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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
| Novartis | INDUSTRY |
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In this research study we are studying the effects of the combination of lapatinib plus Herceptin in subjects with breast cancer that has spread outside of the breast. We are also studying whether positron emission tomography (PET/CT) scans can predict which participants will benefit from the study treatment. Finally, we are studying genes and proteins in the tumor tissue that may lead to sensitivity or resistance to Herceptin, and to the combination of Herceptin plus lapatinib. Lapatinib is a compound that may stop cancer cells from growing. Other research studies suggest that lapatinib in combination with Herceptin may help to shrink or stabilize breast cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Other | This cohort is made up of participants without prior trastuzumab for MBC. Adjuvant or neoadjuvant trastuzumab was allowed, if the interval from trastuzumab completion to recurrence exceeded 1 year. 1000 mg daily Lapatinib 2 mg/kg weekly or 6 mg/kg every 3 week dose of trastuzumab |
|
| Cohort 2 | Other | This cohort is made up of participants with one to two lines of chemotherapy for metastatic disease with at least one trastuzumab-containing regimen or patients who recurred within 12 months of adjuvant or neoadjuvant trastuzumab with up to one line of metastatic trastuzumab-based therapy 1000 mg daily Lapatinib 2 mg/kg weekly or 6 mg/kg every 3 week dose of trastuzumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lapatinib | Drug |
|
| |
| Herceptin |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | The objective response rate is the percentage of participants achieving complete response (CR) or partial response (PR) as the best response recorded on treatment based on Response Evaluation Criteria In Solid Tumors Criteria (RECIST 1.1) criteria. CR and PR must meet the following lesion criteria without having any new lesions as well: Target Lesion: (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Non-Target Lesion: (CR): Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (<10 mm short axis). Non-CR/Non-Progressive Disease: Persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits. Must have PR in target lesion. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Top 3 Most Common Treatment RelatedToxicities | Assessed by -Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Top 3 treatment-related all-grade adverse events in terms of incidence. Treatment Related is discerned as follows: Yes: There is a plausible temporal relationship between the onset of the AE and administration of atezolizumab or bevacizumab, and the AE cannot be readily explained by the patient's clinical state, intercurrent illness, or concomitant therapies; and/or the AE follows a known pattern of response to atezolizumab or bevacizumab or with similar treatments; and/or the AE resolves upon discontinuation of the study drugs or dose reduction and, if applicable, reappears upon re-challenge. No: Evidence exists that the AE has an etiology other than the study drugs (e.g., pre existing medical condition, underlying disease, intercurrent illness, or concomitant medication); and/or the AE has no plausible temporal relationship to the study drugs administration. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nancy Lin, MD | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University fo Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| University of Chicago |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26169615 | Derived | Lin NU, Guo H, Yap JT, Mayer IA, Falkson CI, Hobday TJ, Dees EC, Richardson AL, Nanda R, Rimawi MF, Ryabin N, Najita JS, Barry WT, Arteaga CL, Wolff AC, Krop IE, Winer EP, Van den Abbeele AD. Phase II Study of Lapatinib in Combination With Trastuzumab in Patients With Human Epidermal Growth Factor Receptor 2-Positive Metastatic Breast Cancer: Clinical Outcomes and Predictive Value of Early [18F]Fluorodeoxyglucose Positron Emission Tomography Imaging (TBCRC 003). J Clin Oncol. 2015 Aug 20;33(24):2623-31. doi: 10.1200/JCO.2014.60.0353. Epub 2015 Jul 13. |
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Registered between May 2007 and October 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 | This cohort is made up of participants without prior trastuzumab for MBC. Adjuvant or neoadjuvant trastuzumab was allowed, if the interval from trastuzumab completion to recurrence exceeded 1 year. 1000 mg daily Lapatinib 2 mg/kg weekly or 6 mg/kg every 3 week dose of trastuzumab Lapatinib: Oral dose taken daily Herceptin: Given intravenously once a week or once every 3 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
|
|
| Up to 93 months |
| Sites of First Progression | Progression is defined by Response Evaluation Criteria In Solid Tumors Criteria 1.1 (RECIST) as follows: - >20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (including baseline if it's the smallest). The sum must also demonstrate an increase of >5 mm. OR -Appearance of new lesions and/or unequivocal progression of non-target lesions. It must be representative of overall disease status change, not a single lesion increase. For patients with PD at the first on-treatment imaging assessment, patients will be allowed to remain on study until confirmation at the next assessment at investigator discretion if patient is benefiting from treatment. | Up to 93 months |
| Clinical Benefit Rate | Clinical Benefit Rate is the percentage of participants who achieve clinical benefit from the study treatment. Clinical benefit is defined as at least 24 weeks of confirmed Complete Response (CR), Partial Response (PR), or Stable Disease (SD). SD or better is achieved if the following are true: Target Lesions: -At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Non-target Lesions: No progression. No appearance new lesions or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase. | Up to 93 months |
| 3-Year Overall Survival | Overall Survival (OS) is defined as the time from randomization (or registration) to death due to any cause, or censored at date last known alive. 3-Year survival is calculated using Kaplan-Meier methods. | Up to 93 months |
| Median Time to Progression | Time to progression (TTP) is defined as the time from study entry to disease progression by RECIST. Subjects are considered to have progressed if they discontinue treatment due to clinical deterioration from breast cancer or die on-treatment of any cause. TTP is censored at the time of initiation of alternative therapy or time of last contact. The time to progression is calculated using a Kaplan-Meier emthods. Progression is defined by RECIST as: >20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (including baseline if it's the smallest). The sum must also demonstrate an increase of >5 mm. OR Appearance of new lesions and/or unequivocal progression of non-target lesions. It must be representative of overall disease status change, not a single lesion increase. | Up to 93 months |
