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OncoMatch/Clinical Trials/NCT04666961

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

Is NCT04666961 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Tamoxifen 20 mg and Anastrozole 1Mg Tab for ductal carcinoma in situ.

Phase 2RecruitingInstitut Cancerologie de l'OuestNCT04666961Data as of May 2026

Treatment: Tamoxifen 20 mg · Anastrozole 1Mg TabDuctal 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.

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Extracted eligibility criteria

Biomarker criteria

Required: ESR1 positive

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

Excluded: BRCA1 any mutation

Known mutation BRCA1 BRCA2

Excluded: BRCA2 any mutation

Known mutation BRCA1 BRCA2

Disease stage

Required: Stage T0N0

Excluded: Stage PN+

Clinical T0N0

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