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

Part of paid clinical trials in Lebanon, New Hampshire.

Sponsor
Dartmouth-Hitchcock Medical Center
Study ID
NCT07071038
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Switch — DRUG
    Participants in the switch arm will receive a new prescription for either anastrozole or exemestane at a dose of 1mg or 25mg daily, respectively. The choice of AI in the first line setting will be at the discretion of the treating oncologist. If side effects persist after the 1st line switch, the participant will have the option to switch to another AI not yet tried, or to tamoxifen at 20mg daily
  • Guideline Directed Intervention (GDI) — OTHER
    Subjects in this group will receive a guideline-directed intervention "GDI" using medication and/or non-medication treatment options according to the National Comprehensive Cancer Network (NCCN) supportive care guidelines. A GDI Book was created for this trial that lists treatment options and resources for each of the common side effects of hormonal therapy and is available for providers and staff to help select treatment options. For less common side effects with limited evidence-based options, treatment will be determined in collaboration with the treating provider and PI, using best available evidence.

Study Details

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.

Key Dates

Start date
Oct 17, 2025
Status verified
Jan 2026
Primary completion
Aug 5, 2026
Completion
Aug 5, 2027

Study Design

Enrollment
62 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: Switch
    Participants (people taking part in this study) enrolled to this study will receive treatment with the aromatase inhibitor (AI) Letrozole and fill out surveys to check for side effects to see how the side effects are making their daily life harder. If side effects are reported, the Participant will be randomized (placed by chance) to a group where they will receive either a different AI ('switch') or receive guideline directed intervention "GDI" using medication and non-medication treatment options.
  • Active Comparator: Guideline Directed Intervention (GDI)
    Participants will receive evidence-based (proven to work) treatment options for side effects according to national guidelines; these may include medications or non-medication options (guideline-directed interventions, GDIs).

Primary Outcome Measure

Change in Endocrine Symptom Burden at 3 months [ Time Frame: 3 months after randomization ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Dartmouth Cancer CenterLebanonNew Hampshire03756
Elaine P Kuhn, MD, MS (PRINCIPAL_INVESTIGATOR)

Find similar trials in Lebanon, NH

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Dartmouth Cancer Center· Lebanon, NH

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