Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-00025 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This phase II trial studies how well carboplatin and nab-paclitaxel before surgery work in treating patients with triple negative breast cancer that is inflammatory or has spread from where it started to nearby tissue or lymph nodes. Drugs used in chemotherapy, such as carboplatin and nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PRIMARY OBJECTIVES:
I. To test the hypothesis that carboplatin + nab-paclitaxel (paclitaxel albumin-stabilized nanoparticle formulation) therapy will demonstrate a promising neoadjuvant pathologic complete response (pCR) rate for eligible patients.
II. To test the hypothesis that carboplatin + nab-paclitaxel therapy will demonstrate a promising Symmans 0-1 pathological response rate for eligible patients.
SECONDARY OBJECTIVES:
I To evaluate the overall survival and event-free survival of eligible patients treated with carboplatin + nab-paclitaxel neoadjuvant chemotherapy.
II. To evaluate the toxicities and tolerance of carboplatin + nab-paclitaxel therapy in this patient population.
III. To evaluate the role of laboratory correlates in response, toxicity and survival endpoints.
IV. To procure tissue and perform analysis of gene and protein expression profiles of pre-treatment primary tumor (estimated success rate: 80%) and residual tumors (25%) and lymph nodes including the study of tumor niche (50%), studying sequential assessment of cellular characteristics and gene and protein expression profiles.
V. To identify specific mutations in tumor deoxyribonucleic acid (DNA) in comparison to adjacent tissue and germ line DNA procured prior to, during, and subsequent to neoadjuvant chemotherapy, and to detect/measure, as feasible, the presence of such mutations in fragmented circulating DNA from plasma, and to correlate these mutations with the presence/characteristics of circulating tumor cells in order to identify prognostic and predictive indicators of persisting/relapsed disease and targets for therapy.
VI. To assess ribonucleic acid (RNA) (using Mammaprint/Blueprint and 44,000 Agilent platform gene array), (micro) miRNA and exosome and protein profiles in tumor, adjacent tissue and plasma prior to, during, and at completion of neoadjuvant chemotherapy in order to establish prognostic and predictive indicators of outcome, markers of persistent/relapsed disease, and targets for therapy.
VII. To analyze tumor DNA and genomic DNA from plasma by microarray and reverse transcriptase (RT)-polymerase chain reaction (PCR) analysis to assess copy numbers/single nucleotide polymorphisms (SNP)/genomic polymorphisms in genes for the purposes of establishing prognostic and predictive indicators of outcomes; markers of persistence/relapse disease, drug resistance, and drug metabolism; and targets of therapy.
VIII. To assess the prognostic and predictive value of conventional pathological features (stage, estrogen and progesterone receptor and human epidermal growth factor receptor [HER-2] status, presence of lymphovascular invasion, high grade tumor status) in comparison to such values derived from the molecular approaches.
IX. To procure tumor from the primary and definitive surgical specimen for the purpose of establishing breast cancer stem cell lines.
