Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Aventis Pharmaceuticals | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the effectiveness and tolerability of the combination of the following medications given every two weeks in HER2 positive breast cancer patients:
This is an investigator-initiated, Phase II, non-randomized, single-arm, prospective treatment study. The study will consist of neoadjuvant treatment period (weeks 1 to 20), surgical evaluation period (weeks 20 to 24), and a post-surgical/follow-up period (approximately 3 years). Subjects will be treated on an outpatient basis.
Neoadjuvant therapy will consist of epirubicin + cyclophosphamide given every 2 weeks for four cycles followed by a three week break. Subjects will then receive docetaxel every two weeks for four cycles + trastuzumab (one loading dose) then maintenance dose every 2 weeks for 4 treatments.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neoadjuvant therapy | Experimental | Neoadjuvant therapy will consist of epirubicin (100 mg/m^2) + cyclophosphamide (600 mg/m^2) every 2 weeks for 4 cycles; followed by a 3-week break; followed by docetaxel (75 mg/m^2) every 2 weeks for 4 cycles + trastuzumab (6 mg/kg [loading dose] once then 4 mg/kg [maintenance dose]) every 2 weeks for 4 treatments. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| epirubicin | Drug | epirubicin (100 mg/m^2) every 2 weeks for 4 cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects Able to Complete > 85% of the Planned Dose on Schedule | Feasibility will be determined by evaluating the percentage of subjects able to complete the neoadjuvant portion of the study on time with > 85% of the protocol-specified dose. | From the start of treatment through the neoadjuvant treatment period (approximately 20 weeks) |
| Frequency of Grade 3 or 4 Hematologic and Nonhematologic Toxicities | Toxicities are evaluated according to the Common Terminology Criteria for Adverse Events, version 3.0. Grade refers to the severity of the adverse event (AE). Generally, grade 1 = mild AE; grade 2 = moderate AE; grade 3 = severe AE; grade 4 = life-threatening or disabling AE; grade 5 = death related to AE. | Toxicities are evaluated every 2 weeks during neoadjuvant treatment and assessed once during the post-treatment follow-up period, up to 25 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Pathologic Response | Pathologic response was assessed at time of definitive surgery, scheduled to occur 20-24 weeks after study treatment start. Pathologic complete response was defined as no invasive carcinoma in surgical specimen of breast, but residual ductal carcinoma in situ may be present. Pathologic partial response was defined as >= 50% decrease in sum of diameters in pathologic cancer size compared to pretreatment clinical size. Stable disease was defined as < 50% decrease in sum of diameters in pathologic cancer size compared to pretreatment clinical size, and < 25% increase in sum of diameters. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Lee S Schwartzberg, MD, FACP | Accelerated Community Oncology Research Network, Inc. (ACORN) | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advanced Medical Specialties | Miami | Florida | 33176 | United States | ||
| Augusta Oncology Associates |
Informed consent was obtained from all subjects, and all subjects underwent screening procedures to verify eligibility.
5 community oncology research sites across the US within the ACORN network participated in this study. Enrollment started in November 2005 and was completed in June 2008.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Neoadjuvant Therapy | Neoadjuvant therapy will consist of epirubicin (100 mg/m^2) + cyclophosphamide (600 mg/m^2) every 2 weeks for 4 cycles; followed by a 3-week break; followed by docetaxel (75 mg/m^2) every 2 weeks for 4 cycles + trastuzumab (6 mg/kg [loading dose] once then 4 mg/kg [maintenance dose]) every 2 weeks for 4 treatments. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| cyclophosphamide | Drug | cyclophosphamide (600 mg/m^2) every 2 weeks for 4 cycles |
|
|
| docetaxel | Drug | docetaxel (75 mg/m^2) every 2 weeks for 4 cycles |
|
|
| trastuzumab | Drug | trastuzumab (6 mg/kg [loading dose] once then 4 mg/kg [maintenance dose]) every 2 weeks for 4 treatments |
|
|
| At completion of neoadjuvant treatment period, up to 24 weeks. |
| Clinical Response Prior to Surgery | Clinical response was assessed via physical exam every 2 weeks during neoadjuvant treatment and via imaging prior to definitive surgery. Clinical complete response was defined as no evidence of cancer in breast by exam or imaging. Clinical partial response was defined as >= 50 % reduction in sum of diameters to measurement of primary lesion compared to pretreatment by exam or imaging. Clinical stable disease was defined as < 50% reduction in sum of diameters to measurement of primary lesion compared to pretreatment by exam or imaging, and < 25% increase in sum of diameters. | Assessed every 2 weeks during neoadjuvant treatment and prior to definitive surgery, up to 23 weeks. |
| Left Ventricular Ejection Fraction (LVEF) | LVEF was assessed by echocardiogram (ECHO) or multigated angiogram (MUGA) during neoadjuvant treatment and during follow-up. | At screening, prior to cycle 5, prior to surgery, and then during follow-up at Month 6, 12, 24, and 36 |
| Progression-free Survival (PFS) | PFS is defined as the duration of time from start of treatment to time of progression or death, whichever comes first. | PFS was measured from day 1 of treatment until time of progression or death, whichever comes first, assessed up to 48 months. |
| Overall Survival (OS) | Overall survival is defined as the time from treatment start until death from any cause. The median overall survival time is used to measure OS. | Measured from day 1 of treatment until time of death, assessed up to 48 months. |
| Augusta |
| Georgia |
| 30901 |
| United States |
| Cental Georgia Cancer Care | Macon | Georgia | 31201 | United States |
| Northwest Georgia Oncology Centers, PC | Marietta | Georgia | 30060 | United States |
| Hematology Oncology Centers of the Northern Rockies, PC | Billings | Montana | 59101 | United States |
| Arena Oncology Associates | Great Neck | New York | 11021 | United States |