| Chicago |
| Illinois |
| 60452 |
| United States |
| Dana-Farber at Faulkner Hospital | Boston | Massachusetts | 02130 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| University of North Carolina | Chapel Hill | North Carolina | 27599 | United States |
| Vanderbilt University | Nashville | Tennessee | 37232 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| FG001 | Cohort 2 | This cohort is made up of participants with one to two lines of chemotherapy for metastatic disease with at least one trastuzumab-containing regimen or patients who recurred within 12 months of adjuvant or neoadjuvant trastuzumab with up to one line of metastatic trastuzumab-based therapy 1000 mg daily Lapatinib 2 mg/kg weekly or 6 mg/kg every 3 week dose of trastuzumab Lapatinib: Oral dose taken daily Herceptin: Given intravenously once a week or once every 3 weeks |
| Safety Population |
|
| Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 | This cohort is made up of participants without prior trastuzumab for MBC. Adjuvant or neoadjuvant trastuzumab was allowed, if the interval from trastuzumab completion to recurrence exceeded 1 year. 1000 mg daily Lapatinib 2 mg/kg weekly or 6 mg/kg every 3 week dose of trastuzumab Lapatinib: Oral dose taken daily Herceptin: Given intravenously once a week or once every 3 weeks |
| BG001 | Cohort 2 | This cohort is made up of participants with one to two lines of chemotherapy for metastatic disease with at least one trastuzumab-containing regimen or patients who recurred within 12 months of adjuvant or neoadjuvant trastuzumab with up to one line of metastatic trastuzumab-based therapy 1000 mg daily Lapatinib 2 mg/kg weekly or 6 mg/kg every 3 week dose of trastuzumab Lapatinib: Oral dose taken daily Herceptin: Given intravenously once a week or once every 3 weeks |
| 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 |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Eastern Cooperative Oncology Group Performance Status | Count of Participants | Participants |
| ||||||||||||||||
| Stage at Initial Diagnosis | Stage I: Cancer in the breast only, or tumor smaller than 2 cm in diameter with lymph node cancer cell groups of 0.2mm to 2mm in diameter. Stage II: Cancer has either spread to the lymph nodes or is 2cm - 5cm in diameter and human epidermal growth factor receptor 2 positive. Stage III: Cancer may spread to the skin or breast, or infected 4+ axillary lymph nodes or beyond the axillary lymph nodes or near the breastbone. Stage IV: Cancer has spread to other areas of the body, such as the brain, bones, lung and liver | Count of Participants | Participants |
| |||||||||||||||
| Hormone Receptor Status | Count of Participants | Participants |
| ||||||||||||||||
| Human Epidermal Growth Factor Receptor 2 | Count of Participants | Participants |
| ||||||||||||||||
| Disease-Free Interval | Count of Participants | Participants |
| ||||||||||||||||
| Median Number of Metastatic Disease Sites (Range) | Median | Full Range | number of sites |
| |||||||||||||||
| Disease Sites | Count of Participants | Participants |
| ||||||||||||||||
| Prior Therapy | Count of Participants | Participants |
| ||||||||||||||||
| Number of Lines of Chemotherapy for Metastasis or Recurrence | Count of Participants | Participants |
| ||||||||||||||||
| Prior Chemotherapy for Metastasis or Recurrence | Count of Participants | 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 | Objective Response Rate | The objective response rate is the percentage of participants achieving complete response (CR) or partial response (PR) as the best response recorded on treatment based on Response Evaluation Criteria In Solid Tumors Criteria (RECIST 1.1) criteria. CR and PR must meet the following lesion criteria without having any new lesions as well: Target Lesion: (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Non-Target Lesion: (CR): Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (<10 mm short axis). Non-CR/Non-Progressive Disease: Persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits. Must have PR in target lesion. | Given for all treated patients | Posted | Number | 95% Confidence Interval | percentage of participants | 8 weeks |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Top 3 Most Common Treatment RelatedToxicities | Assessed by -Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Top 3 treatment-related all-grade adverse events in terms of incidence. Treatment Related is discerned as follows: Yes: There is a plausible temporal relationship between the onset of the AE and administration of atezolizumab or bevacizumab, and the AE cannot be readily explained by the patient's clinical state, intercurrent illness, or concomitant therapies; and/or the AE follows a known pattern of response to atezolizumab or bevacizumab or with similar treatments; and/or the AE resolves upon discontinuation of the study drugs or dose reduction and, if applicable, reappears upon re-challenge. No: Evidence exists that the AE has an etiology other than the study drugs (e.g., pre existing medical condition, underlying disease, intercurrent illness, or concomitant medication); and/or the AE has no plausible temporal relationship to the study drugs administration. | Posted | Number | toxicity events | Up to 93 months |
| ||||||||||||||||||||||||||||||||
| Secondary | Sites of First Progression | Progression is defined by Response Evaluation Criteria In Solid Tumors Criteria 1.1 (RECIST) as follows: - >20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (including baseline if it's the smallest). The sum must also demonstrate an increase of >5 mm. OR -Appearance of new lesions and/or unequivocal progression of non-target lesions. It must be representative of overall disease status change, not a single lesion increase. For patients with PD at the first on-treatment imaging assessment, patients will be allowed to remain on study until confirmation at the next assessment at investigator discretion if patient is benefiting from treatment. | Posted | Count of Participants | Participants | Up to 93 months |
| ||||||||||||||||||||||||||||||||
| Secondary | Clinical Benefit Rate | Clinical Benefit Rate is the percentage of participants who achieve clinical benefit from the study treatment. Clinical benefit is defined as at least 24 weeks of confirmed Complete Response (CR), Partial Response (PR), or Stable Disease (SD). SD or better is achieved if the following are true: Target Lesions: -At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Non-target Lesions: No progression. No appearance new lesions or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase. | Given for all treated patients | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 93 months |