X. To procure blood samples for the purpose of identifying and characterizing circulating tumor cells.
OUTLINE: Patients receive carboplatin intravenously (IV) over 30 minutes on day 1 and paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes once weekly. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 4 years and then every 6 months for 1 year and then periodically thereafter.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (carboplatin and nab-paclitaxel) | Experimental | Patients receive carboplatin IV over 30 minutes on day 1 and paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes once weekly. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carboplatin | Drug | Given IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| pCR Rate After Treatment. | pCR is RCB 0 by Symmans criteria. The goal of the study is a detection of an increase in rate of pathological complete remission (pCR) from 20% (historical) to 38% | At completion of definitive surgery, up to six months from initial treatment |
| Residual Cancer Burden (RCB) by Symmans Criteria. | Categorization of the outcome of the treatment at completion of definitive surgery by Symmans criteria. "The index score is derived from the largest area and cellularity of residual invasive primary cancer and the number of involved lymph nodes and size of largest metastasis. pCR (stage yp-T0/is, ypN0) has RCB = 0; and RCB class is minimal (RCB-I), moderate (RCB-II), or extensive (RCB-III), on the basis of predefined cut points of 1.36 and 3.28 index scores.) Symmans WF, Wei C, Gould R, et al. J Clin Oncol 35:1049-1060, 2017. Symmans WF, Peintinger F, Hatzis C et al. J Clin Oncol 25:4414-4422, 2007. Order of scale is RCB0 is best, then I, II, III, worse; progressive is the worst. | At completion of definitive surgery, up to six months post-commencement of study chemotherapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Adjuvant Radiation | After adjuvant chemotherapy and before surgery, some patients were given adjuvant radiation. | Up to 6 months |
| Scope of Surgery | After having received adjuvant chemotherapy, and possibly radiation, patients underwent surgery. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Joanne Mortimer, MD, PhD | City of Hope Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Medical Center | Duarte | California | 91010 | United States | ||
| City of Hope- South Pasadena Cancer Center |
Not provided
Participants for this study will be recruited from among patients undergoing treatment at City of Hope Cancer Center for stage II/III -- including inflammatory-- breast adenocarcinoma. Patients will be recruited through encounters by the Breast Oncologists in the Department of Medical Oncology and/or Breast Surgical Oncologists of the Department of General Oncological Surgery.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Treatment (Carboplatin and Nab-paclitaxel) | Patients receive carboplatin IV over 30 minutes on day 1 and paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes once weekly. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. carboplatin: Given IV paclitaxel albumin-stabilized nanoparticle formulation: Given IV |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 9, 2020 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| paclitaxel albumin-stabilized nanoparticle formulation | Drug | Given IV |
|
|
| laboratory biomarker analysis | Other | Correlative studies |
|
| Up to 6 months. |
| Overall Survival | Estimated by the Kaplan-Meier method. Three-year point estimate and 95% confidence interval based on the Greenwood variance, with log-log transformation, will be provided. The corresponding median survival times (with 90% confidence limits) will be determined. Patients' survival times will be measured from the initial date of treatment to the recorded date of death, or most recent follow-up at the end-of-study date. | Up to three years post-commencement of chemotherapy. |
| Progression-free Survival | Estimated by the Kaplan-Meier method. Three-year point estimate and 95% confidence interval based on the Greenwood variance, with log-log transformation, will be provided. Patients' survival times will be measured from the initial date of treatment to the recorded date of progression or death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. | Up to three years. |
| South Pasadena |
| California |
| 91030 |
| United States |
| COMPLETED |
|
| NOT COMPLETED |
|
Eligibility criteria included: Locally advanced (T2 and higher with or without lymph node involvement), and/or inflammatory breast cancer; triple negative biology only. Tumor negative for expression of hormone receptors (IHC < 10%) and not overexpressing HER2 by IHC (O-1), or, in case of IHC of 2, negative by FISH or by alternative gene testing. Greater than 18 years of age, female. Adequate organ function as specified in the protocol.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Treatment (Carboplatin and Nab-paclitaxel) | Patients receive carboplatin IV over 30 minutes on day 1 and paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes once weekly. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. carboplatin: Given IV paclitaxel albumin-stabilized nanoparticle formulation: Given IV |
| 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 |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | 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 | pCR Rate After Treatment. | pCR is RCB 0 by Symmans criteria. The goal of the study is a detection of an increase in rate of pathological complete remission (pCR) from 20% (historical) to 38% | Sixty-seven patients met the eligibility criteria for inclusion in this study. | Posted | Count of Participants | Participants | At completion of definitive surgery, up to six months from initial treatment |
|
|
| ||||||||||||||||||||||||||||
| Primary | Residual Cancer Burden (RCB) by Symmans Criteria. | Categorization of the outcome of the treatment at completion of definitive surgery by Symmans criteria. "The index score is derived from the largest area and cellularity of residual invasive primary cancer and the number of involved lymph nodes and size of largest metastasis. pCR (stage yp-T0/is, ypN0) has RCB = 0; and RCB class is minimal (RCB-I), moderate (RCB-II), or extensive (RCB-III), on the basis of predefined cut points of 1.36 and 3.28 index scores.) Symmans WF, Wei C, Gould R, et al. J Clin Oncol 35:1049-1060, 2017. Symmans WF, Peintinger F, Hatzis C et al. J Clin Oncol 25:4414-4422, 2007. Order of scale is RCB0 is best, then I, II, III, worse; progressive is the worst. | Sixty-seven patients met the eligibility criteria for inclusion in this study. | Posted | Count of Participants | Participants | At completion of definitive surgery, up to six months post-commencement of study chemotherapy. |
|
| |||||||||||||||||||||||||||||
| Secondary | Adjuvant Radiation | After adjuvant chemotherapy and before surgery, some patients were given adjuvant radiation. | Sixty-seven patients met the eligibility criteria for inclusion in this study. | Posted | Count of Participants | Participants | Up to 6 months |
|
| |||||||||||||||||||||||||||||
| Secondary | Scope of Surgery | After having received adjuvant chemotherapy, and possibly radiation, patients underwent surgery. | Patients eligible for this study. | Posted | Count of Participants | Participants | Up to 6 months. |
|
| |||||||||||||||||||||||||||||