| The West Clinic | Memphis | Tennessee | 38120 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Neoadjuvant Therapy | Neoadjuvant therapy will consist of epirubicin (100 mg/m^2) + cyclophosphamide (600 mg/m^2) every 2 weeks for 4 cycles; followed by a 3-week break; followed by docetaxel (75 mg/m^2) every 2 weeks for 4 cycles + trastuzumab (6 mg/kg [loading dose] once then 4 mg/kg [maintenance dose]) every 2 weeks for 4 treatments. |
| 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 |
| ||||||||||||||||||||
| Age Continuous | Mean | Standard Deviation | 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 | Percentage of Subjects Able to Complete > 85% of the Planned Dose on Schedule | Feasibility will be determined by evaluating the percentage of subjects able to complete the neoadjuvant portion of the study on time with > 85% of the protocol-specified dose. | Posted | Number | percentage of participants | From the start of treatment through the neoadjuvant treatment period (approximately 20 weeks) |
|
|
| |||||||||||||||||||||||||||
| Primary | Frequency of Grade 3 or 4 Hematologic and Nonhematologic Toxicities | Toxicities are evaluated according to the Common Terminology Criteria for Adverse Events, version 3.0. Grade refers to the severity of the adverse event (AE). Generally, grade 1 = mild AE; grade 2 = moderate AE; grade 3 = severe AE; grade 4 = life-threatening or disabling AE; grade 5 = death related to AE. | Posted | Number | Events | Toxicities are evaluated every 2 weeks during neoadjuvant treatment and assessed once during the post-treatment follow-up period, up to 25 weeks. | Events | Participants |
|
| ||||||||||||||||||||||||||
| Secondary | Pathologic Response | Pathologic response was assessed at time of definitive surgery, scheduled to occur 20-24 weeks after study treatment start. Pathologic complete response was defined as no invasive carcinoma in surgical specimen of breast, but residual ductal carcinoma in situ may be present. Pathologic partial response was defined as >= 50% decrease in sum of diameters in pathologic cancer size compared to pretreatment clinical size. Stable disease was defined as < 50% decrease in sum of diameters in pathologic cancer size compared to pretreatment clinical size, and < 25% increase in sum of diameters. | 28 patients went to surgery, so 28 patients were included in the surgery sample. Note that 4 patients in the pathologic complete response (pCR) group had residual ductal carcinoma in situ (DCIS). | Posted | Number | Participants | At completion of neoadjuvant treatment period, up to 24 weeks. |
|
| |||||||||||||||||||||||||||
| Secondary | Clinical Response Prior to Surgery | Clinical response was assessed via physical exam every 2 weeks during neoadjuvant treatment and via imaging prior to definitive surgery. Clinical complete response was defined as no evidence of cancer in breast by exam or imaging. Clinical partial response was defined as >= 50 % reduction in sum of diameters to measurement of primary lesion compared to pretreatment by exam or imaging. Clinical stable disease was defined as < 50% reduction in sum of diameters to measurement of primary lesion compared to pretreatment by exam or imaging, and < 25% increase in sum of diameters. | Clinical response assessment was available for 27 patients at the time of surgery. | Posted | Number | Participants | Assessed every 2 weeks during neoadjuvant treatment and prior to definitive surgery, up to 23 weeks. |
|
| |||||||||||||||||||||||||||
| Secondary | Left Ventricular Ejection Fraction (LVEF) | LVEF was assessed by echocardiogram (ECHO) or multigated angiogram (MUGA) during neoadjuvant treatment and during follow-up. | Note that the number of participants analyzed changes with the study interval. At Screening n=30, after Epirubicin/Cyclophosphamide n=30, Pre-surgery n=28, Follow-up Month 6 n=28, Follow-up Month 12 n=20, Follow-up Month 24 n=9, and Follow-up Month 36 n=1. | Posted | Mean | Standard Deviation | LVEF percent | At screening, prior to cycle 5, prior to surgery, and then during follow-up at Month 6, 12, 24, and 36 |
|
| ||||||||||||||||||||||||||
| Secondary | Progression-free Survival (PFS) | PFS is defined as the duration of time from start of treatment to time of progression or death, whichever comes first. | Posted | Median | 95% Confidence Interval | Months | PFS was measured from day 1 of treatment until time of progression or death, whichever comes first, assessed up to 48 months. |
|
| |||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | Overall survival is defined as the time from treatment start until death from any cause. The median overall survival time is used to measure OS. | Posted | Median | 95% Confidence Interval | Months | Measured from day 1 of treatment until time of death, assessed up to 48 months. |
|
|
Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Neoadjuvant Therapy | Neoadjuvant therapy will consist of epirubicin (100 mg/m^2) + cyclophosphamide (600 mg/m^2) every 2 weeks for 4 cycles; followed by a 3-week break; followed by docetaxel (75 mg/m^2) every 2 weeks for 4 cycles + trastuzumab (6 mg/kg [loading dose] once then 4 mg/kg [maintenance dose]) every 2 weeks for 4 treatments. | 4 | 30 | 30 | 30 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Congestive heart failure | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Medical Error | Injury, poisoning and procedural complications | CTCAE (3.0) | Non-systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemoglobin | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Myelosuppression | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Congestive heart failure | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dyspnea | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Ear ache | Ear and labyrinth disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dry eyes | Eye disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Edema | Eye disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Eye/ear twitching | Eye disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hyperlacrimation | Eye disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Myelosis | Eye disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Visual changes | Eye disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Watery eyes | Eye disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Abdominal pain.cramps | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Acid reflux | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Difficulty swallowing | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Esophagitis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemorrhage GI Anus | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Gum soreness | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Mouth sores | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Mouth tenderness | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Mucositis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain - tooth | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Aches | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Chills | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Constipation | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Cramping bilateral/lower sides | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Day sweats | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Decreased libido | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Diarrhea | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dizziness | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fever | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Heartburn | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hot flashes | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Malaise | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Nose bleed | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Flushing | Immune system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Herpes simplex | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Hordeolum | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Oral thrush | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Paranasal sinus reaction | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Pulmonary | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Sinus infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Tooth abscess | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| ALT | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Neutrophils | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Change in appetite | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Weight loss | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fracture | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Low extremity pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain - back | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain - musculoskeletal | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Shoulder/neck soreness | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Weakness | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neck cyst | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Memory loss | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neuropathy | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain - headache | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Peripheral paresthesia | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Taste alteration | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Trouble concentrating | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Burning hands and feet | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Daytime insomnia | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Daytime sleepiness | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Nightmares | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Polyuria | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Irregular menses | Reproductive system and breast disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Menstrual cramps | Reproductive system and breast disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Metromenorrhagia | Reproductive system and breast disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain - breast | Reproductive system and breast disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Vaginal dryness | Reproductive system and breast disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Vaginal itching | Reproductive system and breast disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Allergy rhinitis | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Bilateral crackles | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Runny nose | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Shortness of breath | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Sinus problems | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Sore throat | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Facial rash | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fever blister | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fever blisters | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hyperpigmentation | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Itching | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Nail changes | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Secondary infection (nails) | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Skin pigmentation | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Sinus drainage | Surgical and medical procedures | CTCAE (3.0) | Systematic Assessment |
| |
| Hemorrhage pulmonary | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
Sponsor shall submit to Aventis for review of confidential information and patent protection purposes, any manuscript or abstract prepared for publication at least 30 days prior to submission to publisher. Upon written request by Aventis to Sponsor within such 30 days, Sponsor agrees to delay such publication until Aventis determines that the publication will not compromise any patent rights. However, such delay shall not exceed 90 additional days.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President of Scientific Affairs | Accelerated Community Oncology Research Network, Inc. | 901-435-5570 | mwalker@acorncro.com |
| 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 |
|---|---|
| D015251 | Epirubicin |
| D003520 | Cyclophosphamide |
| D000077143 | Docetaxel |
| D000068878 | Trastuzumab |
| ID | Term |
|---|---|
| D004317 | Doxorubicin |
| 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 |
Not provided
Not provided
| Events |
|
|
|
|
|
|
|