| ID | Type | Description | Link |
|---|---|---|---|
| 00-C-0149 |
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This study will assess the usefulness of a technique called complementary deoxyribonucleic acid (cDNA) microarray-an examination of a wide array of genes to identify disease-associated patterns-for measuring tumor response to chemotherapy in breast cancer patients. The study will look for "markers" that can help select the most effective type of chemotherapy. It will also evaluate the safety and effectiveness of a new drug combination of capecitabine and docetaxel.
Patients age 18 years and older with stage II or III breast cancer whose tumor is 2 centimeters or larger may be eligible for this study. Those enrolled will be treated with surgery, standard chemotherapy using doxorubicin (Adriamycin) and cyclophosphamide (Cytoxan), and the capecitabine and docetaxel combination.
Patients will have a physical examination, mammogram and magnetic resonance imaging to evaluate their tumor before beginning treatment. They will then have four 21-day treatment cycles of docetaxel and capecitabine, as follows: docetaxel intravenously (through a vein) on day 1 and capecitabine pills (by mouth) twice a day from days 2 through 15. No drugs will be given from days 16 through 21. This regimen will be repeated four times, after which the tumor will be re-evaluated by physical examination, mammogram, and magnetic resonance imaging.
Patients will then have surgery to remove the cancer-either lumpectomy with removal of the underarm lymph nodes; mastectomy and removal of the underarm lymph nodes; or modified radical mastectomy. After recovery, they will have four more cycles of chemotherapy, this time with a doxorubicin and cyclophosphamide. Both drugs will be given intravenously on day 1 of four 21-day cycles.
Some patients who had a mastectomy (depending on their tumor characteristics and whether tumor cells were found in their lymph nodes) and all those who had a lumpectomy will also have radiation therapy. Patients with hormone receptor-positive tumors will also receive tamoxifen treatment for 5 years.
In addition to the above procedures, all patients will have tumor biopsies (removal of a small piece of tumor tissue) before beginning treatment, on day 1 of cycle 1, before cycle 2, and at the time of surgery, and physical examinations, chest X-rays, bone scans, computerized tomography (CT) scans, electrocardiograms, multi-gated acquisition scan-MUGA (nuclear medicine test of cardiac function) or echocardiograms of heart function, mammograms and blood tests at various times during the study. Patients will be followed at National Institutes of Health (NIH) for 3 years after diagnosis with physical examinations, blood tests, X-rays, and computed tomography (CT) scans.
Although it is not known whether this treatment will help an individual patient's cancer, possible benefits are tumor shrinkage and decreased risk of disease recurrence. In addition, the information gained about genetic changes after chemotherapy will help determine if additional studies on the use of cDNA microarray to measure tumor response are warranted.
This phase II trial in patients with stage II and stage III breast cancer will test the feasibility of using cDNA microarray as a measure of a tumor's biological response to chemotherapeutic agents by characterizing the cDNA expression patterns in breast cancer before and after primary chemotherapy. Thirty-six patients receive docetaxel/capecitabine induction chemotherapy followed by surgery and doxorubicin/cyclophosphamide adjuvant therapy (TX/AC). We will determine the response rate of TX induction therapy and the toxicities of the sequential combinations (TX/AC). We will also obtain tumor tissue for correlative biological determinations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose A-Cohort 1-Arm 1-Docetaxel & Capecitabine | Experimental | Docetaxel 75 mg/m^2 intravenous day 1, capecitabine 1000 mg/m^2 orally twice daily day 2-15 for 4 cycles |
