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

Launched by INSTITUT CANCEROLOGIE DE L'OUEST · Dec 11, 2020

Keywords

ClinConnect Summary

The HORNEO 01 trial is studying how neoadjuvant hormone therapy can affect the treatment of extensive ductal carcinoma in situ (DCIS), a type of early breast cancer that often requires a mastectomy, or removal of the breast. This trial is important because while mastectomy can be necessary, it can also significantly impact a woman's quality of life. The researchers want to see if giving hormone therapy before surgery can help some women avoid this major surgery and possibly allow for less invasive options instead.

To participate in this trial, women must be at least 40 years old and have a confirmed diagnosis of DCIS that is visible on MRI, with plans for a mastectomy. They should also have a specific type of DCIS that is hormone receptor positive. However, women with invasive breast cancer or certain other conditions won't be eligible. Participants can expect to receive hormone therapy and, depending on how their condition responds, may have different surgical options later on. It's a chance to contribute to important research that could change how we treat this condition in the future.

Gender

FEMALE

Eligibility criteria

• 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.