Epothilone (Ixabepilone) Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer

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ClinicalTrials.gov Identifier: NCT00082433

Recruitment Status : Completed

First Posted : May 11, 2004

Results First Posted : August 17, 2009

Last Update Posted : November 2, 2020

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Sponsor:

Information provided by:

R-Pharm

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Conditions	Cancer Breast Cancer
Interventions	Drug: Ixabepilone + Capecitabine Drug: Capecitabine
Enrollment	1221

Participant Flow

Recruitment Details
Pre-assignment Details	PLEASE NOTE: Completed=number of participants completing ≥18 cycles of treatment; not completed=number of subjects coming off study treatment prior to completing at least 18 cycles, with specified reasons for coming off study treatment. Participants continued to be followed for overall survival.


Arm/Group Title	Ixabepilone + Capecitabine	Capecitabine
Arm/Group Description	Ixabepilone in combination with cap...	Capecitabine alone: Capecitabine 12...
Arm/Group Description	Ixabepilone in combination with capecitabine (combination group): Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each cycle only, plus oral capecitabine 1000 mg/m2 twice a day (BID) (2000 mg/m2 daily dose) x 14 days, followed by 1 week of rest.	Capecitabine alone: Capecitabine 1250 mg/m2 BID (2500 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
Period Title: Overall Study
Started	609	612
Completed	15 ^[1]	15 ^[1]
Not Completed	594	597
Reason Not Completed
Adverse Event	12	17
Death	8	18
Disease Progression/Relapse	270	388
Physician Decision	50	61
Lost to Follow-up	1	2
Study Drug Toxicity	179	66
Withdrawal by Subject	55	30
Still On Treatment	2	1
Not Treated	12	11
Ineligible	2	1
Noncompliance	2	1
New primary cancer	1	0
Impending surgery	0	1
[1] Participants who received 18 or more cycles of treatment.

Baseline Characteristics

Arm/Group Title		Ixabepilone + Capecitabine	Capecitabine	Total
Arm/Group Description		Ixabepilone in combination with cap...	Capecitabine alone: Capecitabine 12...	Total of all reporting groups
Arm/Group Description		Ixabepilone in combination with capecitabine (combination group): Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each cycle only, plus oral capecitabine 1000 mg/m2 twice a day (BID) (2000 mg/m2 daily dose) x 14 days, followed by 1 week of rest.	Capecitabine alone: Capecitabine 1250 mg/m2 BID (2500 mg/m2 daily dose) x 14 days, followed by 1 week of rest.	Total of all reporting groups
Overall Number of Baseline Participants		609	612	1221
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Customized Measure Type: Number Unit of measure: Participants	Number Analyzed	609 participants	612 participants	1221 participants
<65 years		532	531	1063
≥65 years		77	81	158
<50 years		225	235	460
≥50 years		384	377	761
Age, Continuous Median (Full Range) Unit of measure: Years
	Number Analyzed	609 participants	612 participants	1221 participants
		53.0 (23.0 to 78.0)	53.0 (24.0 to 81.0)	53.0 (23.0 to 81.0)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	609 participants	612 participants	1221 participants
	Female	609 100.0%	612 100.0%	1221 100.0%
	Male	0 0.0%	0 0.0%	0 0.0%
Race/Ethnicity, Customized Measure Type: Number Unit of measure: Participants	Number Analyzed	609 participants	612 participants	1221 participants
American Indian or Alaska Native		1	2	3
Asian		90	69	159
Black or African American		25	21	46
White		480	502	982
Unknown or Not Reported		13	18	31
Karnofsky performance Status ^[1] Measure Type: Number Unit of measure: Units on a scale	Number Analyzed	609 participants	612 participants	1221 participants
100		219	265	484
90		187	188	375
80		151	130	281
70		44	26	70
<70		2	2	4
not reported		6	1	7
		[1] Measure Description: Karnofsky Performance Scale Index measures a patient's functional impairment: 100-80=able to carry on normal activity and work, no special care; 70-50=unable to work; able to live at home and care for most personal needs with assistance; 40=unable to care for self; requires institutional or hospital care. Score reported in multiples of 10.
Menopausal Status Measure Type: Number Unit of measure: Participants	Number Analyzed	609 participants	612 participants	1221 participants
Premenopausal		93	90	183
Perimenopausal		32	32	64
Postmenopausal		475	481	956
Not Reported		9	9	18
Organ Sites Measure Type: Number Unit of measure: Participants	Number Analyzed	609 participants	612 participants	1221 participants
Ascites		13	16	29
Bone		283	287	570
Brain		0	1	1
Breast		41	54	95
Chest Wall Mass		47	38	85
CNS		1	0	1
Cutaneous		64	57	121
Effusion		7	7	14
Intestine		1	1	2
Lymph Node		236	233	469
Mediastinum		54	52	106
Other		17	30	47
Pleura		86	84	170
Subcutaneous		23	24	47
Visceral, Liver		273	276	549
Visceral, Lung		221	217	438
Visceral, Other		24	26	50
Presence with at least 1 lesion Measure Type: Number Unit of measure: Participants
	Number Analyzed	609 participants	612 participants	1221 participants
		606	612	1218

Outcome Measures

1.Primary Outcome


Title	Overall Survival (OS)
Description	Overall survival was defined as the time in months from randomization ...
Description	Overall survival was defined as the time in months from randomization until the date of death. For those patients who had not died, survival duration was censored at the last date the patient was known to be alive. Median OS with 95% CI estimated using the Kaplan-Meier Product Limit Method.
Time Frame	from date of randomization until death

Outcome Measure Data

Analysis Population Description

Analysis was conducted on all randomized patients on an intent to treat basis. This study required at least 846 events (deaths) to ensure the 2-sided, α = 0.05 level, log-rank test to have 90% power to show a statistically significant difference in OS between treatment groups when the hazard ratio (HR) is 0.8.


