Breast CancerPhase 2SWIVELNCT07071038
Evaluating the Use of a Medication 'Switch' vs Guideline-directed Interventions for Relieving Side Effects of Aromatase Inhibitors Among Breast Cancer Patients
A Phase 2 study testing Switch and Guideline Directed Intervention (GDI) in people with Breast Cancer and Adjuvant Treatment, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Adjuvant Treatment, Early Stage Breast Cancer
- What is being tested?
- Switch and Guideline Directed Intervention (GDI)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Oct 2025to 5 Aug 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Dartmouth Cancer Center
Lebanon, New Hampshire, 03756
Elaine P Kuhn, MD, MS
About this study
Official title: 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
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.
Read the detailed description
This is a two-arm, randomized-controlled trial with option for cross-over that compares the effectiveness of a 'switch' in hormonal therapy to guideline-directed intervention (GDI) for frontline management of side effects of aromatase inhibitors among breast cancer patients. Researchers plan to enroll post-menopausal patients with breast cancer who receive a first-time prescription for an aromatase inhibitor (AI). The anticipated enrollment is 124 participants to meet the goal of 62 evaluable participants.
Baseline symptom burden and quality of life will be assessed by validated surveys prior to starting AI. After starting AI, participants will be contacted at 2 weeks, and then every 4-weeks to screen for the development of bothersome side effects using a validated screening tool. The screening tool (FACIT GP5) is a single-item questionnaire that asks participants to respond to the following: "I am bothered by side effects of treatment," with answers ranging from 'Not at all' (score 0) to 'Very much' (score 4). Participants who score either a 3 or 4 on the FACIT GP5 will be considered to have a positive screening result. They will be randomized 1:1 to either receiving a different AI ('switch') or guideline-directed intervention (GDI). A 'GDI Book' was created for this study and will serve as a reference for selecting GDI treatment.
Participants who continue to have symptoms despite completing two lines of treatment within their assigned arm will be allowed to cross-over to the other treatment arm. Patients who are otherwise doing well in their treatment arm may stay in that treatment arm for the duration of the study. Cross-over is entirely optional.
Participants who do not develop side effects will continue to be monitored on study for up to 6 months. Participants with side effects that do not meet criteria for randomization (FACIT GP5 scores of 1 or 2) will receive standard of care at the discretion their treating provider.
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. For participants that are not randomized, urine will be collected at 6, 12 and 24 months only. Urine samples will be collected during routine office visits when possible. Urine test results will remain anonymous (the treating provider will not know the results).
- Conditions
- Breast Cancer, Adjuvant Treatment, Early Stage Breast Cancer
- Being tested
- Switch, Guideline Directed Intervention (GDI)
- 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
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SwitchDrug
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)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Switch | Active comparator | 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. Receives: Drug: Switch |
| Guideline Directed Intervention (GDI) | Active comparator | 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). Receives: Other: Guideline Directed Intervention (GDI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Endocrine Symptom Burden at 3 months
The primary outcome of this study is the change in the Functional Assessment of Cancer Therapy Endocrine Subscale (FACT-ES) endocrine symptom subscale (ESS-23) survey score as measured from the time of randomization to 3 months, or at the time of cross-over or discontinuation of AI due to intolerable side effects, whichever comes first. The ESS-23 score ranges from 0-92, with lower scores indicating higher symptom burden.
Measured: 3 months after randomization
Secondary outcomes (8)
Change in Symptom Burden at 3 and 6 months (FACT-ES)
Change in FACT-ES Endocrine Subscale survey scores from time to randomization to 3-months and at 6 months, after allowing for cross-over in an intention to treat analysis
Measured: 3 and 6 months after randomization
Change in Symptom Burden at 3 and 6 months (PROMIS)
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) survey scores (fatigue, depression, anxiety, pain, sleep disturbance, physical function) from baseline to 3 and 6 months in an intention to treat analysis. Each PROMIS short form symptom survey consists of 8 items, and raw scores are converted to T-scores ranging from 0-100 with associated standard errors based on the general US population. Higher T scores correspond to more symptom burden. The change in average T scores for relevant symptom surveys will be compared between groups.
Measured: 3 and 6 months
Change in Symptom Burden at 3 and 6 Months (FSFI)
Change in Female Sexual Function Index (FSFI) survey score from baseline to 3 and 6 months in an intention to treat analysis. The FSFI is a 19-item validated survey, answers are given on a 5-point Likert scale and questions are weighted to give a total score ranging from 2-36, with higher scores indicating better sexual function.
Measured: 3 and 6 months
Quality of life at 3 and 6 months
Change in the Functional Assessment of Cancer Therapy-General (FACT-G) survey score from time to randomization to 3- and 6-months. The FACT-G measures physical, social, emotional and function well-being, with a total of 27 items that are answered on a 5-point Likert scale. Total scores range from 0-108, with higher scores indicating better quality of life.
Measured: 3 and 6 months after randomization
Adherence to Endocrine Therapy at 3 and 6 months
Adherence to endocrine therapy will be assessed by urine testing and corroborated by VOILS survey and pharmacy records. The VOILS Adherence scale assesses patient-reported extent and reasons for nonadherence. Answers are given on a 5-point Likert scale, with higher scores indicating a greater degree of non-adherence.
Measured: 3 and 6 months after randomization
Long-Term Adherence to Endocrine Therapy at 12 and 24 months
Long-term adherence to endocrine therapy will be assessed by urine testing and corroborated by VOILS survey and pharmacy records.
Measured: 12 and 24 months after randomization
Factors Associated with Adherence to Endocrine Therapy
Patient-perceived self-efficacy, illness perception and hopefulness will be evaluated using validated surveys at the time of enrollment. Those survey scores will be assessed for associations with long-term adherence to endocrine therapy.
Measured: 2 years after randomization
Distant Disease-Free Survival at 1, 2 and 5 Years
Distant disease-free survival will be assessed by chart review at 1, 2, and 5 years after randomization.
Measured: 5 years after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start17 Oct 2025
- Primary completion5 Aug 2026 (estimated)
- Study completion5 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is phase II, randomized-controlled trial with option for cross-over that compares the effectiveness of a 'switch' in hormonal therapy to guideline-directed intervention (GDI) for frontline management of side effects of aromatase inhibitors among breast cancer patients. After starting AI, participants will be contacted at 2 weeks, and then every 4-weeks to screen for development of bothersome side effects using a validated screening tool. Participants with a positive screen will receive standard of care advice for managing side effects, and in addition will be randomized 1:1 to either receiving a different AI ("switch") or GDI. In addition to baseline, surveys will be administered at time of positive screening (randomization), and 3- and 6-months.
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elaine.P.Kuhn, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07071038
- Sponsor's protocol ID
- Study02001994
- Other IDs
- 23KUH994, NCI-2025-09080
- Acronym
- SWIVEL
- Status last verified
- Jan 2026
- First submitted
- 23 Jun 2025
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07071038
- Acronym / sponsor ID
- SWIVEL / Study02001994
- Conditions
- Breast Cancer, Adjuvant Treatment, Early Stage Breast Cancer
- Keywords
- breast cancer surgery, aromatase inhibitor, aromatase side effects, hormone therapy, quality of life, adherence, early breast cancer, switching medications
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Study start
- 17 Oct 2025 (actual)
- Primary completion
- 5 Aug 2026 (estimated)
- Study completion
- 5 Aug 2027 (estimated)
- First posted
- 17 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a two-arm, randomized-controlled trial with option for cross-over that compares the effectiveness of a 'switch' in hormonal therapy to guideline-directed intervention (GDI) for frontline management of side effects of aromatase inhibitors among breast cancer patients. Researchers plan to enroll post-menopausal patients with breast cancer who receive a first-time prescription for an aromatase inhibitor (AI). The anticipated enrollment is 124 participants to meet the goal of 62 evaluable participants.
