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Randomized Study Evaluating Ixabepilone Plus Capecitabine or Docetaxel Plus Capecitabine in Metastatic Breast Cancer (IXTEND)

Primary Purpose

Breast Neoplasms

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2
Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2
Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2
Sponsored by
R-Pharm
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participants with metastatic breast cancer
  • Measurable disease
  • Up to 1 chemotherapy regimen is acceptable. Participants who have received paclitaxel in the neoadjuvant or adjuvant setting acceptable, only if the last dose of paclitaxel was received 12 months or less before the treatment. There is no timeframe for prior paclitaxel in the metastatic setting.
  • Human epidermal growth factor receptor 2-positive participants allowed if they have progressed after receiving treatment with trastuzumab or lapatinib
  • Eastern Cooperative Oncology Group Performance status of 0-1
  • Age younger than 18 years
  • Women of childbearing potential must be using an adequate method of contraception to avoid pregnancy throughout the study and for at least 4 weeks after the last dose of investigational products

Exclusion Criteria:

  • More than 1 chemotherapy regimen for the treatment of metastatic breast cancer
  • Prior treatment with any epothilone, capecitabine, or docetaxel
  • Prior radiation must not have included 30% or more of major bone marrow-containing areas (pelvis, lumbar spine). If prior radiation was less than 30%, a minimum interval of 2 weeks must be allowed between the last radiation treatment and administration of study medication. There must be at least 1 week between focal/palliative radiation and administration of study medication.
  • Any current or previous history of brain and/or leptomeningeal metastases
  • Neuropathy greater than Grade 2
  • Any concurrent malignancy other than nonmelanoma skin cancer or carcinoma in situ of the cervix
  • Uncontrolled diabetes mellitus
  • Chronic hepatitis
  • HIV-positive status
  • Administration of trastuzumab, lapatinib, bevacizumab, or other systemic treatment for cancer must be discontinued 28 days prior to study medication. Hormonal anticancer agents must be discontinued at least 14 days prior to study medication. Hormonal replacement therapy is acceptable
  • Biphosphonates for palliation of bone metastases allowed if initiated at least 7 days before study entry

Sites / Locations

  • Dch Cancer Treatment Center
  • Scripps Cancer Center
  • Cancer Center of Central Connecticut
  • Local Institution
  • Georgetown University Medical Center
  • Local Institution
  • Local Institution
  • Medical Oncology Associates of Augusta, PC
  • Local Institution
  • Northwestern University Feinberg School of Medicine
  • John W Kugler, MD
  • Midwestern Regional Medical Center
  • Center for Cancer Care at Goshen Health System
  • Monroe Medical Associates
  • Cancer Center of Kansas
  • University of Kentucky
  • University Medical Center, Inc
  • Hematology/Oncology Clinic
  • Mary Bird Perkins Cancer Center
  • Sinai Hospital of Baltimore
  • Center for Cancer & Blood Disorders, PC
  • Jackson Oncology Associates, Pllc
  • The Center for Cancer and Hematologic Disease
  • The Cancer Center at Hackensack University Medical Center
  • Howell Office Plaza
  • Local Institution
  • Cooper Hospital, Division of Hematology/Oncology
  • UNM Cancer Center
  • New Mexico Cancer Care Associates (NMCCA)
  • Arena Oncology Associates, PC
  • Hematology Oncology Associates of Rockland
  • Gaston Hematology and Oncology
  • Marion L Shepard Cancer Center
  • Akron General Medical Center
  • Summa Health System
  • Local Institution
  • Mid Ohio Oncology/Hematology, Inc, dba The Mark H Zangmeister Center
  • Doylestown Hospital
  • Hematology & Oncology Associates of Nepa
  • Regional Hematology Oncology, PC
  • St Mary Medical Center
  • Local Institution
  • Albert Einstein Cancer Center
  • Local Institution
  • Charleston Cancer Center
  • Lowcountry Hematology & Oncology, PA
  • Santee Hematology/Oncology
  • Sanford Cancer Center Oncology Clinic
  • Kingsport Hematology Oncology
  • The University of Tennessee Medical Center
  • Austin Cancer Centers
  • Cancer Specialists of South Texas
  • Coastal Bend Cancer Center
  • Edward L Middleman, MD
  • Section Chief Medical Oncology
  • Jose A Figueroa, MD
  • Southlake Oncology
  • Peninsula Cancer Institute
  • Providence Cancer Center
  • Leah L Dietrich, MD

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2

Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2

Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2

Arm Description

Outcomes

Primary Outcome Measures

Number of Participants With Best Tumor Response as Assessed With Response Evaluation Criteria in Solid Tumors (RECIST)
RECIST definitions: Complete reponse (CR)=disappearance of all nontarget lesions; partial response (PR)=at least 30% reduction in the sum of the longest diameter (LD) of all target lesions in reference to the baseline sum LD; stable disease (SD)=neither PR nor progressive disease (PD) criteria were met; PD=at least 20% increase in the sum of the LD of all target lesions, taking as reference the smallest sum LD recorded at or following baseline. Tumor status assessed by investigator.
Percentage of Participants With Best Response to Treatment of Complete or Partial
The tumor response rate is defined as the number of participants with a best tumor response of CR or PR (as assessed by the investigator according to RECIST criteria), divided by the number of participants randomized in that arm.

Secondary Outcome Measures

Percentage of Triple-negative (TN) Participants With Best Response to Treatment of Complete or Partial
The tumor response rate is defined as the total number of participants whose best response is CR or PR, divided by the number of randomized participants. Participants not evaluable for response are considered to be nonresponders. TN participants are those with tumors that do not express estrogen or progesterone receptors and that do not over express human epidermal growth factor receptor 2 (HER2).
Percentage of Nontriple-negative (NTN) Participants With Best Response to Treatment of Complete or Partial Per Cohort
The tumor response rate is defined as the total number of participants whose best response is CR or PR, divided by the number of randomized participants. Participants not evaluable for response are considered to be nonresponders. NTN participants are who are not TN participants (TN participants are those with tumors that do not express estrogen or progesterone receptors and that do not overexpress HER2) and who received ixabepilone plus capecitabine or docetaxel plus capecitabine.
Number of Participants With Death, Adverse Events (AEs), Drug-related AEs, Serious AEs (SAEs), Drug-related SAEs, AEs Leading to Discontinuation (AEDs), Drug-related AEDs, and Drug-related Peripheral Neuropathy
An AE is any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related=possibly, probably, or certainly related or of unknown relationship to study treatment. Grade 3=Severe, Grade 4=Life-threatening.
Number of Participants With Abnormalities in Hematology Laboratory Results by Worst Common Terminology Criteria (CTC) Grade
CTC Grade 1=Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2=Moderate; minimal, local or noninvasive intervention indicated. Grade 3=Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling. Grade 4=Life-threatening consequences; urgent intervention indicated.
Number of Participants With Abnormalities in Serum Chemistry Laboratory Results
ULN=Upper limit of normal among all laboratory ranges. Alanine aminotransferase (ALT) Grade 1:>ULN to 2.5*ULN; Grade 2: >2.5 to 5.0*ULN; Grade 3: >5.0 to 20.0*ULN; Grade 4: >20.0*ULN. Aspartate aminotransferase (AST) Grade 1: >ULN to 2.5*ULN; Grade 2: >2.5 to 5.0*ULN; Grade 3: >5.0 to 20.0*ULN; Grade 4: >20.0*ULN. Total bilirubin Grade 1: >ULN to 1.5*ULN; Grade 2: >1.5 to 3.0*ULN; Grade 3: >3.0 to 10.0*ULN; Grade 4: >10.0*ULN. Creatine Grade 1: >ULN to 1.5*ULN; Grade 2: 1.5 to 3.0*ULN; Grade 3: >3.0 to 6.0*ULN; Grade 4: >6.0*ULN.
Time to Progression
Time to progression is defined as the time from date of randomization until the date that PD is first reported. Participants who die without a reported prior progression are considered to have progressed on the day of their death. Those who did not progress or die are censored at the day of their last tumor assessment.
Duration of Response
Duration of overall response is computed for participants whose best response is either PR or CR and is measured from the time measurement criteria are first met for CR or PR (whichever status is recorded first) until the first date of documented PD or death. Participants who did not relapse or die are censored on the date of their last tumor assessment.
Median Number of Treatment Cycles
The first dosing date is defined as the date of the first dose of chemotherapy or capecitabine, whichever was administered first. Cycles are defined as the time from Day 1 of the cycle until the day before the next cycle. The last cycle per participant is the 21-day period following Day 1 of that cycle.

Full Information

First Posted
October 17, 2007
Last Updated
February 9, 2016
Sponsor
R-Pharm
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1. Study Identification

Unique Protocol Identification Number
NCT00546364
Brief Title
Randomized Study Evaluating Ixabepilone Plus Capecitabine or Docetaxel Plus Capecitabine in Metastatic Breast Cancer
Acronym
IXTEND
Official Title
IXTEND: A Randomized Phase 2 Study to Evaluate the Combination of Ixabepilone Plus Capecitabine or Capecitabine Plus Docetaxel in the Treatment of Metastatic Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Terminated
Why Stopped
Slow Accrual
Study Start Date
February 2008 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
R-Pharm

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to assess the effect of ixabepilone plus capecitabine or docetaxel plus capecitabine on shrinking or slowing the growth of metastatic breast cancer in women. The safety of this combination therapy will also be evaluated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2
Arm Type
Experimental
Arm Title
Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2
Arm Type
Experimental
Arm Title
Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2
Other Intervention Name(s)
IXEMPRA®, BMS-247550
Intervention Description
Ixabepilone, 40 mg/m^2, administered as a 3-hour intravenous (IV) infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, self-administered on an outpatient basis twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle.
Intervention Type
Drug
Intervention Name(s)
Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2
Intervention Description
Ixabepilone, 32 mg/m^2, administered as a 3-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, self-administered on an outpatient basis twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle.
Intervention Type
Drug
Intervention Name(s)
Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2
Intervention Description
Docetaxel 75 mg/m^2 administered as a 1-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, self-administered on an outpatient basis twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle.
Primary Outcome Measure Information:
Title
Number of Participants With Best Tumor Response as Assessed With Response Evaluation Criteria in Solid Tumors (RECIST)
Description
RECIST definitions: Complete reponse (CR)=disappearance of all nontarget lesions; partial response (PR)=at least 30% reduction in the sum of the longest diameter (LD) of all target lesions in reference to the baseline sum LD; stable disease (SD)=neither PR nor progressive disease (PD) criteria were met; PD=at least 20% increase in the sum of the LD of all target lesions, taking as reference the smallest sum LD recorded at or following baseline. Tumor status assessed by investigator.
Time Frame
Baseline to 6 weeks (end of Cycle 2)
Title
Percentage of Participants With Best Response to Treatment of Complete or Partial
Description
The tumor response rate is defined as the number of participants with a best tumor response of CR or PR (as assessed by the investigator according to RECIST criteria), divided by the number of participants randomized in that arm.
Time Frame
Baseline to 6 weeks (end of Cycle 2)
Secondary Outcome Measure Information:
Title
Percentage of Triple-negative (TN) Participants With Best Response to Treatment of Complete or Partial
Description
The tumor response rate is defined as the total number of participants whose best response is CR or PR, divided by the number of randomized participants. Participants not evaluable for response are considered to be nonresponders. TN participants are those with tumors that do not express estrogen or progesterone receptors and that do not over express human epidermal growth factor receptor 2 (HER2).
Time Frame
Baseline to 6 weeks (end of Cycle 2)
Title
Percentage of Nontriple-negative (NTN) Participants With Best Response to Treatment of Complete or Partial Per Cohort
Description
The tumor response rate is defined as the total number of participants whose best response is CR or PR, divided by the number of randomized participants. Participants not evaluable for response are considered to be nonresponders. NTN participants are who are not TN participants (TN participants are those with tumors that do not express estrogen or progesterone receptors and that do not overexpress HER2) and who received ixabepilone plus capecitabine or docetaxel plus capecitabine.
Time Frame
Baseline to 6 weeks (end of Cycle 2)
Title
Number of Participants With Death, Adverse Events (AEs), Drug-related AEs, Serious AEs (SAEs), Drug-related SAEs, AEs Leading to Discontinuation (AEDs), Drug-related AEDs, and Drug-related Peripheral Neuropathy
Description
An AE is any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related=possibly, probably, or certainly related or of unknown relationship to study treatment. Grade 3=Severe, Grade 4=Life-threatening.
Time Frame
Baseline to end of Cycle 1 (21 days), continuously
Title
Number of Participants With Abnormalities in Hematology Laboratory Results by Worst Common Terminology Criteria (CTC) Grade
Description
CTC Grade 1=Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2=Moderate; minimal, local or noninvasive intervention indicated. Grade 3=Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling. Grade 4=Life-threatening consequences; urgent intervention indicated.
