Novel Epothilone Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer

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ClinicalTrials.gov Identifier: NCT00080301

Recruitment Status : Completed

First Posted : March 30, 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	Breast Cancer Metastases
Interventions	Drug: Ixabepilone + Capecitabine Drug: Capecitabine
Enrollment	752

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	Ixabepilone + Capecitabine	Capecitabine
Arm/Group Description	Ixabepilone 40 mg/m2 administered a...	Capecitabine 1250 mg/m2 BID x 14 da...
Arm/Group Description	Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each 21-day cycle, plus oral capecitabine 1000 mg/m2 twice a day (BID) x 14 days	Capecitabine 1250 mg/m2 BID x 14 days
Period Title: Overall Study
Started	375	377
Never Treated	5	10
Still on Treatment	0	1
Completed	370 ^[1]	366 ^[1]
Not Completed	5	11
Reason Not Completed
Randomized but Never Treated	5	10
Still on Treatment as of CSR date	0	1
[1] Participants who are off treatment

Baseline Characteristics

Arm/Group Title		Ixabepilone + Capecitabine	Capecitabine	Total
Arm/Group Description		Ixabepilone 40 mg/m2 administered a...	Capecitabine 1250 mg/m2 BID x 14 da...	Total of all reporting groups
Arm/Group Description		Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each 21-day cycle, plus oral capecitabine 1000 mg/m2 twice a day (BID) x 14 days	Capecitabine 1250 mg/m2 BID x 14 days	Total of all reporting groups
Overall Number of Baseline Participants		375	377	752
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Customized Measure Type: Number Unit of measure: Participants	Number Analyzed	375 participants	377 participants	752 participants
<65 years		336	322	658
>= 65 years		39	54	93
<50 years		135	145	280
>= 50 years		240	231	471
Unknown		0	1	1
Age, Continuous Median (Full Range) Unit of measure: Years
	Number Analyzed	375 participants	377 participants	752 participants
		53.0 (25.0 to 76.0)	52.0 (25.0 to 79.0)	53.0 (25.0 to 79.0)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	375 participants	377 participants	752 participants
	Female	375 100.0%	376 99.7%	751 99.9%
	Male	0 0.0%	1 0.3%	1 0.1%
Race/Ethnicity, Customized Measure Type: Number Unit of measure: Participants	Number Analyzed	375 participants	377 participants	752 participants
American Indian or Alaska Native		1	0	1
Asian		83	87	170
Black or African American		11	11	22
White		257	247	504
Other		23	32	55
Disease Sites Measure Type: Number Unit of measure: Participants	Number Analyzed	375 participants	377 participants	752 participants
Ascites		14	14	28
Bone		168	162	330
Breast		61	63	124
Chest Wall		53	53	106
Effusion		57	55	112
Lymph Node		250	249	499
Other		20	18	38
Peritoneum		7	14	21
Pleura		29	35	64
Skin/Soft Tissue		60	62	122
Visceral, Liver		245	228	473
Visceral, Lung		180	174	354
Visceral, Other		34	28	62
Disease Sites at Baseline Measure Type: Number Unit of measure: Participants	Number Analyzed	375 participants	377 participants	752 participants
Liver ± Lung ± Skin/Soft Tissue ± Bone		245	228	473
Lung ± Skin/Soft Tissue ± Bone		71	87	158
Skin/Soft Tissue ± Bone		49	52	101
Bone		0	3	3
Other		6	5	11
Karnofsky Performance Status ^[1] Measure Type: Number Unit of measure: Units on a scale	Number Analyzed	375 participants	377 participants	752 participants
100		108	105	213
90		145	132	277
80		86	102	188
70		33	34	67
<70		0	1	1
Not reported		3	3	6
		[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; 40-0=Unable to care for self; institutional or hospital care needed. Score reported in multiples of 10.
Menopausal Status Measure Type: Number Unit of measure: Participants	Number Analyzed	375 participants	377 participants	752 participants
Premenopausal		54	51	105
Perimenopausal		19	23	42
Postmenopausal		288	289	577
Not reported		14	14	28
Number of Disease Sites Measure Type: Number Unit of measure: Participants	Number Analyzed	375 participants	377 participants	752 participants
1 disease site		39	34	73
2 disease sites		85	98	183
3 disease sites		110	121	231
4 disease sites		79	69	148
≥5 disease sites		58	53	111
Presence of All Lesions Measure Type: Number Unit of measure: Participants	Number Analyzed	375 participants	377 participants	752 participants
Subjects with at least 1 lesion		371	375	746
Subjects with no lesions		4	2	6
Visceral Disease in Liver and/or Lung Measure Type: Number Unit of measure: Participants	Number Analyzed	375 participants	377 participants	752 participants
Yes		316	315	631
No		55	60	115
Missing		4	2	6

Outcome Measures

1.Primary Outcome


Title	Progression-free Survival (PFS) Per Independent Radiology Review Committee (IRRC)
Description	PFS defined as the time in months from randomization to date of progre...
Description	PFS defined as the time in months from randomization to date of progression. Patients who died without a reported prior progression were considered to have progressed on date of death; those who didn't progress or die were censored on date of last tumor assessment. Median PFS time with 95% CI estimated using the Kaplan Meier product limit method.
Time Frame	based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity

Outcome Measure Data

Analysis Population Description

PFS was analyzed on all randomized patients on an intention to treat basis.


