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.
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
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.
Crossover
Switch
DrugParticipants 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 interventionSubjects 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.
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.
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
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.
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.
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.
TSQM Screening Tool
A modified version of the Treatment Satisfaction Questionnaire for Medication (TSQM) will be assessed as a screening tool to identify patients who are having clinically meaningful side effects requiring intervention.
Responder Thresholds to Define Clinically Meaningful Change in Symptoms
Symptom surveys have classically been assessed over time using the 'minimally important difference' (MID) to define clinically meaningful results. This exploratory objective will test the sensitivity of a predefined 'responder threshold' (score change) to identify participants with clinically meaningful improvement in symptoms, according to recent FDA recommendations.
Disparities and Access to Care
Patient perceived barriers to the use of evidence-based interventions will be assessed by exit survey.
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