Baseline symptom burden and quality of life will be assessed by validated surveys prior to starting AI. After starting AI, participants will be contacted at 2 weeks, and then every 4-weeks to screen for the development of bothersome side effects using a validated screening tool. The screening tool (FACIT GP5) is a single-item questionnaire that asks participants to respond to the following: "I am bothered by side effects of treatment," with answers ranging from 'Not at all' (score 0) to 'Very much' (score 4). Participants who score either a 3 or 4 on the FACIT GP5 will be considered to have a positive screening result. They will be randomized 1:1 to either receiving a different AI ('switch') or guideline-directed intervention (GDI). A 'GDI Book' was created for this study and will serve as a reference for selecting GDI treatment.
Participants who continue to have symptoms despite completing two lines of treatment within their assigned arm will be allowed to cross-over to the other treatment arm. Patients who are otherwise doing well in their treatment arm may stay in that treatment arm for the duration of the study. Cross-over is entirely optional.
Participants who do not develop side effects will continue to be monitored on study for up to 6 months. Participants with side effects that do not meet criteria for randomization (FACIT GP5 scores of 1 or 2) will receive standard of care at the discretion their treating provider.
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. For participants that are not randomized, urine will be collected at 6, 12 and 24 months only. Urine samples will be collected during routine office visits when possible. Urine test results will remain anonymous (the treating provider will not know the results).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is phase II, randomized-controlled trial with option for cross-over that compares the effectiveness of a 'switch' in hormonal therapy to guideline-directed intervention (GDI) for frontline management of side effects of aromatase inhibitors among breast cancer patients. After starting AI, participants will be contacted at 2 weeks, and then every 4-weeks to screen for development of bothersome side effects using a validated screening tool. Participants with a positive screen will receive standard of care advice for managing side effects, and in addition will be randomized 1:1 to either receiving a different AI ("switch") or GDI. In addition to baseline, surveys will be administered at time of positive screening (randomization), and 3- and 6-months.
| Arm | Type | Receives |
|---|---|---|
| Switch | Active comparator | Drug: SwitchParticipants (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. |
| Guideline Directed Intervention (GDI) | Active comparator | Other: 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SwitchParticipants 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 | Drug | Switch |
| 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. | Other | Guideline Directed Intervention (GDI) |
Primary outcome
Change in Endocrine Symptom Burden at 3 months
Time frame: 3 months after randomization
The primary outcome of this study is the change in the Functional Assessment of Cancer Therapy Endocrine Subscale (FACT-ES) endocrine symptom subscale (ESS-23) survey score as measured from the time of randomization to 3 months, or at the time of cross-over or discontinuation of AI due to intolerable side effects, whichever comes first. The ESS-23 score ranges from 0-92, with lower scores indicating higher symptom burden.
8 secondary outcomes
Change in Symptom Burden at 3 and 6 months (FACT-ES)
Time frame: 3 and 6 months after randomization
Change in Symptom Burden at 3 and 6 months (PROMIS)
Time frame: 3 and 6 months
Change in Symptom Burden at 3 and 6 Months (FSFI)
Time frame: 3 and 6 months
Quality of life at 3 and 6 months
Time frame: 3 and 6 months after randomization
Adherence to Endocrine Therapy at 3 and 6 months
Time frame: 3 and 6 months after randomization
Long-Term Adherence to Endocrine Therapy at 12 and 24 months
Time frame: 12 and 24 months after randomization
Factors Associated with Adherence to Endocrine Therapy
Time frame: 2 years after randomization
Distant Disease-Free Survival at 1, 2 and 5 Years
Time frame: 5 years after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Switch and Guideline Directed Intervention (GDI) in people with Breast Cancer and Adjuvant Treatment, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kristina M. Willey (603-650-7705, Kristina.M.Willey@hitchcock.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Endocrine Symptom Burden at 3 months (time frame: 3 months after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.