Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| MSKCC-07013 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Dana-Farber Cancer Institute | OTHER |
| GlaxoSmithKline | INDUSTRY |
The purpose of this study is to study a new treatment for HER-2/neu (+) breast cancer.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AC, PACLITAXEL , TRASTUZUMAB & LAPATINIB | Experimental | The regimen consists of AC (doxorubicin 60 mg/m2, cyclophosphamide 600 mg/m2) q 14 days x 4 with pegfilgrastim, followed by weekly paclitaxel (80 mg/m2) x 12 + trastuzumab (H) + lapatinib (L). Pegfilgrastim 6mg is given subcutaneously (SQ) on day # 2 of each AC. Filgrastim may be used in lieu of pegfilgrastim at the physician's discretion. Trastuzumab will be administered weekly starting with paclitaxel treatment # 1. Near the completion of all chemotherapy, patients may receive trastuzumab on a q 3-weekly schedule, starting as early as with paclitaxel cycle # 12. The total duration of trastuzumab from beginning to end is 52 weeks. Lapatinib will be given orally at 1000 mg daily, starting with trastuzumab for a total duration of 52 weeks. Hormonal therapy such as tamoxifen or an aromatase inhibitor will be given to patients with hormone receptor positive disease at the physician's discretion. Radiation therapy to the breast or chest is recommended to patients as appropriate. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| trastuzumab | Biological |
| ||
| cyclophosphamide |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Who Completed All Planned Therapy | The number of patients who completed all planned therapy (dose-dense adjuvant/ neoadjuvant chemotherapy regimen) in HER-2/neu-overexpressed/ amplified breast cancer patients. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Who Were Evaluated for Toxicity | Please see adverse event section in the results. Toxicities were assessed by the National Cancer Institute Common Toxicity Criteria (NCI CTC) version 3.0. | 2 years |
Not provided
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the breast
Bilateral synchronous breast tumors allowed
Any nodal status or tumor size allowed
HER2/neu-positive disease
Hormone receptor status not specified
PATIENT CHARACTERISTICS:
Male or female
Menopausal status not specified
ECOG performance status 0-1
Absolute neutrophil count ≥ 1,000/mm³
Platelet count ≥ 100,000/mm³
Bilirubin ≤ 1.1 mg/dL
SGOT or SGPT ≤ 2.5 times upper limit of normal (ULN)
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective barrier contraception during and after completion of study therapy
LVEF ≥ 50% by MUGA scan
No peripheral neuropathy > grade 1
No active second malignancy within the past 5 years except for adequately treated nonmelanoma skin cancer or in situ carcinoma of the cervix
No known allergy or hypersensitivity to doxorubicin hydrochloride, cyclophosphamide, paclitaxel, or other drugs formulated in Cremophor EL
No psychiatric illness or concurrent medical conditions that would preclude study treatment
No other conditions, including any of the following:
No QT prolongation (> 500 ms)
No active unresolved infections
No sensitivity to E. coli derived proteins
PRIOR CONCURRENT THERAPY:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Chau T. Dang, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Clifford A. Hudis, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Boston | Massachusetts | 02115 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20479410 | Result | Dang C, Lin N, Moy B, Come S, Sugarman S, Morris P, Abbruzzi A, Chen C, Steingart R, Patil S, Norton L, Winer E, Hudis C. Dose-dense doxorubicin and cyclophosphamide followed by weekly paclitaxel with trastuzumab and lapatinib in HER2/neu-overexpressed/amplified breast cancer is not feasible because of excessive diarrhea. J Clin Oncol. 2010 Jun 20;28(18):2982-8. doi: 10.1200/JCO.2009.26.5900. Epub 2010 May 17. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | AC, PACLITAXEL , TRASTUZUMAB & LAPATINIB | The regimen consists of AC (doxorubicin 60 mg/m2, cyclophosphamide 600 mg/m2) q 14 days x 4 with pegfilgrastim, followed by weekly paclitaxel (80 mg/m2) x 12 + trastuzumab (H) + lapatinib (L). Pegfilgrastim 6mg is given subcutaneously (SQ) on day # 2 of each AC. Filgrastim may be used in lieu of pegfilgrastim at the physician's discretion. Trastuzumab will be administered weekly starting with paclitaxel treatment # 1. Near the completion of all chemotherapy, patients may receive trastuzumab on a q 3-weekly schedule, starting as early as with paclitaxel cycle # 12. The total duration of trastuzumab from beginning to end is 52 weeks. Lapatinib will be given orally at 1000 mg daily, starting with trastuzumab for a total duration of 52 weeks. Hormonal therapy such as tamoxifen or an aromatase inhibitor will be given to patients with hormone receptor positive disease at the physician's discretion. Radiation therapy to the breast or chest is recommended to patients as appropriate. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
