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Docetaxel or Paclitaxel in Reducing Chemotherapy-Induced Peripheral Neuropathy in African American Patients With Stage I-III Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04001829
Recruitment Status : Recruiting
First Posted : June 28, 2019
Last Update Posted : July 29, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group )

Brief Summary:
This phase II trial studies how well docetaxel or paclitaxel work in reducing chemotherapy-induced peripheral neuropathy in African American patients with stages I-III breast cancer. Drugs used in chemotherapy, such as docetaxel and 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. It is not yet known whether giving docetaxel or paclitaxel may work better than other methods in reducing chemotherapy-induced peripheral neuropathy in patients with breast cancer.

Condition or disease Intervention/treatment Phase
Anatomic Stage I Breast Cancer AJCC v8 Anatomic Stage IA Breast Cancer AJCC v8 Anatomic Stage IB Breast Cancer AJCC v8 Anatomic Stage II Breast Cancer AJCC v8 Anatomic Stage IIA Breast Cancer AJCC v8 Anatomic Stage IIB Breast Cancer AJCC v8 Anatomic Stage III Breast Cancer AJCC v8 Anatomic Stage IIIA Breast Cancer AJCC v8 Anatomic Stage IIIB Breast Cancer AJCC v8 Anatomic Stage IIIC Breast Cancer AJCC v8 Invasive Breast Carcinoma Prognostic Stage I Breast Cancer AJCC v8 Prognostic Stage IA Breast Cancer AJCC v8 Prognostic Stage IB Breast Cancer AJCC v8 Prognostic Stage II Breast Cancer AJCC v8 Prognostic Stage IIA Breast Cancer AJCC v8 Prognostic Stage IIB Breast Cancer AJCC v8 Prognostic Stage III Breast Cancer AJCC v8 Prognostic Stage IIIA Breast Cancer AJCC v8 Prognostic Stage IIIB Breast Cancer AJCC v8 Prognostic Stage IIIC Breast Cancer AJCC v8 Drug: Docetaxel Drug: Paclitaxel Other: Quality-of-Life Assessment Other: Questionnaire Administration Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Prospective Validation Trial of Taxane Therapy (Docetaxel or Weekly Paclitaxel) and Risk of Chemotherapy-Induced Peripheral Neuropathy in African American Women
Actual Study Start Date : June 27, 2019
Estimated Primary Completion Date : June 1, 2023
Estimated Study Completion Date : June 1, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm A (paclitaxel)
Patients receive paclitaxel IV over 3 hours once weekly. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients may also receive trastuzumab and/or pertuzumab per institution routine care per treating physician's discretion.
Drug: Paclitaxel
Given IV
Other Names:
  • Anzatax
  • Asotax
  • Bristaxol
  • Praxel
  • Taxol
  • Taxol Konzentrat

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Experimental: Arm B (docetaxel)
Patients receive docetaxel IV over 1 hour once every 3 weeks. Treatment repeats every 21 days for 4-6 cycles in the absence of disease progression or unacceptable toxicity. Patients may also receive cyclophosphamide, doxorubicin, trastuzumab, and/or pertuzumab per institution routine care per treating physician's discretion.
Drug: Docetaxel
Given IV
Other Names:
  • Docecad
  • RP56976
  • Taxotere
  • Taxotere Injection Concentrate

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies




Primary Outcome Measures :
  1. Validation of a prior germline predictor of paclitaxel-induced peripheral neuropathy (Arm A) [ Time Frame: Baseline ]
    Patients will be coded as having the event as long as grade 2-4 neuropathy based on Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 occurred at any time during the observation period. Patients without neuropathy or with maximum of grade 1 neuropathy during the whole observation period will be coded as having no event.


Secondary Outcome Measures :
  1. Grade 2-4 taxane-induced peripheral neuropathy (TIPN) [ Time Frame: Up to 3 years post-registration ]
    Will be based on CTCAE between both Arm A versus (vs.) Arm.