Arm/Group Title	Ixabepilone + Capecitabine	Capecitabine
Arm/Group Description:	Ixabepilone 40 mg/m2 administered a...	Capecitabine 1250 mg/m2 BID x 14 da...
Arm/Group Description:	Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each 21-day cycle, plus oral capecitabine 1000 mg/m2 twice a day (BID) x 14 days	Capecitabine 1250 mg/m2 BID x 14 days
Overall Number of Participants Analyzed	375	377
Median (95% Confidence Interval) Unit of Measure: Months
	5.85 (5.45 to 6.97)	4.17 (3.81 to 4.50)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ixabepilone + Capecitabine, Capecitabine
	Comments	Study required 615 events to achieve 90% power to detect a hazard ratio of 0.77 using a 2-sided α = 0.05 log-rank test. The analysis was a comparison between the 2 treatment arms using a 2-sided α=0.0483 log-rank test (adjusted for an interim analysis using the O'Brien Fleming spending function) to reject the null hypothesis of equality of progression free survival. The analysis was conducted when 639 events (310 in combination:329 in capecitabine) were observed from the 752 randomized patients.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	.0003
	Comments	Test was stratified by 1) presence of visceral metastases in liver or lung, 2) minimum of either doxorubicin 420 mg/m2 or epirubicin 360 mg/m2, and relapse > 6 months in adjuvant setting, and 3) prior chemotherapy for metastatic disease. (yes/no)
	Method	Log Rank
	Comments	95.17% confidence interval is adjusted for the interim analysis.

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.75
	Confidence Interval	95.17% 0.64 to 0.88
	Estimation Comments	[Not Specified]

2.Secondary Outcome


Title	Overall Response Rate (ORR) Per IRRC
Description	Participants with best response of "Complete" or "Parti...
Description	Participants with best response of "Complete" or "Partial" according to Response Evaluation Criteria in Solid Tumors (RECIST) a 4-item scale wherein complete response=disappearance of all target lesions and partial response=30% decrease in the sum of the longest diameter of target lesions
Time Frame	based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity

Outcome Measure Data

Analysis Population Description

The analysis of ORR was conducted on all randomized patients on an intent to treat basis.


Arm/Group Title	Ixabepilone + Capecitabine	Capecitabine
Arm/Group Description:	Ixabepilone 40 mg/m2 administered a...	Capecitabine 1250 mg/m2 BID x 14 da...
Arm/Group Description:	Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each 21-day cycle, plus oral capecitabine 1000 mg/m2 twice a day (BID) x 14 days	Capecitabine 1250 mg/m2 BID x 14 days
Overall Number of Participants Analyzed	375	377
Mean (95% Confidence Interval) Unit of Measure: percent
	34.7 (29.9 to 39.7)	14.3 (10.9 to 18.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ixabepilone + Capecitabine, Capecitabine
	Comments	The study had 95 percent power to detect a significant difference in ORR if the true response rate was 32 percent in the combination arm and 20 percent in the capecitabine arm.
	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	3.15
	Confidence Interval	95% 2.20 to 4.50
	Estimation Comments	[Not Specified]

3.Secondary Outcome


Title	Duration of Response Per IRRC
Description	Computed for all patients with a best response of "Partial" ...
Description	Computed for all patients with a best response of "Partial" or "Complete" per RECIST (a 4-item scale as described in previous outcome measure), calculated from the time when these criteria were first met until the first date of documented progression or death.
Time Frame	based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity

Outcome Measure Data

Analysis Population Description

Results for duration of response apply to only those subjects with a response (defined as complete or partial response).


Arm/Group Title	Ixabepilone + Capecitabine	Capecitabine
Arm/Group Description:	Ixabepilone 40 mg/m2 administered a...	Capecitabine 1250 mg/m2 BID x 14 da...
Arm/Group Description:	Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each 21-day cycle, plus oral capecitabine 1000 mg/m2 twice a day (BID) x 14 days	Capecitabine 1250 mg/m2 BID x 14 days
Overall Number of Participants Analyzed	130	54
Median (95% Confidence Interval) Unit of Measure: months
	6.4 (5.6 to 7.1)	5.6 (4.2 to 7.5)

4.Secondary Outcome


Title	Time to Response Per IRRC
Description	Time to response was summarized using descriptive statistics and was d...
Description	Time to response was summarized using descriptive statistics and was defined as the time from first dose of study treatment until measurement criteria were first met for Partial Response or Complete Response.
Time Frame	based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity

Outcome Measure Data

Analysis Population Description

Results for time to response apply to only those subjects with a response (defined as complete or partial response)


Arm/Group Title	Ixabepilone + Capecitabine	Capecitabine
Arm/Group Description:	Ixabepilone 40 mg/m2 administered a...	Capecitabine 1250 mg/m2 BID x 14 da...
Arm/Group Description:	Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each 21-day cycle, plus oral capecitabine 1000 mg/m2 twice a day (BID) x 14 days	Capecitabine 1250 mg/m2 BID x 14 days
Overall Number of Participants Analyzed	130	54
Median (Full Range) Unit of Measure: weeks
	11.7 (4.4 to 61.4)	12.0 (4.3 to 41.9)

5.Secondary Outcome


Title	Overall Survival (OS)
Description	OS was defined as the time from randomization to death. Participants w...
Description	OS was defined as the time from randomization to death. Participants who did not die at the time of the analysis were censored at the latest follow-up date. Median OS with 95% CI was estimated using the Kaplan Meier product limit method.
Time Frame	from date of randomization until death

Outcome Measure Data

Analysis Population Description

Overall survival was analyzed on all randomized patients on an intent to treat basis.


Arm/Group Title	Ixabepilone + Capecitabine	Capecitabine
Arm/Group Description:	Ixabepilone 40 mg/m2 administered a...	Capecitabine 1250 mg/m2 BID x 14 da...
Arm/Group Description:	Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each 21-day cycle, plus oral capecitabine 1000 mg/m2 twice a day (BID) x 14 days	Capecitabine 1250 mg/m2 BID x 14 days
Overall Number of Participants Analyzed	375	377
Median (95% Confidence Interval) Unit of Measure: Months
	12.9 (11.5 to 14.2)	11.1 (10.0 to 12.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ixabepilone + Capecitabine, Capecitabine
	Comments	Study required 631 deaths to achieve 80% power to detect a Hazard ratio of 0.8 using a 2-sided α = 0.05 log rank test. The analysis was a comparison between the 2 treatment arms using a 2-sided α=0.05 log-rank test to reject the null hypothesis of equality of survival. The analysis was conducted when 639 deaths (318 in combination:321 in capecitabine) were observed from the 752 randomized patients.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.1936
	Comments	Test was stratified by presence of visceral metastases in liver or lung (y/n), minimum of either doxorubicin 420 mg/m2 or epirubicin 360 mg/m2, and relapse > 6 months in adjuvant setting (y/n), and prior chemotherapy for metastatic disease (y/n).
	Method	Log Rank
	Comments	Test was conducted at the α=0.05 level and no adjustments were performed.

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.90
	Confidence Interval	95.17% 0.77 to 1.05
	Estimation Comments	Confidence Interval adjusted for interim analysis.

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 treated participants; all participants who received at least 1 dose of study therapy.Participants with baseline hepatic impairment (combination arm, n = 29; capecitabine arm, n = 35), defined as Grade ≥2 AST, ALT or Grade ≥1 total bilirubin, were contraindicated due to disproportionate number of toxic deaths.


Arm/Group Title	Ixabepilone + Capecitabine	Capecitabine
Arm/Group Description:	Ixabepilone in combination with cap...	Capecitabine 1250 mg/m2 BID x 14 da...
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 1250 mg/m2 BID x 14 days
Overall Number of Participants Analyzed	369	368
Measure Type: Number Unit of Measure: Participants
Deaths on-study or within 30 days of last dose	33	40
Treatment-related Serious Adverse Events (SAEs)	91	31
Treatment-related Adverse Events (AEs)	357	330
Treatment-related AEs leading to Discontinuation	137	25

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 40 mg/m2 administered a...	Capecitabine 1250 mg/m2 BID x 14 da...
Arm/Group Description:	Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each 21-day cycle, plus oral capecitabine 1000 mg/m2 twice a day (BID) x 14 days	Capecitabine 1250 mg/m2 BID x 14 days
Overall Number of Participants Analyzed	375	377
Mean (95% Confidence Interval) Unit of Measure: units on a scale
Week 3 (n=282; n=273)	-0.4 (-0.97 to 0.20)	0.3 (-0.28 to 0.84)
Week 6 (n=227; n=214)	-0.2 (-0.90 to 0.48)	1.1 (0.30 to 1.83)
Week 9 (n=194; n=184)	-0.6 (-1.31 to 0.19)	1.8 (0.97 to 2.58)
Week 12 (n=173; n=158)	-1.3 (-2.19 to -0.42)	1.4 (0.55 to 2.18)
Week 15 (n=148; n=145)	-0.7 (-1.65 to 0.27)	1.7 (0.73 to 2.72)
Week 18 (n=122; n=121)	-1.0 (-2.18 to 0.13)	1.7 (0.76 to 2.63)
Week 21 (n=116; n=101)	-0.7 (-1.63 to 0.28)	1.1 (0.01 to 2.21)
Week 24 (n=95; n=82)	-0.8 (-1.89 to 0.38)	2.3 (1.13 to 3.41)

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	.0002
	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	127/368 (34.51%)	151/369 (40.92%)
Blood and lymphatic system disorders
ANAEMIA ^† 1	3/368 (0.82%)	11/369 (2.98%)
LEUKOPENIA ^† 1	0/368 (0.00%)	6/369 (1.63%)
NEUTROPENIA ^† 1	0/368 (0.00%)	18/369 (4.88%)
COAGULOPATHY ^† 1	3/368 (0.82%)	0/369 (0.00%)
LYMPHADENOPATHY ^† 1	0/368 (0.00%)	1/369 (0.27%)
THROMBOCYTOPENIA ^† 1	2/368 (0.54%)	7/369 (1.90%)
BONE MARROW FAILURE ^† 1	0/368 (0.00%)	1/369 (0.27%)
FEBRILE NEUTROPENIA ^† 1	4/368 (1.09%)	15/369 (4.07%)
DISSEMINATED INTRAVASCULAR COAGULATION ^† 1	0/368 (0.00%)	1/369 (0.27%)
Cardiac disorders
ATRIAL FLUTTER ^† 1	0/368 (0.00%)	1/369 (0.27%)
CARDIAC ARREST ^† 1	0/368 (0.00%)	1/369 (0.27%)
CARDIOMYOPATHY ^† 1	0/368 (0.00%)	1/369 (0.27%)
ANGINA PECTORIS ^† 1	0/368 (0.00%)	1/369 (0.27%)
CARDIAC FAILURE ^† 1	0/368 (0.00%)	1/369 (0.27%)
ATRIAL FIBRILLATION ^† 1	0/368 (0.00%)	1/369 (0.27%)
MYOCARDIAL ISCHAEMIA ^† 1	1/368 (0.27%)	1/369 (0.27%)
PERICARDIAL EFFUSION ^† 1	1/368 (0.27%)	0/369 (0.00%)
MYOCARDIAL INFARCTION ^† 1	0/368 (0.00%)	1/369 (0.27%)
CARDIOPULMONARY FAILURE ^† 1	0/368 (0.00%)	1/369 (0.27%)
VENTRICULAR DYSFUNCTION ^† 1	0/368 (0.00%)	3/369 (0.81%)
CARDIO-RESPIRATORY ARREST ^† 1	2/368 (0.54%)	1/369 (0.27%)
ACUTE MYOCARDIAL INFARCTION ^† 1	0/368 (0.00%)	1/369 (0.27%)
ARRHYTHMIA SUPRAVENTRICULAR ^† 1	0/368 (0.00%)	1/369 (0.27%)
Gastrointestinal disorders
ILEUS ^† 1	1/368 (0.27%)	3/369 (0.81%)
NAUSEA ^† 1	5/368 (1.36%)	8/369 (2.17%)
ASCITES ^† 1	2/368 (0.54%)	1/369 (0.27%)
COLITIS ^† 1	1/368 (0.27%)	0/369 (0.00%)
MELAENA ^† 1	1/368 (0.27%)	0/369 (0.00%)
VOMITING ^† 1	8/368 (2.17%)	12/369 (3.25%)
CHEILITIS ^† 1	1/368 (0.27%)	0/369 (0.00%)
DIARRHOEA ^† 1	15/368 (4.08%)	14/369 (3.79%)
DYSPEPSIA ^† 1	0/368 (0.00%)	1/369 (0.27%)
ENTERITIS ^† 1	2/368 (0.54%)	0/369 (0.00%)
GASTRITIS ^† 1	1/368 (0.27%)	1/369 (0.27%)
STOMATITIS ^† 1	1/368 (0.27%)	3/369 (0.81%)
CONSTIPATION ^† 1	2/368 (0.54%)	1/369 (0.27%)
HAEMATEMESIS ^† 1	1/368 (0.27%)	0/369 (0.00%)
OESOPHAGITIS ^† 1	0/368 (0.00%)	1/369 (0.27%)
PANCREATITIS ^† 1	0/368 (0.00%)	1/369 (0.27%)
PEPTIC ULCER ^† 1	1/368 (0.27%)	0/369 (0.00%)
ABDOMINAL PAIN ^† 1	4/368 (1.09%)	4/369 (1.08%)
ABDOMINAL PAIN UPPER ^† 1	1/368 (0.27%)	0/369 (0.00%)
EROSIVE OESOPHAGITIS ^† 1	1/368 (0.27%)	0/369 (0.00%)
GASTROINTESTINAL ULCER ^† 1	0/368 (0.00%)	1/369 (0.27%)
GASTROINTESTINAL HAEMORRHAGE ^† 1	2/368 (0.54%)	0/369 (0.00%)
GASTROINTESTINAL OBSTRUCTION ^† 1	1/368 (0.27%)	0/369 (0.00%)
LARGE INTESTINAL OBSTRUCTION ^† 1	0/368 (0.00%)	1/369 (0.27%)
LOWER GASTROINTESTINAL HAEMORRHAGE ^† 1	0/368 (0.00%)	2/369 (0.54%)
General disorders
PAIN ^† 1	0/368 (0.00%)	2/369 (0.54%)
DEATH ^† 1	1/368 (0.27%)	2/369 (0.54%)
CHILLS ^† 1	0/368 (0.00%)	1/369 (0.27%)
FATIGUE ^† 1	1/368 (0.27%)	3/369 (0.81%)
PYREXIA ^† 1	3/368 (0.82%)	9/369 (2.44%)
ASTHENIA ^† 1	2/368 (0.54%)	3/369 (0.81%)
CHEST PAIN ^† 1	1/368 (0.27%)	1/369 (0.27%)
SUDDEN DEATH ^† 1	0/368 (0.00%)	1/369 (0.27%)
