Clinical Trial

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

Study acronym: HORNEO01
Recruiting Phase 2
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Record status
This record was last updated April 22, 2022 (before its estimated August 1, 2024 completion). Its status may not reflect the trial's current state.
Summary
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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2020-12-11; most recent amendment 2022-04-21.
Status change: Not Yet Recruiting → Recruiting 2021-11-08
Trial Details
NCT Number NCT04666961
Lead Sponsor Institut Cancerologie de l'Ouest
Conditions Ductal Carcinoma in Situ, Extensive Disease, Mastectomy
Enrollment 262 participants
Start Date 2021-02-03
Primary Completion 2024-08-01 (estimated)
Study Completion 2033-08-01 (estimated)
Updated on ClinicalTrials.gov 2022-04-22