  2. Patient-related outcome (PRO)-based neurotoxicity [ Time Frame: Up to 3 years post-registration ]
    Will be assessed using the Functional Assessment of Cancer Therapy (FACT)/Gynecologic Oncology Group (GOG)-Neurotoxicity (NTX) questionnaire. The FACT/GOG-Ntx neurotoxicity total score will be analyzed as a continuous variable. Linear mixed effect models with random intercept (repeated measures within single patients with unstructured covariance matrices) will be fit to estimate the average difference in FACT/GOG-Ntx neurotoxicity total score between high versus (vs.) low risk genotype groups in the paclitaxel arm. Time and patient and disease characteristics will be included as covariates in the linear mixed effect model. Genotype group-by-time interaction will be tested to see whether the difference between the two genotype groups depends on time. For comparison between arm A and arm B, the FACT/GOG-Ntx neurotoxicity total score change between the baseline and at end of treatment will be compared using two sample t test.

  3. Health-related quality of life (HRQoL) between both arms [ Time Frame: Up to 3 years post-registration ]
    The HRQoL total score will be analyzed as a continuous variable and compared between low and high-risk genotypes groups of the paclitaxel arm, and between the paclitaxel arm and the docetaxel arm groups, using two-sample t tests. Multivariable linear mixed effect models will also be fit to evaluate the time trend of HRQoL and to estimate the average group difference in HRQoL after adjusting for other covariates. Group-by-time interaction will be tested to see whether the difference in HRQoL between groups depends on time.

  4. Physical function between both arms [ Time Frame: Up to 3 years post-registration ]
    Will be measured using the (PROMIS) Physical Function version (v)2.0 Short From 10a. The PROMIS Physical Function T score will be analyzed as a continuous variable, and it will be compared between the two treatment arms (A&B) and for the high risk vs. low risk genotypes (in arm A) using two-sample t tests

  5. Financial toxicity between both arms [ Time Frame: Up to 6 months post-registration ]
    Will be assessed using the Comprehensive Score for Financial Toxicity (COST) scores and compared using a two-sample t tests.

  6. PRO-CTCAE scores of numbness, tingling, and general pain between both arms [ Time Frame: Up to 3 years post-registration ]
    Will present PRO-CTCAE scores for each attribute (frequency, severity and/or interference) separately and compare PRO-CTCAE severity (coded 0-4) with CTCAE grades for the corresponding time period.


Other Outcome Measures:
  1. Association between Social economic determinants of health and treatment completion [ Time Frame: Baseline ]
    Social determinants of health (zip code, marital status, education, income & insurance status) will be associated with treatment completion per protocol

  2. Social economic determinants of health and FACT-Ntx neurotoxicity scores [ Time Frame: Baseline ]
    Social determinants of health (zip code, marital status, education, income & insurance status) will be associated with FACT-Ntx neurotoxicity scores

  3. Association between social determinants of health and FACT-Ntx HRQoL scores [ Time Frame: Baseline ]
    Social determinants of health (zip code, marital status, education, income & insurance status) will be associated with FACT-Ntx HRQoL scores



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must be women with a known stage I-III invasive breast cancer diagnosis. Registration must occur within 84 days from the date of diagnosis
  • Patients must be capable and willing to provide informed consent
  • Patients must have plans to receive either neoadjuvant or adjuvant:

    • Every 3-week docetaxel x 4-6 cycles OR
    • Weekly paclitaxel x 4 cycles
    • NOTE: Recommended therapies for various therapy regimens are outlined based on estrogen receptor (ER)/progesterone receptor (PR)/HER2 and nodal status. Where there are options, the treating physician will choose a regimen best fitted for that patient. If the physician does not feel any of the regimens are the best fit for the patient, the patient should not be enrolled. Physicians will also document why a regimen was felt to be inappropriate when an option
  • Patients must self-identify their race as black, African American, or of African descent; patients may be of any ethnicity
  • Patients must not have received prior taxane or prior/concurrent platinum therapy
  • Patients with a history of other cancers are eligible if they have not received prior taxane or platinum or vinca alkaloid therapy
  • Patients must not have pre-existing peripheral neuropathy
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Patients must not have a total bilirubin > upper limit of normal (ULN)
  • Patients must not have aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) above 1.5 times the ULN concomitant with alkaline phosphatase above 2.5 times the ULN
  • Patients must not be pregnant or lactating

