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
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Change in Endocrine Symptom Burden at 3 months
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Switch
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.
干预措施: Switch (Drug)
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).
干预措施: Guideline Directed Intervention (GDI) (Other)
结局指标
主要结局
Change in Endocrine Symptom Burden at 3 months
时间窗: 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.
次要结局
- Change in Symptom Burden at 3 and 6 months (FACT-ES)(3 and 6 months after randomization)
- Change in Symptom Burden at 3 and 6 months (PROMIS)(3 and 6 months)
- Change in Symptom Burden at 3 and 6 Months (FSFI)(3 and 6 months)
- Quality of life at 3 and 6 months(3 and 6 months after randomization)
- Adherence to Endocrine Therapy at 3 and 6 months(3 and 6 months after randomization)
- Long-Term Adherence to Endocrine Therapy at 12 and 24 months(12 and 24 months after randomization)
- Factors Associated with Adherence to Endocrine Therapy(2 years after randomization)
- Distant Disease-Free Survival at 1, 2 and 5 Years(5 years after randomization)
研究者
Elaine.P.Kuhn
Principal Investigator
Dartmouth-Hitchcock Medical Center