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| ID | Type | Description | Link |
|---|---|---|---|
| TITAN |
Not provided
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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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This is a randomized, Phase III, open-label, multicenter study.
Patients will be randomized in a 1:1 ratio to receive one of two different treatment arms. Patients in treatment arm 1 will receive AC followed by ixabepilone. Patients in treatment arm 2 will receive AC followed by weekly paclitaxel.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Doxorubicin/cyclophosphamide, ixabepilone | Experimental | Doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 administered for 4 cycles of 21 days each, followed by ixabepilone at 40 mg/m2 given for 4 cycles of 21 days each. |
|
| Doxorubicin/cyclophosphamide, paclitaxel | Active Comparator | Doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 administered for 4 cycles of 21 days each, followed by paclitaxel at 80 mg/m2 weekly for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Doxorubicin | Drug | Doxorubicin 60 mg/m2 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free Survival | The percentage of participants with disease-free survival at 3 and 5 years. Disease-free survival (DFS) is measured from the time between randomization and the date of first documented disease recurrence, or death from any cause. | up to 5.25 years (63 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | The percentage of participants with overall survival at 3 and 5 years are presented. Overall survival (OS) defined as the time between randomization to date of death from any cause. | up to 5.25 years (63 months) |
Not provided
Inclusion Criteria:
Female patients greater than or equal to18 years of age.
Histologically confirmed invasive unilateral breast cancer (regardless of
histology).
Early-stage breast cancer, defined as:
Definitive loco-regional surgery must have been completed as specified
below:
Patients must have undergone either breast conservation surgery
(i.e., lumpectomy) or total mastectomy.
Surgical margins of the resected section must be histologically free of
invasive adenocarcinoma and ductal carcinoma in situ.
be considered as a positive margin; therefore, such patients will be eligible for this study without additional resection.
Sentinel node biopsy and/or either lymph node sampling procedure or axillary dissection.
Multicentric and multifocal invasive breast cancer is eligible if loco-regional surgery has been completed as described above.
Patients with synchronous bilateral cancers are eligible only if:
HER2 negative tumors. HER2 negativity must be confirmed by one of the
following:
Estrogen receptor negative (<10% staining by IHC for estrogen receptor).
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
Patient must be <= 84 days from having completed definitive primary breast surgery (either lumpectomy or mastectomy).
MammoSite brachytherapy radiation is acceptable if it is performed
immediately following surgery and prior to chemotherapy. It is recommended that chemotherapy be started no earlier than 2 weeks following the removal of the MammoSite balloon catheter.
Adequate hematologic function, defined by:
Adequate liver function, defined by:
elevation due to Gilbert's disease or a similar syndrome involving slow
conjugation of bilirubin).
Adequate renal function, defined by:
Complete staging work-up <=12 weeks prior to initiation of study treatment
with computed tomography (CT) scans of the chest and abdomen/pelvis (abdomen/pelvis preferred; abdomen accepted), and either a positron emission tomography (PET) scan or a bone scan.
Adequate cardiac function, defined by a left ventricular ejection fraction
(LVEF) value of >50% (or normal per institutional guidelines) by MUGA scan or echocardiogram (ECHO).
Adequate recovery from recent surgery. At least 1 week must have elapsed from the time of a minor surgery (i.e., sentinel node biopsy, port-acath (placement); at least 3 weeks must have elapsed from the time of a major surgery (i.e., lumpectomy, partial or total mastectomy, axillary lymph node dissection, breast reconstruction procedure).
Patients with previous history of invasive cancers (including breast cancer)
are eligible if definitive treatment was completed more than 5 years prior to
initiating current study treatment, and there is no evidence of recurrent disease.
Women of childbearing potential must have a negative serum or urine pregnancy test performed within 7 days prior to start of treatment. If a woman becomes pregnant or suspects she is pregnant while participating in this study, she must agree to inform her treating physician immediately.
Patient must be accessible for treatment and follow-up.
Women of childbearing potential must agree to use an acceptable method of birth control to avoid pregnancy for the duration of study treatment, and for 3 months thereafter.
All patients must be able to understand the investigational nature of the
study and give written informed consent prior to study entry.
Exclusion Criteria:
Women who are pregnant or breastfeeding.
History of previous diagnosis of invasive breast cancer (unless treated >5 years previously with no recurrence). History of previously treated ductal carcinoma in situ (DCIS) is acceptable.
