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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorDartmouth-Hitchcock Medical Center

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Switch
  • Guideline Directed Intervention (GDI)

Treatment groups

62 Participants
are divided into 2 treatment groups

Locations

1
Dartmouth Cancer Center03756, LebanonNew Hampshire, United States

Sponsors and collaborators

Dartmouth-Hitchcock Medical Center

Lead sponsor