosis of diabetes
  • Therapy with medications that could affect glucose metabolism
  • Screening fasting glucose ≥ 126 mg/dl, and/or HbA1c ≥ 6.5%
  • History of upper GI surgery that alters gastric emptying or causing malabsorption e.g., bariatric surgery, fundoplication

Study Design

Enrollment

81 participants

Anticipated

Interventions and Outcome Measures

Arms

Observational

Patients undergo blood sample collection, glucose testing, DEXA scan to measure body composition, complete a questionnaire and have their medical records reviewed on study.

Interventions

Non-Interventional Study

Non-Interventional Study

Primary outcome measure

  • Disposition Index (DI) [ Time Frame: Baseline; up to 1 year ]
  • Glucose homeostasis - tamoxifen compared to no treatment [ Time Frame: Baseline; up to 1 year ]
  • Glucose homeostasis - aromatase inhibitor compared to tamoxifen [ Time Frame: Baseline; up to 1 year ]

Central Contacts and Locations

Central contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

Kalpana Muthusamy, MBBS, MD

More Information

Sponsor

Mayo Clinic

Last update posted

Sep 2, 2026

Last verified

Sep, 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 2026-09-02.