Any evidence or suspicion of metastatic disease other than ipsilateral
axillary lymph nodes.
Any tumor >=T4 (cutaneous invasion, deep adherence, inflammatory breast cancer).
Previous anthracycline chemotherapy.
Concurrent use of CYP3A4 inhibitors from 72 hours prior to initiation of
study treatment until the end of treatment with ixabepilone.
Previous treatment for this breast cancer (including neoadjuvant
chemotherapy).
Previous cancer (with the exception of non-melanoma skin cancer or cervical carcinoma in situ) in the past 5 years (including invasive contralateral breast cancer).
Peripheral neuropathy of > grade 1 per NCI CTCAE v3.0.
Cardiac disease, including: congestive heart failure (CHF) > Class II per
New York Heart Association (NYHA) classification; unstable angina (anginal symptoms at rest) or new-onset angina (i.e., began within the last 3 months), or myocardial infarction within the past 6 months; symptomatic CHF, unstable angina pectoris, cardiac arrhythmia, or cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.
History of hypersensitivity to CremophorEL (polyoxyethylated castor oil) or
a drug formulated in CremophorEL such as paclitaxel.
Use of any investigational agent within 30 days of administration of the first dose of study drug.
Patients may not receive any other investigational or anti-cancer treatments while participating in this study.
Concurrent severe, uncontrolled infection or intercurrent illness including,
but not limited to, ongoing or active infection, or psychiatric illness/social
situations that would limit compliance with study requirements.
Mental condition that would prevent patient comprehension of the nature of, and risk associated with, the study.
Inability to comply with study and/or follow-up procedures.
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| Name | Affiliation | Role |
|---|---|---|
| Denise A Yardley, M.D. | SCRI Development Innovations, LLC | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northeast Alabama Regional Medical Center | Anniston | Alabama | 36207 | United States | ||
| Cancer Center of Huntsville |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28508185 | Background | Yardley DA, Arrowsmith ER, Daniel BR, Eakle J, Brufsky A, Drosick DR, Kudrik F, Bosserman LD, Keaton MR, Goble SA, Bubis JA, Priego VM, Pendergrass K, Manalo Y, Bury M, Gravenor DS, Rodriguez GI, Inhorn RC, Young RR, Harwin WN, Silver C, Hainsworth JD, Burris HA 3rd. TITAN: phase III study of doxorubicin/cyclophosphamide followed by ixabepilone or paclitaxel in early-stage triple-negative breast cancer. Breast Cancer Res Treat. 2017 Aug;164(3):649-658. doi: 10.1007/s10549-017-4285-6. Epub 2017 May 15. |
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Subjects were randomized in a 1:1 ratio to either of 2 arms: 306 to AC/Ixabepilone (Ixa); 308 to AC/paclitaxel (Pac). 489 patients completed all planned treatment with AC/Ixa or AC/Pac.
The trial was designed to evaluate if doxorubicin+cyclophosphamide (AC) followed by ixabepilone was more effective than AC followed by standard weekly paclitaxel as adjuvant treatment for patients with operable triple negative breast cancer (TNBC). Between Dec 2008 and Jan 2011, 614 women with early-stage TNBC were enrolled from 63 U.S. sites.