|
| doxorubicin hydrochloride | Drug |
|
| lapatinib ditosylate | Drug |
|
| paclitaxel | Drug |
|
| laboratory biomarker analysis | Other |
|
| Memorial Sloan-Kettering Cancer Center |
| New York |
| New York |
| 10021 |
| United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | AC, PACLITAXEL , TRASTUZUMAB & LAPATINIB | The regimen consists of AC (doxorubicin 60 mg/m2, cyclophosphamide 600 mg/m2) q 14 days x 4 with pegfilgrastim, followed by weekly paclitaxel (80 mg/m2) x 12 + trastuzumab (H) + lapatinib (L). Pegfilgrastim 6mg is given subcutaneously (SQ) on day # 2 of each AC. Filgrastim may be used in lieu of pegfilgrastim at the physician's discretion. Trastuzumab will be administered weekly starting with paclitaxel treatment # 1. Near the completion of all chemotherapy, patients may receive trastuzumab on a q 3-weekly schedule, starting as early as with paclitaxel cycle # 12. The total duration of trastuzumab from beginning to end is 52 weeks. Lapatinib will be given orally at 1000 mg daily, starting with trastuzumab for a total duration of 52 weeks. Hormonal therapy such as tamoxifen or an aromatase inhibitor will be given to patients with hormone receptor positive disease at the physician's discretion. Radiation therapy to the breast or chest is recommended to patients as appropriate. |
| 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 |
|
| 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 | Number of Patients Who Completed All Planned Therapy | The number of patients who completed all planned therapy (dose-dense adjuvant/ neoadjuvant chemotherapy regimen) in HER-2/neu-overexpressed/ amplified breast cancer patients. | Posted | Number | participants | 2 years |
|
|
| |||||||||||||||||||||||||||
| Secondary | Number of Patients Who Were Evaluated for Toxicity | Please see adverse event section in the results. Toxicities were assessed by the National Cancer Institute Common Toxicity Criteria (NCI CTC) version 3.0. | Posted | Count of Participants | Participants | 2 years |
|
|
|
Not provided
Not provided
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 | AC, PACLITAXEL , TRASTUZUMAB & LAPATINIB | The regimen consists of AC (doxorubicin 60 mg/m2, cyclophosphamide 600 mg/m2) q 14 days x 4 with pegfilgrastim, followed by weekly paclitaxel (80 mg/m2) x 12 + trastuzumab (H) + lapatinib (L). Pegfilgrastim 6mg is given subcutaneously (SQ) on day # 2 of each AC. Filgrastim may be used in lieu of pegfilgrastim at the physician's discretion. Trastuzumab will be administered weekly starting with paclitaxel treatment # 1. Near the completion of all chemotherapy, patients may receive trastuzumab on a q 3-weekly schedule, starting as early as with paclitaxel cycle # 12. The total duration of trastuzumab from beginning to end is 52 weeks. Lapatinib will be given orally at 1000 mg daily, starting with trastuzumab for a total duration of 52 weeks. Hormonal therapy such as tamoxifen or an aromatase inhibitor will be given to patients with hormone receptor positive disease at the physician's discretion. Radiation therapy to the breast or chest is recommended to patients as appropriate. | 23 | 95 | 94 | 95 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cholesterol,high(hypercholestremia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTC-3.0 | Systematic Assessment |
| |
| Dehydration | Gastrointestinal disorders | CTC-3.0 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTC-3.0 | Systematic Assessment |
| |
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | CTC-3.0 | Systematic Assessment |
| |
| Edema: limb | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
| |
| Fatigue (asthenia, lethargy, malaise) | General disorders | CTC-3.0 | Systematic Assessment |
| |
| Fever | General disorders | CTC-3.0 | Systematic Assessment |
| |
| Flu-like syndrome | General disorders | CTC-3.0 | Systematic Assessment |
| |
| Gastrointestinal, other | Gastrointestinal disorders | CTC-3.0 | Systematic Assessment |
| |
| Hematoma | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
| |
| Hemoglobin | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
| |
| Hypertension | Cardiac disorders | CTC-3.0 | Systematic Assessment |
| |
| Hypotension | Cardiac disorders | CTC-3.0 | Systematic Assessment |
| |
| Inf norm ANC/gr1/2 neut-Cellulitis(skin) | Infections and infestations | CTC-3.0 | Systematic Assessment |
