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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000321924 | |||
| AVENTIS-GIA-11156 | |||
| GENENTECH-H2269s |
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| Name | Class |
|---|---|
| Aventis Pharmaceuticals | INDUSTRY |
| Genentech, Inc. | INDUSTRY |
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RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as trastuzumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether docetaxel and carboplatin are more effective with or without trastuzumab in treating breast cancer.
PURPOSE: This randomized phase II trial is studying how well giving docetaxel together with carboplatin and trastuzumab before surgery works compared to docetaxel and carboplatin alone before surgery in treating women with locally advanced breast cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (neoadjuvant therapy) | Experimental | see intervention description |
|
| Arm II (neoadjuvant therapy) | Experimental | please see intervention description |
|
| HER2/neu negative patients | Experimental | please see intervention description |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| trastuzumab | Biological | Cycle 5-7 post-op only Day 1 4mg/kg IV Day 8, 15 2mg/kg IV Cycle 8 Cycle 8 Day 1, 8, 15 2mg/kg IV Day 22 6mg/kg IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the Objective Response Rate of Patients Treated With Taxotere/Carboplatin With or Without Herceptin Preoperatively. | Objective response rate of patients treated with Taxotere/carboplatin with or without Herceptin preoperatively. Objective response equals the combination of complete response (CR), partial response (PR) and marginal response (MR). Tumor size was assessed by (1) physical examination, (2) mammography and (3) MRI. 5 response groups: complete response (CR), partial response (PR), marginal response (MR), stable disease (SD) & disease progression (DP). Pathologic response assigned into 2 groups: pCR and non-pCR. pCR-no evidence of residual invasive disease in specimen. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Tumor Response by Physical Exam and Imaging Studies | 5 years | |
| Tumor Response Assessment | Measured by physical examination compared to breast mammography and MRI assessment | 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Helena R. Chang, MD, PhD | Jonsson Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | United States | ||
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Dates of recruitment period: 2002-2007 Types of location: oncology outpatient clinics
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm I (Neoadjuvant Therapy) | see intervention description carboplatin: Cycle 1-8 Day 1 or 2 AUC = 6 IV (AUC = area under the curve, total drug exposure over time) docetaxel: Cycle 1-8 Day 1 or 2: 75 mg/m2 IV trastuzumab: Cycle 1-4 pre-op Day 1 4mg/kg IV Day 8, 15 2mg/kg IV Cycle 5-7 post-op Day 1 4mg/kg IV Day 8, 15 2mg/kg IV Cycle 8 Day 1, 8, 15 2mg/kg IV Day 22 6mg/kg IV |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| carboplatin | Drug | Cycle 1-8 Day 1 or 2 AUC = 6 IV |
|
| docetaxel | Drug | Cycle 1-8 Day 1 or 2: 75 mg/m2 IV |
|
|
| trastuzumab | Biological | Cycle 1-4 pre-op Day 1 4mg/kg IV Day 8, 15 2mg/kg IV Cycle 5-7 post-op Day 1 4mg/kg IV Day 8, 15 2mg/kg IV Cycle 8 Day 1, 8, 15 2mg/kg IV Day 22 6mg/kg IV |
|
|
| Clinico-histologic Predictors of pCR (Pathologic Complete Response) | 5 years |
| Pathologic Nodal Status | According to Primary Tumor Response Pathologic lymph node status N0 Axillary and other nearby lymph nodes do not have cancer (when looked at under a microscope) N1 Micrometastases (very small clusters of cancer) OR 1-3 axillary lymph nodes have cancer AND/OR Internal mammary nodes have tiny amounts of cancer found on sentinel node biopsy N2 4-9 axillary lymph nodes have cancer OR Internal mammary nodes have cancer, but axillary lymph nodes do not have cancer N3 10 or more axillary lymph nodes have cancer OR Infraclavicular (under the clavicle) nodes have cancer OR Internal mammary nodes have cancer plus 1 or more axillary lymph nodes have cancer OR 4 or more axillary lymph nodes have cancer plus internal mammary nodes have cancer or micrometastases found on sentinel node biopsy OR Supraclavicular (above the clavicle) nodes have cancer | 5 years |
| USC/Norris Comprehensive Cancer Center and Hospital |
| Los Angeles |
| California |
| 90089-9181 |
| United States |
| Jonsson Comprehensive Cancer Center at UCLA | Los Angeles | California | 90095-1781 | United States |