| ||||||||||||||||||||||||||||||
| Secondary | 3-Year Overall Survival | Overall Survival (OS) is defined as the time from randomization (or registration) to death due to any cause, or censored at date last known alive. 3-Year survival is calculated using Kaplan-Meier methods. | Given for all treated patients | Posted | Number | 95% Confidence Interval | probability of survival | Up to 93 months |
| ||||||||||||||||||||||||||||||
| Secondary | Median Time to Progression | Time to progression (TTP) is defined as the time from study entry to disease progression by RECIST. Subjects are considered to have progressed if they discontinue treatment due to clinical deterioration from breast cancer or die on-treatment of any cause. TTP is censored at the time of initiation of alternative therapy or time of last contact. The time to progression is calculated using a Kaplan-Meier emthods. Progression is defined by RECIST as: >20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (including baseline if it's the smallest). The sum must also demonstrate an increase of >5 mm. OR Appearance of new lesions and/or unequivocal progression of non-target lesions. It must be representative of overall disease status change, not a single lesion increase. | Given for all treated patients | Posted | Number | 95% Confidence Interval | months | Up to 93 months |
|
Up to 93 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
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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 | Cohort 1 | This cohort is made up of participants without prior trastuzumab for MBC. Adjuvant or neoadjuvant trastuzumab was allowed, if the interval from trastuzumab completion to recurrence exceeded 1 year. 1000 mg daily Lapatinib 2 mg/kg weekly or 6 mg/kg every 3 week dose of trastuzumab Lapatinib Herceptin | 15 | 41 | 2 | 41 | 40 | 41 |
| EG001 | Cohort 2 | This cohort is made up of participants with one to two lines of chemotherapy for metastatic disease with at least one trastuzumab-containing regimen or patients who recurred within 12 months of adjuvant or neoadjuvant trastuzumab with up to one line of metastatic trastuzumab-based therapy 1000 mg daily Lapatinib 2 mg/kg weekly or 6 mg/kg every 3 week dose of trastuzumab Lapatinib Herceptin | 34 | 46 | 7 | 46 | 44 | 46 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea w/o prior colostomy | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Diarrhea w/o prior colostomy | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| GI-other | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdomen, pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Alkaline phosphatase | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Alkalosis | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Allergic reaction | Immune system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Allergy-other | Immune system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| ALT, SGPT | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Arachnoiditis/meningismus/radiculitis | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| AST, SGOT | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Ataxia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Back, pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Bicarbonate | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Bilirubin | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Bone, pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Brachial plexopathy | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Breast, pain | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Bronchospasm, wheezing | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Chemoradiation dermatitis | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
| |
| Chest wall, pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Chest/thoracic pain NOS | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Cognitive disturbance | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Constitutional, other | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| C-P arrest, non-fatal, cause unknown | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Creatinine | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Diarrhea w/o prior colostomy | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Distention/bloating, abdominal | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dry eye syndrome | Eye disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Edema limb | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Edema trunk/genital | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Erythema multiforme | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Extremity upper (function) | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Extremity-limb, pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Extremity-lower (gait/walking) | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Fever w/o neutropenia | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
| |
| GI10 | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| gi111 | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| GI-other | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hand-foot reaction | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Head/headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hearing-other | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hematologic-other | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hemoglobin | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hemolysis | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hemorrhage-other | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hemorrhoids | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hepatic-other | Hepatobiliary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hot flashes | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hyopthyroidism | Endocrine disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypercalcemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypercholesterolemia | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypernatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hyperthyroidism, thyrotoxicosis | Endocrine disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypertriglyceridemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypoglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Infection Gr0-2 neut, lip/perioral | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Infection Gr0-2 neut, sinus | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Infection Gr0-2 neut, skin | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Infection Gr0-2 neut, upper airway | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Infection w/ gr3-4 neut, urinary tract | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Infection w/ unk ANC bladder | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Infection w/ unk ANC lung | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Infection w/ unk ANC middle ear | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Infection w/ unk ANC sinus | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Infection w/ unk ANC ungual (nails) | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Infection w/ unk ANC upper airway NOS | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Infection w/ unk ANC upper airway NOS | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Infection-other | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Intra-op injury Other (Specify) | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