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| ID | Title | Description |
|---|---|---|
| FG000 | AC/Ixabepilone | Doxorubicin+cyclophosphamide (AC) every 3 weeks for 4 cycles (12 weeks), followed by ixabepilone every 3 weeks for 4 cycles (12 weeks). Doxorubicin: 60 mg/m2 Cyclophosphamide: 600 mg/m2 Ixabepilone (Ixempra): 40 mg/m2 |
| FG001 | AC/Paclitaxel |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| AC Therapy |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Cyclophosphamide | Drug | Cyclophosphamide 600 mg/m2 |
|
|
| Ixabepilone (Ixempra) | Drug | Ixabepilone 40 mg/m2 |
|
|
| Paclitaxel (Taxol) | Drug | Paclitaxel 80 mg/m2 |
|
|
| Huntsville |
| Alabama |
| 35801 |
| United States |
| Clearview Cancer Institute | Huntsville | Alabama | 35805 | United States |
| University of Southern Alabama | Mobile | Alabama | 36604 | United States |
| Northeast Arkansas Clinic | Jonesboro | Arkansas | 72401 | United States |
| Wilshire Oncology Medical Group | La Verne | California | 91750 | United States |
| New Hope Cancer and Research Institute | Pomona | California | 91767 | United States |
| Eastern Connecticut Hematology Oncology | Norwich | Connecticut | 06360 | United States |
| Aventura Medical Center | Aventura | Florida | 33180 | United States |
| Lynn Cancer Institute | Boca Raton | Florida | 33428 | United States |
| Florida Cancer Care | Davie | Florida | 33328 | United States |
| Holy Cross Hospital | Fort Lauderdale | Florida | 33308 | United States |
| Florida Cancer Specialists | Fort Myers | Florida | 33901 | United States |
| Memorial Regional Cancer Center | Hollywood | Florida | 33021 | United States |
| Integrated Community Oncology Network | Jacksonville | Florida | 32256 | United States |
| Watson Clinic Center for Cancer Care and Research | Lakeland | Florida | 33805 | United States |
| Space Coast Medical Associates | Titusville | Florida | 32796 | United States |
| Piedmont Healthcare | Atlanta | Georgia | 30309 | United States |
| Emory/Winship Cancer Institute | Atlanta | Georgia | 30322 | United States |
| Augusta Oncology Associates | Augusta | Georgia | 30901 | United States |
| Medical Oncology Associates of Augusta | Augusta | Georgia | 30901 | United States |
| Medical College of Georgia Cancer Specialists | Augusta | Georgia | 30912 | United States |
| Northeast Georgia Medical Center | Gainesville | Georgia | 30501 | United States |
| Suburban Hem Onc | Lawrenceville | Georgia | 30045 | United States |
| Mid-Illinois Hematology & Oncology | Normal | Illinois | 61761 | United States |
| Hematology Oncology of the North Shore | Skokie | Illinois | 60076 | United States |
| Oncology Hematology Associates of SW Indiana | Evansville | Indiana | 47714 | United States |
| Hematology Oncology of Indiana | Indianapolis | Indiana | 46260 | United States |
| Providence Medical Group | Terre Haute | Indiana | 47802 | United States |
| Kansas City Cancer Centers | Overland Park | Kansas | 66210 | United States |
| Cotton O'Neil Cancer Center | Topeka | Kansas | 66606 | United States |
| Consultants in Blood Disorders and Cancer | Louisville | Kentucky | 40207 | United States |
| Baton Rouge General Medical Center | Baton Rouge | Louisiana | 70806 | United States |
| Mercy Hospital | Portland | Maine | 04101 | United States |
| Weinberg Cancer Institute at Franklin Square | Baltimore | Maryland | 21237 | United States |
| Center for Cancer and Blood Disorders | Bethesda | Maryland | 20817 | United States |
| Fallon Clinic | Worcester | Massachusetts | 01608 | United States |
| Grand Rapids Clinical Oncology Program | Grand Rapids | Michigan | 49503 | United States |
| Fairview Medical Oncology Clinic | Edina | Minnesota | 55436 | United States |
| St. Louis Cancer Care | Chesterfield | Missouri | 63017 | United States |
| Research Medical Center | Kansas City | Missouri | 64132 | United States |
| St. John's Clinic | Springfield | Missouri | 65804 | United States |
| Methodist Cancer Center | Omaha | Nebraska | 68114 | United States |
| St. Clare's Hospital Oncology and Hematology | Denville | New Jersey | 07834 | United States |
| Hematology Oncology Associates of Northern NJ | Morristown | New Jersey | 07960 | United States |