| Wilshire Oncology Medical Group, Incorporated - Pomona | Pomona | California | 91767-3021 | United States |
| FG001 | Arm II (Neoadjuvant Therapy) | please see intervention description trastuzumab: Cycle 5-7 post-op only Day 1 4mg/kg IV Day 8, 15 2mg/kg IV Cycle 8 Cycle 8 Day 1, 8, 15 2mg/kg IV Day 22 6mg/kg IV carboplatin: Cycle 1-8 Day 1 or 2 AUC = 6 IV docetaxel: Cycle 1-8 Day 1 or 2: 75 mg/m2 IV |
| FG002 | HER2/Neu Negative Patients | please see intervention description carboplatin: Cycle 1-8 Day 1 or 2 AUC = 6 IV docetaxel: Cycle 1-8 Day 1 or 2: 75 mg/m2 IV |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm I (Neoadjuvant Therapy) | see intervention description carboplatin: Cycle 1-8 Day 1 or 2 AUC = 6 IV docetaxel: Cycle 1-8 Day 1 or 2: 75 mg/m2 IV trastuzumab: Cycle 1-4 pre-op Day 1 4mg/kg IV Day 8, 15 2mg/kg IV Cycle 5-7 post-op Day 1 4mg/kg IV Day 8, 15 2mg/kg IV Cycle 8 Day 1, 8, 15 2mg/kg IV Day 22 6mg/kg IV |
| BG001 | Arm II (Neoadjuvant Therapy) | please see intervention description trastuzumab: Cycle 5-7 post-op only Day 1 4mg/kg IV Day 8, 15 2mg/kg IV Cycle 8 Cycle 8 Day 1, 8, 15 2mg/kg IV Day 22 6mg/kg IV carboplatin: Cycle 1-8 Day 1 or 2 AUC = 6 IV docetaxel: Cycle 1-8 Day 1 or 2: 75 mg/m2 IV |
| BG002 | HER2/Neu Negative Patients | please see intervention description carboplatin: Cycle 1-8 Day 1 or 2 AUC = 6 IV docetaxel: Cycle 1-8 Day 1 or 2: 75 mg/m2 IV |
| BG003 | 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, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
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| 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 | Evaluate the Objective Response Rate of Patients Treated With Taxotere/Carboplatin With or Without Herceptin Preoperatively. | Objective response rate of patients treated with Taxotere/carboplatin with or without Herceptin preoperatively. Objective response equals the combination of complete response (CR), partial response (PR) and marginal response (MR). Tumor size was assessed by (1) physical examination, (2) mammography and (3) MRI. 5 response groups: complete response (CR), partial response (PR), marginal response (MR), stable disease (SD) & disease progression (DP). Pathologic response assigned into 2 groups: pCR and non-pCR. pCR-no evidence of residual invasive disease in specimen. | pCR was not assessed for 2 patients in the HER2 - (Pre-Op TC) group [1 protocol violation, 1 bilateral disease] and for 1 patient in the HER2+ (Pre-Op TC, Post-Op Herceptin) group [protocol violation] | Posted | Number | participants | 5 years |
|
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Clinical Tumor Response by Physical Exam and Imaging Studies | Clinical response was not assessed for 2 patients in the HER2 - (Pre-Op TC) group [1 protocol violation, 1 bilateral disease] and for 1 patient in the HER2+ (Pre-Op TC, Post-Op Herceptin) group [protocol violation] | Posted | Number | participants | 5 years |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Tumor Response Assessment | Measured by physical examination compared to breast mammography and MRI assessment | pCR was not assessed for 2 patients in the HER2 - (Pre-Op TC) group [1 protocol violation, 1 bilateral disease] and for 1 patient in the HER2+ (Pre-Op TC, Post-Op Herceptin) group [protocol violation]" | Posted | Number | participants | 5 years |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Clinico-histologic Predictors of pCR (Pathologic Complete Response) | ER (estrogen-receptor), PR (progesterone-receptor), HER2 (human epidermal growth factor receptor 2), FISH (Fluorescence in situ hybridization), IDC (invasive ductal carcinoma), ILC (invasive lobular carcinoma), | Posted | Number | participants | 5 years |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Pathologic Nodal Status | According to Primary Tumor Response Pathologic lymph node status N0 Axillary and other nearby lymph nodes do not have cancer (when looked at under a microscope) N1 Micrometastases (very small clusters of cancer) OR 1-3 axillary lymph nodes have cancer AND/OR Internal mammary nodes have tiny amounts of cancer found on sentinel node biopsy N2 4-9 axillary lymph nodes have cancer OR Internal mammary nodes have cancer, but axillary lymph nodes do not have cancer N3 10 or more axillary lymph nodes have cancer OR Infraclavicular (under the clavicle) nodes have cancer OR Internal mammary nodes have cancer plus 1 or more axillary lymph nodes have cancer OR 4 or more axillary lymph nodes have cancer plus internal mammary nodes have cancer or micrometastases found on sentinel node biopsy OR Supraclavicular (above the clavicle) nodes have cancer | only 71 subjects of the 74 subjects could be analyzed for this outcome measure due to data collection error. | Posted | Number | participants | 5 years |
|
3 years from 1st study drug administration
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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 I: HER+ (Pre-Op TCH) | Arm I carboplatin: Cycle 1-8 Day 1 or 2 AUC = 6 IV docetaxel: Cycle 1-8 Day 1 or 2: 75 mg/m2 IV trastuzumab: Cycle 1-4 pre-op Day 1 4mg/kg IV Day 8, 15 2mg/kg IV | 6 | 15 | 6 | 15 | 15 | 15 |
| EG001 | Arm II: HER2+ (Pre-Op TC, Post-Op Herceptin) | Arm II trastuzumab: Cycle 5-7 post-op only Day 1 4mg/kg IV Day 8, 15 2mg/kg IV Cycle 8 Cycle 8 Day 1, 8, 15 2mg/kg IV Day 22 6mg/kg IV carboplatin: Cycle 1-8 Day 1 or 2 AUC = 6 IV docetaxel: Cycle 1-8 Day 1 or 2: 75 mg/m2 IV Cycle 5-7 post-op Day 1 4mg/kg IV Day 8, 15 2mg/kg IV Cycle 8 Day 1, 8, 15 2mg/kg IV Day 22 6mg/kg IV | 4 | 14 | 4 | 14 | 12 | 14 |
| EG002 | Arm III: HER2- (Pre-Op TC) | HER2/neu negative patients carboplatin: Cycle 1-8 Day 1 or 2 AUC = 6 IV docetaxel: Cycle 1-8 Day 1 or 2: 75 mg/m2 IV | 10 | 45 | 10 | 45 | 45 | 45 |
| EG003 | Total | 20 | 74 | 20 | 74 | 72 | 74 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Severe Dehydration | General disorders | CTCAE (Unspecified) | Non-systematic Assessment |
| |
| febrile neutropenia | Infections and infestations | CTCAE (Unspecified) | Non-systematic Assessment |
| |
| hypokalemia | General disorders | CTCAE (Unspecified) | Non-systematic Assessment |
| |
| Neutropenia | Infections and infestations | CTCAE (Unspecified) | Non-systematic Assessment |
| |
| Upper Extremity Cellulites | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | Non-systematic Assessment |
| |
| diarrhea and dehydration | Gastrointestinal disorders | CTCAE (Unspecified) | Non-systematic Assessment |
| |
| pain, swelling, mastectomy site cellulitis | General disorders | CTCAE (Unspecified) | Non-systematic Assessment |
| |
| death progressive disease | General disorders | CTCAE (Unspecified) | Non-systematic Assessment |
| |
| divetricular abscess | General disorders | CTCAE (Unspecified) | Non-systematic Assessment |
| |
| fever | General disorders | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | Non-systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | CTCAE (Unspecified) | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE (Unspecified) | Non-systematic Assessment |
| |
| ALT Elevated | Investigations | CTCAE (Unspecified) | Non-systematic Assessment |
| |
| APT Elevated | Investigations | CTCAE (Unspecified) | Non-systematic Assessment |
| |
| AST Elevated | Investigations | CTCAE (Unspecified) | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | CTCAE (Unspecified) | Non-systematic Assessment |
| |
| Albumin Decreased | Investigations | CTCAE (Unspecified) | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (Unspecified) | Non-systematic Assessment |
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| Anxiety | Psychiatric disorders | CTCAE (Unspecified) | Non-systematic Assessment |
| |
| Appetite Change | Metabolism and nutrition disorders | CTCAE (Unspecified) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | Non-systematic Assessment |
| |
| Blurry Vision | Eye disorders | CTCAE (Unspecified) | Non-systematic Assessment |
| |
| Body Ache | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | Non-systematic Assessment |
| |
| Chest Complain | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | Non-systematic Assessment |
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| Chills | General disorders | CTCAE (Unspecified) | Non-systematic Assessment |
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| Cold Symptons | General disorders | CTCAE (Unspecified) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (Unspecified) | Non-systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | CTCAE (Unspecified) | Non-systematic Assessment |
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| Diarrhea | Metabolism and nutrition disorders | CTCAE (Unspecified) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (Unspecified) | Non-systematic Assessment |
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| Dry Mucosa | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | Non-systematic Assessment |
| |
| Edema | General disorders | CTCAE (Unspecified) | Non-systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | Non-systematic Assessment |
