Patients with extensive ductal carcinoma in situ with an indication for total mastectomy MedDRA version: 21.1 Level: PT Classification code 10006189 Term: Breast cancer in situ System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: tamoxifene
Product Name: tamoxifene
Pharmaceutical Form: Tablet
Trade Name: anastrozole
Product Name: anastrozole
Pharmaceutical Form: Tablet
Sponsors
INSTITUT DE CANCEROLOGIE DE L'OUEST
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Demonstrate the efficacy of neoadjuvant hormone therapy in patients with extensive CCIS in order to propose conservative surgery after 6 months of treatment as an alternative to mastectomy, routinely performed in this indication.;Secondary Objective: a) Evaluate the impact of neoadjuvant hormone therapy on dimension along the largest axis observed on MRI after 3 months and 6 months of hormone therapy treatment ; b) Evaluate recurrence-free survival at 5 and 10 years post-surgery; c) Evaluate overall survival at 5 and 10 years post-surgery; d) To identify immunological and histological predictors of tumor response to neoadjuvant hormone therapy after 6 months of hormone therapy ; e) To evaluate the impact of neoadjuvant hormone therapy on the presence of an infiltrating contingent found on the surgical specimen after 6 months of hormone therapy. f) Evaluate the evolution of the quality of life in the 10 years following surgery, according to the type of surgery (mastectomy or conservative surgery), and according to socio-demographic and psychological factors (anxiety, depression).;Primary end point(s): The efficacy of neoadjuvant hormone therapy will be evaluated by the % of conservative surgeries performed after 6 months of treatment.;Timepoint(s) of evaluation of this end point: 6 month | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): a) Variations du diamètre de la lésion cible selon le plus grand axe (antéro-postérieure, interne-externe ou supérieure-inférieure) observé à partir de l’IRM, avant traitement, après 3 mois et après 6 mois d’hormonothérapie ; b) Taux de survie sans récidive à 5 ans et à 10 ans post-chirurgie ; c)T aux de survie globale à 5 ans et à 10 ans post-chirurgie ; d) Variations du diamètre de la lésion cible selon le plus grand axe (antéro-postérieure, interne-externe ou supérieure-inférieure) observé à partir de l’IRM, avant traitement, après 3 mois et après 6 mois d’hormonothérapie selon les facteurs immunologiques et histologiques de la macrobiopsie ; e) % de contingent infiltrant retrouvé sur la pièce chirurgicale après 6 mois d’hormonothérapie ; f) Qualité de vie : ? Questionnaire SF-36 à l’inclusion, à 6 et 12 mois post-chirurgie puis tous les ans pendant 9 ans. ? Questionnaire EORTC QLQ-C30 à l’inclusion, à 6 et 12 mois post-chirurgie puis tous les ans pendant 4 ans. ;Timepoint(s) of evaluation of this end point: a) & d) & e) 3 month - 6 month b) & c) & f) 5 and 10 years | — |
Countries
France
Contacts
Public ContactPROMOTION - DRC
INSTITUT DE CANCEROLOGIE DE L'OUEST
Outcome results
None listed