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
| Name | Class |
|---|---|
| ImmunoRestoration | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
The purpose of the study is to find out if an investigational drug called Dendritic Cell (DC1) vaccine added to standard neoadjuvant (given before main treatment) therapy can help people with HER2 (human epidermal growth factor receptor 2) positive breast cancer.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lead In - Dose level 1 | Experimental | Six participants will be treated at dose level 1: DC vaccine given at the dose of 50 million once per week for 6 weeks |
|
| Lead In: Dose Level 2 | Experimental | Six participants will be treated at dose level 2: DC vaccine given at the dose of 100 million once per week for 6 weeks |
|
| Expansion -Estrogen Receptor (ER) positive | Experimental | An additional 24 participants will be enrolled at dose level 2 if determined to be safe in lead in phase to have a total of 28 evaluable participants for pathologic response assessment (including 6 pts from the lead in phase). |
|
| Expansion -Estrogen Receptor (ER) negative | Experimental | An additional 23 participants will be enrolled at dose level 2 if determined to be safe in lead in phase to have a total of 28 evaluable participants for pathologic response assessment (including 6 pts from the lead in phase). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HER-2 pulsed DC1 | Biological | Vaccine will be administered weekly for 6 weeks. Boosters will be given at months 6, 9 and 12. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lead in Phase: Immunogenicity of each dose level | Immunogenicity: will be characterized by quantifying CD4TH1 response via ELISPot. ELISPot is an enzyme-linked immunospot assay. It is a highly sensitive immunoassay that measures the frequency of cytokine-secreting cells at the single-cell level. | at 4 weeks |
| Expansion Phase: Pathologic Complete Response Rate | Pathologic complete response rate of participants treated in the Expansion Phase. Clinical efficacy will be defined by the pathologic complete response (pCR) rate, the percentage of patients who achieve pCR based on surgical pathology assessment. Pathologic Complete Response defined as no residual invasive disease in the breast and nodes (ypT0/is N0) at definitive surgery after completion of protocol therapy. The pathologic response to treatment will be assessed by the pathologist. The "Residual Cancer Burden" (RCB) for each patient as described in the online calculator also will be evaluated per the pathologist. (http://www3.mdanderson.org/app/medcalc/index.cfm?pagename=jsconvert3) | at 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Expansion Phase: Radiologic tumor response rate after 6 weeks | Radiologic tumor response rate measured by MRI | at 6 weeks |
| Expansion Phase: Radiologic tumor response rate at completion of therapy |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Neveen Abdo | Contact | 813-745-4412 | Neveen.Abdo@moffitt.org |
| Name | Affiliation | Role |
|---|---|---|
| Hyo (Heather) Han, MD | Moffitt Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moffitt Cancer Center | Recruiting | Tampa | Florida | 33612 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39636623 | Derived | Han HS, Aldrich AL, Garg SK, Weinfurtner RJ, Nguyen JV, Mo Q, Whiting J, Childress J, Soliman H, Costa R, Armaghani A, Soyano A, Kiluk J, Hoover S, Lee MC, Khakpour N, Shenoi N, Jameel Z, Koski GK, Czerniecki BJ. Alteration of the Tumor Microenvironment With Intratumoral Dendritic Cells Before Chemotherapy in ERBB2 Breast Cancer: A Nonrandomized Clinical Trial. JAMA Oncol. 2025 Feb 1;11(2):119-127. doi: 10.1001/jamaoncol.2024.5371. |
| Label | URL |
|---|---|
| Moffitt Cancer Center Clinical Trials website | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Trastuzumab | Drug | 8mg/kg IV Trastuzumab will be given week 1, followed by 6 mg/kg on subsequent cycles every 3 weeks |
|
|
| Pertuzumab | Drug | 840 mg IV Pertuzumab will be given week 1, followed by 420 mg on subsequent cycles every 3 weeks. |
|
|
| Paclitaxel | Drug | 80 mg/m^2 IV paclitaxel will be given weekly weeks 7-18 |
|
|
| Resection surgery | Procedure | After week 18, participants will undergo standard of care resection surgery. |
|
Radiologic tumor response rate measured by MRI
| at 12 months |
| Expansion Phase: Immunogenicity | Immunogenicity: will be characterized by quantifying CD4TH1 response via ELISPot. ELISPot is an enzyme-linked immunospot assay. It is a highly sensitive immunoassay that measures the frequency of cytokine-secreting cells at the single-cell level. | at 12 months |
| Recurrence Free Survival | Recurrence free survival defined as the length of time after treatment that patient survives without any signs or symptoms of cancer. | up to 5 years |
| 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
| ID | Term |
|---|---|
| D000068878 | Trastuzumab |
| C485206 | pertuzumab |
| D017239 | Paclitaxel |
| D000068196 | Albumin-Bound Paclitaxel |
| D015412 | Mastectomy, Segmental |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |
| D008408 | Mastectomy |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided