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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
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
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
Moffitt Cancer Center
Tampa, Florida, United States
RECRUITINGMaximum 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).
Time frame: 4 weeks after start of treatment
Number of Dose Limiting Toxicities
Number of DLTs experienced by participants
Time frame: 5 weeks after start of treatment
Participants with pathological complete response after receiving HER2/HER3 DC1 intratumoral injections
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Time frame: 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.
Time frame: 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.
Time frame: Up to 36 Months