Time Frame
Baseline in Cycle 1 (21 days) and then prior to start of each 21-day cycle
Title
Number of Participants With Abnormalities in Serum Chemistry Laboratory Results
Description
ULN=Upper limit of normal among all laboratory ranges. Alanine aminotransferase (ALT) Grade 1:>ULN to 2.5*ULN; Grade 2: >2.5 to 5.0*ULN; Grade 3: >5.0 to 20.0*ULN; Grade 4: >20.0*ULN. Aspartate aminotransferase (AST) Grade 1: >ULN to 2.5*ULN; Grade 2: >2.5 to 5.0*ULN; Grade 3: >5.0 to 20.0*ULN; Grade 4: >20.0*ULN. Total bilirubin Grade 1: >ULN to 1.5*ULN; Grade 2: >1.5 to 3.0*ULN; Grade 3: >3.0 to 10.0*ULN; Grade 4: >10.0*ULN. Creatine Grade 1: >ULN to 1.5*ULN; Grade 2: 1.5 to 3.0*ULN; Grade 3: >3.0 to 6.0*ULN; Grade 4: >6.0*ULN.
Time Frame
Baseline in Cycle 1 (21 days) and then prior to start of each 21-day cycle
Title
Time to Progression
Description
Time to progression is defined as the time from date of randomization until the date that PD is first reported. Participants who die without a reported prior progression are considered to have progressed on the day of their death. Those who did not progress or die are censored at the day of their last tumor assessment.
Time Frame
Baseline to date progressive disease reported
Title
Duration of Response
Description
Duration of overall response is computed for participants whose best response is either PR or CR and is measured from the time measurement criteria are first met for CR or PR (whichever status is recorded first) until the first date of documented PD or death. Participants who did not relapse or die are censored on the date of their last tumor assessment.
Time Frame
Baseline (date of randomization) to date CR or PR criteria first met
Title
Median Number of Treatment Cycles
Description
The first dosing date is defined as the date of the first dose of chemotherapy or capecitabine, whichever was administered first. Cycles are defined as the time from Day 1 of the cycle until the day before the next cycle. The last cycle per participant is the 21-day period following Day 1 of that cycle.
Time Frame
Day 1 to end of Cycle 18, maximum (54 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants with metastatic breast cancer Measurable disease Up to 1 chemotherapy regimen is acceptable. Participants who have received paclitaxel in the neoadjuvant or adjuvant setting acceptable, only if the last dose of paclitaxel was received 12 months or less before the treatment. There is no timeframe for prior paclitaxel in the metastatic setting. Human epidermal growth factor receptor 2-positive participants allowed if they have progressed after receiving treatment with trastuzumab or lapatinib Eastern Cooperative Oncology Group Performance status of 0-1 Age younger than 18 years Women of childbearing potential must be using an adequate method of contraception to avoid pregnancy throughout the study and for at least 4 weeks after the last dose of investigational products Exclusion Criteria: More than 1 chemotherapy regimen for the treatment of metastatic breast cancer Prior treatment with any epothilone, capecitabine, or docetaxel Prior radiation must not have included 30% or more of major bone marrow-containing areas (pelvis, lumbar spine). If prior radiation was less than 30%, a minimum interval of 2 weeks must be allowed between the last radiation treatment and administration of study medication. There must be at least 1 week between focal/palliative radiation and administration of study medication. Any current or previous history of brain and/or leptomeningeal metastases Neuropathy greater than Grade 2 Any concurrent malignancy other than nonmelanoma skin cancer or carcinoma in situ of the cervix Uncontrolled diabetes mellitus Chronic hepatitis HIV-positive status Administration of trastuzumab, lapatinib, bevacizumab, or other systemic treatment for cancer must be discontinued 28 days prior to study medication. Hormonal anticancer agents must be discontinued at least 14 days prior to study medication. Hormonal replacement therapy is acceptable Biphosphonates for palliation of bone metastases allowed if initiated at least 7 days before study entry
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Dch Cancer Treatment Center
City
Tuscaloosa
State/Province
Alabama
ZIP/Postal Code
35401
Country
United States
Facility Name
Scripps Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Cancer Center of Central Connecticut
City
Southington
State/Province
Connecticut
ZIP/Postal Code
06489
Country
United States
Facility Name
Local Institution
City
Newark
State/Province
Delaware
ZIP/Postal Code
19718
Country
United States
Facility Name
Georgetown University Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Local Institution
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Local Institution
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Medical Oncology Associates of Augusta, PC
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30901
Country
United States
Facility Name
Local Institution
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Northwestern University Feinberg School of Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
John W Kugler, MD
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615
Country
United States
Facility Name
Midwestern Regional Medical Center
City
Zion
State/Province
Illinois