Arm/Group Title	Ixabepilone + Capecitabine	Capecitabine
Arm/Group Description:	Ixabepilone in combination with cap...	Capecitabine alone: Capecitabine 12...
Arm/Group Description:	Ixabepilone in combination with capecitabine (combination group): Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each cycle only, plus oral capecitabine 1000 mg/m2 twice a day (BID) (2000 mg/m2 daily dose) x 14 days, followed by 1 week of rest.	Capecitabine alone: Capecitabine 1250 mg/m2 BID (2500 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
Overall Number of Participants Analyzed	609	612
Median (95% Confidence Interval) Unit of Measure: months
	16.39 (14.95 to 17.91)	15.64 (13.86 to 17.02)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ixabepilone + Capecitabine, Capecitabine
	Comments	This primary analysis was a comparison between the 2 treatment arms using a 2-sided, α=0.05 level log-rank test (to reject the null hypothesis of equality of survival). The analysis was conducted when 880 deaths (430 in combination:450 in capecitabine) were observed from the 1221 randomized participants.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	.1162
	Comments	The test was stratified by (taxane resistance [yes/no], measurable disease versus non-measurable disease, prior chemotherapy for metastatic disease [yes/no], and anthracycline resistance [yes/no]).
	Method	Log Rank
	Comments	The analysis was conducted at the 0.05 level and no adjustments were performed

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	.90
	Confidence Interval	95% .78 to 1.03
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Ixabepilone + Capecitabine, Capecitabine
	Comments	This prespecified secondary analysis was a Cox model adjusted for age, Karnofsky performance status, number of organ sites, estrogen receptor status, hepatic impairment, time from diagnosis, liver/lung metastases.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	.0231
	Comments	[Not Specified]
	Method	Regression, Cox
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	.85
	Confidence Interval	95% .75 to .98
	Estimation Comments	[Not Specified]

2.Secondary Outcome


Title	Progression-Free Survival (PFS)
Description	PFS was defined for each patient as the time in months from randomizat...
Description	PFS was defined for each patient as the time in months from randomization to the date of progression. Patients who died without a reported prior progression were considered to have progressed on their date of death. Patients who did not progress or die were censored on the date of their last tumor assessment.
Time Frame	every 6 weeks (± 3 days) from randomization while on treatment until documented progression

Outcome Measure Data

Analysis Population Description

All randomized patients with measurable disease as stratified at the time of randomization; n=480 and n=480 for the 2 treatment groups, respectively. Analysis was conducted once 903 progressions or deaths were observed in 960 participants.


Arm/Group Title	Ixabepilone + Capecitabine	Capecitabine
Arm/Group Description:	Ixabepilone in combination with cap...	Capecitabine alone: Capecitabine 12...
Arm/Group Description:	Ixabepilone in combination with capecitabine (combination group): Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each cycle only, plus oral capecitabine 1000 mg/m2 twice a day (BID) (2000 mg/m2 daily dose) x 14 days, followed by 1 week of rest.	Capecitabine alone: Capecitabine 1250 mg/m2 BID (2500 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
Overall Number of Participants Analyzed	480	480
Median (95% Confidence Interval) Unit of Measure: months
	6.24 (5.59 to 6.77)	4.40 (4.14 to 5.42)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ixabepilone + Capecitabine, Capecitabine
	Comments	The analysis was conducted when 903 progressions or deaths (446 in combination:457 in capecitabine) were observed in 960 participants.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	.0005
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	.79
	Confidence Interval	95% .69 to .90
	Estimation Comments	[Not Specified]

3.Secondary Outcome


Title	Response Rate (RR)
Description	RR=number of patients in that group whose best response is "parti...
Description	RR=number of patients in that group whose best response is "partial"(30% decrease in the sum of the longest diameter of target lesions) or "complete" (disappearance of all target lesions), according to the 4-item Response Evaluation Criteria in Solid Tumors (RECIST), divided by the total number of response-evaluable participants
Time Frame	every 6 weeks (± 3 days) from randomization while on treatment until documented progression

Outcome Measure Data

Analysis Population Description

Response-evaluable participants (all treated participants with the correct diagnosis of adenocarcinoma originating in the breast who had measurable disease as determined at baseline).


Arm/Group Title	Ixabepilone + Capecitabine	Capecitabine
Arm/Group Description:	Ixabepilone in combination with cap...	Capecitabine alone: Capecitabine 12...
Arm/Group Description:	Ixabepilone in combination with capecitabine (combination group): Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each cycle only, plus oral capecitabine 1000 mg/m2 twice a day (BID) (2000 mg/m2 daily dose) x 14 days, followed by 1 week of rest.	Capecitabine alone: Capecitabine 1250 mg/m2 BID (2500 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
Overall Number of Participants Analyzed	462	462
Mean (95% Confidence Interval) Unit of Measure: percentage of participants
	43.3 (38.7 to 47.9)	28.8 (24.7 to 33.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ixabepilone + Capecitabine, Capecitabine
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	<.0001
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.89
	Confidence Interval	95% 1.44 to 2.50
	Estimation Comments	[Not Specified]

4.Secondary Outcome


Title	Duration of Response
Description	Measured from the time RECIST criteria (described in previous outcome ...
Description	Measured from the time RECIST criteria (described in previous outcome measure) were first met for "complete" or "partial" response until first date of documented disease progression or death. Patients who neither relapsed nor died were censored on the date of last tumor assessment. Median w/ 95% CI estimated using Kaplan Meier Product Limit Method.
Time Frame	every 6 weeks (± 3 days) from randomization while on treatment until documented progression

Outcome Measure Data

Analysis Population Description

Response-evaluable participants (all treated patients with the correct diagnosis of adenocarcinoma originating in the breast who had measurable disease as determined at baseline)


Arm/Group Title	Ixabepilone + Capecitabine	Capecitabine
Arm/Group Description:	Ixabepilone in combination with cap...	Capecitabine alone: Capecitabine 12...
Arm/Group Description:	Ixabepilone in combination with capecitabine (combination group): Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each cycle only, plus oral capecitabine 1000 mg/m2 twice a day (BID) (2000 mg/m2 daily dose) x 14 days, followed by 1 week of rest.	Capecitabine alone: Capecitabine 1250 mg/m2 BID (2500 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
Overall Number of Participants Analyzed	200	133
Median (95% Confidence Interval) Unit of Measure: Months
	6.1 (5.5 to 7.0)	6.3 (5.3 to 7.6)

5.Secondary Outcome


Title	Time to Response
Description	Time to response was defined as the time from the first dose of study ...
Description	Time to response was defined as the time from the first dose of study therapy until measurement criteria were first met for "partial" or "complete" (whichever status was recorded first) per RECIST criteria (a 4-item scale described in the previous outcome measure).
Time Frame	every 6 weeks (± 3 days) from randomization while on treatment until documented progression

Outcome Measure Data

Analysis Population Description

Response-evaluable participants (all treated patients with the correct diagnosis of adenocarcinoma originating in the breast who had measurable disease as determined at baseline)


Arm/Group Title	Ixabepilone + Capecitabine	Capecitabine
Arm/Group Description:	Ixabepilone in combination with cap...	Capecitabine alone: Capecitabine 12...
Arm/Group Description:	Ixabepilone in combination with capecitabine (combination group): Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each cycle only, plus oral capecitabine 1000 mg/m2 twice a day (BID) (2000 mg/m2 daily dose) x 14 days, followed by 1 week of rest.	Capecitabine alone: Capecitabine 1250 mg/m2 BID (2500 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
Overall Number of Participants Analyzed	200	133
Median (Full Range) Unit of Measure: weeks
	6.6 (4.7 to 47.9)	6.6 (4.6 to 59.4)

6.Secondary Outcome


Title	Treatment-Related Safety Summary
Description	Laboratory values, adverse events, and other symptoms were graded usin...
Description	Laboratory values, adverse events, and other symptoms were graded using the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTC) Version 3.0
Time Frame	safety was assessed on a continual basis every cycle while on-treatment and every 4 weeks post treatment until toxicities resolved or were deemed irreversible.

Outcome Measure Data

Analysis Population Description

All patients who received at least 1 dose of ixabepilone and/or capecitabine. Participants with baseline hepatic impairment (combination arm, n = 50; capecitabine arm, n = 37), defined as Grade ≥2 AST, ALT or Grade ≥1 total bilirubin, were contraindicated due to disproportionate number of toxic deaths observed in study CA163-046.


Arm/Group Title	Ixabepilone + Capecitabine	Capecitabine
Arm/Group Description:	Ixabepilone in combination with cap...	Capecitabine alone: Capecitabine 12...
Arm/Group Description:	Ixabepilone in combination with capecitabine (combination group): Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each cycle only, plus oral capecitabine 1000 mg/m2 twice a day (BID) (2000 mg/m2 daily dose) x 14 days, followed by 1 week of rest.	Capecitabine alone: Capecitabine 1250 mg/m2 BID (2500 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
Overall Number of Participants Analyzed	595	603
Measure Type: Number Unit of Measure: Participants
Deaths within 30 days of last dose	19	42
Treatment-related serious adverse events	125	64
Treatment-related Grade 3-4 adverse events	458	240
Treatment-related AEs leading to discontinuation	286	66

7.Secondary Outcome


Title	Symptom Assessment Score Changes From Baseline for Functional Assessment of Cancer Therapy-Breast Symptom Index (FBSI)
Description	Quality of life, as measured by the FBSI, an 8-item, participant-repor...
Description	Quality of life, as measured by the FBSI, an 8-item, participant-reported instrument to measure symptoms. Each item has 5 possible responses ranging from 0 (not at all) to 4 (very much). The scoring was conducted according to the Functional Assessment of Chronic Illness Therapy manual, Version 4; higher scores reflect fewer symptoms.
Time Frame	Baseline and prior to each 21-day cycle of treatment, and at first posttreatment follow-up assessment

Outcome Measure Data

Analysis Population Description

Analysis was conducted on all randomized participants on an intent to treat basis. (Note: while table only reports data up to 24 wks, which represents most results, statistical analysis includes ALL assessments through study and follow-up; a few participants were assessed after more than 100 weeks.)


Arm/Group Title	Ixabepilone + Capecitabine	Capecitabine
Arm/Group Description:	Ixabepilone in combination with cap...	Capecitabine alone: Capecitabine 12...
Arm/Group Description:	Ixabepilone in combination with capecitabine (combination group): Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each cycle only, plus oral capecitabine 1000 mg/m2 twice a day (BID) (2000 mg/m2 daily dose) x 14 days, followed by 1 week of rest.	Capecitabine alone: Capecitabine 1250 mg/m2 BID (2500 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
Overall Number of Participants Analyzed	609	612
Mean (95% Confidence Interval) Unit of Measure: units on a scale
Week 3 (n=440; n=429)	-0.5 (-0.96 to 0.20)	0.0 (-0.44 to 0.45)
Week 6 (n=379; n=353)	-0.9 (-1.45 to -0.31)	0.5 (0.02 to 1.06)
Week 9 (n=330; n=283)	-1.5 (-2.15 to -0.79)	0.7 (0.06 to 1.24)
Week 12 (n=283; n=250)	-1.4 (-2.06 to -0.64)	1.1 (0.48 to 1.78)
Week 15 (n=255; n=240)	-1.9 (-2.73 to -1.15)	1.5 (0.90 to 2.18)
Week 18 (n=205; n=202)	-1.3 (-2.07 to -0.50)	1.2 (0.41 to 1.89)
Week 21 (n=166; n=185)	-1.4 (-2.36 to -0.37)	1.7 (0.97 to 2.45)
Week 24 (n=149; n=141)	-1.4 (-2.46 to -0.41)	1.1 (0.19 to 1.96)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ixabepilone + Capecitabine, Capecitabine
	Comments	There was a statistically significant difference between groups in change from baseline FBSI score favoring capecitabine. A mean change from baseline of 2.5 was considered a clinically meaningful difference (minimally important difference or MID). On-treatment mean changes in the FBSI did not reach the MID in either group.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Wei-Lachin
	Comments	[Not Specified]

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	Capecitabine	Ixabepilone + Capecitabine
Arm/Group Description	[Not Specified]	[Not Specified]
Arm/Group Description	[Not Specified]	[Not Specified]
All-Cause Mortality
	Capecitabine	Ixabepilone + Capecitabine
	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--
Serious Adverse Events Serious Adverse Events
	Capecitabine	Ixabepilone + Capecitabine
	Affected / at Risk (%)	Affected / at Risk (%)
Total	192/603 (31.84%)	205/595 (34.45%)
Blood and lymphatic system disorders
ANAEMIA ^† 1	5/603 (0.83%)	7/595 (1.18%)
LEUKOPENIA ^† 1	1/603 (0.17%)	8/595 (1.34%)
NEUTROPENIA ^† 1	8/603 (1.33%)	18/595 (3.03%)
LYMPH NODE PAIN ^† 1	0/603 (0.00%)	1/595 (0.17%)
THROMBOCYTOPENIA ^† 1	3/603 (0.50%)	4/595 (0.67%)
FEBRILE NEUTROPENIA ^† 1	5/603 (0.83%)	34/595 (5.71%)
Cardiac disorders
PERICARDITIS ^† 1	1/603 (0.17%)	0/595 (0.00%)
ANGINA UNSTABLE ^† 1	0/603 (0.00%)	1/595 (0.17%)
CARDIAC FAILURE ^† 1	0/603 (0.00%)	1/595 (0.17%)
SINUS TACHYCARDIA ^† 1	0/603 (0.00%)	2/595 (0.34%)
ATRIAL FIBRILLATION ^† 1	2/603 (0.33%)	0/595 (0.00%)
PERICARDIAL EFFUSION ^† 1	4/603 (0.66%)	0/595 (0.00%)
ACUTE CORONARY SYNDROME ^† 1	1/603 (0.17%)	0/595 (0.00%)
CARDIO-RESPIRATORY ARREST ^† 1	1/603 (0.17%)	1/595 (0.17%)
VENTRICULAR EXTRASYSTOLES ^† 1	0/603 (0.00%)	1/595 (0.17%)
CARDIAC FAILURE CONGESTIVE ^† 1	1/603 (0.17%)	0/595 (0.00%)
Ear and labyrinth disorders
VERTIGO ^† 1	0/603 (0.00%)	1/595 (0.17%)
Eye disorders
EYE PAIN ^† 1	1/603 (0.17%)	0/595 (0.00%)
ECTROPION ^† 1	0/603 (0.00%)	1/595 (0.17%)
EYELID PTOSIS ^† 1	1/603 (0.17%)	0/595 (0.00%)
VISUAL DISTURBANCE ^† 1	0/603 (0.00%)	1/595 (0.17%)
BLINDNESS UNILATERAL ^† 1	0/603 (0.00%)	1/595 (0.17%)
ULCERATIVE KERATITIS ^† 1	1/603 (0.17%)	0/595 (0.00%)
Gastrointestinal disorders
ILEUS ^† 1	1/603 (0.17%)	0/595 (0.00%)
NAUSEA ^† 1	7/603 (1.16%)	12/595 (2.02%)
ASCITES ^† 1	1/603 (0.17%)	0/595 (0.00%)
COLITIS ^† 1	1/603 (0.17%)	0/595 (0.00%)
VOMITING ^† 1	17/603 (2.82%)	24/595 (4.03%)
DIARRHOEA ^† 1	33/603 (5.47%)	23/595 (3.87%)
GASTRITIS ^† 1	1/603 (0.17%)	0/595 (0.00%)
STOMATITIS ^† 1	2/603 (0.33%)	5/595 (0.84%)
CONSTIPATION ^† 1	2/603 (0.33%)	6/595 (1.01%)
HAEMORRHOIDS ^† 1	0/603 (0.00%)	1/595 (0.17%)
OESOPHAGITIS ^† 1	0/603 (0.00%)	2/595 (0.34%)
ABDOMINAL PAIN ^† 1	3/603 (0.50%)	7/595 (1.18%)
PANCREATIC CYST ^† 1	1/603 (0.17%)	0/595 (0.00%)
MOUTH ULCERATION ^† 1	1/603 (0.17%)	0/595 (0.00%)
GASTRITIS EROSIVE ^† 1	0/603 (0.00%)	1/595 (0.17%)
ABDOMINAL PAIN UPPER ^† 1	1/603 (0.17%)	1/595 (0.17%)
GASTROINTESTINAL PAIN ^† 1	1/603 (0.17%)	0/595 (0.00%)
INTESTINAL OBSTRUCTION ^† 1	2/603 (0.33%)	0/595 (0.00%)
UPPER GASTROINTESTINAL HAEMORRHAGE ^† 1	1/603 (0.17%)	0/595 (0.00%)
General disorders
PAIN ^† 1	2/603 (0.33%)	3/595 (0.50%)
FATIGUE ^† 1	6/603 (1.00%)	8/595 (1.34%)
PYREXIA ^† 1	8/603 (1.33%)	6/595 (1.01%)
ASTHENIA ^† 1	2/603 (0.33%)	1/595 (0.17%)
CHEST PAIN ^† 1	2/603 (0.33%)	1/595 (0.17%)
HYPOTHERMIA ^† 1	0/603 (0.00%)	1/595 (0.17%)
SUDDEN DEATH ^† 1	1/603 (0.17%)	1/595 (0.17%)
EXTRAVASATION ^† 1	0/603 (0.00%)	1/595 (0.17%)
CATHETER THROMBOSIS ^† 1	1/603 (0.17%)	0/595 (0.00%)
MULTI-ORGAN FAILURE ^† 1	0/603 (0.00%)	1/595 (0.17%)
CATHETER SITE OEDEMA ^† 1	0/603 (0.00%)	1/595 (0.17%)
MUCOSAL INFLAMMATION ^† 1	4/603 (0.66%)	6/595 (1.01%)
INJECTION SITE EXTRAVASATION ^† 1	0/603 (0.00%)	1/595 (0.17%)
PERFORMANCE STATUS DECREASED ^† 1	1/603 (0.17%)	0/595 (0.00%)
GENERAL PHYSICAL HEALTH DETERIORATION ^† 1	4/603 (0.66%)	5/595 (0.84%)
Hepatobiliary disorders
CHOLANGITIS ^† 1	1/603 (0.17%)	0/595 (0.00%)
HEPATIC PAIN ^† 1	1/603 (0.17%)	0/595 (0.00%)
CHOLELITHIASIS ^† 1	1/603 (0.17%)	0/595 (0.00%)
HEPATIC FAILURE ^† 1	3/603 (0.50%)	2/595 (0.34%)
CHOLECYSTITIS ACUTE ^† 1	1/603 (0.17%)	0/595 (0.00%)
HYPERBILIRUBINAEMIA ^† 1	2/603 (0.33%)	0/595 (0.00%)
PORTAL VEIN THROMBOSIS ^† 1	0/603 (0.00%)	1/595 (0.17%)
Immune system disorders
HYPERSENSITIVITY ^† 1	0/603 (0.00%)	4/595 (0.67%)
Infections and infestations
SEPSIS ^† 1	3/603 (0.50%)	6/595 (1.01%)
EMPYEMA ^† 1	1/603 (0.17%)	0/595 (0.00%)
CYSTITIS ^† 1	1/603 (0.17%)	1/595 (0.17%)
INFECTION ^† 1	4/603 (0.66%)	4/595 (0.67%)
PNEUMONIA ^† 1	5/603 (0.83%)	6/595 (1.01%)
CELLULITIS ^† 1	1/603 (0.17%)	3/595 (0.50%)
ERYSIPELAS ^† 1	1/603 (0.17%)	0/595 (0.00%)
MENINGITIS ^† 1	0/603 (0.00%)	1/595 (0.17%)
PARONYCHIA ^† 1	0/603 (0.00%)	1/595 (0.17%)
ABSCESS LIMB ^† 1	1/603 (0.17%)	0/595 (0.00%)
LYMPHANGITIS ^† 1	1/603 (0.17%)	0/595 (0.00%)
SEPTIC SHOCK ^† 1	1/603 (0.17%)	2/595 (0.34%)
TUBERCULOSIS ^† 1	1/603 (0.17%)	1/595 (0.17%)
FUNGAL SEPSIS ^† 1	1/603 (0.17%)	0/595 (0.00%)
NAIL INFECTION ^† 1	0/603 (0.00%)	1/595 (0.17%)
GASTROENTERITIS ^† 1	2/603 (0.33%)	1/595 (0.17%)
LOBAR PNEUMONIA ^† 1	0/603 (0.00%)	1/595 (0.17%)
WOUND INFECTION ^† 1	3/603 (0.50%)	1/595 (0.17%)
BRONCHOPNEUMONIA ^† 1	1/603 (0.17%)	0/595 (0.00%)
NEUTROPENIC SEPSIS ^† 1	0/603 (0.00%)	1/595 (0.17%)
VAGINAL CELLULITIS ^† 1	1/603 (0.17%)	0/595 (0.00%)
ABDOMINAL INFECTION ^† 1	1/603 (0.17%)	0/595 (0.00%)
ANORECTAL INFECTION ^† 1	0/603 (0.00%)	1/595 (0.17%)
BACTERIAL INFECTION ^† 1	0/603 (0.00%)	1/595 (0.17%)
LOCALISED INFECTION ^† 1	0/603 (0.00%)	1/595 (0.17%)
NEUTROPENIC INFECTION ^† 1	0/603 (0.00%)	1/595 (0.17%)
PNEUMONIA STREPTOCOCCAL ^† 1	1/603 (0.17%)	0/595 (0.00%)
URINARY TRACT INFECTION ^† 1	0/603 (0.00%)	1/595 (0.17%)
CATHETER RELATED INFECTION ^† 1	3/603 (0.50%)	4/595 (0.67%)
GASTROINTESTINAL INFECTION ^† 1	0/603 (0.00%)	1/595 (0.17%)
RESPIRATORY TRACT INFECTION ^† 1	1/603 (0.17%)	0/595 (0.00%)
GASTROENTERITIS NORWALK VIRUS ^† 1	1/603 (0.17%)	0/595 (0.00%)
LOWER RESPIRATORY TRACT INFECTION ^† 1	1/603 (0.17%)	2/595 (0.34%)
UPPER RESPIRATORY TRACT INFECTION ^† 1	0/603 (0.00%)	1/595 (0.17%)
Injury, poisoning and procedural complications
FRACTURE ^† 1	1/603 (0.17%)	4/595 (0.67%)
OVERDOSE ^† 1	1/603 (0.17%)	7/595 (1.18%)
DRUG TOXICITY ^† 1	1/603 (0.17%)	0/595 (0.00%)
ANKLE FRACTURE ^† 1	0/603 (0.00%)	1/595 (0.17%)
FEMUR FRACTURE ^† 1	0/603 (0.00%)	3/595 (0.50%)
TIBIA FRACTURE ^† 1	1/603 (0.17%)	0/595 (0.00%)
WRIST FRACTURE ^† 1	0/603 (0.00%)	1/595 (0.17%)
FIBULA FRACTURE ^† 1	1/603 (0.17%)	0/595 (0.00%)
PELVIC FRACTURE ^† 1	1/603 (0.17%)	0/595 (0.00%)
INCISIONAL HERNIA ^† 1	1/603 (0.17%)	0/595 (0.00%)
LOWER LIMB FRACTURE ^† 1	0/603 (0.00%)	1/595 (0.17%)
PUBIC RAMI FRACTURE ^† 1	1/603 (0.17%)	0/595 (0.00%)
TRACHEAL OBSTRUCTION ^† 1	0/603 (0.00%)	1/595 (0.17%)
TRANSFUSION REACTION ^† 1	0/603 (0.00%)	1/595 (0.17%)
FEMORAL NECK FRACTURE ^† 1	1/603 (0.17%)	0/595 (0.00%)
PROCEDURAL COMPLICATION ^† 1	0/603 (0.00%)	1/595 (0.17%)
LUMBAR VERTEBRAL FRACTURE ^† 1	1/603 (0.17%)	0/595 (0.00%)
Investigations
DIAGNOSTIC PROCEDURE ^† 1	1/603 (0.17%)	0/595 (0.00%)
HAEMOGLOBIN DECREASED ^† 1	0/603 (0.00%)	1/595 (0.17%)
BLOOD ALBUMIN DECREASED ^† 1	0/603 (0.00%)	1/595 (0.17%)
PLATELET COUNT DECREASED ^† 1	2/603 (0.33%)	2/595 (0.34%)
BLOOD PHOSPHORUS INCREASED ^† 1	0/603 (0.00%)	1/595 (0.17%)
NEUTROPHIL COUNT DECREASED ^† 1	0/603 (0.00%)	3/595 (0.50%)
PROTHROMBIN TIME PROLONGED ^† 1	1/603 (0.17%)	0/595 (0.00%)
WHITE BLOOD CELL COUNT DECREASED ^† 1	0/603 (0.00%)	3/595 (0.50%)
ALANINE AMINOTRANSFERASE INCREASED ^† 1	2/603 (0.33%)	0/595 (0.00%)
ASPARTATE AMINOTRANSFERASE INCREASED ^† 1	1/603 (0.17%)	1/595 (0.17%)
Metabolism and nutrition disorders
ANOREXIA ^† 1	5/603 (0.83%)	2/595 (0.34%)
DEHYDRATION ^† 1	7/603 (1.16%)	7/595 (1.18%)
HYPOKALAEMIA ^† 1	1/603 (0.17%)	2/595 (0.34%)
HYPERKALAEMIA ^† 1	1/603 (0.17%)	0/595 (0.00%)
HYPOGLYCAEMIA ^† 1	1/603 (0.17%)	1/595 (0.17%)
HYPONATRAEMIA ^† 1	1/603 (0.17%)	1/595 (0.17%)
HYPERCALCAEMIA ^† 1	1/603 (0.17%)	0/595 (0.00%)
HYPERGLYCAEMIA ^† 1	1/603 (0.17%)	0/595 (0.00%)
Musculoskeletal and connective tissue disorders
MYALGIA ^† 1	1/603 (0.17%)	2/595 (0.34%)
BACK PAIN ^† 1	2/603 (0.33%)	1/595 (0.17%)
BONE PAIN ^† 1	4/603 (0.66%)	3/595 (0.50%)
ARTHRALGIA ^† 1	2/603 (0.33%)	3/595 (0.50%)
FLANK PAIN ^† 1	1/603 (0.17%)	0/595 (0.00%)
PAIN IN EXTREMITY ^† 1	0/603 (0.00%)	1/595 (0.17%)
MUSCULOSKELETAL PAIN ^† 1	1/603 (0.17%)	2/595 (0.34%)
PATHOLOGICAL FRACTURE ^† 1	2/603 (0.33%)	0/595 (0.00%)
MUSCULOSKELETAL CHEST PAIN ^† 1	1/603 (0.17%)	0/595 (0.00%)
SYSTEMIC LUPUS ERYTHEMATOSUS ^† 1	0/603 (0.00%)	2/595 (0.34%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
TUMOUR PAIN ^† 1	2/603 (0.33%)	3/595 (0.50%)
COLON CANCER ^† 1	0/603 (0.00%)	1/595 (0.17%)
BREAST CANCER ^† 1	1/603 (0.17%)	1/595 (0.17%)
BREAST NEOPLASM ^† 1	1/603 (0.17%)	0/595 (0.00%)
MALIGNANT ASCITES ^† 1	2/603 (0.33%)	0/595 (0.00%)
MALIGNANT MELANOMA ^† 1	1/603 (0.17%)	0/595 (0.00%)
METASTASES TO BONE ^† 1	0/603 (0.00%)	1/595 (0.17%)
METASTASES TO LUNG ^† 1	0/603 (0.00%)	1/595 (0.17%)
BREAST CANCER METASTATIC ^† 1	1/603 (0.17%)	0/595 (0.00%)
MALIGNANT PLEURAL EFFUSION ^† 1	11/603 (1.82%)	5/595 (0.84%)
MALIGNANT NEOPLASM PROGRESSION ^† 1	43/603 (7.13%)	17/595 (2.86%)
PERICARDIAL EFFUSION MALIGNANT ^† 1	1/603 (0.17%)	0/595 (0.00%)
METASTASES TO CENTRAL NERVOUS SYSTEM ^† 1	4/603 (0.66%)	4/595 (0.67%)
Nervous system disorders
ATAXIA ^† 1	1/603 (0.17%)	0/595 (0.00%)
SYNCOPE ^† 1	1/603 (0.17%)	1/595 (0.17%)
DYSTONIA ^† 1	0/603 (0.00%)	1/595 (0.17%)
EPILEPSY ^† 1	0/603 (0.00%)	1/595 (0.17%)
HEADACHE ^† 1	3/603 (0.50%)	2/595 (0.34%)
DIZZINESS ^† 1	6/603 (1.00%)	0/595 (0.00%)
NEURALGIA ^† 1	0/603 (0.00%)	1/595 (0.17%)
CONVULSION ^† 1	0/603 (0.00%)	2/595 (0.34%)
MONOPLEGIA ^† 1	1/603 (0.17%)	0/595 (0.00%)
SOMNOLENCE ^† 1	1/603 (0.17%)	0/595 (0.00%)
HEMIPARESIS ^† 1	1/603 (0.17%)	1/595 (0.17%)
PARAESTHESIA ^† 1	0/603 (0.00%)	1/595 (0.17%)
HYPOAESTHESIA ^† 1	0/603 (0.00%)	1/595 (0.17%)
ENCEPHALOPATHY ^† 1	1/603 (0.17%)	0/595 (0.00%)
POLYNEUROPATHY ^† 1	0/603 (0.00%)	1/595 (0.17%)
CEREBRAL ISCHAEMIA ^† 1	1/603 (0.17%)	1/595 (0.17%)
AUTONOMIC NEUROPATHY ^† 1	0/603 (0.00%)	1/595 (0.17%)
TRANSIENT ISCHAEMIC ATTACK ^† 1	0/603 (0.00%)	1/595 (0.17%)
PERIPHERAL MOTOR NEUROPATHY ^† 1	1/603 (0.17%)	3/595 (0.50%)
DEMYELINATING POLYNEUROPATHY ^† 1	0/603 (0.00%)	1/595 (0.17%)
PERIPHERAL SENSORY NEUROPATHY ^† 1	0/603 (0.00%)	6/595 (1.01%)
DEPRESSED LEVEL OF CONSCIOUSNESS ^† 1	0/603 (0.00%)	1/595 (0.17%)
Psychiatric disorders
DEPRESSED MOOD ^† 1	1/603 (0.17%)	0/595 (0.00%)
CONFUSIONAL STATE ^† 1	4/603 (0.66%)	2/595 (0.34%)
Renal and urinary disorders
DYSURIA ^† 1	0/603 (0.00%)	1/595 (0.17%)
OLIGURIA ^† 1	0/603 (0.00%)	1/595 (0.17%)
RENAL ATROPHY ^† 1	1/603 (0.17%)	0/595 (0.00%)
RENAL FAILURE ^† 1	3/603 (0.50%)	0/595 (0.00%)
HYDRONEPHROSIS ^† 1	1/603 (0.17%)	0/595 (0.00%)
RENAL FAILURE ACUTE ^† 1	1/603 (0.17%)	0/595 (0.00%)
CYSTITIS HAEMORRHAGIC ^† 1	0/603 (0.00%)	1/595 (0.17%)
Reproductive system and breast disorders
VAGINAL HAEMORRHAGE ^† 1	0/603 (0.00%)	1/595 (0.17%)
Respiratory, thoracic and mediastinal disorders
COUGH ^† 1	2/603 (0.33%)	0/595 (0.00%)
HYPOXIA ^† 1	1/603 (0.17%)	0/595 (0.00%)
DYSPNOEA ^† 1	25/603 (4.15%)	10/595 (1.68%)
EPISTAXIS ^† 1	1/603 (0.17%)	0/595 (0.00%)
ALVEOLITIS ^† 1	1/603 (0.17%)	0/595 (0.00%)
PNEUMONITIS ^† 1	0/603 (0.00%)	1/595 (0.17%)
PNEUMOTHORAX ^† 1	1/603 (0.17%)	3/595 (0.50%)
LUNG DISORDER ^† 1	2/603 (0.33%)	0/595 (0.00%)
PLEURITIC PAIN ^† 1	1/603 (0.17%)	2/595 (0.34%)
PLEURAL EFFUSION ^† 1	13/603 (2.16%)	7/595 (1.18%)
PULMONARY OEDEMA ^† 1	2/603 (0.33%)	0/595 (0.00%)
PULMONARY EMBOLISM ^† 1	3/603 (0.50%)	5/595 (0.84%)
RESPIRATORY FAILURE ^† 1	3/603 (0.50%)	1/595 (0.17%)
ACUTE RESPIRATORY FAILURE ^† 1	1/603 (0.17%)	0/595 (0.00%)
ACUTE RESPIRATORY DISTRESS SYNDROME ^† 1	1/603 (0.17%)	0/595 (0.00%)
Skin and subcutaneous tissue disorders
RASH ^† 1	1/603 (0.17%)	3/595 (0.50%)
BLISTER ^† 1	0/603 (0.00%)	1/595 (0.17%)
PURPURA ^† 1	1/603 (0.17%)	0/595 (0.00%)
ERYTHEMA ^† 1	0/603 (0.00%)	1/595 (0.17%)
DERMATITIS ^† 1	0/603 (0.00%)	1/595 (0.17%)
SKIN ULCER ^† 1	0/603 (0.00%)	1/595 (0.17%)
SKIN LESION ^† 1	0/603 (0.00%)	1/595 (0.17%)
NAIL DISORDER ^† 1	0/603 (0.00%)	1/595 (0.17%)
SKIN REACTION ^† 1	0/603 (0.00%)	1/595 (0.17%)
SWELLING FACE ^† 1	1/603 (0.17%)	0/595 (0.00%)
EXFOLIATIVE RASH ^† 1	0/603 (0.00%)	2/595 (0.34%)
SKIN EXFOLIATION ^† 1	0/603 (0.00%)	1/595 (0.17%)
SKIN DISCOLOURATION ^† 1	0/603 (0.00%)	1/595 (0.17%)
DERMATITIS EXFOLIATIVE ^† 1	0/603 (0.00%)	1/595 (0.17%)
STEVENS-JOHNSON SYNDROME ^† 1	1/603 (0.17%)	0/595 (0.00%)