| Southern Oncology and Hematology | Vineland | New Jersey | 08360 | United States |
| New Mexico Oncology Hematology Consultants | Albuquerque | New Mexico | 87109 | United States |
| Alamance Regional Medical Center | Burlington | North Carolina | 27215 | United States |
| Oncology Hematology Care | Cincinnati | Ohio | 45242 | United States |
| Mid Ohio Oncology/Hematology, Inc./ The Mark H. Zangmeister Center | Columbus | Ohio | 43219 | United States |
| Hematology/Oncology Inc | Elyria | Ohio | 44035 | United States |
| Hickman Cancer Center (Flower Hospital) | Sylvania | Ohio | 43560 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| Bux-Mont Oncology, Fox Chase Cancer Center | Rockledge | Pennsylvania | 18960 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| South Carolina Oncology Associates, PA | Columbia | South Carolina | 29210 | United States |
| Lowcountry Hematology Oncology | Mt. Pleasant | South Carolina | 29464 | United States |
| Coastal Cancer Center | Myrtle Beach | South Carolina | 29572 | United States |
| Spartanburg Regional Medical Center | Spartanburg | South Carolina | 29303 | United States |
| Associates in Hematology Oncology | Chattanooga | Tennessee | 37404 | United States |
| Chattanooga Oncology Hematology Associates | Chattanooga | Tennessee | 37404 | United States |
| Family Cancer Center | Collierville | Tennessee | 38017 | United States |
| Tennessee Oncology, PLLC | Nashville | Tennessee | 37023 | United States |
| Coastal Bend Cancer Center | Corpus Christi | Texas | 78463 | United States |
| Center for Cancer and Blood Disorders | Fort Worth | Texas | 76104 | United States |
| Medical Oncology Methodist Hospital | Houston | Texas | 77030 | United States |
| South Texas Oncology and Hematology | San Antonio | Texas | 78258 | United States |
| Peninsula Cancer Institute | Newport News | Virginia | 23601 | United States |
| Virginia Cancer Institute | Richmond | Virginia | 23235 | United States |
| San Juan Hospital | San Juan | Puerto Rico |
Doxorubicin+cyclophosphamide (AC) every 3 weeks for 4 cycles (12 weeks), followed by weekly paclitaxel for 12 weeks. Doxorubicin: 60 mg/m2 Cyclophosphamide: 600 mg/m2 Paclitaxel (Taxol): 80 mg/m2 |
|
| COMPLETED | 5 patients were randomized but never treated. |
|
| NOT COMPLETED |
|
|
| Adjuvant Therapy |
|
|
Analyses of baseline characteristics, demographics and efficacy includes all randomized patients.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Ixabepilone | Doxorubicin and cyclophosphamide (AC) given every 3 weeks for 4 cycles, followed by ixabepilone every 3 weeks for 4 cycles. Doxorubicin: 60 mg/m2 Cyclophosphamide: 600 mg/m2 Ixabepilone (Ixempra): 40 mg/m2 |
| BG001 | Paclitaxel | Doxorubicin and cyclophosphamide (AC) given every 3 weeks for 4 cycles, followed by paclitaxel weekly for 12 weeks. Doxorubicin: 60 mg/m2 Cyclophosphamide: 600 mg/m2 Paclitaxel (Taxol): 80 mg/m2 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||
| Menopausal Status | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Disease-free Survival | The percentage of participants with disease-free survival at 3 and 5 years. Disease-free survival (DFS) is measured from the time between randomization and the date of first documented disease recurrence, or death from any cause. | The intent-to-treat population (all randomized patients) are included in the analysis. | Posted | Number | 95% Confidence Interval | percentage of participants | up to 5.25 years (63 months) |
|
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival | The percentage of participants with overall survival at 3 and 5 years are presented. Overall survival (OS) defined as the time between randomization to date of death from any cause. | The intent-to-treat population (all randomized patients) are included in the analysis. | Posted | Number | 95% Confidence Interval | percentage of participants | up to 5.25 years (63 months) |
|
|
Every 3 weeks up to 28 weeks
Adverse events (AEs) were collected for all patients who received at least 1 dose of treatment - from date of first treatment through the 30-day end of treatment period. All patients had at least one AE.
