Neoadjuvant hormone therapy for extensive ductal carcinoma in situ

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the impact of neoadjuvant hormone therapy on the surgical management of extensive ductal carcinoma in situ (DCIS) in patients who would typically require a mastectomy. Patients diagnosed with extensive DCIS will receive hormone therapy with either Tamoxifen or Anastrozole before surgery, with the aim of potentially allowing for less invasive surgical options. The study involves thorough screening and monitoring, including imaging assessments to evaluate the effectiveness of the hormone therapy. The goal is to improve surgical outcomes and quality of life for patients with this condition.

Why it matters

Who can join: the full rules

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.

Where it's running

• ICO - Site Paul Papin
  Angers, France Recruiting
• Institut Bergonie
  Bordeaux, France Recruiting
• Institut de cancérologie de Montpellier
  Montpellier, France Recruiting
• Centre Antoine Lacassagne
  Nice, France Recruiting
• Hopital Saint Joseph
  Paris, France Recruiting
• Institut de Cancérologie de l'Ouest
  Saint-Herblain, France Recruiting

Study contacts

• Principal investigator: Victoire BRILLAUD-MEFLAH, MD — Institut de Cancérologie de l'Ouest
• Study coordinator: Victoire BRILLAUD-MEFLAH, MD
• Email: Victoire.brillaud-meflah@ico.unicancer.fr
• Phone: 0240679818

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.