| TITRE |
(EN) Breast Cancer Clinical Validation Study to Predict Recurrence of High-Risk Early Breast Cancer Treated With Neoadjuvant Therapy Using a Bespoke Circulating Tumor DNA Assay to Detect Molecular Residual Disease |
| PROTOCOLE ID |
EXActDNA-003 /? NSABP B-64 |
| CLINICAL TRIAL.gov ID |
NCT06401421 |
| TYPE(S) DE CANCER |
Sein |
| PHASE |
Autres |
| TYPE D'ÉTUDE |
Diagnostic |
| INSTITUTION |
CENTRE UNIVERSITAIRE DE SANTE MCGILL
1001 boul. Décarie
|
| VILLE |
Montréal
|
| INVESTIGATEUR(RICE) PRINCIPAL(E) |
Nathaniel Bouganim
|
| COORDONATEUR(RICE) |
Stelliana Moreno
stelliana.moreno@muhc.mcgill.ca
514-934-1934 poste 43131
|
| STATUT |
Actif en recrutement
|
| CRITÈRES D'ÉLIGIBILITÉ |
(EN)
- The participant or a legally authorized representative must provide study-specific informed consent prior to study entry.
- The participant must be ≥ 18 years of age.
- ECOG performance status 0 or 1.
- Histologically confirmed invasive carcinoma of the breast.
- Planned neoadjuvant therapy which includes cytotoxic chemotherapy.
- Tumor size ≥ 2.1 cm in greatest diameter.
- Unifocal or multifocal cancer documented to be the same histologic clinical subtype.
- Clinically node positive or if node negative, any one of the following:
- TNBC or HER2+ subtype
- HR+/HER2-negative with at least one of the following:
- High tumor grade (G3) ii. Ki67 index of 20% or higher iii. High genomic risk (Oncotype DX® (ODX) Breast Recurrence Score of > 25, MammaPrint® High, etc.)
- Willing and able to comply with the study requirements, which includes the collection of a total of 34 cc (2.5 Tablespoons) of blood for each research blood draw.
- Available residual tissue from diagnostic biopsy from the breast or an involved ipsilateral lymph node for submission to create a bespoke ctDNA assay.
|
| CRITÈRES D'EXCLUSION |
(EN)
- Definitive clinical or radiologic evidence of metastatic disease.
- Initiated neoadjuvant therapy for current breast cancer diagnosis.
- Synchronous diagnosis of another invasive cancer, other than this breast cancer, except for non-melanoma skin cancers.
- Completed all therapy (including endocrine therapy) <5 years ago for any previous invasive solid organ malignancy (with exception of non-melanoma skin cancers) including prior breast cancer. Individuals with a prior history of noninvasive (in situ) carcinomas may participate if they have received definitive treatment.
- Completed all therapy for any previous hematologic malignancy < 5 years ago.
- Multicentric or contralateral invasive breast cancers.
- Known pregnancy at time of enrollment.
- Prior solid organ transplant.
- Prior allogeneic hematopoietic stem cell transplant.
|