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME ^† 1	3/603 (0.50%)	5/595 (0.84%)
Surgical and medical procedures
CATHETER PLACEMENT ^† 1	1/603 (0.17%)	0/595 (0.00%)
CENTRAL VENOUS CATHETERISATION ^† 1	0/603 (0.00%)	3/595 (0.50%)
Vascular disorders
SHOCK ^† 1	1/603 (0.17%)	0/595 (0.00%)
PHLEBITIS ^† 1	0/603 (0.00%)	1/595 (0.17%)
THROMBOSIS ^† 1	2/603 (0.33%)	2/595 (0.34%)
HYPOTENSION ^† 1	1/603 (0.17%)	4/595 (0.67%)
LYMPHOEDEMA ^† 1	1/603 (0.17%)	0/595 (0.00%)
HYPERTENSION ^† 1	0/603 (0.00%)	1/595 (0.17%)
THROMBOPHLEBITIS ^† 1	1/603 (0.17%)	0/595 (0.00%)
VENOUS THROMBOSIS ^† 1	0/603 (0.00%)	1/595 (0.17%)
DEEP VEIN THROMBOSIS ^† 1	6/603 (1.00%)	3/595 (0.50%)
VENOUS THROMBOSIS LIMB ^† 1	1/603 (0.17%)	0/595 (0.00%)
JUGULAR VEIN THROMBOSIS ^† 1	1/603 (0.17%)	0/595 (0.00%)
† Indicates events were collected by systematic assessment 1 Term from vocabulary, MedDRA 10.1
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Capecitabine	Ixabepilone + Capecitabine
	Affected / at Risk (%)	Affected / at Risk (%)
Total	564/603 (93.53%)	590/595 (99.16%)
Blood and lymphatic system disorders
ANAEMIA ^† 1	44/603 (7.30%)	69/595 (11.60%)
LEUKOPENIA ^† 1	28/603 (4.64%)	85/595 (14.29%)
NEUTROPENIA ^† 1	49/603 (8.13%)	159/595 (26.72%)
Gastrointestinal disorders
NAUSEA ^† 1	243/603 (40.30%)	315/595 (52.94%)
VOMITING ^† 1	168/603 (27.86%)	250/595 (42.02%)
DIARRHOEA ^† 1	244/603 (40.46%)	266/595 (44.71%)
DYSPEPSIA ^† 1	45/603 (7.46%)	51/595 (8.57%)
STOMATITIS ^† 1	68/603 (11.28%)	118/595 (19.83%)
CONSTIPATION ^† 1	73/603 (12.11%)	161/595 (27.06%)
ABDOMINAL PAIN ^† 1	77/603 (12.77%)	88/595 (14.79%)
ABDOMINAL PAIN UPPER ^† 1	47/603 (7.79%)	55/595 (9.24%)
General disorders
PAIN ^† 1	20/603 (3.32%)	32/595 (5.38%)
FATIGUE ^† 1	166/603 (27.53%)	272/595 (45.71%)
PYREXIA ^† 1	66/603 (10.95%)	84/595 (14.12%)
ASTHENIA ^† 1	72/603 (11.94%)	128/595 (21.51%)
OEDEMA PERIPHERAL ^† 1	43/603 (7.13%)	63/595 (10.59%)
MUCOSAL INFLAMMATION ^† 1	53/603 (8.79%)	79/595 (13.28%)
Investigations
WEIGHT DECREASED ^† 1	104/603 (17.25%)	194/595 (32.61%)
WEIGHT INCREASED ^† 1	47/603 (7.79%)	26/595 (4.37%)
HAEMOGLOBIN DECREASED ^† 1	22/603 (3.65%)	44/595 (7.39%)
PLATELET COUNT DECREASED ^† 1	13/603 (2.16%)	33/595 (5.55%)
NEUTROPHIL COUNT DECREASED ^† 1	21/603 (3.48%)	67/595 (11.26%)
WHITE BLOOD CELL COUNT DECREASED ^† 1	13/603 (2.16%)	44/595 (7.39%)
Metabolism and nutrition disorders
ANOREXIA ^† 1	99/603 (16.42%)	183/595 (30.76%)
Musculoskeletal and connective tissue disorders
MYALGIA ^† 1	22/603 (3.65%)	146/595 (24.54%)
BACK PAIN ^† 1	62/603 (10.28%)	70/595 (11.76%)
BONE PAIN ^† 1	45/603 (7.46%)	55/595 (9.24%)
ARTHRALGIA ^† 1	30/603 (4.98%)	119/595 (20.00%)
MUSCULAR WEAKNESS ^† 1	5/603 (0.83%)	30/595 (5.04%)
PAIN IN EXTREMITY ^† 1	56/603 (9.29%)	112/595 (18.82%)
MUSCULOSKELETAL PAIN ^† 1	37/603 (6.14%)	85/595 (14.29%)
Nervous system disorders
HEADACHE ^† 1	73/603 (12.11%)	97/595 (16.30%)
DIZZINESS ^† 1	50/603 (8.29%)	69/595 (11.60%)
DYSGEUSIA ^† 1	14/603 (2.32%)	67/595 (11.26%)
HYPOREFLEXIA ^† 1	17/603 (2.82%)	37/595 (6.22%)
PARAESTHESIA ^† 1	45/603 (7.46%)	115/595 (19.33%)
NEUROPATHY PERIPHERAL ^† 1	12/603 (1.99%)	46/595 (7.73%)
PERIPHERAL MOTOR NEUROPATHY ^† 1	23/603 (3.81%)	56/595 (9.41%)
PERIPHERAL SENSORY NEUROPATHY ^† 1	64/603 (10.61%)	258/595 (43.36%)
Psychiatric disorders
INSOMNIA ^† 1	37/603 (6.14%)	84/595 (14.12%)
Respiratory, thoracic and mediastinal disorders
COUGH ^† 1	68/603 (11.28%)	89/595 (14.96%)
DYSPNOEA ^† 1	84/603 (13.93%)	99/595 (16.64%)
Skin and subcutaneous tissue disorders
RASH ^† 1	25/603 (4.15%)	68/595 (11.43%)
ALOPECIA ^† 1	20/603 (3.32%)	245/595 (41.18%)
DRY SKIN ^† 1	39/603 (6.47%)	51/595 (8.57%)
ERYTHEMA ^† 1	12/603 (1.99%)	34/595 (5.71%)
PRURITUS ^† 1	17/603 (2.82%)	31/595 (5.21%)
NAIL DISORDER ^† 1	77/603 (12.77%)	193/595 (32.44%)
SKIN HYPERPIGMENTATION ^† 1	75/603 (12.44%)	79/595 (13.28%)
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME ^† 1	412/603 (68.33%)	383/595 (64.37%)
† Indicates events were collected by systematic assessment 1 Term from vocabulary, MedDRA 10.1