ZIP/Postal Code
60099
Country
United States
Facility Name
Center for Cancer Care at Goshen Health System
City
Goshen
State/Province
Indiana
ZIP/Postal Code
46526
Country
United States
Facility Name
Monroe Medical Associates
City
Munster
State/Province
Indiana
ZIP/Postal Code
46321
Country
United States
Facility Name
Cancer Center of Kansas
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
University Medical Center, Inc
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Hematology/Oncology Clinic
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Mary Bird Perkins Cancer Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Sinai Hospital of Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
Facility Name
Center for Cancer & Blood Disorders, PC
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
Jackson Oncology Associates, Pllc
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
Country
United States
Facility Name
The Center for Cancer and Hematologic Disease
City
Cherry Hill
State/Province
New Jersey
ZIP/Postal Code
08003
Country
United States
Facility Name
The Cancer Center at Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Howell Office Plaza
City
Howell
State/Province
New Jersey
ZIP/Postal Code
07731
Country
United States
Facility Name
Local Institution
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07112
Country
United States
Facility Name
Cooper Hospital, Division of Hematology/Oncology
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Facility Name
UNM Cancer Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
New Mexico Cancer Care Associates (NMCCA)
City
Santa Fe
State/Province
New Mexico
ZIP/Postal Code
87505
Country
United States
Facility Name
Arena Oncology Associates, PC
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Hematology Oncology Associates of Rockland
City
Nyack
State/Province
New York
ZIP/Postal Code
10960
Country
United States
Facility Name
Gaston Hematology and Oncology
City
Gastonia
State/Province
North Carolina
ZIP/Postal Code
28054
Country
United States
Facility Name
Marion L Shepard Cancer Center
City
Washington
State/Province
North Carolina
ZIP/Postal Code
27889
Country
United States
Facility Name
Akron General Medical Center
City
Akron
State/Province
Ohio
ZIP/Postal Code
44302
Country
United States
Facility Name
Summa Health System
City
Akron
State/Province
Ohio
ZIP/Postal Code
44304
Country
United States
Facility Name
Local Institution
City
Canton
State/Province
Ohio
ZIP/Postal Code
44710
Country
United States
Facility Name
Mid Ohio Oncology/Hematology, Inc, dba The Mark H Zangmeister Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43219
Country
United States
Facility Name
Doylestown Hospital
City
Doylestown
State/Province
Pennsylvania
ZIP/Postal Code
18901
Country
United States
Facility Name
Hematology & Oncology Associates of Nepa
City
Dunmore
State/Province
Pennsylvania
ZIP/Postal Code
18512
Country
United States
Facility Name
Regional Hematology Oncology, PC
City
Langhorne
State/Province
Pennsylvania
ZIP/Postal Code
19047
Country
United States
Facility Name
St Mary Medical Center
City
Langhorne
State/Province
Pennsylvania
ZIP/Postal Code
19047
Country
United States
Facility Name
Local Institution
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
Albert Einstein Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19141
Country
United States
Facility Name
Local Institution
City
Woonsocket
State/Province
Rhode Island
ZIP/Postal Code
02895
Country
United States
Facility Name
Charleston Cancer Center
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Lowcountry Hematology & Oncology, PA
City
Mt Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Santee Hematology/Oncology
City
Sumter
State/Province
South Carolina
ZIP/Postal Code
29150
Country
United States
Facility Name
Sanford Cancer Center Oncology Clinic
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57104
Country
United States
Facility Name
Kingsport Hematology Oncology
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
The University of Tennessee Medical Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Austin Cancer Centers
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
Cancer Specialists of South Texas
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78412
Country
United States
Facility Name
Coastal Bend Cancer Center
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78463
Country
United States
Facility Name
Edward L Middleman, MD
City
Duncanville
State/Province
Texas
ZIP/Postal Code
75137
Country
United States
Facility Name
Section Chief Medical Oncology
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Jose A Figueroa, MD
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79410
Country
United States
Facility Name
Southlake Oncology
City
Southlake
State/Province
Texas
ZIP/Postal Code
76092
Country
United States
Facility Name
Peninsula Cancer Institute
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23601
Country
United States
Facility Name
Providence Cancer Center
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Leah L Dietrich, MD
City
La Crosse
State/Province
Wisconsin
ZIP/Postal Code
54601
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Randomized Study Evaluating Ixabepilone Plus Capecitabine or Docetaxel Plus Capecitabine in Metastatic Breast Cancer

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