Evaluating the Use of a Medication 'Switch' vs Guideline-directed Interventions for Relieving Side Effects of Aromatase Inhibitors Among Breast Cancer Patients
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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Urine samples
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Urine samples will be collected as a part of this study, to assess for adherence to endocrine therapy at the time of randomization, and at 3, 6 12 and 24 months after randomization."
- "Urine samples will be collected during routine office visits when possible."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study compares switching medicines with using recommended treatments to ease side effects of aromatase inhibitors. These hormone medicines help lower the chance of breast cancer coming back after surgery. The study is for women past menopause with certain types of breast cancer and aims to help them stay on treatment.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- A tissue sample must show DCIS (cancer inside the breast milk ducts) or stage I–III invasive breast cancer (cancer that has spread into nearby breast tissue).
- The cancer must be ER-positive, meaning estrogen can help it grow.
- Invasive cancer must be HER2-negative, based on the study’s test rules. HER2 is a protein that helps cancer cells grow.
- Treatment after surgery with letrozole, anastrozole, or exemestane must be a suitable choice for you.
- You must plan to continue hormone treatment for at least 2 years after joining.
- You must be a woman over 18 and past menopause: no period for over 2 years, or over 1 year with blood tests showing menopause.
- Blood tests must meet the study’s limits for infection-fighting cells, platelets (cells that help stop bleeding), and liver function.
- You must be able to understand the study and agree to take part.
Who can't join
- You had hormone treatment for cancer, or to prevent breast cancer, in the past 10 years.
- You receive any other treatment after surgery for breast cancer. Bisphosphonates or denosumab for bone health problems are allowed.
- You are prescribed tamoxifen as your first hormone treatment instead of an aromatase inhibitor.
- You are pregnant or breastfeeding.
- You are a prisoner.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility 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.
Study sites (1)
NH
- Dartmouth Cancer Center · Lebanon, NH 03756Elaine P Kuhn, MD, MS · Principal investigatorMore trials in Lebanon