Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The goal of this clinical trial is to learn if adding cancer-specific amplitude-modulated radiofrequency electromagnetic field therapy (TheraBionic P1 device) to the treatment of resectable early-stage breast cancer will affect the pathological response.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TheraBionic P1 device | Experimental | Self Administered Amplitude-modulated electromagnetic fields three times daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TheraBionic P1 Device | Device | Amplitude-modulated electromagnetic fields will be self-administered and given continuously to patients in three 60-minute treatments per day, administered in the morning, middle of the day and in the evening prior to surgical resection of early stage breast cancer. |
| Measure | Description | Time Frame |
|---|---|---|
| Pathological Response to Treatment | Proportion of responders based on residual cancer cells in a resection specimen will be quantified. The response rate will be estimated as the proportion of patients who respond to treatment relative to all patients. The corresponding two-sided 95% confidence interval (CI) will be calculated using Clopper and Pearson's method | At time of surgery (after approximately 2 weeks of treatment and tumor resection) |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in microRNA expression in tumor tissue | Changes in microRNA expression in tumor tissue pre- and post-treatment will be calculated as the difference between pre- and post-treatment expression values with two-sided 95% CI estimated using a standard t-distribution-based formula for paired differences. | Baseline to post-surgical resection |
| Measure | Description | Time Frame |
|---|---|---|
| Positron Emission Tomography with 3'-Deoxy-3'-18F-Fluorothymidine (PET-FLT) association of response to treatment | Changes in the SUV max as measured by FLT-PET prior to treatment compared to after treatment and before resection. SUV (standard uptake value) max values will be log-transformed and descriptively summarized using the mean, standard deviation, and two-sided 95% CI. Changes in SUV max pre- and post-treatment will be calculated as the difference between the pre- and post-treatment values with two-sided 95% CI estimated using a standard t-distribution-based formula for paired differences. The association between changes in SUV max and response will be explored using logistic regression analysis. Optional study for the first 5 participants. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lubina Arjyal, M.D. | Contact | 1-800-karmanos | arjyall@karmanos.org |
| Name | Affiliation | Role |
|---|---|---|
| Lubina Arjyal, M.D. | Wayne State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karmanos Cancer Institute at McLaren Clarkston | Recruiting | Clarkston | Michigan | 48346 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Changes in Ki-67 expression in tumor tissue | Changes in Ki-67 expression in tumor tissue pre- and post-treatment will be calculated as the difference between pre- and post-treatment expression values with two-sided 95% CI estimated using a standard t-distribution-based formula for paired differences. | Baseline to post-surgical resection |
| Changes in tumor apoptosis marker Cleaved caspase-3 (CC3) in tumor tissue | Changes in CC3 expression in tumor tissue pre- and post-treatment will be calculated as the difference between pre- and post-treatment expression values with two-sided 95% CI estimated using a standard t-distribution-based formula for paired differences. | Baseline to post-surgical resection |
| Changes in cell cycle arrest marker p27 in tumor tissue | Changes in p27 expression in tumor tissue pre- and post-treatment will be calculated as the difference between pre- and post-treatment expression values with two-sided 95% CI estimated using a standard t-distribution-based formula for paired differences. | Baseline to post-surgical resection |
| Overall survival (OS) | OS will be graphically summarized using Kaplan-Meier (KM) curves, with corresponding medians and two-sided 95% CIs computed using KM estimates. Additionally, OS rates at every six months post-treatment will be estimated using the KM estimated, with two-sided 95% CIs provided for each time point. | Up to 5 years post-surgery |
| Progression Free Survival (PFS) | PFS will be graphically summarized using Kaplan-Meier (KM) curves, with corresponding medians and two-sided 95% CIs computed using KM estimates. Additionally, PFS rates at every six months post-treatment will be estimated using the KM estimated, with two-sided 95% CIs provided for each time point. | Up to 5 years post-surgery |
| From Screening to after 7 days of treatment with the TheraBionic Device. |
| Karmanos Cancer Institute | Recruiting | Detroit | Michigan | 48201 | United States |
|
| Karmanos Cancer Institute Weisberg Cancer Treatment Center | Recruiting | Farmington Hills | Michigan | 48334 | United States |
|
| Karmanos Cancer Institute at McLaren Flint | Recruiting | Flint | Michigan | 48532 | United States |
|
| Karmanos Cancer Institute at McLaren Greater Lansing | Recruiting | Lansing | Michigan | 48910 | United States |
|
| Karmanos Cancer Institute at McLaren Lapeer Region | Recruiting | Lapeer | Michigan | 48466 | United States |
|
| Karmanos Cancer Institute at McLaren Northern Michigan | Recruiting | Petoskey | Michigan | 49770 | United States |
|
| Karmanos Cancer Institute at McLaren Port Huron | Recruiting | Port Huron | Michigan | 48060 | United States |
|
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided