Breast Neoplasms
Conditions
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.
Interventions
DRUGIxabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2
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.
DRUGIxabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2
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.
DRUGDocetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2
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.
Sponsors
R-Pharm
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Best Tumor Response as Assessed With Response Evaluation Criteria in Solid Tumors (RECIST) | Baseline to 6 weeks (end of Cycle 2) | 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 | Baseline to 6 weeks (end of Cycle 2) | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | Baseline to end of Cycle 1 (21 days), continuously | 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 | Baseline in Cycle 1 (21 days) and then prior to start of each 21-day cycle | 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 | Baseline in Cycle 1 (21 days) and then prior to start of each 21-day cycle | 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. |
| Percentage of Triple-negative (TN) Participants With Best Response to Treatment of Complete or Partial | Baseline to 6 weeks (end of Cycle 2) | 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). |
| Duration of Response | Baseline (date of randomization) to date CR or PR criteria first met | 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 | Day 1 to end of Cycle 18, maximum (54 weeks) | 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 to Progression | Baseline to date progressive disease reported | 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. |
| Percentage of Nontriple-negative (NTN) Participants With Best Response to Treatment of Complete or Partial Per Cohort | Baseline to 6 weeks (end of Cycle 2) | 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. |
Countries
United States
Participant flow
Pre-assignment details
Of 62 participants enrolled, 62 were randomized and received treatment. Investigators had to terminate the study because an adequate number of participants could not be enrolled.
Participants by arm
| Arm | Count |
|---|---|
| Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2 Ixabepilone, 40 mg/m\^2, administered as a 3-hour intravenous (IV) continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m\^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis. | 20 |
| Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2 Ixabepilone, 32 mg/m\^2, administered as a 3-hour IV continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m\^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis. | 22 |
| Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2 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, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis. | 20 |
| Total | 62 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Administrative reason by sponsor | 1 | 0 | 0 |
| Overall Study | Completed and off treatment | 1 | 0 | 2 |
| Overall Study | Disease progression | 5 | 11 | 8 |
| Overall Study | Mixed response | 1 | 0 | 0 |
| Overall Study | No longer meets study criteria | 1 | 1 | 0 |
| Overall Study | Palliative treatment | 1 | 0 | 1 |
| Overall Study | Physician Decision | 0 | 0 | 1 |
| Overall Study | Poor compliance/noncompliance | 0 | 0 | 1 |
| Overall Study | Prior taxotere | 1 | 0 | 0 |
| Overall Study | Sponsor decision | 0 | 0 | 1 |
| Overall Study | Target lesions resected | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 5 | 6 | 3 |
Baseline characteristics
| Characteristic | 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 | Total |
|---|---|---|---|---|
| Age, Continuous | 55.5 years | 59 years | 55.5 years | 57.5 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 4 Participants | 4 Participants | 13 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 15 Participants | 18 Participants | 16 Participants | 49 Participants |
| Sex: Female, Male Female | 20 Participants | 22 Participants | 20 Participants | 62 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 20 / 20 | 22 / 22 | 20 / 20 |
| serious Total, serious adverse events | 5 / 20 | 5 / 22 | 7 / 20 |
Outcome results
Primary
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.
Time frame: Baseline to 6 weeks (end of Cycle 2)
Population: All participants with measurable disease who have a correct cancer diagnosis and have received any treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2 | Number of Participants With Best Tumor Response as Assessed With Response Evaluation Criteria in Solid Tumors (RECIST) | Partial response (PR) | 6 Participants |
| Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2 | Number of Participants With Best Tumor Response as Assessed With Response Evaluation Criteria in Solid Tumors (RECIST) | Discontinued before first tumor assessment | 3 Participants |
| Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2 | Number of Participants With Best Tumor Response as Assessed With Response Evaluation Criteria in Solid Tumors (RECIST) | Progressive disease (PD) | 4 Participants |
| Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2 | Number of Participants With Best Tumor Response as Assessed With Response Evaluation Criteria in Solid Tumors (RECIST) | Complete response (CR) | 1 Participants |
| Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2 | Number of Participants With Best Tumor Response as Assessed With Response Evaluation Criteria in Solid Tumors (RECIST) | Unable to determine | 0 Participants |
| Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2 | Number of Participants With Best Tumor Response as Assessed With Response Evaluation Criteria in Solid Tumors (RECIST) | No tumor assessment due to other reasons | 0 Participants |
| Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2 | Number of Participants With Best Tumor Response as Assessed With Response Evaluation Criteria in Solid Tumors (RECIST) | Stable disease (SD) | 6 Participants |
| Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2 | Number of Participants With Best Tumor Response as Assessed With Response Evaluation Criteria in Solid Tumors (RECIST) | Progressive disease (PD) | 9 Participants |
| Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2 | Number of Participants With Best Tumor Response as Assessed With Response Evaluation Criteria in Solid Tumors (RECIST) | Complete response (CR) | 1 Participants |
| Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2 | Number of Participants With Best Tumor Response as Assessed With Response Evaluation Criteria in Solid Tumors (RECIST) | Partial response (PR) | 8 Participants |
| Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2 | Number of Participants With Best Tumor Response as Assessed With Response Evaluation Criteria in Solid Tumors (RECIST) | Stable disease (SD) | 3 Participants |
| Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2 | Number of Participants With Best Tumor Response as Assessed With Response Evaluation Criteria in Solid Tumors (RECIST) | Discontinued before first tumor assessment | 0 Participants |
| Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2 | Number of Participants With Best Tumor Response as Assessed With Response Evaluation Criteria in Solid Tumors (RECIST) | No tumor assessment due to other reasons | 0 Participants |
| Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2 | Number of Participants With Best Tumor Response as Assessed With Response Evaluation Criteria in Solid Tumors (RECIST) | Unable to determine | 1 Participants |
| Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2 | Number of Participants With Best Tumor Response as Assessed With Response Evaluation Criteria in Solid Tumors (RECIST) | Discontinued before first tumor assessment | 1 Participants |
| Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2 | Number of Participants With Best Tumor Response as Assessed With Response Evaluation Criteria in Solid Tumors (RECIST) | Partial response (PR) | 6 Participants |
| Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2 | Number of Participants With Best Tumor Response as Assessed With Response Evaluation Criteria in Solid Tumors (RECIST) | Unable to determine | 0 Participants |
| Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2 | Number of Participants With Best Tumor Response as Assessed With Response Evaluation Criteria in Solid Tumors (RECIST) | No tumor assessment due to other reasons | 1 Participants |
| Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2 | Number of Participants With Best Tumor Response as Assessed With Response Evaluation Criteria in Solid Tumors (RECIST) | Progressive disease (PD) | 9 Participants |
| Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2 | Number of Participants With Best Tumor Response as Assessed With Response Evaluation Criteria in Solid Tumors (RECIST) | Stable disease (SD) | 3 Participants |
| Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2 | Number of Participants With Best Tumor Response as Assessed With Response Evaluation Criteria in Solid Tumors (RECIST) | Complete response (CR) | 0 Participants |
Primary
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.
Time frame: Baseline to 6 weeks (end of Cycle 2)
Population: All participants with measurable disease who have a correct cancer diagnosis and have received any treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2 | Percentage of Participants With Best Response to Treatment of Complete or Partial | 35 Percentage of patients |
| Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2 | Percentage of Participants With Best Response to Treatment of Complete or Partial | 41 Percentage of patients |
| Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2 | Percentage of Participants With Best Response to Treatment of Complete or Partial | 30 Percentage of patients |
Secondary
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.
Time frame: Baseline (date of randomization) to date CR or PR criteria first met
Population: This study was terminated due to inadequate enrollment. Consequently, duration of response was not analyzed.
Secondary
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.
Time frame: Day 1 to end of Cycle 18, maximum (54 weeks)
Population: All participants who received at least 1 dose of ixabepilone plus capecitabine or of docetaxel plus capecitabine.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2 | Median Number of Treatment Cycles | 3.0 Treatment cycles |
| Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2 | Median Number of Treatment Cycles | 4.5 Treatment cycles |
| Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2 | Median Number of Treatment Cycles | 6.0 Treatment cycles |
Secondary
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.
Time frame: Baseline in Cycle 1 (21 days) and then prior to start of each 21-day cycle
Population: All participants who received at least 1 dose of ixabepilone plus capecitabine or of docetaxel plus capecitabine.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2 | Number of Participants With Abnormalities in Hematology Laboratory Results by Worst Common Terminology Criteria (CTC) Grade | Neutropenia (Grades 1-4) | 18 Participants |
| Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2 | Number of Participants With Abnormalities in Hematology Laboratory Results by Worst Common Terminology Criteria (CTC) Grade | Neutropenia (Grade 3 or 4) | 12 Participants |
| Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2 | Number of Participants With Abnormalities in Hematology Laboratory Results by Worst Common Terminology Criteria (CTC) Grade | Leukopenia (Grades 1-4) | 20 Participants |
| Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2 | Number of Participants With Abnormalities in Hematology Laboratory Results by Worst Common Terminology Criteria (CTC) Grade | Leukopenia (Grade 3 or 4) | 9 Participants |
| Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2 | Number of Participants With Abnormalities in Hematology Laboratory Results by Worst Common Terminology Criteria (CTC) Grade | Thrombocytopenia (Grades 1-4) | 9 Participants |
| Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2 | Number of Participants With Abnormalities in Hematology Laboratory Results by Worst Common Terminology Criteria (CTC) Grade | Thrombocytopenia (Grade 3 or 4) | 0 Participants |
| Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2 | Number of Participants With Abnormalities in Hematology Laboratory Results by Worst Common Terminology Criteria (CTC) Grade | Anemia (Grades 1-4) | 18 Participants |
| Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2 | Number of Participants With Abnormalities in Hematology Laboratory Results by Worst Common Terminology Criteria (CTC) Grade | Anemia (Grade 3 or 4) | 0 Participants |
| Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2 | Number of Participants With Abnormalities in Hematology Laboratory Results by Worst Common Terminology Criteria (CTC) Grade | Leukopenia (Grades 1-4) | 19 Participants |
| Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2 | Number of Participants With Abnormalities in Hematology Laboratory Results by Worst Common Terminology Criteria (CTC) Grade | Anemia (Grades 1-4) | 21 Participants |
| Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2 | Number of Participants With Abnormalities in Hematology Laboratory Results by Worst Common Terminology Criteria (CTC) Grade | Leukopenia (Grade 3 or 4) | 9 Participants |
| Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2 | Number of Participants With Abnormalities in Hematology Laboratory Results by Worst Common Terminology Criteria (CTC) Grade | Thrombocytopenia (Grades 1-4) | 11 Participants |
| Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2 | Number of Participants With Abnormalities in Hematology Laboratory Results by Worst Common Terminology Criteria (CTC) Grade | Thrombocytopenia (Grade 3 or 4) | 1 Participants |
| Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2 | Number of Participants With Abnormalities in Hematology Laboratory Results by Worst Common Terminology Criteria (CTC) Grade | Neutropenia (Grades 1-4) | 15 Participants |
| Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2 | Number of Participants With Abnormalities in Hematology Laboratory Results by Worst Common Terminology Criteria (CTC) Grade | Neutropenia (Grade 3 or 4) | 10 Participants |
| Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2 | Number of Participants With Abnormalities in Hematology Laboratory Results by Worst Common Terminology Criteria (CTC) Grade | Anemia (Grade 3 or 4) | 1 Participants |
| Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2 | Number of Participants With Abnormalities in Hematology Laboratory Results by Worst Common Terminology Criteria (CTC) Grade | Leukopenia (Grades 1-4) | 17 Participants |
| Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2 | Number of Participants With Abnormalities in Hematology Laboratory Results by Worst Common Terminology Criteria (CTC) Grade | Neutropenia (Grade 3 or 4) | 15 Participants |
| Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2 | Number of Participants With Abnormalities in Hematology Laboratory Results by Worst Common Terminology Criteria (CTC) Grade | Neutropenia (Grades 1-4) | 17 Participants |
| Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2 | Number of Participants With Abnormalities in Hematology Laboratory Results by Worst Common Terminology Criteria (CTC) Grade | Leukopenia (Grade 3 or 4) | 12 Participants |
| Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2 | Number of Participants With Abnormalities in Hematology Laboratory Results by Worst Common Terminology Criteria (CTC) Grade | Anemia (Grades 1-4) | 17 Participants |
| Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2 | Number of Participants With Abnormalities in Hematology Laboratory Results by Worst Common Terminology Criteria (CTC) Grade | Thrombocytopenia (Grade 3 or 4) | 0 Participants |
| Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2 | Number of Participants With Abnormalities in Hematology Laboratory Results by Worst Common Terminology Criteria (CTC) Grade | Thrombocytopenia (Grades 1-4) | 7 Participants |
| Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2 | Number of Participants With Abnormalities in Hematology Laboratory Results by Worst Common Terminology Criteria (CTC) Grade | Anemia (Grade 3 or 4) | 0 Participants |
Secondary
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 frame: Baseline in Cycle 1 (21 days) and then prior to start of each 21-day cycle
Population: All participants who received at least 1 dose of ixabepilone plus capecitabine or of docetaxel plus capecitabine.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2 | Number of Participants With Abnormalities in Serum Chemistry Laboratory Results | ALT, high (Grades 1-4) | 4 Participants |
| Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2 | Number of Participants With Abnormalities in Serum Chemistry Laboratory Results | ALT, high (Grade 3 or 4) | 0 Participants |
| Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2 | Number of Participants With Abnormalities in Serum Chemistry Laboratory Results | AST, high (Grades 1-4) | 7 Participants |
| Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2 | Number of Participants With Abnormalities in Serum Chemistry Laboratory Results | AST, high (Grade 3 or 4) | 0 Participants |
| Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2 | Number of Participants With Abnormalities in Serum Chemistry Laboratory Results | Total bilirubin, high (Grades 1-4) | 0 Participants |
| Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2 | Number of Participants With Abnormalities in Serum Chemistry Laboratory Results | Total bilirubin, high (Grade 3 or 4) | 0 Participants |
| Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2 | Number of Participants With Abnormalities in Serum Chemistry Laboratory Results | Creatinine, high (Grades 1-4) | 1 Participants |
| Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2 | Number of Participants With Abnormalities in Serum Chemistry Laboratory Results | Creatinine, high (Grade 3 or 4) | 0 Participants |
| Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2 | Number of Participants With Abnormalities in Serum Chemistry Laboratory Results | AST, high (Grades 1-4) | 5 Participants |
| Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2 | Number of Participants With Abnormalities in Serum Chemistry Laboratory Results | Creatinine, high (Grades 1-4) | 1 Participants |
| Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2 | Number of Participants With Abnormalities in Serum Chemistry Laboratory Results | AST, high (Grade 3 or 4) | 0 Participants |
| Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2 | Number of Participants With Abnormalities in Serum Chemistry Laboratory Results | Total bilirubin, high (Grades 1-4) | 1 Participants |
| Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2 | Number of Participants With Abnormalities in Serum Chemistry Laboratory Results | Total bilirubin, high (Grade 3 or 4) | 0 Participants |
| Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2 | Number of Participants With Abnormalities in Serum Chemistry Laboratory Results | ALT, high (Grades 1-4) | 3 Participants |
| Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2 | Number of Participants With Abnormalities in Serum Chemistry Laboratory Results | ALT, high (Grade 3 or 4) | 0 Participants |
| Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2 | Number of Participants With Abnormalities in Serum Chemistry Laboratory Results | Creatinine, high (Grade 3 or 4) | 0 Participants |
| Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2 | Number of Participants With Abnormalities in Serum Chemistry Laboratory Results | AST, high (Grades 1-4) | 5 Participants |
| Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2 | Number of Participants With Abnormalities in Serum Chemistry Laboratory Results | ALT, high (Grade 3 or 4) | 0 Participants |
| Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2 | Number of Participants With Abnormalities in Serum Chemistry Laboratory Results | ALT, high (Grades 1-4) | 5 Participants |
| Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2 | Number of Participants With Abnormalities in Serum Chemistry Laboratory Results | AST, high (Grade 3 or 4) | 0 Participants |
| Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2 | Number of Participants With Abnormalities in Serum Chemistry Laboratory Results | Creatinine, high (Grades 1-4) | 2 Participants |
| Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2 | Number of Participants With Abnormalities in Serum Chemistry Laboratory Results | Total bilirubin, high (Grade 3 or 4) | 0 Participants |
| Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2 | Number of Participants With Abnormalities in Serum Chemistry Laboratory Results | Total bilirubin, high (Grades 1-4) | 0 Participants |
| Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2 | Number of Participants With Abnormalities in Serum Chemistry Laboratory Results | Creatinine, high (Grade 3 or 4) | 0 Participants |
Secondary
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.
Time frame: Baseline to end of Cycle 1 (21 days), continuously
Population: All participants who received at least 1 dose of ixabepilone plus capecitabine or of docetaxel plus capecitabine.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2 | 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 | Drug-related AEDs | 2 Participants |
| Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2 | 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 | AEs | 20 Participants |
| Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2 | 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 | Drug-related AEDs (Grade 4) | 1 Participants |
| Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2 | 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 | Drug-related AEs (Grade 4) | 6 Participants |
| Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2 | 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 | Drug-related peripheral neuropathy | 10 Participants |
| Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2 | 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 | Drug-related peripheral neuropathy (Grade 3) | 4 Participants |
| Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2 | 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 | Drug-related peripheral neuropathy (Grade 4) | 0 Participants |
| Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2 | 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 | Drug-related AEDs (Grade 3) | 1 Participants |
| Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2 | 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 | SAEs | 7 Participants |
| Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2 | 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 | Drug-related SAEs | 3 Participants |
| Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2 | 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 | Drug-related AEs | 20 Participants |
| Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2 | 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 | Drug-related SAEs (Grade 3) | 2 Participants |
| Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2 | 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 | Drug-related SAEs (Grade 4) | 1 Participants |
| Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2 | 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 | Deaths | 2 Participants |
| Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2 | 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 | AEDs | 4 Participants |
| Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2 | 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 | Drug-related AEs (Grade 3) | 8 Participants |
| Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2 | 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 | Drug-related AEs | 22 Participants |
| Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2 | 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 | Drug-related AEs (Grade 3) | 9 Participants |
| Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2 | 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 | Drug-related AEDs (Grade 3) | 3 Participants |
| Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2 | 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 | SAEs | 5 Participants |
| Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2 | 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 | Deaths | 1 Participants |
| Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2 | 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 | Drug-related AEDs (Grade 4) | 1 Participants |
| Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2 | 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 | Drug-related AEDs | 7 Participants |
| Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2 | 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 | Drug-related SAEs | 3 Participants |
| Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2 | 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 | Drug-related peripheral neuropathy | 15 Participants |
| Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2 | 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 | Drug-related AEs (Grade 4) | 3 Participants |
| Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2 | 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 | Drug-related SAEs (Grade 4) | 1 Participants |
| Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2 | 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 | Drug-related peripheral neuropathy (Grade 3) | 2 Participants |
| Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2 | 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 | AEs | 22 Participants |
| Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2 | 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 | AEDs | 9 Participants |
| Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2 | 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 | Drug-related peripheral neuropathy (Grade 4) | 0 Participants |
| Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2 | 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 | Drug-related SAEs (Grade 3) | 2 Participants |
| Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2 | 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 | Drug-related peripheral neuropathy (Grade 4) | 0 Participants |
| Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2 | 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 | Deaths | 2 Participants |
| Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2 | 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 | AEs | 20 Participants |
| Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2 | 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 | Drug-related AEs | 19 Participants |
| Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2 | 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 | Drug-related AEs (Grade 3) | 8 Participants |
| Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2 | 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 | Drug-related AEs (Grade 4) | 6 Participants |
| Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2 | 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 | SAEs | 5 Participants |
| Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2 | 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 | Drug-related SAEs | 3 Participants |
| Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2 | 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 | Drug-related SAEs (Grade 3) | 2 Participants |
| Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2 | 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 | Drug-related SAEs (Grade 4) | 1 Participants |
| Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2 | 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 | AEDs | 4 Participants |
| Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2 | 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 | Drug-related AEDs | 3 Participants |
| Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2 | 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 | Drug-related AEDs (Grade 3) | 2 Participants |
| Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2 | 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 | Drug-related AEDs (Grade 4) | 0 Participants |
| Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2 | 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 | Drug-related peripheral neuropathy | 5 Participants |
| Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2 | 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 | Drug-related peripheral neuropathy (Grade 3) | 0 Participants |
Secondary
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.
Time frame: Baseline to 6 weeks (end of Cycle 2)
Population: All NTN participants who received ixabepilone plus capecitabine or docetaxel plus capecitabine.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2 | Percentage of Nontriple-negative (NTN) Participants With Best Response to Treatment of Complete or Partial Per Cohort | 33 Percentage of NTN Participants |
| Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2 | Percentage of Nontriple-negative (NTN) Participants With Best Response to Treatment of Complete or Partial Per Cohort | 54 Percentage of NTN Participants |
| Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2 | Percentage of Nontriple-negative (NTN) Participants With Best Response to Treatment of Complete or Partial Per Cohort | 42 Percentage of NTN Participants |
Secondary
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).
Time frame: Baseline to 6 weeks (end of Cycle 2)
Population: All TN participants who received ixabepilone plus capecitabine or docetaxel plus capecitabine.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2 | Percentage of Triple-negative (TN) Participants With Best Response to Treatment of Complete or Partial | 38 Percentage of TN Participants |
| Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2 | Percentage of Triple-negative (TN) Participants With Best Response to Treatment of Complete or Partial | 22 Percentage of TN Participants |
| Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2 | Percentage of Triple-negative (TN) Participants With Best Response to Treatment of Complete or Partial | 13 Percentage of TN Participants |
Secondary
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.
Time frame: Baseline to date progressive disease reported
Population: This study was terminated due to inadequate enrollment. Consequently, time to progression was not analyzed.