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 (Jun 2026). This Phase 2 trial studies multiple treatments including Tamoxifen 20 mg and Anastrozole 1Mg Tab for ductal carcinoma in situ.
Treatment: Tamoxifen 20 mg · Anastrozole 1Mg Tab — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
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
Demographics
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT04666961 currently recruiting?
Yes, this trial is currently recruiting patients.
Does this trial require ESR1?
Yes, ESR1 positive is a required biomarker for enrollment.
Are patients with BRCA1 alterations eligible?
No. BRCA1 any mutation is an exclusion criterion.
Are patients with BRCA2 alterations eligible?
No. BRCA2 any mutation is an exclusion criterion.
What disease stage is eligible?
Stage T0N0 is required.
Is this trial open to male patients?
No. This trial enrolls female patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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