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| Name | Class |
|---|---|
| University of South Florida | OTHER |
| University of Miami | OTHER |
| Morton Plant Mease Health Care | OTHER |
| AdventHealth |
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Genomics assays that measure specific gene expression patterns in a patient's primary tumor have become important prognostic tools for breast cancer patients. This study is designed to test the ability of MammaPrint® in combination with TargetPrint®, BluePrint®, and TheraPrint®, as well as traditional pathologic and clinical prognostic factors, to predict responsiveness to neo-adjuvant chemotherapy in patients with locally advanced breast cancer (LABC).
Patients with suspected primary breast cancer on mammography and clinical examination will be assessed for eligibility by having a needle core biopsy to confirm invasive carcinoma.
A fresh unfixed tumor specimen, incisional or core biopsy will be sent to Agendia to determine the MammaPrint risk profile, the BluePrint molecular subtyping profile, the TargetPrint ER, PR and HER2 single gene readout, the 56-geneTheraPrint Research Gene Panel and the additional genes as measured on the whole genome (44k) array.
Surgical Protocol:
Determination of nodal status:
Neo-adjuvant chemotherapy
Definitive surgery:
Response will be measured by pathological Complete Response (pCR) and by centrally assessed Residual Cancer Burden (RCB).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HER2 negative patients | Active Comparator | In order to provide some consistency in management and have a treatment policy in place only recommended therapy with several well accepted and presumed equivalent chemotherapy regimens will be used. The proposed neo-adjuvant chemotherapy regimens for HER2 negative patients include:
|
|
| Her2 positive patients | Active Comparator | The proposed neo-adjuvant chemotherapy regimens for HER2 negative patients is TCH chemotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAC chemotherapy | Drug | Docetaxel 75 mg/m2 IV day 1, Doxorubicin 50 mg/m2 IV day 1, Cyclophosphamide 500 mg/m2 IV day 1; Cycled every 21 days for 6 cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Determine the predictive power of chemosensitivity of MammaPrint as measured by pCR. | 6-12 months | |
| Determine the predictive power of chemosensitivity of the combination of MammaPrint and BluePrint as measured by pCR. | 6-12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Compare TargetPrint single gene read out of ER, PR and HER2 with local and centralized IHC and/or CISH/FISH assessment of ER, PR and HER2. | Baseline. First study visit. | |
| Identify possible correlations between the TheraPrint Research Gene Panel outcomes and chemoresponsiveness. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charles E Cox, MD | University of South Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Alabama, Mitchell Cancer Institute | Mobile | Alabama | 36688 | United States | ||
| Morton Plant Mease Health Care |
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| OTHER |
| Plano Cancer Center | UNKNOWN |
| Ohio State University Comprehensive Cancer Center | OTHER |
| University of Oklahoma | OTHER |
| University of South Alabama | OTHER |
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| TC chemotherapy | Drug | Docetaxel 75 mg/m2 IV day 1, Cyclophosphamide 600 mg/m2 IV day 1; Cycled every 21 days for 6 cycles |
|
| Dose Dense AC or FEC100 followed by paclitaxel or docetaxel chemotherapy | Drug | Doxorubicin 60 mg/m2 IV day 1, Cyclophosphamide 600 mg/m2 IV day 1, Cycled every 14 days for 4 cycles, OR 5-Fluorouracil 500 mg/m2 IV day 1, Epirubicin 100 mg/m2 IV day 1, Cyclophosphamide 500 mg/m2 IV day 1; Cycled every 21 days for 3 cycles Followed by Paclitaxel 80 mg/m2 by 1 h IV infusion weekly for 12 weeks, OR Docetaxel 100mg/m2 IV day 1 cycled every 21 days for 3 or 4 cycles |
