Breast Cancer, HER2-positive Breast Cancer, Triple Negative Breast Cancer
Conditions
Brief summary
This study will evaluate the efficacy and non-inferiority of a non-surgical approach for the treatment of patients with locally advanced breast cancer.
Detailed description
Primary Objective: To determine if a non-surgical approach to breast cancer patients with an exceptional response to NAC leads to similar recurrence rates compared to standard of care (SOC). Exploratory Objectives 1. To study personalized predictive biomarkers of response to chemotherapy and predictors of residual disease from tumor samples and circulating biomarkers. 2. To validate our internally developed deep learning model to predict pathological complete response (pCR) postNAC in breast cancer patients. Outline: This is a phase II trial that will accrue up to 84 participants. Patients will receive standard of care (SOC) neoadjuvant chemotherapy and will be evaluated for enhanced clinical complete response (ecCR) after treatment. The ecCR will be evaluated using a trimodal approach, which includes the use to Magnetic Resonance Imaging (MRI), image-guided biopsy, and circulating tumor DNA (ctDNA) analysis. Participants who achieve an ecCR will be placed in the non-surgical arm (Arm A), while those who do not achieve an ecCR will be placed in the surgical arm (Arm B).
Interventions
DRUGNeoadjuvant Chemotherapy
Participants will receive standard of care neoadjuvant chemotherapy
RADIATIONRadiation Therapy
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.
PROCEDUREMRI
Participants will undergo MRI
PROCEDUREBreast Cancer Surgery
Participants will undergo surgery to treat their breast cancer. Either a lumpectomy or a mastectomy will be performed.
PROCEDUREBiopsy
Participants undergo biopsy
PROCEDUREBiospecimen collection
Participants undergo blood and plasma collection
Sponsors
Ohio State University Comprehensive Cancer Center
Gateway for Cancer Research
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 Epidermal Receptor 2 (HER2)-positive or triple negative breast cancer (TNBC) tumor molecular subtype 5. Planning to receive neoadjuvant chemotherapy (NAC) and radiation therapy (RT)
Exclusion criteria
1. Pregnancy or lactation 2. Inmate or prisoner 3. Treatment with an investigational drug or other intervention throughout their breast cancer treatment 4. Patients with skin involvement and/or distant metastases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease-Free Rate | At 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Locoregional control | At 2, 3 and 5 years | 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. |
| Disease-free survival | Up to 5 years | Survival analysis will be conducted for time to event data, and the disease control or survival rate at specific times will be estimated based on the survival analysis along with the 95% CI. |
| Treatment related adverse events | Up to 5 years | Toxicities will be recorded using CTCAE v5.0 |
Countries
United States
Contacts
CONTACTThe Ohio State University Comprehensive Cancer Center
PRINCIPAL_INVESTIGATORSachin Jhawar, MD
Ohio State University Comprehensive Cancer Center
Outcome results
None listed