Switching aromatase inhibitors versus guideline-based side-effect care to help with AI side effects

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a two-arm, randomized Phase 2 trial that enrolls postmenopausal women starting their first prescription for an aromatase inhibitor after surgery for ER-positive early breast cancer. Participants are screened for bothersome side effects with a single-item FACIT GP5 questionnaire at 2 weeks and then every 4 weeks; those who report high bother are randomized 1:1 to either switch to a different aromatase inhibitor or receive guideline-directed interventions from a study-specific GDI Book. If symptoms persist after two treatment lines within an arm, participants may cross over to the other arm. The study plans to enroll 124 participants to yield 62 evaluable patients and uses validated symptom and quality-of-life measures at baseline and follow-up.

Why it matters

Who can join: the full rules

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.

Where it's running

• Dartmouth Cancer Center
  Lebanon, New Hampshire, United States Recruiting

Study contacts

• Study coordinator: Kristina M. Willey
• Email: Kristina.M.Willey@hitchcock.org
• Phone: 603-650-7705

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.