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| Dose B-Cohort 2-Arm 2 Reduced dose-Docetaxel & Capecitabine | Experimental | Docetaxel 60 mg/m^2 intravenous day 1, capecitabine 937.5 mg/m^2 orally twice daily day 2-15 for 4 cycles |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Docetaxel - Dose A | Drug | Dose A-Cohort 1 Docetaxel 75 mg/m^2 intravenous day 1 |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module. | 6 years |
| Overall Clinical Response Rate | Overall response rate is defined as the percentage of participants with a CR (complete disappearance of all target lesions), PR (a 30% decrease in the sum of the longest diameter of target lesions) determined by clinical measurements per the Response Evaluation Criteria in Solid Tumors (RECIST) and/or a complete pathologic response (disappearance of all invasive tumor pathologically or presence of ductal carcinoma in situ) per the Chevallier criteria. For details about the RECIST or Chevallier criteria see the protocol link module. | 6 years |
| Complementary Deoxyribonucleic Acid (cDNA) Expression | Patients were classified as responders or non-responders based on change in tumor size by clinical exam and pathologic response.For instance, patients with a pathological complete response, micro-invasive disease at surgery, or clinical complete response after four cycles of treatment were considered responders. Changes in gene expression associated with treatment was assessed before/after chemotherapy. All gene expression summary intensities below 50 were thresholded to the value of 50 and genes showing variability significantly smaller than the median gene variability were screened out. | 6 years |
| Number of Participants, e.g. Responders and Non-responders With a Percent Change in Expression Patterns After Chemotherapy With Changes in Expression Patterns After Chemotherapy in Preclinical Models | Patients were classified as responders or non-responders based on change in tumor size by clinical exam and pathologic response.For instance, patients with a pathological complete response, micro-invasive disease at surgery, or clinical complete response after four cycles of treatment were considered responders. Changes in gene expression associated with treatment was assessed before/after chemotherapy. All gene expression summary intensities below 50 were thresholded to the value of 50 and genes showing variability significantly smaller than the median gene variability were screened out. |
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Stage II or III breast cancer with a tumor size of greater than 2 cm. Patients with a previous biopsy are eligible provided adequate tumor tissue remains for biopsy in this study.
At least 18 years of age.
Adequate hematopoietic function as defined by absolute neutrophil count greater than 1200/mm^3 and platelet count greater than 100,000/mm^3.
Adequate renal function as defined by creatinine less than 1.6 mg/dL.
Adequate hepatic function as defined by total (T.) bilirubin less than 1.4 mg/dL and serum glutamic oxaloacetic transaminase (SGOT)/serum glutamic pyruvic transaminase (SGPT) less than 1.5 times the upper limit of normal and alkaline phosphatase less than 2.5 times upper limit of normal
Zubrod Performance status 0-2.
EXCLUSION CRITERIA:
Medical or psychiatric condition that, in the opinion of the Principal Investigator, would preclude chemotherapy administration. Patients may be evaluated by psychiatry or medical subspecialties as appropriate.
Pregnant or lactating women
Known bleeding disorders
Hypersensitivity to Tween 80 (Polysorbate)
Cardiac ejection fraction below normal limits, myocardial infarction within the past 12 months, or symptomatic arrhythmia requiring medical intervention.
Prior chemotherapy or hormonal therapy for breast cancer. Patients treated with hormonal chemoprevention (tamoxifen or raloxifene) will be eligible.
Active malignancy diagnosed within the last 5 years. (Cervical cancer or non-melanomatous skin cancer that has been treated with curative intent will be eligible).