| |
| Joint, pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Keratitis | Eye disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Left ventricular systolic dysfunction | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Leukocytes | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Liver, pain | Hepatobiliary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Lymph node, pain | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Lymphatics-other | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Lymphopenia | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Metabolic/Laboratory-other | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Muco/stomatitis (symptom) oral cavity | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Muco/stomatitis by exam, larynx | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Muco/stomatitis by exam, oral cavity | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Muco/stomatitis by exam, oral cavity | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Muscle, pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Musculoskeletal/soft tissue-other | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Nail changes | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Nasal cavity/paranasal sinus reaction | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Neck, pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Neurologic-other | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Neuropathy CN III pupil/eyelid/extraocul | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Neuropathy-motor | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Neuropathy-sensory | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Neutrophils | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Nose, hemorrhage | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Ocular-other | Eye disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Oral cavity, pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pain NOS | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pain-other | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pelvic, pain | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Platelets | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Portal vein flow | Hepatobiliary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pruritus/itching | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pulmonary/Upper Respiratory-other | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Rash/desquamation | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Rash: acne/acneiform | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Rectum, hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Renal/GU-other | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Rigors/chills | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Sinus, pain | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Skin breakdown/decubitus ulcer | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Skin, pain | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Skin-other | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Stomach, pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Sweating | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Taste disturbance | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Teeth | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Throat/pharynx/larynx, pain | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Thrombosis/thrombus/embolism | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Tremor | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Vagina, hemorrhage | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Vaginal dryness | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Vasovagal episode | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Vision-blurred | Eye disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Vision-flashing lights/floaters | Eye disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Voice changes/dysarthria | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Weight gain | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Weight loss | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Wound - non-infectious | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nancy Lin | Dana-Farber Cancer Institute | 6176322335 | Nancy_Lin@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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077341 | Lapatinib |
| D000068878 | Trastuzumab |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| 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
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Black and African American |
|
| Asian |
|
| Other |
|
| 01 - Restricted |
|
| 02 - Ambulatory |
|
| Stage II |
|
| Stage III |
|
| Stage IV |
|
| Unknown |
|
| Estrogen Receptor Negative and Progesterone Receptor Negative |
|
| Unknown or Not Done |
|
| Metastatic Lesion |
|
| Negative / Equivocal |
|
| Unknown / Not Done |
|
| Metastatic Lesion |
|
| Greater than 2 years |
|
| Less than or equal to 2 years |
|
| Lung |
|
| Pleural Effusion |
|
| Liver |
|
| Bone |
|
| Breast or Chest Wall |
|
| Lymph Nodes |
|
| Other |
|
| Adjuvant or neoadjuvant chemotherapy |
|
| Anthracycline |
|
| Taxane |
|
| Trastuzumab |
|
| One |
|
| Two |
|
| Three |
|
| Trastuzumab-Emtansine |
|
| Pertuzumab |
|
|
|
|
|
This cohort is made up of participants with one to two lines of chemotherapy for metastatic disease with at least one trastuzumab-containing regimen or patients who recurred within 12 months of adjuvant or neoadjuvant trastuzumab with up to one line of metastatic trastuzumab-based therapy
1000 mg daily Lapatinib
2 mg/kg weekly or 6 mg/kg every 3 week dose of trastuzumab
Lapatinib: Oral dose taken daily
Herceptin: Given intravenously once a week or once every 3 weeks
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
|