Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2017-01705 | Registry Identifier | NCI CTRP | |
| 2017-0547 | Other Identifier | UW IRB | |
| A534260 | Other Identifier | UW Madison | |
| SMPH\MEDICINE\HEM-ONC | Other Identifier | UW Madison | |
| Protocol Version 11/26/2019 | Other Identifier | UW Madison |
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This is a phase II single-arm, open-label, prospective study to evaluate the efficacy of the low dose weekly Carboplatin/Paclitaxel followed by dose-dense Doxorubicin/Cyclophosphamide in subjects with triple-negative breast cancer in neoadjuvant settings.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neoadjuvant Chemotherapy | Experimental | Regimen A (cycles 1-4): Paclitaxel 80 mg/m2; administer intravenously on day 1, 8, 15 of cycles 1, 2, 3, 4 (every 3 weeks) Carboplatin AUC=2 (dose calculation by determining creatine clearance with Cockroft Gault using adjusted body weight); administer intravenously on day 1, 8, 15 of cycles 1, 2, 3, 4 (every 3 weeks) Regimen B (cycles 5-8): Doxorubicin 60 mg/m2; administer intravenously on day 1 of cycles 5, 6, 7, 8 (every 2 weeks) Cyclophosphamide 600 mg/m2; administer intravenously on day 1 of cycles 5, 6, 7, 8 (every 2 weeks) Pegfilgrastim (for use on Doxorubicin/Cyclophosphamide cycles only), filgrastim, or biosimilar support on day 2 - 3 of cycles 5, 6, 7, 8 (every 2 weeks) There is a one week break between the end of cycle 4 and the beginning of cycle 5. Regimen C: Surgical intervention for management of breast cancer diagnosis; procedure and timing as determined by surgical team. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carboplatin | Drug | Carboplatin is a platinum compound alkylating agent which covalently binds to DNA; interferes with the function of DNA by producing interstrand DNA cross-links. |
| Measure | Description | Time Frame |
|---|---|---|
| Number and Percentage of Participants With Pathologic Complete Response (pCR) Rate | pCR is defined as the absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy. pCR will be assessed according to RECIST 1.1 criteria. The point estimate of the primary efficacy endpoint pCR and its exact 95% confidence intervals (CI) will be calculated. In evaluating pCR, subjects with missing data will be considered non-responders. | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Cycles of Chemotherapy Administered | To evaluate the number of cycles low dose weekly Carboplatin/Paclitaxel regimen administered. Simple descriptive statistics will be used to describe the number of cycles of chemotherapy administered. | Week 12 to week 18 to account for possible delays |
| Total Dose of Chemotherapy Administered |
Not provided
Inclusion Criteria:
Subjects must have histologically or cytologically confirmed invasive breast cancer which meets the following criteria:
Candidate for neoadjuvant chemotherapy.
Age > 18 years and < 75 years
ECOG Performance Status < 1.
Left ventricular ejection fraction (LVEF) ≥ LLN (per institutional normal) determined by
Adequate organ and marrow function as determined by study protocol
Non Pregnant. Women of childbearing potential must have a negative pregnancy test (HCG serum or urine) within 30 days prior to study registration and to be repeated if not done within 7 days of starting chemotherapy.
Female subjects must meet one of the following:
Male subjects, even if surgically sterilized (i.e., status post vasectomy) must agree to one of the following:
Ability to understand a written informed consent document, and the willingness to sign it.
Exclusion Criteria:
Not provided
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| Name | Affiliation | Role |
|---|---|---|
| Kari Wisinski, MD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Swedish American Hospital | Rockford | Illinois | 61104 | United States | ||
| University of Wisconsin Carbone Cancer Center |
Not provided
| Label | URL |
|---|---|
| UW Carbone Cancer Center home page | View source |
Not provided
29 participants were assigned, but only 28 participants started treatment
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Neoadjuvant Chemotherapy | Participants receive Paclitaxel and Carboplatin AUC=2 on days 1, 8, 15 of cycles 1, 2, 3, 4 (every 3 weeks). There is a one week break between the end of cycle 4 and the beginning of cycle 5. Participants receive Doxorubicin and Cyclophosphamide on day 1 of cycles 5, 6, 7, 8 (every 2 weeks). Participants also receive Pegfilgrastim, filgrastim, or biosimilar support on day 2 - 3 of cycles 5, 6, 7, 8 (every 2 weeks) Participants undergo surgical intervention for management of breast cancer diagnosis; procedure and timing as determined by surgical team. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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 | Nov 26, 2019 |
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| Paclitaxel | Drug | Paclitaxel promotes microtubule assembly by enhancing the action of tubulin dimers, stabilizing existing microtubules, and inhibiting their disassembly, interfering with the late G2 mitotic phase, and inhibiting cell replication. In addition, the drug can distort mitotic spindles, resulting in the breakage of chromosomes. Paclitaxel may also suppress cell proliferation and modulate immune response. |
|
| Doxorubicin | Drug | Inhibition of DNA and RNA synthesis by intercalation between DNA base pairs by inhibition of topoisomerase II and by steric obstruction. Doxorubicin intercalates at points of local uncoiling of the double helix. Although the exact mechanism is unclear, it appears that direct binding to DNA (intercalation) and inhibition of DNA repair (topoisomerase II inhibition) result in blockade of DNA and RNA synthesis and fragmentation of DNA. Doxorubicin is also a powerful iron chelator; the iron-doxorubicin complex can bind DNA and cell membranes and produce free radicals that immediately cleave the DNA and cell membranes. |
|
|
| Cyclophosphamide | Drug | Cyclophosphamide is an alkylating agent that prevents cell division by cross-linking DNA strands and decreasing DNA synthesis. It is a cell cycle phase nonspecific agent. Cyclophosphamide also possesses potent immunosuppressive activity. Cyclophosphamide is a prodrug that must be metabolized to active metabolites in the liver. |
|
|
| Pegfilgrastim | Drug | Pegfilgrastim provides growth factor support in a single dose. It stimulates bone marrow to create neutrophils for patients undergoing chemotherapy. |
|
| Filgrastim | Drug | Filgrastim provides growth factor support in multiple doses. It stimulates bone marrow to create neutrophils for patients undergoing chemotherapy. |
|
To evaluate the total dose of weekly Carboplatin/Paclitaxel regimen administered. Simple descriptive statistics will be used to describe the dose amount of chemotherapy administered. |
| Week 12 to week 18 to account for possible delays |
| Delays of Administered Chemotherapy | To evaluate the delays of low dose weekly Carboplatin/Paclitaxel regimen administered. Simple descriptive statistics will be used to describe the delays of chemotherapy administered. | Week 12 to week 18 to account for possible delays |
| Number of Treatment-related Toxicities Experienced by Participants | Count of any treatment-related toxicities from the low dose weekly Carboplatin/Paclitaxel regimen. Will be assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 | Up to week 12 |
| Recurrence-free Survival (RFS) | To evaluate two-year RFS after treatment with this neoadjuvant regimen. Count of participants without evidence for local-regional or distant relapse, second primary, or death will be reported. | Up to 2 years |
| Overall Survival (OS) | To evaluate the two-year overall survival after treatment with this neoadjuvant regimen. Count of participants who achieved 2 year OS is reported. | Up to 2 years |
| Madison |
| Wisconsin |
| 53792 |
| United States |
| Columbia St. Mary's Cancer Center | Milwaukee | Wisconsin | 53211 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| ProHealth Care | Waukesha | Wisconsin | 53188 | United States |
| Aspirus Regional Cancer Center Wausau | Wausau | Wisconsin | 54401 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
1 participant withdrew after being assigned but prior to treatment. Characteristics were collected for baseline hence 29 baseline participants being reported
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Neoadjuvant Chemotherapy | Paclitaxel (cycles 1-4): Doxorubicin, Cyclophosphamide, and Pegfilgrastim (cycles 5-8): Surgical intervention for management of breast cancer diagnosis; procedure and timing as determined by surgical team. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number and Percentage of Participants With Pathologic Complete Response (pCR) Rate | pCR is defined as the absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy. pCR will be assessed according to RECIST 1.1 criteria. The point estimate of the primary efficacy endpoint pCR and its exact 95% confidence intervals (CI) will be calculated. In evaluating pCR, subjects with missing data will be considered non-responders. | 4 participants did not reach the timepoint at which pCR was measured, therefore are not counted in the analysis | Posted | Count of Participants | Participants | Up to 2 years |
|
|
| ||||||||||||||||||||||||||
| Secondary | Number of Cycles of Chemotherapy Administered | To evaluate the number of cycles low dose weekly Carboplatin/Paclitaxel regimen administered. Simple descriptive statistics will be used to describe the number of cycles of chemotherapy administered. | Posted | Count of Participants | Participants | Week 12 to week 18 to account for possible delays |
|
| ||||||||||||||||||||||||||||
| Secondary | Total Dose of Chemotherapy Administered | To evaluate the total dose of weekly Carboplatin/Paclitaxel regimen administered. Simple descriptive statistics will be used to describe the dose amount of chemotherapy administered. | 2 participants were withdrawn from study prior to completing carbo-paclitaxel; thus, have not been included in this measure | Posted | Number | doses administered | Week 12 to week 18 to account for possible delays |
|
| |||||||||||||||||||||||||||
| Secondary | Delays of Administered Chemotherapy | To evaluate the delays of low dose weekly Carboplatin/Paclitaxel regimen administered. Simple descriptive statistics will be used to describe the delays of chemotherapy administered. | 2 participants were withdrawn from study prior to completing carbo-paclitaxel; thus, have not been included in this measure | Posted | Count of Participants | Participants | Week 12 to week 18 to account for possible delays |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Treatment-related Toxicities Experienced by Participants | Count of any treatment-related toxicities from the low dose weekly Carboplatin/Paclitaxel regimen. Will be assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 | Posted | Number | treatment related toxicities | Up to week 12 |
|
| ||||||||||||||||||||||||||||
| Secondary | Recurrence-free Survival (RFS) | To evaluate two-year RFS after treatment with this neoadjuvant regimen. Count of participants without evidence for local-regional or distant relapse, second primary, or death will be reported. | 4 participants did not reach the timepoint at which RFS was measured, therefore are not counted in the analysis | Posted | Count of Participants | Participants | Up to 2 years |
|
| |||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | To evaluate the two-year overall survival after treatment with this neoadjuvant regimen. Count of participants who achieved 2 year OS is reported. | 3 participants did not reach the timepoint at which OS was measured, therefore are not counted in the analysis | Posted | Count of Participants | Participants | Up to 2 years |
|
|
2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Neoadjuvant Chemotherapy | Regimen A (cycles 1-4): Paclitaxel 80 mg/m2; administer intravenously on day 1, 8, 15 of cycles 1, 2, 3, 4 (every 3 weeks) Carboplatin AUC=2 (dose calculation by determining creatine clearance with Cockroft Gault using adjusted body weight); administer intravenously on day 1, 8, 15 of cycles 1, 2, 3, 4 (every 3 weeks) Regimen B (cycles 5-8): Doxorubicin 60 mg/m2; administer intravenously on day 1 of cycles 5, 6, 7, 8 (every 2 weeks) Cyclophosphamide 600 mg/m2; administer intravenously on day 1 of cycles 5, 6, 7, 8 (every 2 weeks) Pegfilgrastim (for use on Doxorubicin/Cyclophosphamide cycles only), filgrastim, or biosimilar support on day 2 - 3 of cycles 5, 6, 7, 8 (every 2 weeks) There is a one week break between the end of cycle 4 and the beginning of cycle 5. Regimen C: Surgical intervention for management of breast cancer diagnosis; procedure and timing as determined by surgical team. | 3 | 28 | 17 | 28 | 10 | 10 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Atrial fibrilation | Cardiac disorders | Systematic Assessment |
| ||
| Sinus tachycardia | Cardiac disorders | Systematic Assessment |
| ||
| Supraventricular tachycardia | Cardiac disorders | Systematic Assessment |
| ||
| Adrenal insufficiency | Endocrine disorders | Systematic Assessment |
| ||
| Abdomincal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Mucositis oral | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Chills | General disorders | Systematic Assessment |
| ||
| Fatigue | General disorders | Systematic Assessment |
| ||
| Cholecystitis | Hepatobiliary disorders | Systematic Assessment |
| ||
| Infections and infestations - Other, specify | Infections and infestations | Systematic Assessment |
| ||
| Lung infection | Infections and infestations | Systematic Assessment |
| ||
| Otitis media | Infections and infestations | Systematic Assessment |
| ||
| Sepsis | Infections and infestations | Systematic Assessment |
| ||
| Sinusitis | Infections and infestations | Systematic Assessment |
| ||
| Vascular access complication | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Neutrophil count decreased | Investigations | Systematic Assessment |
| ||
| platelet count decreased | Investigations | Systematic Assessment |
| ||
| White blood cell decreased | Investigations | Systematic Assessment |
| ||
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Muscle weakness lower limb | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Peripheral motor neuropathy | Nervous system disorders | Systematic Assessment |
| ||
| Peripheral sensory neuropathy | Nervous system disorders | Systematic Assessment |
| ||
| Acute kidney injury | Renal and urinary disorders | Systematic Assessment |
| ||
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Thromboembolic event | Vascular disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Neutrophil count decreased | Investigations | Non-systematic Assessment |
| ||
| Platelet count decreased | Investigations | Non-systematic Assessment |
| ||
| White blood cell decreased | Investigations | Non-systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Dyspepsia | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Mucositis oral | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Dry mouth | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Bloating | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Enterocolitis | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Fecal incontinence | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Gastritis | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Dysgeusia | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Stomach pain | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Aspartate aminotransferase increased | Investigations | Non-systematic Assessment |
| ||
| Alanine aminotransferase increased | Investigations | Non-systematic Assessment |
| ||
| Lymphocyte count decreased | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Creatinine increased | Investigations | Non-systematic Assessment |
| ||
| Weight gain | Investigations | Non-systematic Assessment |
| ||
| Weight loss | Investigations | Non-systematic Assessment |
| ||
