Active Not Recruiting NA INTERVENTIONAL 2-arm NCT05568472

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

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)

Sponsor: National Cancer Institute (NCI)

Conditions 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

Interventions Best Practice Biospecimen Collection Endocrine Drug Therapy Health Education Questionnaire Administration Symptom Specific Assessment Tool

Updated 9 times since 2022 Last updated: Apr 1, 2025 Started: Mar 29, 2023 Primary completion: May 1, 2027 Completion: May 1, 2028

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A NA clinical study on Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, this trial is ongoing. The trial is conducted by National Cancer Institute (NCI) and has accumulated 9 data snapshots since 2023. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Status Flow

Change History

9 versions recorded

Sep 2025 — Present [monthly]

Active Not Recruiting NA
May 2025 — Sep 2025 [monthly]

Active Not Recruiting NA

Status: Recruiting → Active Not Recruiting
Dec 2024 — May 2025 [monthly]

Recruiting NA
Sep 2024 — Dec 2024 [monthly]

Recruiting NA
Jul 2024 — Sep 2024 [monthly]

Recruiting NA

▶ Show 4 earlier versions

Dec 2023 — Jul 2024 [monthly]

Recruiting NA
May 2023 — Dec 2023 [monthly]

Recruiting NA
Feb 2023 — May 2023 [monthly]

Recruiting NA

Status: Not Yet Recruiting → Recruiting
Nov 2022 — Feb 2023 [monthly]

Not Yet Recruiting NA

First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

National Cancer Institute (NCI)
SWOG Cancer Research Network

Data source: SWOG Cancer Research Network

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Akron, United States , Albert Lea, United States , Albuquerque, United States , Allentown, United States , Amarillo, United States , Ames, United States , Anderson, United States , Ann Arbor, United States , Antigo, United States , Antioch, United States and 317 more locations