Clinical Trial 23056

• Overview

  Study Title:

  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)

  Objective:

  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. 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.

• Inclusion Criteria

  Inclusion Criteria:
  • Participants must be female and have Stage I, II, or III hormone receptor positive breast cancer based on clinical or pathologic evaluation
  • Participants must have been pre- or peri-menopausal at the time of breast cancer diagnosis by satisfying one of the following: Had a menstrual period (by self-report) within the 12 months before breast cancer diagnosis, OR Had a serum or plasma estradiol and/or follicle stimulating hormone (FSH) concentration consistent with premenopausal status (based on institutional standards) within the 12 months before breast cancer diagnosis or when checked after breast cancer diagnosis
  • Participants must have started initial treatment with standard of care oral endocrine therapy (ET) (i.e., tamoxifen, anastrozole, exemestane, or letrozole; within 14 days prior to randomization or be planning to start initial treatment with standard of care oral ET within 14 days after randomization
  • Participants who currently have ovarian function (estradiol above the postmenopausal range) must be planning to undergo ovarian suppression or ablation concomitantly with oral ET medication, starting before or at the same time as oral ET initiation. > Participants with chemotherapy-induced amenorrhea or ovarian failure at time of registration must be planning to start ovarian suppression or ablation if they have recurrence of ovarian function during study participation (circulating estradiol concentration in the premenopausal range or recurrence of menses)
  • Participants must have completed surgery for treatment of breast cancer at least 14 days prior to randomization NOTE: Concomitant radiotherapy at the time of randomization and/or during study participation is allowed
  • Participants who received chemotherapy must have finished it at least 14 days prior to randomization NOTE: Concomitant maintenance targeted or biologic therapy such as human epidermal growth factor receptor 2 [anti-HER2] therapy, poly-ADP ribose polymerase [PARP] inhibitor therapy, CDK4/6 inhibitor therapy, osteoclast inhibitor therapy at the time of randomization and/or during study participation is allowed
  • Participants must be 18 years of age or older
  • Participants must have a complete medical history within 60 days prior to randomization
  • Participants must be able to complete Patient-Reported Outcome (PRO) instruments in English or Spanish
  • Other criteria may apply

• Exclusion Criteria

  Exclusion Criteria:
  • Participants must not have distant metastatic breast cancer
  • Participants who have started or plan to start treatment with tamoxifen during study participation must not have received prior tamoxifen for treatment or prevention of breast cancer
  • Participants who have started or plan to start treatment with an aromatase inhibitor during study participation must not have received prior aromatase inhibitor therapy for treatment or prevention of breast cancer
  • Participants must not be taking or planning to take oral estrogen-or progesterone-containing treatments during study participation
  • Participants must not be planning to become pregnant during the 80 weeks of study participation
  • Participants must not receive additional anti-cancer treatments such as experimental therapy or immunotherapy, biologics as part of another clinical trial
  • Participants must not have a non-breast malignancy for which they are currently receiving treatment

If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.