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Bristol-Myers Squibb Study Director
Organization:	Bristol-Myers Squibb
EMail:	Clinical.Trials@bms.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Wedam SB, Beaver JA, Amiri-Kordestani L, Bloomquist E, Tang S, Goldberg KB, Sridhara R, Ibrahim A, Kim G, Kluetz P, McKee A, Pazdur R. US Food and Drug Administration Pooled Analysis to Assess the Impact of Bone-Only Metastatic Breast Cancer on Clinical Trial Outcomes and Radiographic Assessments. J Clin Oncol. 2018 Apr 20;36(12):1225-1231. doi: 10.1200/JCO.2017.74.6917. Epub 2018 Mar 9.

Vahdat LT, Vrdoljak E, Gomez H, Li RK, Bosserman L, Sparano JA, Baselga J, Mukhopadhyay P, Valero V. Efficacy and safety of ixabepilone plus capecitabine in elderly patients with anthracycline- and taxane-pretreated metastatic breast cancer. J Geriatr Oncol. 2013 Oct;4(4):346-52. doi: 10.1016/j.jgo.2013.07.006. Epub 2013 Aug 23.

Jassem J, Fein L, Karwal M, Campone M, Peck R, Poulart V, Vahdat L. Ixabepilone plus capecitabine in advanced breast cancer patients with early relapse after adjuvant anthracyclines and taxanes: a pooled subset analysis of two phase III studies. Breast. 2012 Feb;21(1):89-94. doi: 10.1016/j.breast.2011.09.003. Epub 2011 Sep 21.

Roche H, Conte P, Perez EA, Sparano JA, Xu B, Jassem J, Peck R, Kelleher T, Hortobagyi GN. Ixabepilone plus capecitabine in metastatic breast cancer patients with reduced performance status previously treated with anthracyclines and taxanes: a pooled analysis by performance status of efficacy and safety data from 2 phase III studies. Breast Cancer Res Treat. 2011 Feb;125(3):755-65. doi: 10.1007/s10549-010-1251-y. Epub 2010 Dec 3.

Layout table for additonal information

Responsible Party:	Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00082433
Other Study ID Numbers:	CA163-048
First Submitted:	May 7, 2004
First Posted:	May 11, 2004
Results First Submitted:	May 1, 2009
Results First Posted:	August 17, 2009
Last Update Posted:	November 2, 2020

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