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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age40+
SponsorInstitut Cancerologie de l'Ouest

About this trial

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.

Eligibility criteria

Qualifiers

Patient ≥ 40 years old

Histological diagnosis of ductal carcinoma in situ without infiltrating contingent

Clinical T0N0

Estrogen receptor positive (OR+) regardless of progesterone receptor (PR) status

Disqualifiers

Invasive breast carcinoma

Lobular carcinoma in situ

pN+ patient

Indication for conservative surgery

Trial design

Treatments tested in this trial

  • Tamoxifen 20 mg
  • Anastrozole 1Mg Tab

Treatment groups

262 Participants
are divided into 1 treatment group