Recruiting
Phase 2

Aromatase Inhibitor

Sponsor:

Dartmouth-Hitchcock Medical Center

Code:

NCT07071038

Conditions

Breast Cancer

Adjuvant Treatment

Early Stage Breast Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Switch

Guideline Directed Intervention (GDI)

Study Details

Brief summary:

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

Breast Cancer

Adjuvant Treatment

Early Stage Breast Cancer

Study ID

NCT07071038

Start date

Oct 17, 2025

Status verified date

Jan, 2026

Completion date

Aug 5, 2027

Anticipated

Primary completion date

Aug 5, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Design

Enrollment

62 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

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).

Interventions

Switch

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)

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Kristina M. Willey

603-650-7705Kristina.M.Willey@hitchcock.org

Locations

Dartmouth Cancer Center

Recruiting

Lebanon, New Hampshire, United States, 03756

Principal Investigator:

Elaine P Kuhn, MD, MS

More Information

Sponsor

Dartmouth-Hitchcock Medical Center

Last update posted

Feb 12, 2026

Last verified

Jan, 2026

Keywords

  • breast cancer surgery
  • aromatase inhibitor
  • aromatase side effects
  • hormone therapy
  • quality of life
  • adherence
  • early breast cancer
  • switching medications
  • hormonal therapy
  • letrozole
  • anastrozole
  • exemestane
  • tamoxifen
  • adjuvant therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dartmouth-Hitchcock Medical Center on 2026-02-12.