GENERALISED OEDEMA ^† 1	1/368 (0.27%)	0/369 (0.00%)
MUCOSAL INFLAMMATION ^† 1	3/368 (0.82%)	4/369 (1.08%)
PERFORMANCE STATUS DECREASED ^† 1	0/368 (0.00%)	1/369 (0.27%)
GENERAL PHYSICAL HEALTH DETERIORATION ^† 1	1/368 (0.27%)	1/369 (0.27%)
Hepatobiliary disorders
HEPATIC FAILURE ^† 1	4/368 (1.09%)	1/369 (0.27%)
ACUTE HEPATIC FAILURE ^† 1	0/368 (0.00%)	1/369 (0.27%)
HEPATOCELLULAR DAMAGE ^† 1	1/368 (0.27%)	0/369 (0.00%)
Immune system disorders
HYPERSENSITIVITY ^† 1	0/368 (0.00%)	2/369 (0.54%)
TYPE IV HYPERSENSITIVITY REACTION ^† 1	0/368 (0.00%)	1/369 (0.27%)
Infections and infestations
SEPSIS ^† 1	0/368 (0.00%)	5/369 (1.36%)
MYIASIS ^† 1	1/368 (0.27%)	0/369 (0.00%)
CYSTITIS ^† 1	0/368 (0.00%)	1/369 (0.27%)
INFECTION ^† 1	2/368 (0.54%)	1/369 (0.27%)
PNEUMONIA ^† 1	3/368 (0.82%)	17/369 (4.61%)
CELLULITIS ^† 1	0/368 (0.00%)	3/369 (0.81%)
ERYSIPELAS ^† 1	1/368 (0.27%)	1/369 (0.27%)
LARYNGITIS ^† 1	0/368 (0.00%)	1/369 (0.27%)
PARONYCHIA ^† 1	0/368 (0.00%)	1/369 (0.27%)
BACTERAEMIA ^† 1	1/368 (0.27%)	0/369 (0.00%)
SEPTIC SHOCK ^† 1	1/368 (0.27%)	1/369 (0.27%)
HERPES ZOSTER ^† 1	2/368 (0.54%)	2/369 (0.54%)
GASTROENTERITIS ^† 1	1/368 (0.27%)	2/369 (0.54%)
LOBAR PNEUMONIA ^† 1	0/368 (0.00%)	1/369 (0.27%)
PERITONEAL INFECTION ^† 1	1/368 (0.27%)	0/369 (0.00%)
NEUTROPENIC INFECTION ^† 1	0/368 (0.00%)	1/369 (0.27%)
ENTEROCOLITIS INFECTIOUS ^† 1	0/368 (0.00%)	1/369 (0.27%)
PNEUMONIA STAPHYLOCOCCAL ^† 1	0/368 (0.00%)	1/369 (0.27%)
GASTROINTESTINAL INFECTION ^† 1	1/368 (0.27%)	0/369 (0.00%)
RESPIRATORY TRACT INFECTION ^† 1	1/368 (0.27%)	2/369 (0.54%)
GENITOURINARY TRACT INFECTION ^† 1	1/368 (0.27%)	0/369 (0.00%)
LOWER RESPIRATORY TRACT INFECTION ^† 1	0/368 (0.00%)	1/369 (0.27%)
Injury, poisoning and procedural complications
FALL ^† 1	0/368 (0.00%)	2/369 (0.54%)
OVERDOSE ^† 1	1/368 (0.27%)	0/369 (0.00%)
HIP FRACTURE ^† 1	1/368 (0.27%)	0/369 (0.00%)
ANKLE FRACTURE ^† 1	1/368 (0.27%)	1/369 (0.27%)
FEMUR FRACTURE ^† 1	1/368 (0.27%)	0/369 (0.00%)
VASCULAR ACCESS COMPLICATION ^† 1	0/368 (0.00%)	1/369 (0.27%)
POST LUMBAR PUNCTURE SYNDROME ^† 1	1/368 (0.27%)	0/369 (0.00%)
Investigations
HAEMOGLOBIN DECREASED ^† 1	1/368 (0.27%)	1/369 (0.27%)
GRIP STRENGTH DECREASED ^† 1	0/368 (0.00%)	1/369 (0.27%)
PLATELET COUNT DECREASED ^† 1	2/368 (0.54%)	2/369 (0.54%)
NEUTROPHIL COUNT DECREASED ^† 1	0/368 (0.00%)	1/369 (0.27%)
GRANULOCYTE COUNT DECREASED ^† 1	0/368 (0.00%)	1/369 (0.27%)
WHITE BLOOD CELL COUNT DECREASED ^† 1	0/368 (0.00%)	1/369 (0.27%)
Metabolism and nutrition disorders
ANOREXIA ^† 1	2/368 (0.54%)	2/369 (0.54%)
DEHYDRATION ^† 1	3/368 (0.82%)	8/369 (2.17%)
HYPOKALAEMIA ^† 1	0/368 (0.00%)	3/369 (0.81%)
HYPOVOLAEMIA ^† 1	0/368 (0.00%)	1/369 (0.27%)
HYPOCALCAEMIA ^† 1	0/368 (0.00%)	1/369 (0.27%)
HYPOGLYCAEMIA ^† 1	1/368 (0.27%)	0/369 (0.00%)
HYPONATRAEMIA ^† 1	0/368 (0.00%)	3/369 (0.81%)
HYPERCALCAEMIA ^† 1	1/368 (0.27%)	1/369 (0.27%)
HYPERGLYCAEMIA ^† 1	0/368 (0.00%)	2/369 (0.54%)
METABOLIC ACIDOSIS ^† 1	0/368 (0.00%)	1/369 (0.27%)
DIABETIC KETOACIDOSIS ^† 1	1/368 (0.27%)	0/369 (0.00%)
Musculoskeletal and connective tissue disorders
MYALGIA ^† 1	0/368 (0.00%)	3/369 (0.81%)
TRISMUS ^† 1	0/368 (0.00%)	1/369 (0.27%)
BACK PAIN ^† 1	1/368 (0.27%)	1/369 (0.27%)
BONE PAIN ^† 1	3/368 (0.82%)	1/369 (0.27%)
ARTHRALGIA ^† 1	1/368 (0.27%)	1/369 (0.27%)
MUSCLE SPASMS ^† 1	0/368 (0.00%)	1/369 (0.27%)
PAIN IN EXTREMITY ^† 1	1/368 (0.27%)	2/369 (0.54%)
MUSCULOSKELETAL PAIN ^† 1	1/368 (0.27%)	0/369 (0.00%)
PATHOLOGICAL FRACTURE ^† 1	1/368 (0.27%)	1/369 (0.27%)
MUSCULOSKELETAL CHEST PAIN ^† 1	0/368 (0.00%)	1/369 (0.27%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CANCER PAIN ^† 1	1/368 (0.27%)	0/369 (0.00%)
BREAST CANCER ^† 1	1/368 (0.27%)	0/369 (0.00%)
METASTATIC PAIN ^† 1	1/368 (0.27%)	0/369 (0.00%)
CERVIX CARCINOMA ^† 1	1/368 (0.27%)	0/369 (0.00%)
INFECTED NEOPLASM ^† 1	0/368 (0.00%)	1/369 (0.27%)
MALIGNANT ASCITES ^† 1	1/368 (0.27%)	1/369 (0.27%)
METASTASES TO BONE ^† 1	0/368 (0.00%)	1/369 (0.27%)
NEOPLASM MALIGNANT ^† 1	1/368 (0.27%)	0/369 (0.00%)
METASTASES TO LIVER ^† 1	2/368 (0.54%)	0/369 (0.00%)
METASTASES TO MENINGES ^† 1	0/368 (0.00%)	1/369 (0.27%)
MALIGNANT PLEURAL EFFUSION ^† 1	2/368 (0.54%)	2/369 (0.54%)
MALIGNANT NEOPLASM PROGRESSION ^† 1	36/368 (9.78%)	19/369 (5.15%)
PERICARDIAL EFFUSION MALIGNANT ^† 1	4/368 (1.09%)	0/369 (0.00%)
METASTASES TO CENTRAL NERVOUS SYSTEM ^† 1	8/368 (2.17%)	7/369 (1.90%)
RENAL CELL CARCINOMA STAGE UNSPECIFIED ^† 1	1/368 (0.27%)	0/369 (0.00%)
Nervous system disorders
APHASIA ^† 1	1/368 (0.27%)	0/369 (0.00%)
SYNCOPE ^† 1	1/368 (0.27%)	1/369 (0.27%)
HEADACHE ^† 1	1/368 (0.27%)	1/369 (0.27%)
LETHARGY ^† 1	0/368 (0.00%)	1/369 (0.27%)
DIZZINESS ^† 1	0/368 (0.00%)	4/369 (1.08%)
NEURALGIA ^† 1	0/368 (0.00%)	1/369 (0.27%)
CONVULSION ^† 1	2/368 (0.54%)	0/369 (0.00%)
SOMNOLENCE ^† 1	0/368 (0.00%)	1/369 (0.27%)
PARAESTHESIA ^† 1	0/368 (0.00%)	1/369 (0.27%)
HYPOAESTHESIA ^† 1	0/368 (0.00%)	1/369 (0.27%)
MENTAL IMPAIRMENT ^† 1	0/368 (0.00%)	1/369 (0.27%)
CEREBRAL ISCHAEMIA ^† 1	0/368 (0.00%)	1/369 (0.27%)
COGNITIVE DISORDER ^† 1	1/368 (0.27%)	1/369 (0.27%)
CEREBRAL HAEMORRHAGE ^† 1	0/368 (0.00%)	1/369 (0.27%)
COORDINATION ABNORMAL ^† 1	1/368 (0.27%)	1/369 (0.27%)
INTERCOSTAL NEURALGIA ^† 1	1/368 (0.27%)	0/369 (0.00%)
LOSS OF CONSCIOUSNESS ^† 1	0/368 (0.00%)	1/369 (0.27%)
NEUROPATHY PERIPHERAL ^† 1	0/368 (0.00%)	2/369 (0.54%)
PARESIS CRANIAL NERVE ^† 1	1/368 (0.27%)	0/369 (0.00%)
SPINAL CORD COMPRESSION ^† 1	1/368 (0.27%)	1/369 (0.27%)
MARCHIAFAVA-BIGNAMI DISEASE ^† 1	1/368 (0.27%)	0/369 (0.00%)
PERIPHERAL MOTOR NEUROPATHY ^† 1	1/368 (0.27%)	3/369 (0.81%)
PERIPHERAL SENSORY NEUROPATHY ^† 1	0/368 (0.00%)	5/369 (1.36%)
Psychiatric disorders
ANXIETY ^† 1	1/368 (0.27%)	0/369 (0.00%)
DEPRESSION ^† 1	0/368 (0.00%)	1/369 (0.27%)
DISORIENTATION ^† 1	1/368 (0.27%)	0/369 (0.00%)
CONFUSIONAL STATE ^† 1	2/368 (0.54%)	2/369 (0.54%)
Renal and urinary disorders
HAEMATURIA ^† 1	1/368 (0.27%)	0/369 (0.00%)
RENAL FAILURE ^† 1	1/368 (0.27%)	1/369 (0.27%)
RENAL IMPAIRMENT ^† 1	1/368 (0.27%)	0/369 (0.00%)
URINARY RETENTION ^† 1	1/368 (0.27%)	0/369 (0.00%)
RENAL FAILURE ACUTE ^† 1	1/368 (0.27%)	0/369 (0.00%)
Reproductive system and breast disorders
UTERINE HAEMORRHAGE ^† 1	1/368 (0.27%)	0/369 (0.00%)
Respiratory, thoracic and mediastinal disorders
HYPOXIA ^† 1	0/368 (0.00%)	1/369 (0.27%)
DYSPNOEA ^† 1	7/368 (1.90%)	14/369 (3.79%)
DYSPHONIA ^† 1	0/368 (0.00%)	1/369 (0.27%)
HYDROTHORAX ^† 1	1/368 (0.27%)	0/369 (0.00%)
PNEUMONITIS ^† 1	4/368 (1.09%)	0/369 (0.00%)
PNEUMOTHORAX ^† 1	1/368 (0.27%)	2/369 (0.54%)
LUNG DISORDER ^† 1	0/368 (0.00%)	1/369 (0.27%)
PLEURITIC PAIN ^† 1	1/368 (0.27%)	0/369 (0.00%)
PLEURAL EFFUSION ^† 1	9/368 (2.45%)	6/369 (1.63%)
HYDROPNEUMOTHORAX ^† 1	1/368 (0.27%)	1/369 (0.27%)
PULMONARY EMBOLISM ^† 1	1/368 (0.27%)	2/369 (0.54%)
RESPIRATORY FAILURE ^† 1	1/368 (0.27%)	4/369 (1.08%)
PULMONARY HAEMORRHAGE ^† 1	1/368 (0.27%)	0/369 (0.00%)
ACUTE PULMONARY OEDEMA ^† 1	0/368 (0.00%)	1/369 (0.27%)
PHARYNGOLARYNGEAL PAIN ^† 1	0/368 (0.00%)	1/369 (0.27%)
ACUTE RESPIRATORY DISTRESS SYNDROME ^† 1	1/368 (0.27%)	0/369 (0.00%)
Skin and subcutaneous tissue disorders
RASH ^† 1	0/368 (0.00%)	1/369 (0.27%)
SKIN ULCER ^† 1	1/368 (0.27%)	0/369 (0.00%)
ERYTHEMA MULTIFORME ^† 1	0/368 (0.00%)	1/369 (0.27%)
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME ^† 1	1/368 (0.27%)	5/369 (1.36%)
Vascular disorders
THROMBOSIS ^† 1	0/368 (0.00%)	3/369 (0.81%)
VASCULITIS ^† 1	0/368 (0.00%)	1/369 (0.27%)
HYPOTENSION ^† 1	2/368 (0.54%)	3/369 (0.81%)
LYMPHOEDEMA ^† 1	1/368 (0.27%)	0/369 (0.00%)
HYPERTENSION ^† 1	0/368 (0.00%)	1/369 (0.27%)
THROMBOPHLEBITIS ^† 1	1/368 (0.27%)	0/369 (0.00%)
HYPOVOLAEMIC SHOCK ^† 1	0/368 (0.00%)	1/369 (0.27%)
POOR VENOUS ACCESS ^† 1	1/368 (0.27%)	2/369 (0.54%)
DEEP VEIN THROMBOSIS ^† 1	4/368 (1.09%)	0/369 (0.00%)
JUGULAR VEIN THROMBOSIS ^† 1	1/368 (0.27%)	0/369 (0.00%)
† Indicates events were collected by systematic assessment 1 Term from vocabulary, MedDRA 9.1
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Capecitabine	Ixabepilone + Capecitabine
	Affected / at Risk (%)	Affected / at Risk (%)
Total	350/368 (95.11%)	360/369 (97.56%)
Blood and lymphatic system disorders
ANAEMIA ^† 1	10/368 (2.72%)	19/369 (5.15%)
LEUKOPENIA ^† 1	1/368 (0.27%)	22/369 (5.96%)
NEUTROPENIA ^† 1	9/368 (2.45%)	51/369 (13.82%)
Eye disorders
LACRIMATION INCREASED ^† 1	21/368 (5.71%)	21/369 (5.69%)
Gastrointestinal disorders
NAUSEA ^† 1	164/368 (44.57%)	209/369 (56.64%)
VOMITING ^† 1	106/368 (28.80%)	158/369 (42.82%)
DIARRHOEA ^† 1	147/368 (39.95%)	179/369 (48.51%)
DYSPEPSIA ^† 1	35/368 (9.51%)	34/369 (9.21%)
STOMATITIS ^† 1	39/368 (10.60%)	61/369 (16.53%)
CONSTIPATION ^† 1	57/368 (15.49%)	120/369 (32.52%)
ABDOMINAL PAIN ^† 1	51/368 (13.86%)	68/369 (18.43%)
ABDOMINAL DISTENSION ^† 1	12/368 (3.26%)	19/369 (5.15%)
ABDOMINAL PAIN UPPER ^† 1	31/368 (8.42%)	45/369 (12.20%)
General disorders
PAIN ^† 1	8/368 (2.17%)	27/369 (7.32%)
FATIGUE ^† 1	97/368 (26.36%)	160/369 (43.36%)
PYREXIA ^† 1	47/368 (12.77%)	56/369 (15.18%)
ASTHENIA ^† 1	57/368 (15.49%)	101/369 (27.37%)
CHEST PAIN ^† 1	19/368 (5.16%)	22/369 (5.96%)
OEDEMA PERIPHERAL ^† 1	46/368 (12.50%)	51/369 (13.82%)
MUCOSAL INFLAMMATION ^† 1	39/368 (10.60%)	59/369 (15.99%)
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION ^† 1	16/368 (4.35%)	23/369 (6.23%)
Investigations
WEIGHT DECREASED ^† 1	43/368 (11.68%)	88/369 (23.85%)
HAEMOGLOBIN DECREASED ^† 1	4/368 (1.09%)	21/369 (5.69%)
NEUTROPHIL COUNT DECREASED ^† 1	6/368 (1.63%)	27/369 (7.32%)
WHITE BLOOD CELL COUNT DECREASED ^† 1	3/368 (0.82%)	23/369 (6.23%)
Metabolism and nutrition disorders
ANOREXIA ^† 1	69/368 (18.75%)	127/369 (34.42%)
DECREASED APPETITE ^† 1	8/368 (2.17%)	21/369 (5.69%)
Musculoskeletal and connective tissue disorders
MYALGIA ^† 1	24/368 (6.52%)	130/369 (35.23%)
BACK PAIN ^† 1	53/368 (14.40%)	46/369 (12.47%)
BONE PAIN ^† 1	19/368 (5.16%)	26/369 (7.05%)
ARTHRALGIA ^† 1	25/368 (6.79%)	87/369 (23.58%)
PAIN IN EXTREMITY ^† 1	30/368 (8.15%)	70/369 (18.97%)
MUSCULOSKELETAL PAIN ^† 1	16/368 (4.35%)	41/369 (11.11%)
MUSCULOSKELETAL CHEST PAIN ^† 1	20/368 (5.43%)	20/369 (5.42%)
Nervous system disorders
HEADACHE ^† 1	41/368 (11.14%)	63/369 (17.07%)
DIZZINESS ^† 1	36/368 (9.78%)	48/369 (13.01%)
DYSGEUSIA ^† 1	14/368 (3.80%)	42/369 (11.38%)
PARAESTHESIA ^† 1	22/368 (5.98%)	71/369 (19.24%)
HYPOAESTHESIA ^† 1	9/368 (2.45%)	29/369 (7.86%)
NEUROPATHY PERIPHERAL ^† 1	5/368 (1.36%)	29/369 (7.86%)
PERIPHERAL MOTOR NEUROPATHY ^† 1	8/368 (2.17%)	68/369 (18.43%)
PERIPHERAL SENSORY NEUROPATHY ^† 1	30/368 (8.15%)	139/369 (37.67%)
Psychiatric disorders
INSOMNIA ^† 1	25/368 (6.79%)	61/369 (16.53%)
Respiratory, thoracic and mediastinal disorders
COUGH ^† 1	59/368 (16.03%)	73/369 (19.78%)
DYSPNOEA ^† 1	67/368 (18.21%)	61/369 (16.53%)
Skin and subcutaneous tissue disorders
RASH ^† 1	27/368 (7.34%)	45/369 (12.20%)
ALOPECIA ^† 1	16/368 (4.35%)	121/369 (32.79%)
DRY SKIN ^† 1	25/368 (6.79%)	23/369 (6.23%)
ERYTHEMA ^† 1	17/368 (4.62%)	25/369 (6.78%)
PRURITUS ^† 1	15/368 (4.08%)	21/369 (5.69%)
NAIL DISORDER ^† 1	36/368 (9.78%)	76/369 (20.60%)
SKIN HYPERPIGMENTATION ^† 1	53/368 (14.40%)	41/369 (11.11%)
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME ^† 1	228/368 (61.96%)	235/369 (63.69%)
† Indicates events were collected by systematic assessment 1 Term from vocabulary, MedDRA 9.1

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 of Results:

Thomas ES, Gomez HL, Li RK, Chung HC, Fein LE, Chan VF, Jassem J, Pivot XB, Klimovsky JV, de Mendoza FH, Xu B, Campone M, Lerzo GL, Peck RA, Mukhopadhyay P, Vahdat LT, Roche HH. Ixabepilone plus capecitabine for metastatic breast cancer progressing after anthracycline and taxane treatment. J Clin Oncol. 2007 Nov 20;25(33):5210-7. doi: 10.1200/JCO.2007.12.6557. Epub 2007 Oct 29.

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

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:	NCT00080301
Other Study ID Numbers:	CA163-046
First Submitted:	March 26, 2004
First Posted:	March 30, 2004
Results First Submitted:	May 1, 2009
Results First Posted:	August 17, 2009
Last Update Posted:	November 2, 2020

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