| Secondary | Overall Survival | Estimated by the Kaplan-Meier method. Three-year point estimate and 95% confidence interval based on the Greenwood variance, with log-log transformation, will be provided. The corresponding median survival times (with 90% confidence limits) will be determined. Patients' survival times will be measured from the initial date of treatment to the recorded date of death, or most recent follow-up at the end-of-study date. | Sixty-seven patients met the eligibility criteria for inclusion in this study. | Posted | Number | 95% Confidence Interval | percentage of surviving patients: 3-yr | Up to three years post-commencement of chemotherapy. |
|
| ||||||||||||||||||||||||||||
| Secondary | Progression-free Survival | Estimated by the Kaplan-Meier method. Three-year point estimate and 95% confidence interval based on the Greenwood variance, with log-log transformation, will be provided. Patients' survival times will be measured from the initial date of treatment to the recorded date of progression or death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. | Sixty-seven patients met the eligibility criteria for inclusion in this study. | Posted | Number | 95% Confidence Interval | percentage of pts | Up to three years. |
|
|
Serious and Other Adverse Events monitored through completion of treatment, up to 6 years, 7 months. All-Cause Mortality monitored up to 8 years.
All patients eligible for this study were graded for toxicities.
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 | Treatment (Carboplatin and Nab-paclitaxel) | Patients receive carboplatin IV over 30 minutes on day 1 and paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes once weekly. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. carboplatin: Given IV paclitaxel albumin-stabilized nanoparticle formulation: Given IV | 5 | 67 | 5 | 67 | 67 | 67 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| 10016288-Febrile neutropenia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10016558-Fever | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10046571-Urinary tract infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| 10012174-Dehydration | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10042613-Surgical and medical procedures - Other, specify | Surgical and medical procedures | CTCAE (4.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| 10002272-Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10016288-Febrile neutropenia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10007541-Cardiac disorders - Other, specify | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10019279-Heart failure | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10033557-Palpitations | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10040741-Sinus bradycardia | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10040752-Sinus tachycardia | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10061589-Aortic valve disease | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10014020-Ear pain | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10047340-Vertigo | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10065838-Middle ear inflammation | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10020705-Hyperparathyroidism | Endocrine disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10020850-Hyperthyroidism | Endocrine disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10005886-Blurred vision | Eye disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10010741-Conjunctivitis | Eye disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10013774-Dry eye | Eye disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10015919-Eye disorders - Other, specify | Eye disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10015958-Eye pain | Eye disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10016757-Flashing lights | Eye disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10016778-Floaters | Eye disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10047848-Watering eyes | Eye disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10000060-Abdominal distension | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10000081-Abdominal pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10005265-Bloating | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10010774-Constipation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10012727-Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10013781-Dry mouth | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10013946-Dyspepsia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10013950-Dysphagia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10016766-Flatulence | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10017947-Gastrointestinal disorders - Other, specify | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10018286-Gingival pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10028130-Mucositis oral | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10028813-Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10030980-Oral hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10031009-Oral pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10044055-Toothache | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10047700-Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10066874-Gastroesophageal reflux disease | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10008531-Chills | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10016256-Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10016558-Fever | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10017577-Gait disturbance | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10022095-Injection site reaction | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10033371-Pain | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10050068-Edema limbs | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10062466-Localized edema | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10062501-Non-cardiac chest pain | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10001718-Allergic reaction | Immune system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10002218-Anaphylaxis | Immune system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10007810-Catheter related infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| 10021881-Infections and infestations - Other, specify | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| 10040872-Skin infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| 10046300-Upper respiratory infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| 10046571-Urinary tract infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| 10055078-Bronchial infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| 10061304-Nail infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| 10062255-Soft tissue infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| 10065772-Vulval infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| 10069138-Papulopustular rash | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| 10006504-Bruising | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
| |
| 10016173-Fall | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
| |
| 10048031-Wound dehiscence | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
| |
| 10053692-Wound complication | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
| |
| 10061103-Dermatitis radiation | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
| |
