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| Name | Class |
|---|---|
| Dana-Farber Cancer Institute | OTHER |
| Brigham and Women's Hospital | OTHER |
| Massachusetts General Hospital | OTHER |
| Beth Israel Deaconess Medical Center |
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The purpose of this study is to find out what effects the preoperative combination therapies of herceptin/navelbine or herceptin/taxotere/carboplatin will have on patients with early stage HER-2 positive breast cancer.
Before starting treatment, a clip will be placed via catheter into the tumor bed, so the surgeon can locate the site of the tumor. During clip placement, tissue biopsy will be taken of the tumor. One to two weeks after the first dose of herceptin another biopsy will be performed.
Patients will be placed into one of 2 arms.
Phase A of Arm 1 is one dose of herceptin followed by an MRI of the affected breast and a second biopsy 1-2 weeks following this dose. Phase B of Arm 1 begins on week 3 and ends on week 14 and involves weekly injections of herceptin and navelbine. Surgery will take place a minimum of 3 weeks after the patients last dose of herceptin and navelbine.
Phase A of Arm 2 is one dose of herceptin followed by an MRI of the affected breast and second biopsy 1-2 weeks following this dose. Phase B of Arm 2 begins on week 3 and ends on week 14 and involves herceptin weekly, taxotere and carboplatin every 3 weeks. Surgery will take place a minimum of 3 weeks after the patients last dose of herceptin, taxotere and carboplatin.
Blood tests will be performed every 3 weeks during pre-operative treatment and every 6 months after surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Active Comparator | Herceptin/navelbine |
|
| Arm 2 | Active Comparator | Taxotere/carboplatin/herceptin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Herceptin | Drug | One dose given followed by an MRI, then weekly injections beginning week 3 and ending week 14. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pathological Complete Response After Preoperative Therapy With Herceptin/Navelbine Versus Taxotere/Carboplatin/Herceptin in Patients With HER-2 Positive Early Breast Cancer | Pathological Complete Response is defined as the complete disappearance of invasive tumor in the breast at the time of surgery | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric Winer, MD | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale Cancer Center | New Haven | Connecticut | 06520 | United States | ||
| Beth Israel Deaconess Medical Center |
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A total of 81 patients were enrolled on the study between 12/2003 and 8/2008.
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| ID | Title | Description |
|---|---|---|
| FG000 | Herceptin/Navelbine | Herceptin( 2mg/kg)navelbine (25mg/kg2) x 12 weeks |
| FG001 | Taxotere/Carboplatin/Herceptin | Taxotere (75mg/kg2)/carboplatin (AUC6)/herceptin(2mg/kg)[TC q 3 weeks/H q 1 wk) x 4 cycles](streamdown:incomplete-link) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1 | Herceptin/navelbine |
| BG001 | Arm 2 | Taxotere/carboplatin/herceptin |
| BG002 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pathological Complete Response After Preoperative Therapy With Herceptin/Navelbine Versus Taxotere/Carboplatin/Herceptin in Patients With HER-2 Positive Early Breast Cancer | Pathological Complete Response is defined as the complete disappearance of invasive tumor in the breast at the time of surgery | Please Note that in Arm 2, the number of participants analyzed is equal to 39, which differs from the Number of Participants reported in the baseline measure (N= 40) because one participant withdrew her consent, so was not evaluable. | Posted | Number | percentage of participants | 12 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1 | Herceptin/navelbine |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukocytes | Immune system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Eric Winer | Dana-Farber Cancer Institute | 617-632-2335 | eric_winer@dfci.harvard.edu |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000068878 | Trastuzumab |
| D000077235 | Vinorelbine |
| D000077143 | Docetaxel |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| OTHER |
| Yale University | OTHER |
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| Navelbine | Drug | Weekly injections given starting week 3 and ending week 14 |
|
|
| Taxotere | Drug | Given every three weeks starting week 3 and ending on week 14 |
|
|
| Carboplatin | Drug | Given every three weeks starting week 3 and ending on week 14 |
|
|
| Boston |
| Massachusetts |
| 02115 |
| United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02115 | United States |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Taxotere/carboplatin/herceptin
|
|
| 5 |
| 41 |
| 27 |
| 41 |
| EG001 | Arm 2 | Taxotere/carboplatin/herceptin | 5 | 40 | 25 | 40 |
| Febrile Neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| SGPT (ALT) | Hepatobiliary disorders | Systematic Assessment |
|
| Neutropenia | Immune system disorders | Systematic Assessment |
|
| Febrile Neutropenia | Immune system disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| SGOT (AST) | Hepatobiliary disorders | Systematic Assessment |
|
| SGPT (ALT) | Hepatobiliary disorders | Systematic Assessment |
|
| Anorexia | Gastrointestinal disorders | Systematic Assessment |
|
| Dehydration | Blood and lymphatic system disorders | Systematic Assessment |
|
| Irregular Menses | Reproductive system and breast disorders | Systematic Assessment |
|
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| D017437 |
| Skin and Connective Tissue Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |