Switching aromatase inhibitors versus guideline-based side-effect care to help with AI side effects
The 'SWIVEL' Study (Switch Vs Effects Relief): Effectiveness of a Medication 'Switch' vs Guideline-Directed Interventions for Relieving Side Effects of Aromatase Inhibitors Among Breast Cancer Patients
This test tries switching one aromatase inhibitor to another versus using guideline-based side-effect care to see which helps postmenopausal women with early-stage ER-positive breast cancer stay on their hormone therapy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 62 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Dartmouth-Hitchcock Medical Center Academic / other |
| Drugs / interventions | denosumab |
| Locations | 1 site (Lebanon, New Hampshire) |
| Trial ID | NCT07071038 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Postmenopausal women with ER-positive DCIS or stage I-III invasive, HER2-negative breast cancer who are starting an aromatase inhibitor and plan to continue adjuvant endocrine therapy for at least two years.
Not a fit: Premenopausal patients, those with HER2-positive disease, patients who are already well beyond initiation of AI therapy, or those who cannot tolerate alternate AIs are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the approach could help more women stay on aromatase inhibitor therapy and reduce the risk of cancer recurrence by improving side-effect management.
How similar studies have performed: Prior research suggests switching between aromatase inhibitors or using symptom-management strategies can help some women tolerate therapy, but a randomized frontline comparison with optional cross-over is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Lebanon, New Hampshire
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.