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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
| Massachusetts General Hospital | OTHER |
| Brigham and Women's Hospital | OTHER |
| New Hampshire Oncology-Hematology PA |
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Dose dense chemotherapy, which is the term for Adriamycin and Cyclophosphamide (AC) followed by Taxol chemotherapy given every two weeks, is the standard chemotherapy for the treatment of ER+ or PR+ breast cancer. In this trial, the standard chemotherapy is being combined with bevacizumab. Bevacizumab is an antibody which works differently from the way other chemotherapy drugs work. Bevacizumab slows or stops cell growth in cancerous tumors by decreasing the blood supply to the tumors by binding to a substance found on cancer cells called VEGF (vascular endothelial growth factor). Bevacizumab is approved by the FDA for the treatment of colorectal cancer and lung cancer. However, it is not approved for the treatment of breast cancer. Another goal of this research is to determine whether we can develop a way to identify tumors that will respond well to this study treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HR+, HER2- | Active Comparator | Patients with Hormone Receptor Positive, HER2 negative Breast Cancer. A single dose of Bevacizumab 10mg/kg, followed two weeks later by Adriamycin60 mg/m2 and Cyclophosphamide 600 mg/m2 with Bevacizumab 10mg/kg every 2 weeks x4, followed by Taxol 175 mg/m2 with Bevacizumab 10 mg/kg every 2 weeks x3, followed by Taxol 175 mg/m2 x1. |
|
| Triple Negative Breast Cancer Cohort | Active Comparator | Hormone receptor negative, HER2 negative Cohort. Receive same drug protocol as Arm A. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Doxorubicin | Drug | Standard chemotherapy regimen |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pathologic Complete Response Rate After Preoperative Therapy in This Patient Population. | Pathological Complete response is defined as complete disappearance of invasive tumor in the breast at the time of surgery | 3 Years |
| Measure | Description | Time Frame |
|---|---|---|
| Decrease in Interstitial Fluid Pressure. | To determine if bevacizumab monotherapy results in a decrease in interstitial fluid pressure | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ian Krop, MD, PhD | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States | ||
| Dana-Farber Cancer Institute |
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Study was activated on 10/17/2007 and Closed to accrual on 7/1/2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | HR+, HER2- | Patients with Hormone Receptor Positive, HER2 negative Breast Cancer. A single dose of Bevacizumab 10mg/kg, followed two weeks later by Adriamycin60 mg/m2 and Cyclophosphamide 600 mg/m2 with Bevacizumab 10mg/kg every 2 weeks x4, followed by Taxol 175 mg/m2 with Bevacizumab 10 mg/kg every 2 weeks x3, followed by Taxol 175 mg/m2 x1. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| UNKNOWN |
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| Cyclophosphamide | Drug | Standard chemotherapy regimen |
|
|
| Paclitaxel | Drug | Standard chemotherapy regimen |
|
|
| Bevacizumab | Drug | One intravenous dose given followed 2 weeks later with standard chemotherapy drugs and bevacizumab given intravenously in 8 two-week cycles. |
|
|
| Boston |
| Massachusetts |
| 02115 |
| United States |
| Dana-Farber at Faulkner Hospital | Boston | Massachusetts | 02130 | United States |
| New Hampshire Oncology-Hematology PA | Hooksett | New Hampshire | 03106 | United States |
| FG001 |
| Triple Negative Breast Cancer Cohort |
Hormone receptor negative, HER2 negative Cohort. Receive same drug protocol as Arm A. |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | HR+, HER2- | Patients with Hormone Receptor Positive, HER2 negative Breast Cancer. A single dose of Bevacizumab 10mg/kg, followed two weeks later by Adriamycin60 mg/m2 and Cyclophosphamide 600 mg/m2 with Bevacizumab 10mg/kg every 2 weeks x4, followed by Taxol 175 mg/m2 with Bevacizumab 10 mg/kg every 2 weeks x3, followed by Taxol 175 mg/m2 x1. |
| BG001 | Triple Negative Breast Cancer Cohort | Hormone receptor negative, HER2 negative Cohort. Receive same drug protocol as Arm A. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | Pathologic Complete Response Rate After Preoperative Therapy in This Patient Population. | Pathological Complete response is defined as complete disappearance of invasive tumor in the breast at the time of surgery | Participants who met all study eligibility criteria and signed informed consent. | Posted | Number | percentage of participants | 3 Years |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Decrease in Interstitial Fluid Pressure. | To determine if bevacizumab monotherapy results in a decrease in interstitial fluid pressure | This represents the number of patients with paired IFP measurements from day 0 and day 14 | Posted | Median | Inter-Quartile Range | mm Hg | 3 years |
|
|
4 years
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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 | All Study Participants | Patients with HER2 negative Breast Cancer. A single dose of Bevacizumab 10mg/kg, followed two weeks later by Adriamycin60 mg/m2 and Cyclophosphamide 600 mg/m2 with Bevacizumab 10mg/kg every 2 weeks x4, followed by Taxol 175 mg/m2 with Bevacizumab 10 mg/kg every 2 weeks x3, followed by Taxol 175 mg/m2 x1. | 4 | 104 | 104 | 104 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| cellulitis | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| paranasal sinus reaction | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ALT-SGPT | Hepatobiliary disorders | MedDRA (10.0) | Systematic Assessment |
| |
| AST-SGOT | Hepatobiliary disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Abdomen-pain | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Alkaline Phosphatase | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| Allergic Reaction | Immune system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Anorexia | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Back-pain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Bicarbonate | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Bone-pain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| constipation | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Constitutional-other | General disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Creatinine | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Dry Skin | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| erythema multiforme | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Extremity-limb-pain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (10.0) | Systematic Assessment |
| |
| febrile neutropenia | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| fever w/o neutropenia | General disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Flushing | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| GI-other | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Hand-foot reaction | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Hematologic-other | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Hemoglobin | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Hemorrhoids | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Hot flashes | Endocrine disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Hyperglycemia | Endocrine disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Hypoglycemia | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Infection Gr0-2 neut-upper airway | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Infection-other | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Insomnia | General disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Joint-pain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Leukocytes | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Metabolic/laboratory-other | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Muco/stomatitis (symptom) oral cavity | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Muco/stomatitis by exam-oral cavity | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Muscle-pain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Nail changes | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Neuropathy-motor | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Neuropathy-sensory | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Neutrophils | Eye disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Nose-hemorrhage | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Oral cavity-pain | General disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Pain-other | General disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Platelets | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Pulmonary-Upper Respiratory-other | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Rash/desquamation | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Rigors/chills | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Skin-other | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Sweating | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Taste disturbance | General disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Throat/pharynx/larynx-pain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Voice changes/dysarthria | General disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Weight loss | General disorders | MedDRA (10.0) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Ian Krop | Dana-Farber Cancer Institute | 617-632-2335 | ian.krop@dfci.harvard.edu |
| 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 |
|---|---|
| D004317 | Doxorubicin |
| D003520 | Cyclophosphamide |
| D017239 | Paclitaxel |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| 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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| Male |
|
|