NCT04666961 (HORNEO01) is a Phase 2 clinical trial of Tamoxifen 20 mg in Ductal Carcinoma in Situ, sponsored by Institut Cancerologie de l'Ouest.

Who is sponsoring NCT04666961?

NCT04666961 is sponsored by Institut Cancerologie de l'Ouest.

What drugs are being tested in NCT04666961?

Interventions in NCT04666961: Tamoxifen 20 mg, Anastrozole 1Mg Tab.

What condition does NCT04666961 study?

NCT04666961 studies Ductal Carcinoma in Situ, Extensive Disease, Mastectomy.

Is NCT04666961 still recruiting?

NCT04666961 is currently recruiting now. Last updated 22 April 2022.

Last reviewed 2022-04-22 · How we verify

NCT04666961: HORNEO01

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Impact of Neoadjuvant Hormonal Therapy on the Surgical Management of Extensive Ductal Carcinomas in Situ

Recruiting now Phase 2 Last updated 22 April 2022

What this trial tests

Phase 2 trial testing Tamoxifen 20 mg in Ductal Carcinoma in Situ in 262 participants. Currently enrolling.

Timeline

3 February 2021

Primary endpoint
1 August 2024

1 August 2033

Quick facts

Lead sponsor	Institut Cancerologie de l'Ouest
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	262
Start date	3 February 2021
Primary completion	1 August 2024
Estimated completion	1 August 2033
Sites	8 locations across France

Drugs / interventions tested

Tamoxifen 20 mg — full drug profile →
Anastrozole 1Mg Tab — full drug profile →

Conditions studied

Ductal Carcinoma in Situ — all drugs for Ductal Carcinoma in Situ →
Extensive Disease — all drugs for Extensive Disease →
Mastectomy — all drugs for Mastectomy →

Sponsor

Institut Cancerologie de l'Ouest — full company profile →

Who can join

40 and older, female only, with Ductal Carcinoma in Situ or Extensive Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Ductal carcinoma in situ (DCIS) accounts for approximately 20% of newly diagnosed breast cancer cases. Of these women, 20% require radical management in the form of mastectomy because of the extent of the lesions, which most often manifest as diffuse microcalcifications. This mutilating surgical management contrasts with the excellent prognosis of this pathology and considerably alters the quality of life of patients. Neoadjuvant hormone therapy has shown its efficacy in hormone-dependent infiltrating ductal carcinomas and offers the possibility of conservative surgery after hormone therapy. Adjuvant hormone therapy with Tamoxifen or anti-aromatase drugs has shown its efficacy in the prevention of homo or contralateral recurrence. The HORNEO 01 trial fits perfectly in the current context of surgical de-escalation of ductal carcinomas in situ. The objective of the study is to evaluate the impact of neoadjuvant hormone therapy on the surgical management of extensive DCIS.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Management of Ductal Carcinoma In Situ: An Ontario Health (Cancer Care Ontario) Clinical Practice Guideline.
Brackstone M, Durocher-Allen L, Califaretti N, Eisen A, et al · · 2024 · cited 1× · PMID 39727692 · DOI 10.3390/curroncol31120569

Verify or expand the search:

Other trials of Tamoxifen 20 mg

Trials testing the same drug.

NCT06914674 — Tamoxifen for Advanced Solid Pseudopapillary Tumor of the Pancreas · Phase 2 · recruiting
NCT05133674 — Therapeutic Dose Monitoring (TDM) of Tamoxifen · Phase 2 · unknown

Other recruiting trials for Ductal Carcinoma in Situ

Currently open trials in the same condition.

NCT07095114 — A Study of Disappearing Markers for Daily Radiation Treatment Delivery for Breast Cancer Patients. · NA · recruiting
NCT06218303 — Prototype DAA/TAA Vaccine Targeting MUC1 for Immune Interception and Prevention in Ductal Carcinoma In Situ · Phase 1 · recruiting
NCT06677944 — Preoperative Partial Breast Irradiation in Early-Stage Breast Cancer · Phase 2 · recruiting
NCT05218044 — Cryoablation as a Minimally Invasive Alternative to Surgery for Managing Ductal Carcinoma In Situ · NA · recruiting
NCT03216421 — Intraoperative Radiation Therapy (IORT) in DCIS · NA · active not recruiting

Other Institut Cancerologie de l'Ouest trials

Trials by the same sponsor.

NCT06978296 — HIghly MetAstatic Life Prolonging Therapy-Resistant Prostate Cancer: Role of Stereotactic Radiotherapy for Bone and Lymp · NA · not yet recruiting
NCT06967987 — Study Evaluating the Combination of Bemarituzumab + FLOT Chemotherapy in Perioperative Setting for Resectable Stage cT2- · Phase 2 · withdrawn
NCT06756802 — Reproductive Health in Breast Cancer Survivor · active not recruiting
NCT07007325 — Prospective Feasibility Pilot Study Evaluating the Value of [68Ga]Ga-PENTIXAFOR PET-CT in Patients With Metastatic Small · EARLY_PHASE1 · not yet recruiting
NCT06994702 — Impact of the MRI Restraint System on the Quality of the Synthetic Scan for Intracranial Radiotherapy Treatment · NA · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04666961 (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 Institut Cancerologie de l'Ouest
Last refreshed: 22 April 2022

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/NCT04666961.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing