Monitoring Symptoms to Help Young Women Take Hormone Therapy for Stage I-III Breast Cancer, ASPEN Study (NCT05568472)

🧪 Interventions in This Study

• Best Practice (OTHER)
• Biospecimen Collection (PROCEDURE)
• Endocrine Drug Therapy (PROCEDURE)
• Health Education (BEHAVIORAL)
• Questionnaire Administration (OTHER)
• Symptom Specific Assessment Tool (OTHER)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Participants must be female and have Stage I, II, or III hormone receptor positive breast cancer based on clinical or pathologic evaluation
2. Participants must have been pre- or peri-menopausal at the time of breast cancer diagnosis by satisfying one of the following:
3. had a menstrual period (by self-report) within the 12 months before breast cancer diagnosis, or
4. 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
5. 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
6. 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)
7. 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
8. 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
9. Participants must be \>= 18 years of age
10. Participants must have a complete medical history within 60 days prior to randomization
11. Participants must be able to complete Patient-Reported Outcome (PRO) instruments in English or Spanish Participants must:
12. agree to complete PROs at all scheduled assessments and

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (490 Sites)

Showing the first 25 of 490 sites.

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

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Anatomic Stage I Breast Cancer AJCC v8

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• Identifying Decision Making Needs for Older Adult Women With Stage I-III Breast Cancer Considering Neoadjuvant or Adjuvant Chemotherapy — Houston, Texas
• Evaluation of Alternative Site Goserelin Acetate Injection for Ovarian Function Suppression (OFS) in Local and Locally Advanced Premenopausal Hormone Receptor Positive Breast Cancer Patients — Rochester, Minnesota
• A Physical Activity Program Compared to Health Education for Improving Memory and Attention in Hispanic Women With Newly-Diagnosed Stage I-IIIa Breast Cancer, MAMA Trial — Scottsdale, Arizona
• Decision Making Tool in Supporting Decision Making in Contralateral Prophylactic Mastectomy in Patients With Newly Diagnosed Breast Cancer — Houston, Texas

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💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Review the official NIH record below to find the coordinating site.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.