|
| TCH chemotherapy | Drug | Docetaxel 75 mg/m2 IV day 1, followed by Carboplatin AUC 6 IV day 1; Cycled every 21 days for 6 cycles Trastuzumab initial dose of 4 mg/kg over 90 minute IV infusion, then 2 mg/kg over 30 minute IV infusion weekly for 52 weeks, OR initial dose of 8 mg/kg over 90 minutes IV infusion, then 6 mg/kg over 30-90 minutes IV infusion every three weeks for 52 weeks. |
|
| T + trastuzumab followed by CEF + trastuzumab | Drug | Trastuzumab 4 mg/kg IV for one dose beginning just prior to first dose of paclitaxel. Followed by trastuzumab 2 mk/kg IV weekly for 23 weeks Paclitaxel 80 mg/m2 by 1 h IV infusion weekly for 12 wks Followed by 5-Fluorouracil 500 mg/m2 IV on days 1 and 4 Epirubicin 75 mg/m2 IV on day 1 Cyclophosphamide 500 mg/m2 IV on day 1 cycled every 21 days for 4 cycles Trastuzumab 6mg/kg IV every 21 days for 9 cycles to complete 1yr |
|
| Dose dense AC followed by T + trastuzumab | Drug | Doxorubicin 60 mg/m2 IV day 1 Cyclophosphamide 600 mg/m2 IV day 1 (cycled every 14 days for 4 cycles) Followed by paclitaxel 80 mg/m2 by 1 h IV infusion weekly for 12 wks All cycles are with filgrastim support with trastuzumab 2 mg/kg (4 mg/kg loading dose). Following chemotherapy , trastuzumab to continue every 3 weeks at 6 mg/kg for the duration of 1 week. |
|
| Dose dense AC followed by T + trastuzumab + pertuzumab | Drug | Doxorubicin 60 mg/m2 IV day 1 Cyclophosphamide 600 mg/m2 IV day 1 Cycled every 14 days for 4 cycles Followed by docetaxel 75-100 mg/m2 by 1 h IV infusion weekly for 12 wks All cycles are with filgrastim support with trastuzumab 6 mg/kg (8 mg/kg loading dose with C1) Pertuzumab 420 mg (840 mg loading dose with C1). Following chemotherapy, trastuzumab to continue every 3 weeks at 6 mg/kg for the duration of 1 week. |
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| PTH followed by dose dense AC of FEC | Drug | Docetaxel 75-100 mg/m2 by 1 h IV infusion Cycled every 21 days for 4 cycles With Trastuzumab 6 mg/kg IV (8 mg/kg IV loading dose) q3W And Pertuzumab 420 mg IV (840 mg IV loading dose) q 3w +/- pegfilgrastim 6 mg sq on day 2-3, Followed by 4 cycles of AC or FEC: AC Doxorubicin 60 mg/m2 IV day 1 Cyclophosphamide 600 mg/m2 IV day 1 Cycled every 14 days for 4 cycles with pegfilgrastim 6 mg sq on day 2 FEC 5-Fluorouracil 500 mg/m2 IV on days 1 and 4 Epirubicin 75 mg/m2 IV on day 1 Cyclophosphamide 500 mg/m2 IV on day 1 cycled every 21 days for 4 cycles In all of the above mentioned regimens docetaxel might be substituted with paclitaxel as paclitaxel is better tolerated but is expected to have the same efficacy as docetaxel. |
|
| 6-9 months |
| Identify and/or validate predictive gene expression profiles of clinical response/resistance to chemotherapy. | 6-12 months |
| Compare the three BluePrint molecular subtype categories with IHC-based subtype classification. | Baseline. First study visit. |
| Clearwater |
| Florida |
| 33756 |
| United States |
| University of Miami | Miami | Florida | 33124 | United States |
| University of South Florida Breast Cancer Program | Tampa | Florida | 33613 | United States |
| Helen Ellis Memorial Hospital | Tarpon Springs | Florida | 34689 | United States |
| Eastchester Center for Cancer Care | The Bronx | New York | 10469 | United States |
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43212 | United States |
| University of Oklahoma, Health Sciences Center | Oklahoma City | Oklahoma | 73104 | United States |
| Texas Health, Plano Cancer Institute | Plano | Texas | 75093 | 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 |
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| ID | Term |
|---|---|
| D000068878 | Trastuzumab |
| C485206 | pertuzumab |
| 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 |
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