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 | Ixabepilone | Doxorubicin and cyclophosphamide (AC) given every 3 weeks for 4 cycles, followed by ixabepilone every 3 weeks for 4 cycles. Doxorubicin: 60 mg/m2 Cyclophosphamide: 600 mg/m2 Ixabepilone (Ixempra): 40 mg/m2 | 58 | 305 | 305 | 305 | ||
| EG001 | Paclitaxel | Doxorubicin and cyclophosphamide (AC) given every 3 weeks for 4 cycles, followed by paclitaxel given weekly for 12 weeks. Doxorubicin: 60 mg/m2 Cyclophosphamide: 600 mg/m2 Paclitaxel (Taxol): 80 mg/m2 | 50 | 304 | 304 | 304 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| INFECTION | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| SEPSIS | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| ANAEMIA | Blood and lymphatic system disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| CELLULITIS | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| CHEST PAIN | General disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| NEUTROPHIL COUNT | Investigations | MedDRA (12.0) | Non-systematic Assessment |
| |
| PAIN | General disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| SYNCOPE | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| AORTIC STENOSIS | Vascular disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| BONE PAIN | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| BREAST PAIN | Reproductive system and breast disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| CEREBROVASCULAR ACCIDENT | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| CHEST WALL ABSCESS | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| CLOSTRIDIUM DIFFICILE COLITIS | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| COLITIS | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| DEVICE RELATED INFECTION | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| DIASTOLIC DYSFUNCTION | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| ENDOMETRIAL CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Non-systematic Assessment |
| |
| EROSIVE OESOPHAGITIS | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| FANCONI SYNDROME | Congenital, familial and genetic disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| FEMUR FRACTURE | Injury, poisoning and procedural complications | MedDRA (12.0) | Non-systematic Assessment |
| |
| GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| HYPOTENSION | Vascular disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| NEUTROPENIC INFECTION | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| OSTEONECROSIS | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| OTITIS MEDIA | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| PANCREATITIS | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| PANCREATITIS ACUTE | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| PANCYTOPENIA | Blood and lymphatic system disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| PERICARDIAL EFFUSION | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| PERIPHERAL MOTOR NEUROPATHY | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| PNEUMONITIS | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| RENAL FAILURE | Renal and urinary disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| RENAL FAILURE ACUTE | Renal and urinary disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| SALPINGO-OOPHORECTOMY BILATERAL | Surgical and medical procedures | MedDRA (12.0) | Non-systematic Assessment |
| |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| VIRAL INFECTION | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| WOUND INFECTION | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| ABSCESS LIMB | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| ACUTE RESPIRATORY DISTRESS SYNDROME | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| ACUTE RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| ANGINA PECTORIS | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| BREAST CELLULITIS | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| CARDIOMYOPATHY | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| CATHETER SEPSIS | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| CATHETER THROMBOSIS | General disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| CENTRAL LINE INFECTION | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| CHOLECYSTITIS | Hepatobiliary disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| COMPRESSION FRACTURE | Injury, poisoning and procedural complications | MedDRA (12.0) | Non-systematic Assessment |
| |
| DISSEMINATED INTRAVASCULAR COAGULATION | Blood and lymphatic system disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| HAEMOGLOBIN | Investigations | MedDRA (12.0) | Non-systematic Assessment |
| |
| HYPERSENSITIVITY | Immune system disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| HYPOPHOSPHATAEMIA | Metabolism and nutrition disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| LEFT VENTRICULAR DYSFUNCTION | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| LUNG INFILTRATION | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| PELVIC FRACTURE | Injury, poisoning and procedural complications | MedDRA (12.0) | Non-systematic Assessment |
| |
| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| THROMBOSIS | Vascular disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| TRANSIENT ISCHAEMIC ATTACK | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| UPPER LIMB FRACTURE | Injury, poisoning and procedural complications | MedDRA (12.0) | Non-systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| URETERIC OBSTRUCTION | Renal and urinary disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| VIRAL UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| SUICIDAL IDEATION | Psychiatric disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment | All participants who had at least one dose of study drug. |
|
| Constipation | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment | All participants who had at least one dose of study drug. |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment | All participants who had at least one dose of study drug. |
|
| Vomiting | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment | All participants who had at least one dose of study drug. |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment | All participants who had at least one dose of study drug. |
|
| Stomatitis | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment | All participants who had at least one dose of study drug. |
|
| Gastroesophageal reflux | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment | All participants who had at least one dose of study drug. |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment | All participants who had at least one dose of study drug. |
|
| Fatigue | General disorders | MedDRA (12.0) | Non-systematic Assessment | All participants who had at least one dose of study drug. |
|
| Mucosal Inflammation | General disorders | MedDRA (12.0) | Non-systematic Assessment | All participants who had at least one dose of study drug. |
|
