| TITRE |
(EN) Radiation OmisSion in PAtients With CLinically Node Negative Breast Cancer Undergoing Lumpectomy and With a PathologIc Complete REsponse After Neoadjuvant Chemotherapy |
| PROTOCOLE ID |
ROSALIE |
| CLINICAL TRIAL.gov ID |
NCT05866458 |
| TYPE(S) DE CANCER |
Sein |
| PHASE |
Autres |
| TYPE D'ÉTUDE |
Autre |
| INSTITUTION |
HOPITAL GENERAL JUIF SIR MORTIMER B.DAVIS
3755 rue de la Côte Ste. Catherine
(514) 340-8222
|
| VILLE |
Montréal
|
| INVESTIGATEUR(RICE) PRINCIPAL(E) |
Thierry Muanza
|
| COORDONATEUR(RICE) |
Gladys El Helou
gelhelou@jgh.mcgill.ca
514-340-8222 poste 26581 Olga Prescornic
olga.prescornic.ccomtl@ssss.gouv.qc.ca
514-340-8222 poste 23471
|
| STATUT |
Actif en recrutement
|
| CRITÈRES D'ÉLIGIBILITÉ |
(EN)
- Female patient with a new histological diagnosis of clinical T1-3 N0 breast cancer (any tumour sub-type).
- Negative lymph node involvement at initial presentation, documented by imaging (US or MRI), fine needle aspiration (FNA) or core needle biopsy.
- Treated with a minimum of 8 weeks NAC, with patients with Her2+ disease receiving targeted anti-Her2+ therapy.
- Marker clip placed in the tumour bed prior to or during neoadjuvant chemotherapy when the tumour can still be identified.
- Treated by BCS with complete excision of the tumour bed and axillary staging surgery (either sentinel lymph node biopsy or axillary lymph node dissection).
- Final pathology demonstrating a pCR [defined as absence of residual invasive and in-situ breast cancer within the breast or lymph nodes (ypT0N0)].
|
| CRITÈRES D'EXCLUSION |
(EN)
- Age less than 50 years.
- Inflammatory breast cancer or breast cancer invading the skin or chest wall (T4 disease).
- Multicentric disease (i.e., breast cancer involving more than one quadrant in the same breast).
- Prior history of ipsilateral or contralateral in-situ or invasive breast cancer. Patients with a history of lobular carcinoma in-situ (LCIS) are ineligible.
- Synchronous contralateral in-situ or invasive breast cancer.
- BRCA (breast cancer gene) 1 or 2 genetic mutation carrier, or other genetic mutation present associated with increased risk of breast cancer.
- Other previous non-breast malignancies except adequately treated non-melanoma skin cancers, in situ cancers or other cancers curatively treated with no evidence of disease for ≥ 5 years.
- Inability to complete entire course of neoadjuvant therapy (minimum of 8 weeks of treatment).
- Patients with HR+ (hormone receptor) disease who are not planned to have endocrine therapy initiated.
- Patients with Her2+ disease who have not received or are not planned to receive Her2 targeted therapy.
- ECOG (Eastern Cooperative Oncology Group) performance status > 3.
- Inability to provide informed consent.
|
