A Randomized Phase III Trial Comparing Active Symptom Monitoring Plus Patient Education Versus Patient Education Alone To Improve Persistence With Endocrine Therapy In Young Women With Stage I-III Breast Cancer (ASPEN)
Categories (click each to see list of all clinical trials associated with that category): Breast (ONC)
Current Status: Open
Phase: III (Cancer Control)
Principal Investigator: Krishnamurthy, Jairam
Eligibility: https://clinicaltrials.gov/ct2/show/NCT05568472?term=NCT05568472&draw=2&rank=1#eligibility
Summary
1.1 Primary Objective
a. To compare persistence with the initially prescribed oral endocrine therapy (ET) through 72 weeks for young women being treated for hormone-receptor positive stage I-III breast cancer randomized to Active Symptom Monitoring (ASM) + patient education or patient education alone.
1.2 Secondary Objectives
a. To compare patient-reported adherence with the initially prescribed oral ET over time as assessed with the DOSE-Nonadherence measure between the two arms.
b. To compare worst pain as assessed with the Brief Pain Inventory, in aromatase inhibitors-treated (AI-treated) participants over time between the two arms.
c. To compare hot flashes as assessed with the FACT-ES Endocrine Symptoms Scale in tamoxifen-treated participants over time between the two arms.
1.3 Exploratory Objectives
a. To describe key treatment-emergent symptoms as assessed with the Brief Pain Inventory, the PROMIS-29 Profile, the PROMIS Cognitive Function, and the FACT-ES Endocrine Symptoms Scale over time between the two arms.
b. To develop a composite risk prediction model (including demographics, socioeconomic variables, and clinical variables) to identify participants who are most likely to benefit from ASM.
c. To examine associations between baseline symptom bother as assessed with the GP5 item from the FACT-ES and persistence with oral ET.
d. To examine the pattern by arm of treatment toxicity from the oral ET agents that are prescribed in this study over time during the first 24 weeks.
e. To compare biochemically determined adherence with the initially prescribed oral ET as assessed with centrally evaluated drug concentrations and metabolites between ASM + patient education and patient education alone over time.
f. To examine associations overall and by arm between baseline estradiol concentrations evaluated centrally and development of treatment-emergent symptoms as assessed with the Brief Pain Inventory, the PROMIS-29 Profile, the PROMIS Cognitive Function, and the FACT-ES Endocrine Symptoms Scale.
g. To determine patterns of change overall and by arm in centrally evaluated estradiol concentrations during study participation in participants with chemotherapy-induced ovarian failure, those receiving GnRH agonist therapy, and those who had undergone bilateral salpingo-oophorectomy.
h. To identify inherited genetic variants using genome-wide genotyping that contribute to development of endocrine therapy-emergent toxicity.
1.4 Banking Objective
a. To bank specimens for future correlative studies.