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

Phase 1

• Conditions: Patients with extensive ductal carcinoma in situ with an indication for total mastectomy; MedDRA version: 21.1Level: PTClassification code 10006189Term: Breast cancer in situSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2020-003575-18-FR
• Lead Sponsor: INSTITUT DE CANCEROLOGIE DE L'OUEST

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-12
• Last Update Posted: 8 January 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 262

Inclusion Criteria

1) Elderly 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) CCIS 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 202

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified