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NCT04570956
Oral Tamoxifen vs. TamGel vs. Control in Women With Atypical Hyperplasia, Lobular Carcinoma In Situ, or Increased Breast Cancer Risk
Phase 2 trial testing Tamoxifen in Breast Atypical Hyperplasia in 65 participants. Terminated before completion.
15 October 2024
Quick facts
| Lead sponsor | Mayo Clinic |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 65 |
| Start date | 26 July 2021 |
| Primary completion | 15 October 2024 |
| Estimated completion | 15 October 2024 |
| Sites | 3 locations across United States |
Drugs / interventions tested
- Tamoxifen — full drug profile →
- Topical 4-OHT( 4-hydroxytamoxifen)gel 4 mg/each breast/day — full drug profile →
- Placebo
- Questionnaire Administration
Conditions studied
- Breast Atypical Hyperplasia — all drugs for Breast Atypical Hyperplasia →
- Breast Lobular Carcinoma in Situ — all drugs for Breast Lobular Carcinoma in Situ →
- Breast Atypical Lobular Hyperplasia — all drugs for Breast Atypical Lobular Hyperplasia →
- Breast Carcinoma — all drugs for Breast Carcinoma →
Sponsor
Mayo Clinic
Who can join
Adults 18 to 80, female only, with Breast Atypical Hyperplasia or Breast Lobular Carcinoma in Situ. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The investigators plan to prospectively study breast tissue changes after a short course of Tamoxifen (Tam).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04570956
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Tamoxifen
Trials testing the same drug.
- NCT07499999 — Randomized Double-Blind Phase II Trial of Baby Exemestane Versus Baby Tamoxifen in Post-Menopausal Women at High Risk fo · Phase 2 · not yet recruiting
- NCT06434064 — Tamoxifen and Pegylated Liposomal Doxorubicin for the Treatment of Patients With Metastatic or Inoperable, Locally Advan · Phase 2 · recruiting
- NCT06942039 — Pilot Study of IT Topotecan and Maintenance Chemotherapy for HR-EBTs in Children < 6 Years, Post Consolidation · EARLY_PHASE1 · recruiting
- NCT06979596 — A Study of MK-5684 in People With Certain Solid Tumors (MK-5684-015/OMAHA-015) · Phase 2 · recruiting
- NCT06195306 — Low Dose Tamoxifen With or Without Omega-3 Fatty Acids for Breast Cancer Risk Reduction · Phase 2 · recruiting
Other recruiting trials for Breast Atypical Hyperplasia
Currently open trials in the same condition.
- NCT06195306 — Low Dose Tamoxifen With or Without Omega-3 Fatty Acids for Breast Cancer Risk Reduction · Phase 2 · recruiting
- NCT05941520 — Acolbifene Versus Low Dose Tamoxifen for the Prevention of Breast Cancer in Premenopausal Women at High Risk for Develop · Phase 2 · recruiting
Other Mayo Clinic trials
Trials by the same sponsor.
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- NCT07169799 — Impact of Cryotherapy Spray (Tru-Freeze) for the Eradication of Gastric Antral Vascular Ectasia (ICE-GAVE) · NA · recruiting
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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 NCT04570956 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Mayo Clinic
- Last refreshed: 23 January 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/NCT04570956.
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