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

RecruitingPhase 2Ages 40 Years - anyFemaleInstitut Cancerologie de l'Ouest
NCT04666961 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Patient ≥ 40 years old 2. Histological diagnosis of ductal carcinoma in situ without infiltrating contingent 3. Clinical T0N0 4. Estrogen receptor positive (OR+) regardless of progesterone receptor (PR) status 5. Indication for mastectomy 6. DCIS visible on MRI performed with clip sequence 7. Effective contraceptive method for women of childbearing age who are sexually active and who have reported sexual activity. 8. Informing the patient and obtaining free, informed and written consent signed by the patient and the investigator. 9. Affiliated patient or beneficiary of the social security system. Exclusion Criteria: 1. Invasive breast carcinoma 2. Lobular carcinoma in situ 3. pN+ patient 4. Indication for conservative surgery 5. Contraindications to anastrozole or tamoxifen 6. Concomitant treatments that may interact and reduce the efficacy of tamoxifen by interaction with cytochrome CYP2D6. 7. Histologically proven multifocal lesion 8. Contraindication to breast MRI (pace maker, heart valve, metallic implant, neuronal or peripheral stimulator, severe claustrophobia, ...) 9. History of homolateral breast cancer 10. Ongoing contralateral breast cancer 11. Known mutation BRCA1 BRCA2 12. Other cancer in progress at inclusion 13. Pregnant woman, or breastfeeding, 14. Persons deprived of liberty or under guardianship or trusteeship, 15. Impossibility to undergo the medical follow-up of the trial for geographical, social, psychic or psychiatric reasons.
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What it tests

  • Tamoxifen 20 mg
  • Anastrozole 1Mg Tab
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Where

8 sites
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
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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