Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT07071038

Evaluating the Use of a Medication 'Switch' vs Guideline-directed Interventions for Relieving Side Effects of Aromatase Inhibitors Among Breast Cancer Patients

Led by Dartmouth-Hitchcock Medical Center · Updated on 2026-02-12

62

Participants Needed

1

Research Sites

93 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers have learned that about 50% of women do not finish the standard 5-year breast cancer treatment with an aromatase inhibitor. An aromatase inhibitor is hormone therapy that lowers the chance of breast cancer coming back (recurring) after surgery by blocking an enzyme in fat tissue called aromatase; aromatase changes other hormones in the body to estrogen. Women who do not complete the standard 5-year treatment are at higher risk of their cancer coming back. The goal of this research is to prevent breast cancer from coming back after surgery by helping women to stay on treatment with aromatase inhibitors. Researchers believe the best path to help women to stay on treatment is to create a better way to manage (control) side effects.

CONDITIONS

Official Title

Evaluating the Use of a Medication 'Switch' vs Guideline-directed Interventions for Relieving Side Effects of Aromatase Inhibitors Among Breast Cancer Patients

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologic confirmation of DCIS or invasive breast cancer by biopsy
  • Estrogen receptor alpha (ER)-positive DCIS or invasive cancer
  • HER2-negative invasive cancer (IHC 0-1+ or FISH ratio <1.8 if IHC 2+ or not done)
  • Clinical Stage I-III invasive breast cancer or DCIS
  • Clinically indicated for adjuvant treatment with letrozole, anastrozole, or exemestane
  • Plan to continue adjuvant endocrine therapy for at least 2 years at registration
  • Women aged over 18 years who are post-menopausal (last menstrual period >2 years ago or >1 year with post-menopausal hormone levels)
  • Meet clinical lab criteria: ANC >1,000/mm3, platelet count >75,000/mm3, bilirubin <1.5x ULN, ALT and AST <3x ULN
  • Able to give informed consent
Not Eligible

You will not qualify if you...

  • Prior endocrine therapy for any confirmed cancer or breast cancer prevention in last 10 years
  • Any other adjuvant therapy for breast cancer except bisphosphonates or denosumab for bone issues
  • Prescribed tamoxifen as first endocrine therapy instead of an aromatase inhibitor
  • Pregnant or lactating women
  • Prisoners

AI-Screening

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Trial Site Locations

Total: 1 location

1

Dartmouth Cancer Center

Lebanon, New Hampshire, United States, 03756

Actively Recruiting

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Research Team

K

Kristina M. Willey

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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