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| Name | Affiliation | Role |
|---|---|---|
| JoAnne Zujewski, M.D. | National Cancer Institute (NCI), National Institutes of Health (NIH) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Naval Medical Center | Bethesda | Maryland | 20889 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7563172 | Background | Elledge RM, Gray R, Mansour E, Yu Y, Clark GM, Ravdin P, Osborne CK, Gilchrist K, Davidson NE, Robert N, et al. Accumulation of p53 protein as a possible predictor of response to adjuvant combination chemotherapy with cyclophosphamide, methotrexate, fluorouracil, and prednisone for breast cancer. J Natl Cancer Inst. 1995 Aug 16;87(16):1254-6. doi: 10.1093/jnci/87.16.1254. No abstract available. | |
| 8912545 |
| Label | URL |
|---|---|
| RECIST | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dose A-Cohort 1-Arm 1-Docetaxel & Capecitabine | Docetaxel 75 mg/m^2 intravenous day 1, capecitabine 1000 mg/m^2 orally twice daily day 2-15 for 4 cycles Once the dose was deemed to be too toxic, subsequent patients were enrolled on dose B. |
| FG001 | Dose B-Cohort 2-Arm 2 Reduced Dose-Docetaxel & Capecitabine |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Anastrozole | Drug | 1 mg orally daily for five years |
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| cyclophosphamide | Drug | 600 mg/m^2 will be diluted in 100 mL 0.9% normal saline (NS) and administered intravenously over 30 minutes on day 1 |
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| Docetaxel - Dose B | Drug | Dose B - Cohort 2 Docetaxel 60 mg/m^2 intravenous day 1 |
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| Doxorubicin hydrochloride | Drug | 60 mg/m^2 will be administered as a slow intravenous push on day 1 |
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| Tamoxifen Citrate | Drug | 20 mg/day orally for five years |
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| Capecitabine - Dose B | Drug | Dose B - Cohort 2 capecitabine 937.5 mg/m^2 orally twice daily day 2-15 |
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| Capecitabine - Dose A | Drug | capecitabine 1000 mg/m^2 orally twice daily day 2-15 for 4 cycles |
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| 6 years |
| Background |
| MacGrogan G, Mauriac L, Durand M, Bonichon F, Trojani M, de Mascarel I, Coindre JM. Primary chemotherapy in breast invasive carcinoma: predictive value of the immunohistochemical detection of hormonal receptors, p53, c-erbB-2, MiB1, pS2 and GST pi. Br J Cancer. 1996 Nov;74(9):1458-65. doi: 10.1038/bjc.1996.565. |
| 10334533 | Background | Harvey JM, Clark GM, Osborne CK, Allred DC. Estrogen receptor status by immunohistochemistry is superior to the ligand-binding assay for predicting response to adjuvant endocrine therapy in breast cancer. J Clin Oncol. 1999 May;17(5):1474-81. doi: 10.1200/JCO.1999.17.5.1474. |
| 15501952 | Result | Lebowitz PF, Eng-Wong J, Swain SM, Berman A, Merino MJ, Chow CK, Venzon D, Zia F, Danforth D, Liu E, Zujewski J. A phase II trial of neoadjuvant docetaxel and capecitabine for locally advanced breast cancer. Clin Cancer Res. 2004 Oct 15;10(20):6764-9. doi: 10.1158/1078-0432.CCR-04-0976. |
| 20012355 | Result | Korde LA, Lusa L, McShane L, Lebowitz PF, Lukes L, Camphausen K, Parker JS, Swain SM, Hunter K, Zujewski JA. Gene expression pathway analysis to predict response to neoadjuvant docetaxel and capecitabine for breast cancer. Breast Cancer Res Treat. 2010 Feb;119(3):685-99. doi: 10.1007/s10549-009-0651-3. |
Docetaxel 60 mg/m^2 intravenous day 1 capecitabine 937.5 mg/m^2 orally twice daily day 2-15 |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Docetaxel/Capecitabine - A & B | Docetaxel/Capecitabine - A- Docetaxel 75 mg/m^2 intravenous day 1,capecitabine 1000 mg/m^2 orally twice daily day 2-15 for 4 cycles. Docetaxel/Capecitabine - B- Docetaxel 60 mg/m^2 intravenous day 1 capecitabine 937.5 mg/m^2 orally twice daily day 2-15 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | Participants |
