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NCT05568472
Monitoring Symptoms to Help Young Women Take Hormone Therapy for Stage I-III Breast Cancer, ASPEN Study
NA trial testing Best Practice in Anatomic Stage I Breast Cancer AJCC v8 in 565 participants. Participants enrolled and being followed up; not accepting new ones.
1 May 2027
Quick facts
| Lead sponsor | SWOG Cancer Research Network |
|---|---|
| Phase | NA |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 565 |
| Start date | 29 March 2023 |
| Primary completion | 1 May 2027 |
| Estimated completion | 1 May 2028 |
| Sites | 490 locations across United States, Peru |
Drugs / interventions tested
- Best Practice
- Biospecimen Collection — full drug profile →
- Endocrine Drug Therapy
- Health Education
- Questionnaire Administration
- Symptom Specific Assessment Tool
Conditions studied
- Anatomic Stage I Breast Cancer AJCC v8 — all drugs for Anatomic Stage I Breast Cancer AJCC v8 →
- Anatomic Stage II Breast Cancer AJCC v8 — all drugs for Anatomic Stage II Breast Cancer AJCC v8 →
- Anatomic Stage III Breast Cancer AJCC v8 — all drugs for Anatomic Stage III Breast Cancer AJCC v8 →
- Hormone Receptor-Positive Breast Carcinoma — all drugs for Hormone Receptor-Positive Breast Carcinoma →
Sponsor
SWOG Cancer Research Network
Who can join
18 and older, female only, with Anatomic Stage I Breast Cancer AJCC v8 or Anatomic Stage II Breast Cancer AJCC v8. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Active symptom monitoring for premenopausal women with breast cancer initiating adjuvant endocrine therapy: Protocol for the SWOG S2010 randomized controlled efficacy trial.
Henry NL, Unger JM, Vaidya R, Darke AK, et al · · 2024 · PMID 39395534 · DOI 10.1016/j.cct.2024.107712
Verify or expand the search:
- PubMed search for NCT05568472
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other SWOG Cancer Research Network trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05568472 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by SWOG Cancer Research Network
- Last refreshed: 2 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05568472.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing