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

NCT04666961 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 262

Last updated 2022-04-22

No results posted yet for this study

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.

Conditions

  • Ductal Carcinoma in Situ
  • Extensive Disease
  • Mastectomy

Interventions

DRUG

Tamoxifen 20 mg

Tamoxifen will be initiated in non menopausal patients orally for 6 months in a neoadjuvant situation.

DRUG

Anastrozole 1Mg Tab

Anastrozole will be initiated in menopausal patients orally for 6 months in a neoadjuvant situation.

Sponsors & Collaborators

  • Institut Cancerologie de l'Ouest

    lead OTHER

Principal Investigators

  • Victoire BRILLAUD-MEFLAH, MD · Institut de Cancérologie de l'Ouest

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-03
Primary Completion
2024-08-01
Completion
2033-08-01

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04666961 on ClinicalTrials.gov