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| 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 | Number of Participants With Adverse Events | Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module. | Posted | Number | Participants | 6 years |
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| ||||||||||||||||||||||||||||||
| Primary | Overall Clinical Response Rate | Overall response rate is defined as the percentage of participants with a CR (complete disappearance of all target lesions), PR (a 30% decrease in the sum of the longest diameter of target lesions) determined by clinical measurements per the Response Evaluation Criteria in Solid Tumors (RECIST) and/or a complete pathologic response (disappearance of all invasive tumor pathologically or presence of ductal carcinoma in situ) per the Chevallier criteria. For details about the RECIST or Chevallier criteria see the protocol link module. | Combined data from 2 dose levels in 29 evaluable patients. | Posted | Number | Percentage of participants | 6 years |
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| ||||||||||||||||||||||||||||||
| Primary | Complementary Deoxyribonucleic Acid (cDNA) Expression | Patients were classified as responders or non-responders based on change in tumor size by clinical exam and pathologic response.For instance, patients with a pathological complete response, micro-invasive disease at surgery, or clinical complete response after four cycles of treatment were considered responders. Changes in gene expression associated with treatment was assessed before/after chemotherapy. All gene expression summary intensities below 50 were thresholded to the value of 50 and genes showing variability significantly smaller than the median gene variability were screened out. | Posted | Number | Participants | 6 years |
|
| |||||||||||||||||||||||||||||||
| Primary | Number of Participants, e.g. Responders and Non-responders With a Percent Change in Expression Patterns After Chemotherapy With Changes in Expression Patterns After Chemotherapy in Preclinical Models | Patients were classified as responders or non-responders based on change in tumor size by clinical exam and pathologic response.For instance, patients with a pathological complete response, micro-invasive disease at surgery, or clinical complete response after four cycles of treatment were considered responders. Changes in gene expression associated with treatment was assessed before/after chemotherapy. All gene expression summary intensities below 50 were thresholded to the value of 50 and genes showing variability significantly smaller than the median gene variability were screened out. | Specimens from 21 patients. Analysis was "per protocol" and included only those patients with adequate RNA (ribonucleic acid) for analysis. Since both had the same intervention, the sample size was small, and a dose response was not expected, all patients were analyzed together. | Posted | Number | Participants | 6 years |
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6 years
CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
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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 | Docetaxel/Capecitabine - A & B | Docetaxel/Capecitabine - A- Docetaxel 75 mg/m^2 intravenous day 1,capecitabine 1000 mg/m^2 orally twice daily day 2-15 for 4 cycles. Docetaxel/Capecitabine - B- Docetaxel 60 mg/m2 intravenous day 1 capecitabine 937.5 mg/m2 orally twice daily day 2-15 | 29 | 30 | 29 | 30 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea (without colostomy) | Gastrointestinal disorders | CTCv2.0 | Systematic Assessment |
| |
| Fatigue (lethargy, malaise, asthenia) | General disorders | CTCv2.0 | Systematic Assessment |
| |
| Myalgia (muscle ache) | Musculoskeletal and connective tissue disorders | CTCv2.0 | Systematic Assessment |
| |
| Hand/foot skin reaction | Skin and subcutaneous tissue disorders | CTCv2.0 | Systematic Assessment |
| |
| Neuropathy-sensory | Nervous system disorders | CTCv2.0 | Systematic Assessment |
| |
| Infection, Other | Infections and infestations | CTCv2.0 | Systematic Assessment |
| |
| Abdominal pain or cramping | Gastrointestinal disorders | CTCv2.0 | Systematic Assessment |
| |
