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Impact of Neoadjuvant Hormonal Therapy on the Surgical Management of Extensive Ductal Carcinomas in Situ
Sponsor: Institut Cancerologie de l'Ouest
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.
Key Details
Gender
FEMALE
Age Range
40 Years - Any
Study Type
INTERVENTIONAL
Enrollment
262
Start Date
2021-02-03
Completion Date
2033-08-01
Last Updated
2022-04-22
Healthy Volunteers
No
Interventions
Tamoxifen 20 mg
Tamoxifen will be initiated in non menopausal patients orally for 6 months in a neoadjuvant situation.
Anastrozole 1Mg Tab
Anastrozole will be initiated in menopausal patients orally for 6 months in a neoadjuvant situation.
Locations (8)
ICO - Site Paul Papin
Angers, France
Institut Bergonie
Bordeaux, France
Institut de cancérologie de Montpellier
Montpellier, France
Centre Antoine Lacassagne
Nice, France
Institut Curie - Site de Paris
Paris, France
Hopital Saint Joseph
Paris, France
Institut de Cancérologie de l'Ouest
Saint-Herblain, France
IUCT-O
Toulouse, France