This phase II trial compares the effect of changing (or switching) aromatase inhibitors (AI) to a guideline-directed intervention, standard side effect treatment, in managing side effects in patients with estrogen receptor positive and HER2 negative breast ductal carcinoma in situ (DCIS) and stage I-III invasive breast cancer. Estrogen can cause the growth of breast cancer cells. AIs, such as letrozole, anastrozole, and exemestane, are a type of hormone therapy that lowers the amount of estrogen by blocking an enzyme in fat tissue called aromatase, which changes other hormones in the body to estrogen. This may help stop the growth of tumor cells that need estrogen to grow. Tamoxifen, a type of antiestrogen, blocks the use of estrogen by the tumor cells. Researchers have learned that about 50% of women do not finish the standard 5-year breast cancer treatment with an AI and women who do not complete treatment are at a higher risk of their tumor coming back. Side effects, including hot flashes and pain, are the most common reasons patients list for not completing treatment. Currently, standard treatment for managing side effects involves stopping the AI for a few weeks (a treatment holiday) and using medication and non-medication treatment options specific to the side effects. Switching to a different AI after a treatment holiday may have fewer side effects. Information gathered from this study may help researchers learn whether switching AIs or a guideline-directed intervention is more effective in reducing side effects and improving adherence to AIs in patients with estrogen receptor positive, HER2 negative breast DCIS and stage I-III invasive breast cancer.
Additional locations may be listed on ClinicalTrials.gov for NCT07071038.
Locations matching your search criteria
United States
New Hampshire
Lebanon
Dartmouth Hitchcock Medical Center/Dartmouth Cancer CenterStatus: Active
Contact: Elaine P Kuhn
Phone: 774-268-9343
PRIMARY OBJECTIVE:
I. To determine whether ‘switch’ or guideline-directed intervention (GDI) was more effective at reducing side effects.
SECONDARY OBJECTIVES:
I. To determine whether either ‘switch’ or GDI was more effective at reducing side effects at 3- and 6-months after randomization, allowing for cross-over in an intention-to-treat analysis.
II. To assess whether either ‘switch’ or GDI was more effective at improving quality of life at 3- and 6-months after randomization.
III. To evaluate whether either ‘switch’ or GDI arms had better adherence at 3- and 6- months after randomization.
IV. To determine if more participants retain long-term adherence with endocrine therapy at 12 and 24 months in either arm in an intention to treat analysis.
V. To compare the distant disease-free survival between arms at 12 and 24 months, and at 5 years.
VI. To evaluate the association of patient perceived self-efficacy, illness perception and hopefulness in long-term adherence with endocrine therapy.
EXPLORATORY OBJECTIVES:
I. To determine the sensitivity of a modified Treatment Satisfaction Questionnaire for Medication (TSQM) screening tool to detect patients with clinically meaningful side effects requiring intervention.
II. To determine the sensitivity of a priori defined ‘responder threshold’ to detect patients with clinically meaningful improvement in symptoms for individuals at 3- and 6-months.
III. To identify factors associated with disparities in access to guideline-directed interventions, assessed by exit survey.
OUTLINE: Patients receive letrozole for up to 6 months in the absence of disease progression or unacceptable toxicity. Patients who report clinically meaningful side effect burden (General Physical 5 scores of 3 or 4) are randomized to 1 of 2 arms.
ARM A (GDI): Patients who report clinically meaningful side effects stop letrozole and receive first line evidence-based treatment including medication and non-medication options for managing side effects at the discretion of the treating provider. After a 2-4 week treatment holiday, patients restart letrozole. After at least 4 weeks, patients with continued side effects may switch to second line symptom management per discretion of treating provider. Patients also attend follow up visits over 30 minutes at 2-4 weeks, and at 3, 6, 12 and 24 months after starting AI. Patients who continue to have bothersome side effects after second line management may cross-over to the other treatment arm after a 2-4 week treatment holiday. Additionally, patients undergo urine sample collection throughout the study.
ARM B (SWITCH): Patients who report clinically meaningful side effects stop letrozole. Starting after a 2-4 week treatment holiday, patients receive first line AI with anastrozole or exemestane for at least 4 weeks at the discretion of the treating provider. After at least 4 weeks, patients who require second line treatment receive a different AI with either exemestane, anastrozole, or tamoxifen for up to a total of 35 weeks of treatment. Patients also attend follow up visits over 30 minutes at 2-4 weeks, and at 3, 6, 12 and 24 months after starting AI. Patients who continue to have bothersome side effects after second line management may cross-over to the other treatment arm after a 2-4 week treatment holiday. Additionally, patients undergo urine sample collection throughout the study.
After completion of study treatment, patients are followed up at routine 1 and 2 year follow-up visits.
Lead OrganizationDartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Principal InvestigatorElaine P Kuhn