| |
| Inf norm ANC/gr1/2 neut-Gingivitis(oral-gums) | Infections and infestations | CTC-3.0 | Systematic Assessment |
| |
| Inf unknown ANC-Cellulitis(skin) | Infections and infestations | CTC-3.0 | Systematic Assessment |
| |
| Inf unknown ANC-Pneumonia(lung) | Infections and infestations | CTC-3.0 | Systematic Assessment |
| |
| Infection w/ Gr 3/4 neut, Catheter-related | Infections and infestations | CTC-3.0 | Systematic Assessment |
| |
| Infection w/ Gr 3/4 neut, Skin (cellulites) | Infections and infestations | CTC-3.0 | Systematic Assessment |
| |
| Infection, other | Infections and infestations | CTC-3.0 | Systematic Assessment |
| |
| Left ventricular diastolic dysfunction | Cardiac disorders | CTC-3.0 | Systematic Assessment |
| |
| Leukocytes (total WBC) | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
| |
| Liver dysfunction/failure | Hepatobiliary disorders | CTC-3.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTC-3.0 | Systematic Assessment |
| |
| Neutrophils/granulocytes (ANC/AGC) | Infections and infestations | CTC-3.0 | Systematic Assessment |
| |
| Ocular/Visual - Other (specify) | Eye disorders | CTC-3.0 | Systematic Assessment |
| |
| Pain - Head/headache | General disorders | CTC-3.0 | Systematic Assessment |
| |
| Pain - Muscle | General disorders | CTC-3.0 | Systematic Assessment |
| |
| Pain - Other (specify) | General disorders | CTC-3.0 | Systematic Assessment |
| |
| Pleural effusion (non-malig) | Respiratory, thoracic and mediastinal disorders | CTC-3.0 | Systematic Assessment |
| |
| Pneumonitis/pulm infiltrates | Respiratory, thoracic and mediastinal disorders | CTC-3.0 | Systematic Assessment |
| |
| Prolonged QTc interval | Cardiac disorders | CTC-3.0 | Systematic Assessment |
| |
| Rigors/chills | General disorders | CTC-3.0 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | CTC-3.0 | Systematic Assessment |
| |
| Thrombosis/embolism (vascular access-related) | Vascular disorders | CTC-3.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ALT, SGPT | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
| |
| AST, SGOT | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
| |
| Bilirubin (hyperbilirubinemia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTC-3.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTC-3.0 | Systematic Assessment |
| |
| Dermatology/Skin, other | Skin and subcutaneous tissue disorders | CTC-3.0 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTC-3.0 | Systematic Assessment |
| |
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | CTC-3.0 | Systematic Assessment |
| |
| Fatigue (asthenia, lethargy, malaise) | General disorders | CTC-3.0 | Systematic Assessment |
| |
| Glucose, high (hyperglycemia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
| |
| Hair loss/alopecia (scalp or body) | Skin and subcutaneous tissue disorders | CTC-3.0 | Systematic Assessment |
| |
| Hemoglobin | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
| |
| Hot flashes/flushes | Endocrine disorders | CTC-3.0 | Systematic Assessment |
| |
| Infection | Infections and infestations | CTC-3.0 | Systematic Assessment |
| |
| Irregular menses (change from baseline) | Reproductive system and breast disorders | CTC-3.0 | Systematic Assessment |
| |
| Leukocytes (total WBC) | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
| |
| Mucositis (Clin exam)- Oral cavity | Gastrointestinal disorders | CTC-3.0 | Systematic Assessment |
| |
| Nail changes | Skin and subcutaneous tissue disorders | CTC-3.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTC-3.0 | Systematic Assessment |
| |
| Neuropathy: sensory | Nervous system disorders | CTC-3.0 | Systematic Assessment |
| |
| Neutrophils/granulocytes (ANC/AGC) | Infections and infestations | CTC-3.0 | Systematic Assessment |
| |
| Pain - Head/headache | General disorders | CTC-3.0 | Systematic Assessment |
| |
| Pain - Other (specify) | General disorders | CTC-3.0 | Systematic Assessment |
| |
| Rash/desquamation | Skin and subcutaneous tissue disorders | CTC-3.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTC-3.0 | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Chau Dang | Memorial Sloan Kettering Cancer Center | 914-367-7181 | dangc@mskcc.org |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D018567 | Breast Neoplasms, Male |
| 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 |
|---|---|
| D000068878 | Trastuzumab |
| D003520 | Cyclophosphamide |
| D004317 | Doxorubicin |
| D000077341 | Lapatinib |
| D017239 | Paclitaxel |
| 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 |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D004224 | Diterpenes |
| D013729 | Terpenes |
Not provided
Not provided
|