| Pyrexia | General disorders | MedDRA (12.0) | Non-systematic Assessment | All participants who had at least one dose of study drug. |
|
| Oedema Peripheral | General disorders | MedDRA (12.0) | Non-systematic Assessment | All participants who had at least one dose of study drug. |
|
| Pain | General disorders | MedDRA (12.0) | Non-systematic Assessment | All participants who had at least one dose of study drug. |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Non-systematic Assessment | All participants who had at least one dose of study drug. |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Non-systematic Assessment | All participants who had at least one dose of study drug. |
|
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Non-systematic Assessment | All participants who had at least one dose of study drug. |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Non-systematic Assessment | All participants who had at least one dose of study drug. |
|
| Pruritis | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Non-systematic Assessment | All participants who had at least one dose of study drug. |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment | All participants who had at least one dose of study drug. |
|
| Headache | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment | All participants who had at least one dose of study drug. |
|
| Dysgeusia | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment | All participants who had at least one dose of study drug. |
|
| Peripheral Sensory neuropathy | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment | All participants who had at least one dose of study drug. |
|
| Dizziness | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment | All participants who had at least one dose of study drug. |
|
| Paraesthesia | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment | All participants who had at least one dose of study drug. |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment | All participants who had at least one dose of study drug. |
|
| Bone Pain | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment | All participants who had at least one dose of study drug. |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment | All participants who had at least one dose of study drug. |
|
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment | All participants who had at least one dose of study drug. |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment | All participants who had at least one dose of study drug. |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment | All participants who had at least one dose of study drug. |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment | All participants who had at least one dose of study drug. |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (12.0) | Non-systematic Assessment | All participants who had at least one dose of study drug. |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA (12.0) | Non-systematic Assessment | All participants who had at least one dose of study drug. |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA (12.0) | Non-systematic Assessment | All participants who had at least one dose of study drug. |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (12.0) | Non-systematic Assessment | All participants who had at least one dose of study drug. |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment | All participants who had at least one dose of study drug. |
|
| Urinary tract infection | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment | All participants who had at least one dose of study drug. |
|
| Sinusitis | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment | All participants who had at least one dose of study drug. |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment | All participants who had at least one dose of study drug. |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment | All participants who had at least one dose of study drug. |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment | All participants who had at least one dose of study drug. |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA (12.0) | Non-systematic Assessment | All participants who had at least one dose of study drug. |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (12.0) | Non-systematic Assessment | All participants who had at least one dose of study drug. |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (12.0) | Non-systematic Assessment | All participants who had at least one dose of study drug. |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (12.0) | Non-systematic Assessment | All participants who had at least one dose of study drug. |
|
| Appetite decreased | Metabolism and nutrition disorders | MedDRA (12.0) | Non-systematic Assessment | All participants who had at least one dose of study drug. |
|
| Insomnia | Psychiatric disorders | MedDRA (12.0) | Non-systematic Assessment | All participants who had at least one dose of study drug. |
|
| Anxiety | Psychiatric disorders | MedDRA (12.0) | Non-systematic Assessment | All participants who had at least one dose of study drug. |
|
| Depression | Psychiatric disorders | MedDRA (12.0) | Non-systematic Assessment | All participants who had at least one dose of study drug. |
|
| hot flush | Vascular disorders | MedDRA (12.0) | Non-systematic Assessment | All participants who had at least one dose of study drug. |
|
| Lacrimation increased | Eye disorders | MedDRA (12.0) | Non-systematic Assessment | All participants who had at least one dose of study drug. |
|
| weight decreased | Investigations | MedDRA (12.0) | Non-systematic Assessment | All participants who had at least one dose of study drug. |
|
| Neutrophil count | Investigations | MedDRA (12.0) | Non-systematic Assessment | All participants who had at least one dose of study drug. |
|
The sponsor can review/embargo results communications prior to public release for a period that is >60 days but ≤180 days from date submitted to sponsor, who may require changes to the communication in order to remove specifically identified confidential information (other than study data) and/or delay the proposed publication to enable the sponsor to seek patent protection for inventions. The PI may not publish its results until 18 mos. after the trial has been completed at all sites.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Charles H. Davis, RAC | Sarah Cannon Development Innovations | 615 524-4341 | charles.davis2@scri-innovations.com |
| 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 |
|---|---|
| D004317 | Doxorubicin |
| D003520 | Cyclophosphamide |
| C430592 | ixabepilone |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| 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 |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D004224 | Diterpenes |
| D013729 | Terpenes |
Not provided
Not provided
| Withdrawal by Subject |
|
| Disease recurrence |
|
| Intercurrent Illness |
|
| Protocol Violation |
|
| Other |
|
| Title | Measurements |
|---|---|
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Postmenopausal |
|
|