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Managing Aromatase Inhibitor Side Effects in Breast Cancer

This study is looking for ways to help breast cancer patients stay on their aromatase inhibitor (hormone therapy that lowers the chance of cancer returning) treatment. Many women stop taking these medications early due to side effects, which increases the risk of their cancer coming back. This trial compares two approaches to manage these side effects: switching to a different aromatase inhibitor (anastrozole or exemestane) or using guideline-directed interventions (GDI), which include medication and non-medication options. The goal is to see which method best reduces side effect burden after 3 months. You may be eligible if you are a post-menopausal woman with ER-positive, HER2-negative early-stage breast cancer or DCIS, and are starting an aromatase inhibitor for the first time. The study is currently unclear on its recruitment status and plans to enroll 62 participants.

Study design
This is a randomized-controlled study with two groups. Participants will either switch to a different aromatase inhibitor or receive guideline-directed interventions to manage side effects.
What's involved
You will complete surveys about your symptoms and quality of life before starting treatment. After starting an aromatase inhibitor, you will be contacted at 2 weeks and then every 4 weeks to check for bothersome side effects.
Compensation
Not stated in the trial record.
Follow-up
The main measurement of side effect burden will be taken 3 months after you are assigned to a treatment group.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07071038

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Dartmouth-Hitchcock Medical Center
~62 participants
Updated 2026-02-12 on ClinicalTrials.gov
What's tested:SwitchGuideline Directed Intervention (GDI)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Endocrine Symptom Burden at 3 months
Measured over 3 months after randomization

Conditions

Breast Cancer
Adjuvant Treatment
Early Stage Breast Cancer

Explore related trials

Breast Carcinoma

Where it's being run

1 sites across 1 states
New Hampshire1

Who to contact

Kristina M. Willey
[email protected]
603-650-7705
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Histologic documentation of DCIS or invasive breast cancer by core needle or incisional biopsy.
The DCIS or invasive cancer must be estrogen receptor alpha (ER)-positive
The invasive cancer must be HER2-negative (IHC 0-1+, or with a FISH ratio of \<1.8 if IHC is 2+ or if IHC has not been done)
Clinical Stage I-III invasive breast cancer or DCIS
Patients for whom adjuvant treatment with one of the following would be clinically indicated: letrozole, anastrozole, exemestane
Patients who anticipate continuing with adjuvant endocrine therapy for a minimum of 2 years at the time of registration
Women over 18 years of age who are post-menopausal, defined as last menstrual period \>2 years prior to registration, or \>1 year prior to registration with FSH and estradiol in post-menopausal range.
Patients must meet the following clinical laboratory criteria:
Absolute neutrophil count (ANC) \>1,000/mm3 and platelet count \> 75,000/mm3
Total bilirubin \<1.5 x the upper limit of the normal range (ULN).
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 3 x ULN.
Ability to give informed consent.

Exclusion

Prior endocrine therapy for any histologically-confirmed cancer or prevention of breast cancer in the last 10 years is not allowed.
Any other adjuvant therapy for breast cancer. Exception: Bisphosphonate or denosumab treatment for metabolic bone issues are allowed.
Patients who are prescribed tamoxifen as the first endocrine therapy rather than an aromatase inhibitor.
Women who are pregnant or lactating.
Prisoners.

What this trial measures

  • Change in Endocrine Symptom Burden at 3 months3 months after randomization

    The primary outcome of this study is the change in the Functional Assessment of Cancer Therapy Endocrine Subscale (FACT-ES) endocrine symptom subscale (ESS-23) survey score as measured from the time of randomization to 3 months, or at the time of cross-over or discontinuation of AI due to intolerable side effects, whichever comes first. The ESS-23 score ranges from 0-92, with lower scores indicating higher symptom burden.