    • All females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy
    • A female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy, or 3) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
  • Women of childbearing potential must be strongly advised to use an accepted and effective method of contraception or to abstain from sexual intercourse for the duration of their participation in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04001829


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Locations
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United States, Alaska
Anchorage Associates in Radiation Medicine Recruiting
Anchorage, Alaska, United States, 98508
Contact: Site Public Contact    907-212-6871    AKPAMC.OncologyResearchSupport@providence.org   
Principal Investigator: Alison K. Conlin         
Anchorage Radiation Therapy Center Recruiting
Anchorage, Alaska, United States, 99504
Contact: Site Public Contact    907-212-6871    AKPAMC.OncologyResearchSupport@providence.org   
Principal Investigator: Alison K. Conlin         
Alaska Breast Care and Surgery LLC Recruiting
Anchorage, Alaska, United States, 99508
Contact: Site Public Contact    907-212-6871    AKPAMC.OncologyResearchSupport@providence.org   
Principal Investigator: Alison K. Conlin         
Alaska Oncology and Hematology LLC Recruiting
Anchorage, Alaska, United States, 99508
Contact: Site Public Contact    907-212-6871    AKPAMC.OncologyResearchSupport@providence.org   
Principal Investigator: Alison K. Conlin         
Alaska Women's Cancer Care Recruiting
Anchorage, Alaska, United States, 99508
Contact: Site Public Contact    907-212-6871    AKPAMC.OncologyResearchSupport@providence.org   
Principal Investigator: Alison K. Conlin         
Anchorage Oncology Centre Recruiting
Anchorage, Alaska, United States, 99508
Contact: Site Public Contact    907-212-6871    AKPAMC.OncologyResearchSupport@providence.org   
Principal Investigator: Alison K. Conlin         
Katmai Oncology Group Recruiting
Anchorage, Alaska, United States, 99508
Contact: Site Public Contact    907-212-6871    AKPAMC.OncologyResearchSupport@providence.org   
Principal Investigator: Alison K. Conlin         
Providence Alaska Medical Center Recruiting
Anchorage, Alaska, United States, 99508
Contact: Site Public Contact    907-212-6871    AKPAMC.OncologyResearchSupport@providence.org   
Principal Investigator: Alison K. Conlin         
United States, California
Providence Saint Joseph Medical Center/Disney Family Cancer Center Recruiting
Burbank, California, United States, 91505
Contact: Site Public Contact    818-847-4793    Najee.Boucher@providence.org   
Principal Investigator: Alison K. Conlin         
United States, Idaho
Saint Luke's Mountain States Tumor Institute Recruiting
Boise, Idaho, United States, 83712
Contact: Site Public Contact    208-381-2774    eslinget@slhs.org   
Principal Investigator: Alison K. Conlin         
Saint Luke's Mountain States Tumor Institute - Fruitland Recruiting
Fruitland, Idaho, United States, 83619
Contact: Site Public Contact    208-381-8059    hallsc@slhs.org   
Principal Investigator: Alison K. Conlin         
Saint Luke's Mountain States Tumor Institute - Meridian Recruiting
Meridian, Idaho, United States, 83642
Contact: Site Public Contact    208-381-8059    hallsc@slhs.org   
Principal Investigator: Alison K. Conlin         
Saint Luke's Mountain States Tumor Institute - Nampa Recruiting
Nampa, Idaho, United States, 83686
Contact: Site Public Contact    208-381-8059    hallsc@slhs.org   
Principal Investigator: Alison K. Conlin         
Saint Luke's Mountain States Tumor Institute-Twin Falls Recruiting
Twin Falls, Idaho, United States, 83301
Contact: Site Public Contact    208-381-8059    hallsc@slhs.org   
Principal Investigator: Alison K. Conlin         
United States, Illinois
Illinois CancerCare-Bloomington Recruiting
Bloomington, Illinois, United States, 61704
Contact: Site Public Contact    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: Bryan A. Faller         
Illinois CancerCare-Canton Recruiting
Canton, Illinois, United States, 61520
Contact: Site Public Contact    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: Bryan A. Faller         
Memorial Hospital of Carbondale Recruiting
Carbondale, Illinois, United States, 62902
Contact: Site Public Contact    618-457-5200    clinical.research@sih.net   
Principal Investigator: Bryan A. Faller         
SIH Cancer Institute Recruiting
Carterville, Illinois, United States, 62918
Contact: Site Public Contact    618-985-3333    clinical.research@sih.net   
Principal Investigator: Bryan A. Faller         
Illinois CancerCare-Carthage Recruiting
Carthage, Illinois, United States, 62321
Contact: Site Public Contact    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: Bryan A. Faller         
Centralia Oncology Clinic Recruiting
Centralia, Illinois, United States, 62801
Contact: Site Public Contact    217-876-4740    rhamrick@dmhhs.org   
Principal Investigator: Bryan A. Faller         
John H Stroger Jr Hospital of Cook County Recruiting
Chicago, Illinois, United States, 60612
Contact: Site Public Contact    312-864-5204      
Principal Investigator: Thomas E. Lad         
Cancer Care Specialists of Illinois - Decatur Recruiting
Decatur, Illinois, United States, 62526
Contact: Site Public Contact    217-876-4740    rhamrick@dmhhs.org   
Principal Investigator: Bryan A. Faller         
Decatur Memorial Hospital Recruiting
Decatur, Illinois, United States, 62526
Contact: Site Public Contact    217-876-4740    rhamrick@dmhhs.org   
Principal Investigator: Bryan A. Faller         
Crossroads Cancer Center Recruiting
Effingham, Illinois, United States, 62401
Contact: Site Public Contact    217-876-4740    rhamrick@dmhhs.org   
Principal Investigator: Bryan A. Faller         
Illinois CancerCare-Eureka Recruiting
Eureka, Illinois, United States, 61530
Contact: Site Public Contact    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: Bryan A. Faller         
Illinois CancerCare-Galesburg Recruiting
Galesburg, Illinois, United States, 61401
Contact: Site Public Contact    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: Bryan A. Faller         
Western Illinois Cancer Treatment Center Recruiting
Galesburg, Illinois, United States, 61401
Contact: Site Public Contact    309-344-2831      
Principal Investigator: Bryan A. Faller         
Illinois CancerCare-Kewanee Clinic Recruiting
Kewanee, Illinois, United States, 61443
Contact: Site Public Contact    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: Bryan A. Faller         
Illinois CancerCare-Macomb Recruiting
Macomb, Illinois, United States, 61455
Contact: Site Public Contact    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: Bryan A. Faller         
Illinois CancerCare-Ottawa Clinic Recruiting
Ottawa, Illinois, United States, 61350
Contact: Site Public Contact    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: Bryan A. Faller         
Illinois CancerCare-Pekin Recruiting
Pekin, Illinois, United States, 61554
Contact: Site Public Contact    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: Bryan A. Faller         
Illinois CancerCare-Peoria Recruiting
Peoria, Illinois, United States, 61615
Contact: Site Public Contact    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: Bryan A. Faller         
Methodist Medical Center of Illinois Recruiting
Peoria, Illinois, United States, 61636
Contact: Site Public Contact    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: Bryan A. Faller         
Illinois CancerCare-Peru Recruiting
Peru, Illinois, United States, 61354
Contact: Site Public Contact    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: Bryan A. Faller         
Valley Radiation Oncology Recruiting
Peru, Illinois, United States, 61354
Contact: Site Public Contact    815-664-4141      
Principal Investigator: Bryan A. Faller         
Illinois CancerCare-Princeton Recruiting
Princeton, Illinois, United States, 61356
Contact: Site Public Contact    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: Bryan A. Faller         
Southern Illinois University School of Medicine Recruiting
Springfield, Illinois, United States, 62702
Contact: Site Public Contact    217-545-7929      
Principal Investigator: Bryan A. Faller         
Springfield Clinic Recruiting
Springfield, Illinois, United States, 62702
Contact: Site Public Contact    800-444-7541      
Principal Investigator: Bryan A. Faller         
Memorial Medical Center Recruiting
Springfield, Illinois, United States, 62781
Contact: Site Public Contact    217-788-3528      
Principal Investigator: Bryan A. Faller         
Cancer Care Specialists of Illinois-Swansea Recruiting
Swansea, Illinois, United States, 62226
Contact: Site Public Contact    217-876-4740    rhamrick@dmhhs.org   
Principal Investigator: Bryan A. Faller         
Southwest Illinois Health Services LLP Recruiting
Swansea, Illinois, United States, 62226
Contact: Site Public Contact    618-236-1000    lynns@thecancercenter.com   
Principal Investigator: Bryan A. Faller         
United States, Indiana
IU Health West Hospital Recruiting
Avon, Indiana, United States, 46123
Contact: Site Public Contact    317-278-5632    iutrials@iu.edu   
Principal Investigator: Kathy D. Miller         
IU Health North Hospital Recruiting
Carmel, Indiana, United States, 46032
Contact: Site Public Contact    317-278-5632    iutrials@iu.edu   
Principal Investigator: Kathy D. Miller         
Indiana University/Melvin and Bren Simon Cancer Center Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Site Public Contact    317-278-5632    iutrials@iu.edu   
Principal Investigator: Kathy D. Miller         
IU Health Methodist Hospital Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Site Public Contact    317-278-5632    iutrials@iu.edu   
Principal Investigator: Kathy D. Miller         
Sidney and Lois Eskenazi Hospital Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Site Public Contact    317-278-5632    iutrials@iu.edu   
Principal Investigator: Kathy D. Miller         
Springmill Medical Center Recruiting
Indianapolis, Indiana, United States, 46290
Contact: Site Public Contact    317-278-5632    iutrials@iu.edu   
Principal Investigator: Kathy D. Miller         
United States, Missouri
Parkland Health Center-Bonne Terre Recruiting
Bonne Terre, Missouri, United States, 63628
Contact: Site Public Contact    314-996-5569      
Principal Investigator: Bryan A. Faller         
Saint Francis Medical Center Recruiting
Cape Girardeau, Missouri, United States, 63703
Contact: Site Public Contact    573-334-2230    sfmc@sfmc.net   
Principal Investigator: Bryan A. Faller         
Southeast Cancer Center Recruiting
Cape Girardeau, Missouri, United States, 63703
Contact: Site Public Contact    573-651-5550      
Principal Investigator: Bryan A. Faller         
Capital Region Southwest Campus Recruiting
Jefferson City, Missouri, United States, 65109
Contact: Site Public Contact    573-632-4814    swooden@mail.crmc.org   
Principal Investigator: Bryan A. Faller         
Missouri Baptist Medical Center Recruiting
Saint Louis, Missouri, United States, 63131
Contact: Site Public Contact    314-996-5569      
Principal Investigator: Bryan A. Faller         
Sainte Genevieve County Memorial Hospital Recruiting
Sainte Genevieve, Missouri, United States, 63670
Contact: Site Public Contact    314-996-5569      
Principal Investigator: Bryan A. Faller         
Missouri Baptist Sullivan Hospital Recruiting
Sullivan, Missouri, United States, 63080
Contact: Site Public Contact    314-996-5569      
Principal Investigator: Bryan A. Faller         
Missouri Baptist Outpatient Center-Sunset Hills Recruiting
Sunset Hills, Missouri, United States, 63127
Contact: Site Public Contact    314-996-5569      
Principal Investigator: Bryan A. Faller         
United States, Montana
Saint Patrick Hospital - Community Hospital Recruiting
Missoula, Montana, United States, 59802
Contact: Site Public Contact    406-327-3118    amy.hanneman@providence.org   
Principal Investigator: Alison K. Conlin         
United States, Oregon
Saint Charles Health System Recruiting
Bend, Oregon, United States, 97701
Contact: Site Public Contact    541-706-2909    nosall@stcharleshealthcare.org   
Principal Investigator: Alison K. Conlin         
Clackamas Radiation Oncology Center Recruiting
Clackamas, Oregon, United States, 97015
Contact: Site Public Contact    503-215-2614    CanRsrchStudies@providence.org   
Principal Investigator: Alison K. Conlin         
Providence Oncology and Hematology Care Southeast Recruiting
Clackamas, Oregon, United States, 97015
Contact: Site Public Contact    503-215-2614    CanRsrchStudies@providence.org   
Principal Investigator: Alison K. Conlin         
Bay Area Hospital Recruiting
Coos Bay, Oregon, United States, 97420
Contact: Site Public Contact    541-269-8392    cherie.cox@bayareahospital.org   
Principal Investigator: Alison K. Conlin         
Providence Newberg Medical Center Recruiting
Newberg, Oregon, United States, 97132
Contact: Site Public Contact    503-215-2614    CanRsrchStudies@providence.org   
Principal Investigator: Alison K. Conlin         
Providence Portland Medical Center Recruiting
Portland, Oregon, United States, 97213
Contact: Site Public Contact    503-215-2614    CanRsrchStudies@providence.org   
Principal Investigator: Alison K. Conlin         
Providence Saint Vincent Medical Center Recruiting
Portland, Oregon, United States, 97225
Contact: Site Public Contact    503-215-2614    CanRsrchStudies@providence.org   
Principal Investigator: Alison K. Conlin         
Saint Charles Health System-Redmond Recruiting
Redmond, Oregon, United States, 97756
Contact: Site Public Contact    541-706-2909      
Principal Investigator: Alison K. Conlin         
United States, South Carolina
Lexington Medical Center Recruiting
West Columbia, South Carolina, United States, 29169
Contact: Site Public Contact    803-936-8050      
Principal Investigator: Steven A. Madden         
United States, Washington
Providence Regional Cancer System-Aberdeen Recruiting
Aberdeen, Washington, United States, 98520
Contact: Site Public Contact    360-412-8958    deidre.dillon@providence.org   
Principal Investigator: Alison K. Conlin         
PeaceHealth Saint Joseph Medical Center Recruiting
Bellingham, Washington, United States, 98225
Contact: Site Public Contact    360-715-4133    mjohnson9@peacehealth.org   
Principal Investigator: Alison K. Conlin         
Providence Regional Cancer System-Centralia Recruiting
Centralia, Washington, United States, 98531
Contact: Site Public Contact    360-412-8958    deidre.dillon@providence.org   
Principal Investigator: Alison K. Conlin         
Swedish Cancer Institute-Edmonds Recruiting
Edmonds, Washington, United States, 98026
Contact: Site Public Contact    206-215-3086    PCRC-NCORP@Swedish.org   
Principal Investigator: Alison K. Conlin         
Providence Regional Cancer Partnership Recruiting
Everett, Washington, United States, 98201
Contact: Site Public Contact    425-261-3529    marilyn.birchman@providence.org   
Principal Investigator: Alison K. Conlin         
