RecruitingPhase 2NCT04666961

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


Sponsor

Institut Cancerologie de l'Ouest

Enrollment

262 participants

Start Date

Feb 3, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether hormone therapy given before surgery (neoadjuvant hormonal therapy) can reduce the size of extensive ductal carcinoma in situ (DCIS — a non-invasive breast cancer) enough to potentially allow a less extensive surgery, or to better understand the tumor before a mastectomy. Researchers want to see if this approach changes how surgery is planned and performed. **You may be eligible if you:** - Are 40 years of age or older - Have been diagnosed with DCIS (non-invasive breast cancer) without any invasive component - Have hormone receptor-positive cancer (estrogen receptor positive) - Are scheduled for a mastectomy (full breast removal) - The cancer is visible on MRI **You may NOT be eligible if you:** - Have invasive breast cancer - Have lobular carcinoma in situ - Have cancer that has spread to the lymph nodes - Are eligible for breast-conserving (lumpectomy) surgery instead - Have contraindications to the hormone therapy drug (anastrozole) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTamoxifen 20 mg

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

DRUGAnastrozole 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

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NCT04666961


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