Monitoring Symptoms to Help Young Women Take Hormone Therapy for Stage I-III Breast Cancer, ASPEN Study

Running, not enrolling · Not applicable

Conditions studied: Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Hormone Receptor-Positive Breast Carcinoma

In brief

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.

Key facts

Study ID

NCT05568472

Run by

SWOG Cancer Research Network

People needed

565

Starts

2023-03-29

Expected to finish

2028-05-01

Last updated by the study team

2026-04-02

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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 (e.g., 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
• 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 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
• 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

You may not qualify if…

• 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
• 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 planning to become pregnant during the 80 weeks of 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 have a non-breast malignancy for which they are currently receiving treatment

Where it is running

• Kingman Regional Medical Center — Kingman, Arizona, United States
• Cancer Center at Saint Joseph's — Phoenix, Arizona, United States
• Kaiser Permanente-Deer Valley Medical Center — Antioch, California, United States
• Mission Hope Medical Oncology - Arroyo Grande — Arroyo Grande, California, United States
• PCR Oncology — Arroyo Grande, California, United States
• AIS Cancer Center at San Joaquin Community Hospital — Bakersfield, California, United States
• Marshall Cancer Center — Cameron Park, California, United States
• Mercy Cancer Center �� Carmichael — Carmichael, California, United States
• Mercy San Juan Medical Center — Carmichael, California, United States
• Epic Care-Dublin — Dublin, California, United States
• Kaiser Permanente Dublin — Dublin, California, United States
• Mercy Cancer Center - Elk Grove — Elk Grove, California, United States
• Bay Area Breast Surgeons Inc — Emeryville, California, United States
• Epic Care Partners in Cancer Care — Emeryville, California, United States
• Kaiser Permanente-Fremont — Fremont, California, United States
• Fresno Cancer Center — Fresno, California, United States
• Kaiser Permanente-Fresno — Fresno, California, United States
• Contra Costa Regional Medical Center — Martinez, California, United States
• Fremont - Rideout Cancer Center — Marysville, California, United States
• Kaiser Permanente-Modesto — Modesto, California, United States
• Bay Area Tumor Institute — Oakland, California, United States
• Kaiser Permanente Oakland-Broadway — Oakland, California, United States
• Kaiser Permanente-Oakland — Oakland, California, United States
• Kaiser Permanente-Rancho Cordova Cancer Center — Rancho Cordova, California, United States
• Kapiolani Medical Center for Women and Children — Honolulu, Hawaii, United States

Full record on ClinicalTrials.gov

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