Monitoring Symptoms to Help Young Women Take Hormone Therapy for Stage I-III Breast Cancer, ASPEN Study
This phase III trial compares the effect of active symptom monitoring and patient education to patient education alone in helping young women with stage I-III breast cancer stay on their hormone therapy medicines. The patient education tool contains interactive weblinks which provide patients with education material about breast cancer and side effects of therapy. Symptom monitoring is a weblink via email or text message with questions asking about symptoms. Hormone therapy for breast cancer can cause side effects, and may cause some women to stop treatment early. Asking about symptoms more often may help women keep taking hormone therapy medicines.
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 any time since 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 not have distant metastatic breast cancer
- 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 (+/- gonadotropin-releasing hormone agonist [GnRHa] injection) within 14 days after randomization * NOTES: ** For participants who will be starting GnRHa injection followed by initiation of oral ET after achieving ovarian suppression, participants must be planning to start initial treatment with standard of care GnRHa therapy within 14 days after randomization. Oral ET can be added once ovarian function suppression has been achieved. ** For participants who have already started receiving GnRHa injection, they 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. ** At the time of study enrollment, there should not be a pre-determined plan to change participant’s oral endocrine therapy during study participation.
- Participants who currently have ovarian function (recent menses within the past 90 days or 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 * NOTES: ** At the time of study enrollment, the decision to administer or not administer adjuvant chemotherapy should already have been made ** Concomitant maintenance targeted or biologic therapy (e.g., anti-HER2 therapy, PARP inhibitor therapy, CDK4/6 inhibitor therapy, osteoclast inhibitor therapy) at the time of randomization and/or during study participation is allowed
- 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 * NOTES: ** Participants who start or plan to start treatment with an aromatase inhibitor may have previously received tamoxifen for prevention of breast cancer or treatment of a prior cancer ** Participants may have received prior treatment with an aromatase inhibitor for infertility treatment
- Participants must not be taking or planning to take oral estrogen-or progesterone-containing treatments during study participation
- Participants must not receive additional anti-cancer treatments (i.e., experimental therapy, immunotherapy, biologics, etc.) as part of another clinical trial
- Participants must not co-enroll on this trial and other clinical trials with similar interventions or endpoints
- Participants must be >= 18 years of age
- 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. Participants must: * Agree to complete PROs at all scheduled assessments and * Complete the pre-registration (baseline) PRO forms within 14 days prior to randomization
- Participants must be able to complete symptom questions on a web browser (on a smartphone, tablet, or computer) or respond via voice on a telephone in English or Spanish. Participants must agree to complete symptom questions at all scheduled assessments * NOTE: Participants who do not have access to the internet and who cannot receive telephone calls for interactive voice response system (IVRS) assessments are not eligible
- Participants must not have a non-breast malignancy for which they are currently receiving treatment
- Participants must be offered the opportunity to participate in specimen banking for translational medicine. With participant consent, specimens must be collected and submitted via the Southwest Oncology Group (SWOG) specimen tracking system * NOTE: The optional specimen for banking collection is not required for sites outside of the United States (US).
- Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines
Additional locations may be listed on ClinicalTrials.gov for NCT05568472.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVE:
I. 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:
I. To compare patient-reported adherence with the initially prescribed oral ET over time as assessed with the DOSE-Nonadherence measure between the two arms.
II. To compare worst pain as assessed with the Brief Pain Inventory, in aromatase inhibitors-treated (AI-treated) participants over time between the two arms.
III. To compare hot flashes as assessed with the Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES) Endocrine Symptoms Scale in tamoxifen-treated participants over time between the two arms.
EXPLORATORY OBJECTIVES:
I. To describe key treatment-emergent symptoms as assessed with the Brief Pain Inventory, the Patient-Reported Outcomes Measurement Information System (PROMIS-29) Profile, the PROMIS Cognitive Function, and the FACT-ES Endocrine Symptoms Scale over time between the two arms.
II. 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.
III. To examine associations between baseline symptom bother as assessed with the GP5 item from the FACT-ES and persistence with oral ET.
IV. 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.
V. 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.
VI. To examine associations overall and by arm between baseline sex hormone 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.
VII. To determine patterns of change overall and by arm in centrally evaluated sex hormone during study participation in participants with chemotherapy-induced ovarian failure, those receiving gonadotrophin releasing hormone (GnRH) agonist therapy, and those who had undergone bilateral salpingo-oophorectomy
VIII: To identify inherited genetic variants using genome-wide genotyping that contribute to development of endocrine therapy-emergent toxicity.
BANKING OBJECTIVE:
I. To bank specimens for future correlative studies.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive ET and standard of care clinic visits with a cancer provider at 12, 24, 36, 48, 60, and 72 weeks, and phone visit at 80 weeks to access ongoing use ET medication. Patients are asked 6 brief questions about symptoms weekly by email, text, or phone call for the first 6 months, then every 4 weeks for 12 months. Patients also receive a list of websites with information about breast cancer, side effects of breast cancer medicines, and ways to help with heart health. Patients have the option to submit blood specimen collection at baseline, 3, 12, and 18 months.
ARM II: Patients receive ET and standard of care clinic visits with a cancer provider at 12, 24, 36, 48, 60, and 72 weeks, and phone visit at 80 weeks to access ongoing use ET medication. Patients also receive a list of websites with information about breast cancer, side effects of breast cancer medicines, and ways to help with heart health. Patients have the option to submit blood specimen collection at baseline, 3, 12, and 18 months.
Trial PhasePhase III
Trial Typesupportive care
Lead OrganizationSWOG
Principal InvestigatorNorah Lynn Henry
- Primary IDS2010
- Secondary IDsNCI-2022-06902, SWOG-S2010
- ClinicalTrials.gov IDNCT05568472