| Electrocardiogram QT corrected interval prolonged | Investigations | Non-systematic Assessment |
| ||
| INR increased | Investigations | Non-systematic Assessment |
| ||
| Fatigue | General disorders | Non-systematic Assessment |
| ||
| Fever | General disorders | Non-systematic Assessment |
| ||
| Chills | General disorders | Non-systematic Assessment |
| ||
| Edema limbs | General disorders | Non-systematic Assessment |
| ||
| Localized edema | General disorders | Non-systematic Assessment |
| ||
| Edema face | General disorders | Non-systematic Assessment |
| ||
| Non-cardiac chest pain | General disorders | Non-systematic Assessment |
| ||
| Generalized edema | General disorders | Non-systematic Assessment |
| ||
| Peripheral sensory neuropathy | Nervous system disorders | Non-systematic Assessment |
| ||
| Headache | Nervous system disorders | Non-systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Non-systematic Assessment |
| ||
| Paresthesia | Nervous system disorders | Non-systematic Assessment |
| ||
| Peripheral motor neuropathy | Nervous system disorders | Non-systematic Assessment |
| ||
| Hyperglycemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hypoalbuminemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hyponatremia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hypokalemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hypomagnesemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Anorexia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Dehydration | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hypercalcemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hypoglycemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Alopecia | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Nail discoloration | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Rash maculo-papular | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Dry skin | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Hyperhidrosis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Nail changes | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Nail loss | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Nail ridging | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Palmar-plantar erythrodysesthesia syndrome | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Skin and subcutaneous tissue disorders - Other, specify | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Arthralgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Pain in extremity | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Bone pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Myalgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Neck pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Musculoskeletal and connective tissue disorder - Other, specify | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Sore throat | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Postnasal drip | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Hoarseness | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Hypoxia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Hot flashes | Vascular disorders | Non-systematic Assessment |
| ||
| Hypotension | Vascular disorders | Non-systematic Assessment |
| ||
| Hypertension | Vascular disorders | Non-systematic Assessment |
| ||
| Thromboembolic event | Vascular disorders | Non-systematic Assessment |
| ||
| Hematoma | Vascular disorders | Non-systematic Assessment |
| ||
| Folliculitis | Infections and infestations | Non-systematic Assessment |
| ||
| Skin infection | Infections and infestations | Non-systematic Assessment |
| ||
| Urinary tract infection | Infections and infestations | Non-systematic Assessment |
| ||
| Lung infection | Infections and infestations | Non-systematic Assessment |
| ||
| Nail infection | Infections and infestations | Non-systematic Assessment |
| ||
| Thrush | Infections and infestations | Non-systematic Assessment |
| ||
| Conjunctivitis infective | Infections and infestations | Non-systematic Assessment |
| ||
| Enterocolitis infectious | Infections and infestations | Non-systematic Assessment |
| ||
| Eye infection | Infections and infestations | Non-systematic Assessment |
| ||
| Upper respiratory infection | Infections and infestations | Non-systematic Assessment |
| ||
| Blurred vision | Eye disorders | Non-systematic Assessment |
| ||
| Dry eye | Eye disorders | Non-systematic Assessment |
| ||
| Conjuntivitis infective | Eye disorders | Non-systematic Assessment |
| ||
| Sinus tachycardia | Cardiac disorders | Non-systematic Assessment |
| ||
| Supraventricular tachycardia | Cardiac disorders | Non-systematic Assessment |
| ||
| Dysuria | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Hemoglobinuria | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Urinary frequency | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Breast pain | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Menorrhagia | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Allergic reaction | Immune system disorders | Non-systematic Assessment |
| ||
| Bilirubin increased | Gastrointestinal disorders | Non-systematic Assessment |
|
Complete AE data was not collected; approximately 40% of participants are represented in the data reported in the Adverse Events section. Some enrolling sites have been chronically under- and un-staffed for 2+ years, and have not been able to address the coordinating center's numerous queries related to AE data.
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kari Wisinski, MD | University of Wisconsin Carbone Cancer Center | 608-262-2876 | kbwisinski@medicine.wisc.edu |
| Sep 19, 2022 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| 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 |
| D017239 | Paclitaxel |
| D004317 | Doxorubicin |
| C506643 | liposomal doxorubicin |
| D003520 | Cyclophosphamide |
| C455861 | pegfilgrastim |
| D000069585 | Filgrastim |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D016179 | Granulocyte Colony-Stimulating Factor |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
Not provided
Not provided
| Title | Measurements |
|---|
|
| 60-69 |
|
| 70-79 |
|
| 80-89 |
|
| Unknown |
|
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
| Participants |
|
|
| Participants |
|
|
|
|
|
|
|