Swedish Cancer Institute-Issaquah Recruiting
Issaquah, Washington, United States, 98029
Contact: Site Public Contact    206-215-3086    PCRC-NCORP@Swedish.org   
Principal Investigator: Alison K. Conlin         
Kadlec Clinic Hematology and Oncology Recruiting
Kennewick, Washington, United States, 99336
Contact: Site Public Contact    509-783-4637    research@kadlecmed.org   
Principal Investigator: Alison K. Conlin         
Providence Regional Cancer System-Lacey Recruiting
Lacey, Washington, United States, 98503
Contact: Site Public Contact    360-412-8958    deidre.dillon@providence.org   
Principal Investigator: Alison K. Conlin         
PeaceHealth Saint John Medical Center Recruiting
Longview, Washington, United States, 98632
Contact: Site Public Contact    360-514-2016    kmakin-bond@peacehealth.org   
Principal Investigator: Alison K. Conlin         
Pacific Gynecology Specialists Recruiting
Seattle, Washington, United States, 98104
Contact: Site Public Contact    206-215-3086    PCRC-NCORP@Swedish.org   
Principal Investigator: Alison K. Conlin         
Swedish Medical Center-Ballard Campus Recruiting
Seattle, Washington, United States, 98107
Contact: Site Public Contact    206-215-3086    PCRC-NCORP@Swedish.org   
Principal Investigator: Alison K. Conlin         
Swedish Medical Center-First Hill Recruiting
Seattle, Washington, United States, 98122-4307
Contact: Site Public Contact    206-215-3086    PCRC-NCORP@Swedish.org   
Principal Investigator: Alison K. Conlin         
Swedish Medical Center-Cherry Hill Recruiting
Seattle, Washington, United States, 98122-5711
Contact: Site Public Contact    206-215-3086    PCRC-NCORP@Swedish.org   
Principal Investigator: Alison K. Conlin         
PeaceHealth United General Medical Center Recruiting
Sedro-Woolley, Washington, United States, 98284
Contact: Site Public Contact    360-788-8240      
Principal Investigator: Alison K. Conlin         
Providence Regional Cancer System-Shelton Recruiting
Shelton, Washington, United States, 98584
Contact: Site Public Contact    360-412-8958    deidre.dillon@providence.org   
Principal Investigator: Alison K. Conlin         
PeaceHealth Southwest Medical Center Recruiting
Vancouver, Washington, United States, 98664
Contact: Site Public Contact    360-514-3940    kmakin-bond@peacehealth.org   
Principal Investigator: Alison K. Conlin         
Providence Saint Mary Regional Cancer Center Recruiting
Walla Walla, Washington, United States, 99362
Contact: Site Public Contact    509-897-5993    Cheryl.Dodd@providence.org   
Principal Investigator: Alison K. Conlin         
Providence Regional Cancer System-Yelm Recruiting
Yelm, Washington, United States, 98597
Contact: Site Public Contact    360-412-8958    deidre.dillon@providence.org   
Principal Investigator: Alison K. Conlin         
Sponsors and Collaborators
ECOG-ACRIN Cancer Research Group
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Bryan P Schneider ECOG-ACRIN Cancer Research Group

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Responsible Party: ECOG-ACRIN Cancer Research Group
ClinicalTrials.gov Identifier: NCT04001829     History of Changes
Other Study ID Numbers: EAZ171
NCI-2019-00266 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
EAZ171 ( Other Identifier: ECOG-ACRIN Cancer Research Group )
ECOG-ACRIN-EAZ171 ( Other Identifier: DCP )
EAZ171 ( Other Identifier: CTEP )
UG1CA189828 ( U.S. NIH Grant/Contract )
First Posted: June 28, 2019    Key Record Dates
Last Update Posted: July 29, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Breast Neoplasms
Peripheral Nervous System Diseases
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neuromuscular Diseases
Nervous System Diseases
Paclitaxel
Docetaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action