| Allergic reaction/hypersensitivity (including drug fever) | Immune system disorders | CTCv2.0 | Systematic Assessment |
| |
| Arthralgia (joint pain) | Musculoskeletal and connective tissue disorders | CTCv2.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | CTCv2.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | CTCv2.0 | Systematic Assessment |
| |
| Dehydration | Gastrointestinal disorders | CTCv2.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | CTCv2.0 | Systematic Assessment | (fever of unknown origin without clinically or microbiologically documented infection) |
|
| Headache | Nervous system disorders | CTCv2.0 | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCv2.0 | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCv2.0 | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCv2.0 | Systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | CTCv2.0 | Systematic Assessment |
| |
| Infection (documented clinically or microbiologically) with grade 3 or 4 neutropenia | Infections and infestations | CTCv2.0 | Systematic Assessment |
| |
| Infection without neutropenia | Infections and infestations | CTCv2.0 | Systematic Assessment |
| |
| Injection site reaction | Injury, poisoning and procedural complications | CTCv2.0 | Systematic Assessment |
| |
| Leukocytes (total WBC) | Investigations | CTCv2.0 | Systematic Assessment |
| |
| Lymphatics | Blood and lymphatic system disorders | CTCv2.0 | Systematic Assessment |
| |
| Mood alteration-depression | Psychiatric disorders | CTCv2.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCv2.0 | Systematic Assessment |
| |
| Neutrophils/granulocytes (ANC/AGC) | Investigations | CTCv2.0 | Systematic Assessment |
| |
| Pleural effusion (non-malignant) | Respiratory, thoracic and mediastinal disorders | CTCv2.0 | Systematic Assessment |
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| SGOT (AST) | Investigations | CTCv2.0 | Systematic Assessment |
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| SGPT (ALT) | Investigations | CTCv2.0 | Systematic Assessment |
| |
| Stomatitis/pharyngitis (oral/pharyngeal/mucositis) | Gastrointestinal disorders | CTCv2.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | CTCv2.0 | Systematic Assessment |
| |
| Thrombosis/embolism | Vascular disorders | CTCv2.0 | Systematic Assessment |
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| Urinary frequency/urgency | Renal and urinary disorders | CTCv2.0 | Systematic Assessment |
| |
| Urticaria (hives, welts, wheals) | Skin and subcutaneous tissue disorders | CTCv2.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | CTCv2.0 | Systematic Assessment |
| |
| Wound-infectious | Injury, poisoning and procedural complications | CTCv2.0 | Systematic Assessment |
| |
| Wound-non-infectious | Injury, poisoning and procedural complications | CTCv2.0 | Systematic Assessment |
| |
| Anorexia | Skin and subcutaneous tissue disorders | CTCv2.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea (without colostomy) | Gastrointestinal disorders | CTCv2.0 | Systematic Assessment |
| |
| Memory loss | Nervous system disorders | CTCv2.0 | Systematic Assessment |
| |
| Abdominal pain or cramping | Gastrointestinal disorders | CTCv2.0 | Systematic Assessment |
| |
| Alkaline phosphatase | Metabolism and nutrition disorders | CTCv2.0 | Systematic Assessment |
| |
| Allergic reaction/hypersensitivity (including drug fever) | Immune system disorders | CTCv2.0 | Systematic Assessment |
| |
| Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip) | Immune system disorders | CTCv2.0 | Systematic Assessment |
| |
| Allergy-Other | Immune system disorders | CTCv2.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | CTCv2.0 | Systematic Assessment |
| |
| Arthralgia (joint pain) | Musculoskeletal and connective tissue disorders | CTCv2.0 | Systematic Assessment |
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| Bilirubin | Investigations | CTCv2.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | CTCv2.0 | Systematic Assessment |
| |
| Chest pain (non-cardiac and non-pleuritic) | General disorders | CTCv2.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCv2.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCv2.0 | Systematic Assessment |
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| Creatinine | Investigations | CTCv2.0 | Systematic Assessment |
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| Dehydration | Gastrointestinal disorders | CTCv2.0 | Systematic Assessment |
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| Depressed level of consciousness | Nervous system disorders | CTCv2.0 | Systematic Assessment |
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| Dermatitis, focal (associated with high-dose chemotherapy and bone marrow transplant) | Skin and subcutaneous tissue disorders | CTCv2.0 | Systematic Assessment |
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| Dizziness/lightheadedness | Nervous system disorders | CTCv2.0 | Systematic Assessment |
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| Dry eye | Eye disorders | CTCv2.0 | Systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | CTCv2.0 | Systematic Assessment |
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| Dysmenorrhea | Reproductive system and breast disorders | CTCv2.0 | Systematic Assessment |
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| Dyspepsia/heartburn | Gastrointestinal disorders | CTCv2.0 | Systematic Assessment |
| |
| Dysphagia, esophagitis, odynophagia (painful swallowing) | Gastrointestinal disorders | CTCv2.0 | Systematic Assessment |
| |
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | CTCv2.0 | Systematic Assessment |
| |
| Edema | General disorders | CTCv2.0 | Systematic Assessment |
| |
| Fatigue (lathargy, malaise, asthenia) | General disorders | CTCv2.0 | Systematic Assessment |
| |
| Fever (in absence of neutropenia, where neutropenia is defined as AGC<1.0x109/L) | General disorders | CTCv2.0 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | CTCv2.0 | Systematic Assessment |
| |
| GI-Other | Gastrointestinal disorders | CTCv2.0 | Systematic Assessment |
| |
| Hand-foot skin reaction | Skin and subcutaneous tissue disorders | CTCv2.0 | Systematic Assessment |
| |
| Headache | Psychiatric disorders | CTCv2.0 | Systematic Assessment |
| |
| Hearing-Other | Ear and labyrinth disorders | CTCv2.0 | Systematic Assessment |
| |
| Hematologic-Other | Blood and lymphatic system disorders | CTCv2.0 | Systematic Assessment |
| |
| Hematuria (in absence of vaginal bleeding) | Renal and urinary disorders | CTCv2.0 | Systematic Assessment |
| |
| Hemoglobin (hgb) | Investigations | CTCv2.0 | Systematic Assessment |
| |
| Hot flashes/flashes | Vascular disorders | CTCv2.0 | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCv2.0 | Systematic Assessment |
| |
| Hyperuricemia | Metabolism and nutrition disorders | CTCv2.0 | Systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCv2.0 | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCv2.0 | Systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | CTCv2.0 | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCv2.0 | Systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | CTCv2.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCv2.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCv2.0 | Systematic Assessment |
| |
| Infection without neutropenia | Infections and infestations | CTCv2.0 | Systematic Assessment |
| |
| Infection, Other | Infections and infestations | CTCv2.0 | Systematic Assessment |
| |
| Injection site reaction | Injury, poisoning and procedural complications | CTCv2.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCv2.0 | Systematic Assessment |
| |
| Irregular menses (change from baseline) | Reproductive system and breast disorders | CTCv2.0 | Systematic Assessment |
| |
| Leukocytes (total WBC) | Investigations | CTCv2.0 | Systematic Assessment |
| |
| Libido | Reproductive system and breast disorders | CTCv2.0 | Systematic Assessment |
| |
| Lymphatics | Blood and lymphatic system disorders | CTCv2.0 | Systematic Assessment |
| |
| Lymphatics-Other | Blood and lymphatic system disorders | CTCv2.0 | Systematic Assessment |
| |
| Metabolic-Other | Metabolism and nutrition disorders | CTCv2.0 | Systematic Assessment |
| |
| Mood alteration-anxiety/agitation | Psychiatric disorders | CTCv2.0 | Systematic Assessment |
| |
| Mood alteration-depression | Psychiatric disorders | CTCv2.0 | Systematic Assessment |
| |
| Mouth dryness | Gastrointestinal disorders | CTCv2.0 | Systematic Assessment |
| |
| Muscle weakness (not due to neuropathy) | Musculoskeletal and connective tissue disorders | CTCv2.0 | Systematic Assessment |
| |
| Myalgia (muscle ache) | Musculoskeletal and connective tissue disorders | CTCv2.0 | Systematic Assessment |
| |
| Nail changes | Skin and subcutaneous tissue disorders | CTCv2.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCv2.0 | Systematic Assessment |
| |
| Neuropathy motor | Nervous system disorders | CTCv2.0 | Systematic Assessment |
| |
| Neutrophils/granulocytes (ANC/AGC) | Investigations | CTCv2.0 | Systematic Assessment |
| |
| Ocular-Other | Eye disorders | CTCv2.0 | Systematic Assessment |
| |
| Pain-Other | General disorders | CTCv2.0 | Systematic Assessment |
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| Palpitation | Cardiac disorders | CTCv2.0 | Systematic Assessment |
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| Phlebitis (superficial) | Vascular disorders | CTCv2.0 | Systematic Assessment |
| |
| Pigmentation changes (e.g., vitiligo) | Skin and subcutaneous tissue disorders | CTCv2.0 | Systematic Assessment |
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| Platelets | Investigations | CTCv2.0 | Systematic Assessment |
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| Pruritis | Skin and subcutaneous tissue disorders | CTCv2.0 | Systematic Assessment |
| |
| Pulmonary-Other | Respiratory, thoracic and mediastinal disorders | CTCv2.0 | Systematic Assessment |
| |
| Radiation dermatitis | Skin and subcutaneous tissue disorders | CTCv2.0 | Systematic Assessment |
| |
| Rash/desquamation | Skin and subcutaneous tissue disorders | CTCv2.0 | Systematic Assessment |
| |
| Renal/GU-Other | Renal and urinary disorders | CTCv2.0 | Systematic Assessment |
| |
| Sexual/reproductive function-Other | Reproductive system and breast disorders | CTCv2.0 | Systematic Assessment |
| |
| SGOT (AST) | Metabolism and nutrition disorders | CTCv2.0 | Systematic Assessment |
| |
| SGPT (ALT) | Metabolism and nutrition disorders | CTCv2.0 | Systematic Assessment |
| |
| Skin-Other | Skin and subcutaneous tissue disorders | CTCv2.0 | Systematic Assessment |
| |
| Stomatitis/pharyngitis (oral/pharyngeal mucositis) | Gastrointestinal disorders | CTCv2.0 | Systematic Assessment |
| |
| Stomatitis/pharyngitis (oral/pharyngeal mucositis) for BMT | Gastrointestinal disorders | CTCv2.0 | Systematic Assessment |
| |
| Sweating (diaphoresis) | Skin and subcutaneous tissue disorders | CTCv2.0 | Systematic Assessment |
| |
| Syndromes-Other | General disorders | CTCv2.0 | Systematic Assessment |
| |
| Taste disturbance (dysgeusia) | Gastrointestinal disorders | CTCv2.0 | Systematic Assessment |
| |
| Tearing (watery eyes) | Eye disorders | CTCv2.0 | Systematic Assessment |
| |
| Vaginal bleeding | Blood and lymphatic system disorders | CTCv2.0 | Systematic Assessment |
| |
| Vision-blurred vision | Eye disorders | CTCv2.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCv2.0 | Systematic Assessment |
| |
| Weight loss | Investigations | CTCv2.0 | Systematic Assessment |
| |
| Neuro-sensory | Nervous system disorders | CTCv2.0 | Systematic Assessment |
| |
| Anorexia | Gastrointestinal disorders | CTCv2.0 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| JoAnne Zujewski, M.D. | National Cancer Institute, National Institutes of Health | 301-435-9207 | zujewskij@mail.nih.gov |
| 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 |
|---|---|
| D000077143 | Docetaxel |
| D000069287 | Capecitabine |
| D000077384 | Anastrozole |
| D003520 | Cyclophosphamide |
| D004317 | Doxorubicin |
| D013629 | Tamoxifen |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D009570 | Nitriles |
| D014230 | Triazoles |
| D001393 | Azoles |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
Not provided
Not provided
| Unknown or Not Reported |
|
| Asian |
|
| Hispanic |
|
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