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ACTIVE NOT RECRUITING NA

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

NCT05568472 · View on ClinicalTrials.gov ↗

Study Summary

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.

Interventions

  • PROCEDURE Biospecimen Collection
  • OTHER Questionnaire Administration
  • OTHER Best Practice
  • BEHAVIORAL Health Education
  • PROCEDURE Endocrine Drug Therapy

Study Locations (20)

California

  • Kaiser Permanente-Deer Valley Medical Center — Antioch
  • Mission Hope Medical Oncology - Arroyo Grande — Arroyo Grande
  • PCR Oncology — Arroyo Grande
  • AIS Cancer Center at San Joaquin Community Hospital — Bakersfield
  • Marshall Cancer Center — Cameron Park
  • Mercy Cancer Center �� Carmichael — Carmichael
  • Mercy San Juan Medical Center — Carmichael
  • Epic Care-Dublin — Dublin
  • Kaiser Permanente Dublin — Dublin
  • Mercy Cancer Center - Elk Grove — Elk Grove
  • Bay Area Breast Surgeons Inc — Emeryville
  • Epic Care Partners in Cancer Care — Emeryville
  • Kaiser Permanente-Fremont — Fremont
  • Fresno Cancer Center — Fresno
  • Kaiser Permanente-Fresno — Fresno
  • Contra Costa Regional Medical Center — Martinez
  • Fremont - Rideout Cancer Center — Marysville
  • Kaiser Permanente-Modesto — Modesto

Arizona

  • Kingman Regional Medical Center — Kingman
  • Cancer Center at Saint Joseph's — Phoenix

Trial Details

FieldValue
Enrollment Target 565 participants
Start Date 2023-03-29
Est. Completion 2028-05-01
Phase NA

Sponsor

SWOG Cancer Research Network

212 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05568472

The ClinicalTrials.gov registry entry for NCT05568472 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 565 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is SWOG Cancer Research Network, which has 212 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 4 conditions, with Anatomic Stage III Breast Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions — of which Biospecimen Collection is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05568472 reports 20 study locations spanning 2 distinct geographic areas — top geographies include California, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05568472 about?

NCT05568472 is a clinical study titled "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 e...

What is the current status of trial NCT05568472?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 565 participants. The study started on 2023-03-29. Estimated completion is 2028-05-01.

What conditions does trial NCT05568472 study?

This clinical trial studies the following conditions: Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8, Hormone Receptor-Positive Breast Carcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05568472?

The interventions under investigation include: Biospecimen Collection (PROCEDURE), Questionnaire Administration (OTHER), Best Practice (OTHER), Health Education (BEHAVIORAL), Endocrine Drug Therapy (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05568472?

This trial is sponsored by SWOG Cancer Research Network, which has 212 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05568472 being conducted?

This trial has 20 study locations across Arizona, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial