Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Neoadjuvant Chemotherapy · 1 trial · 3 indications
The study endpoints of disease-free rate and locoregional control will be determined in patient follow up by utilizing MRIs, annual mammograms and clinical assessments in conjunction with ctDNA status.
| Arm | Type | Description |
|---|---|---|
| Arm A (eeCR, non-surgical) | EXPERIMENTAL | Patients will receive standard of care (SOC) neoadjuvant chemotherapy and will be evaluated for enhanced clinical complete response (ecCR) after treatment. Participants who achieve an ecCR will be placed in the non-surgical arm. Participants will receive radiation therapy and routine and additional screening MRIs during follow up. |
| Arm B (non-eeCR, surgical) | EXPERIMENTAL | Patients will receive standard of care (SOC) neoadjuvant chemotherapy and will be evaluated for enhanced clinical complete response (ecCR) after treatment. Participants who do not achieve an ecCR will be placed in the surgical arm. Participants will undergo a lumpectomy or mastectomy, receive radiation therapy, and routine follow-up. |
| Name | Type | Description |
|---|---|---|
| Neoadjuvant Chemotherapy | DRUG | Participants will receive standard of care neoadjuvant chemotherapy |
| Radiation Therapy | RADIATION | Radiotherapy simulation parameters will be at the discretion of the treating physician to account for the patient's body habitus, tumor bed location, and tolerability of the prone or supine positions, however, the recommended approach will be whole-breast RT (WBRT) in the prone position, for cT1-3 N0 patients who achieve ecCR. For cT1-2 N1 patients who achieve ecCR WBRT with nodal inclusion and lymph node boost will be performed in the supine position. |
| MRI | PROCEDURE | Participants will undergo MRI |
| Breast Cancer Surgery | PROCEDURE | Participants will undergo surgery to treat their breast cancer. Either a lumpectomy or a mastectomy will be performed. |
| Biopsy | PROCEDURE | Participants undergo biopsy |
| Biospecimen collection | PROCEDURE | Participants undergo blood and plasma collection |
Inclusion Criteria: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Male or female, aged 18 years or older 4. Early-stage breast cancer diagnosis (cT1-3 N0 or cT1-2 N1) and a Human Epi...
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