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| Eye Tearing | Eye disorders | CTCAE (Unspecified) | Non-systematic Assessment |
| |
| Fever | General disorders | CTCAE (Unspecified) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE (Unspecified) | Non-systematic Assessment |
| |
| Hot Flashes | Vascular disorders | CTCAE (Unspecified) | Non-systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (Unspecified) | Non-systematic Assessment |
| |
| Hypersensitivity | General disorders | CTCAE (Unspecified) | Non-systematic Assessment |
| |
| Hypercalcemia | Metabolism and nutrition disorders | CTCAE (Unspecified) | Non-systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (Unspecified) | Non-systematic Assessment |
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| Hyponatremia | Metabolism and nutrition disorders | CTCAE (Unspecified) | Non-systematic Assessment |
| |
| Indigestion | Gastrointestinal disorders | CTCAE (Unspecified) | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | CTCAE (Unspecified) | Non-systematic Assessment |
| |
| Irregular Menstruation | Reproductive system and breast disorders | CTCAE (Unspecified) | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | CTCAE (Unspecified) | Non-systematic Assessment |
| |
| Hot Flashes | Reproductive system and breast disorders | CTCAE (Unspecified) | Non-systematic Assessment |
| |
| Hypergylcemia | Endocrine disorders | CTCAE (Unspecified) | Non-systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (Unspecified) | Non-systematic Assessment |
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| Leukopenia | Blood and lymphatic system disorders | CTCAE (Unspecified) | Non-systematic Assessment |
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| Lymphopenia | Blood and lymphatic system disorders | CTCAE (Unspecified) | Non-systematic Assessment |
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| Mouth Sore | Gastrointestinal disorders | CTCAE (Unspecified) | Non-systematic Assessment |
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| Nail Change | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (Unspecified) | Non-systematic Assessment |
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| Neuropathy | Nervous system disorders | CTCAE (Unspecified) | Non-systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | CTCAE (Unspecified) | Non-systematic Assessment |
| |
| Nose Bleed | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Non-systematic Assessment |
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| Numbness/Tingling | Nervous system disorders | CTCAE (Unspecified) | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | Non-systematic Assessment |
| |
| Shortness of Breath | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Non-systematic Assessment |
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| Skin Changes | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | Non-systematic Assessment |
| |
| Sweats | General disorders | CTCAE (Unspecified) | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | CTCAE (Unspecified) | Non-systematic Assessment |
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| Taste Change | General disorders | CTCAE (Unspecified) | Non-systematic Assessment |
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| Throat Complaint | Gastrointestinal disorders | CTCAE (Unspecified) | Non-systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | CTCAE (Unspecified) | Non-systematic Assessment |
| |
| Vision Change | Eye disorders | CTCAE (Unspecified) | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | CTCAE (Unspecified) | Non-systematic Assessment |
| |
| Weakness/Fatigue | General disorders | CTCAE (Unspecified) | Non-systematic Assessment |
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| Weight Change | General disorders | CTCAE (Unspecified) | Non-systematic Assessment |
| |
| Hypoglycemia | Metabolism and nutrition disorders | CTCAE (Unspecified) | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Helena Chang, M.D., Ph.D., Revlon/UCLA Breast Center | Jonsson Comprehensive Cancer Center | 310-794-5640 | hchang@mednet.ucla.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 |
|---|---|
| D000068878 | Trastuzumab |
| D016190 | Carboplatin |
| D000077143 | Docetaxel |
| 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 |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| OS (overall survival) |
|
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