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| Name | Class |
|---|---|
| The Shulas' Foundation | UNKNOWN |
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The purpose of the study is to find out if an investigational vaccine called Dendritic Cell (DC) vaccine given together with standard of care chemotherapy drugs can help people with Triple Negative and HR low positive breast cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dendritic Cell Vaccine dose Escalation | Experimental | Dose escalation to determine the maximum tolerated dose (MTD) of HER2- and HER3- primed DC1 study vaccines. Participants will be treated in cohorts of size three to six and the dosage will be escalated if the clinical toxicity is acceptable. A total of 3 dose levels will be used. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HER2 - primed Dendritic cells | Biological | Dendritic cell will be administered at ultra-sound guided injections. Participants will receive 8 intratumoral injections. These injections will be administered twice per week per week (given 3 days apart). Participants will receive alternating injections (3 days apart) of HER2-primed followed by HER3-primed DCs. Participants will be treated at the following dose levels: Dose level 1: HER2 - primed Dendritic cells dose 10-20 million Dose level 2: HER2 - primed Dendritic cells dose 30-50 million Dose level 3: HER2 - primed Dendritic cells dose 80-100 million |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose (MTD) | Maximum Tolerated Dose (MTD) of HER2- and HER3- primed DC1 study vaccines. The MTD will be defined as the highest dose level at which < 2 of 6 patients experience dose-limiting toxicities (DLTs). | 4 weeks after start of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Dose Limiting Toxicities | Number of DLTs experienced by participants | 5 weeks after start of treatment |
| Participants with pathological complete response after receiving HER2/HER3 DC1 intratumoral injections |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ricardo Costa | Contact | 813-745-5051 | Ricardo.Costa@moffitt.org |
| Name | Affiliation | Role |
|---|---|---|
| Ricardo Costa, MD | Moffitt Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moffitt Cancer Center | Recruiting | Tampa | Florida | 33612 | United States |
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| ID | Term |
|---|---|
| D064726 | Triple Negative Breast Neoplasms |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| HER3 - primed Dendritic cells | Biological | Dendritic cell will be administered at ultra-sound guided injections. Participants will receive 8 intratumoral injections. These injections will be administered twice per week per week (given 3 days apart). Participants will receive alternating injections (3 days apart) of HER2-primed followed by HER3-primed DCs. Participants will be treated at the following dose levels: Dose level 1: HER3 - primed Dendritic cells dose 10-20 million Dose level 2: HER3 - primed Dendritic cells dose 30-50 million Dose level 3: HER3 - primed Dendritic cells dose 80-100 million |
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Pathological complete response defined as the absence of invasive breast cancer in the breast and lymph nodes after completion of treatment with DC1 injections and neoadjuvant chemotherapy.
| Up to 24 weeks |
| Participants with clinical and radiological responses after receiving HER2/HER3 DC1 | Clinical or radiological complete responses (CR): Palpable or visible lesion(s) identified at baseline are no longer palpable and there are no new lesion(s) or other signs of disease progression. | Up to 36 Months |
| Participants with clinical and radiological partial responses after receiving HER2/HER3 DC1 | Clinical or radiological partial responses (PR): A reduction in the product of the two largest perpendicular diameters of the primary tumor by 50% or more. | Up to 36 Months |
| Participants with clinical and radiological progression of disease after receiving HER2/HER3 DC1 | Clinical or radiological progression of disease (PD): An increase in the product of the two largest perpendicular diameters of the primary tumor by 25% or more or the presence of a new lesion. | Up to 36 Months |
| Participants with clinical and radiological stable disease after receiving HER2/HER3 DC1 | Clinical or radiological stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. | Up to 36 Months |
| Participants with Recurrence Free Survival (RFS) | Recurrence free survival (RFS) defined as time I months to breast cancer recurrence or death (whichever comes first) since date of surgical treatment of breast cancer. | Up to 36 Months |
| D017437 |
| Skin and Connective Tissue Diseases |