| 10001551-Alanine aminotransferase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| 10001675-Alkaline phosphatase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| 10003481-Aspartate aminotransferase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| 10005364-Blood bilirubin increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| 10007839-CD4 lymphocytes decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| 10011368-Creatinine increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| 10025256-Lymphocyte count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| 10029366-Neutrophil count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| 10035528-Platelet count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| 10047896-Weight gain | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| 10047900-Weight loss | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| 10049182-White blood cell decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| 10050528-Ejection fraction decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| 10002646-Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10012174-Dehydration | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10020587-Hypercalcemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10020639-Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10020647-Hyperkalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10020670-Hypermagnesemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10020680-Hypernatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10020870-Hypertriglyceridemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10020943-Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10020949-Hypocalcemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10021005-Hypoglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10021018-Hypokalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10021028-Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10021038-Hyponatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10021059-Hypophosphatemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10029883-Obesity | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10003239-Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10003988-Back pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10006002-Bone pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10008496-Chest wall pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10016750-Flank pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10028411-Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10028836-Neck pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10031282-Osteoporosis | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10033425-Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10062572-Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10065776-Muscle weakness lower limb | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10029104-Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | Systematic Assessment |
| |
| 10045158-Tumor pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | Systematic Assessment |
| |
| 10013573-Dizziness | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10013911-Dysgeusia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10019211-Headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10027175-Memory impairment | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10029205-Nervous system disorders - Other, specify | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10029223-Neuralgia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10033987-Paresthesia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10034620-Peripheral sensory neuropathy | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10036653-Presyncope | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10044565-Tremor | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10002855-Anxiety | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10012378-Depression | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10022437-Insomnia | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10019450-Hematuria | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10037032-Proteinuria | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10046539-Urinary frequency | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10046543-Urinary incontinence | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10046555-Urinary retention | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10046593-Urinary urgency | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10046628-Urine discoloration | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10062225-Urinary tract pain | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10006298-Breast pain | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10022992-Irregular menstruation | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10036601-Premature menopause | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10046901-Vaginal discharge | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10046904-Vaginal dryness | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10046912-Vaginal hemorrhage | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10001723-Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10011224-Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10013963-Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10015090-Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10028735-Nasal congestion | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10036402-Postnasal drip | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10036790-Productive cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10041232-Sneezing | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10041367-Sore throat | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10047924-Wheezing | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10001760-Alopecia | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10013786-Dry skin | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10020642-Hyperhidrosis | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10028691-Nail discoloration | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10037087-Pruritus | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10037847-Rash acneiform | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10037868-Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10040785-Skin and subcutaneous tissue disorders - Other, specify | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10040865-Skin hyperpigmentation | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10062283-Nail ridging | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10027308-Menopause | Social circumstances | CTCAE (4.0) | Systematic Assessment |
| |
| 10041244-Social circumstances - Other, specify | Social circumstances | CTCAE (4.0) | Systematic Assessment |
| |
| 10016825-Flushing | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10019428-Hematoma | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10020407-Hot flashes | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10020772-Hypertension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10021097-Hypotension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| 10047065-Vascular disorders - Other, specify | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Yuan Yuan | City of Hope Medical Center | 626-359-8111 | Yuyuan@coh.org |
| Aug 23, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D058922 | Inflammatory Breast Neoplasms |
| D001943 | Breast Neoplasms |
| D064726 | Triple Negative 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 |
|---|---|
| D016190 | Carboplatin |
| D013660 | Taxes |
| D000068196 | Albumin-Bound Paclitaxel |
| C520255 | 130-nm albumin-bound paclitaxel |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D004467 | Economics |
| D004472 | Health Care Economics and Organizations |
| D017239 | Paclitaxel |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
Not provided
| Asian |
|
| African American |
|
| Other |
|
| Participants |
|
|
|
|
|
|