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

Study Type:	Interventional
Study Design:	Randomized, Open Label, Active Control, Parallel Assignment
Conditions:	Breast Cancer Metastases
Interventions:	Drug: Ixabepilone + Capecitabine Drug: Capecitabine

	Ixabepilone + Capecitabine	Capecitabine
STARTED	375	377
Never Treated	5	10
Still on Treatment	0	1
COMPLETED	370^[1]	366^[2]
NOT COMPLETED	5	11
Randomized but Never Treated	5	10
Still on Treatment as of CSR date	0	1

[1]	Participants who are off treatment
[2]	Participants who are off treatment

Baseline Characteristics

Reporting Groups

	Description
Ixabepilone + Capecitabine	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	Capecitabine 1250 mg/m2 BID x 14 days

Baseline Measures

	Ixabepilone + Capecitabine	Capecitabine	Total
Number of Participants [units: participants]	375	377	752
Age, Customized [units: 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 [units: years] Median ( Full Range )	53.0 ( 25.0 to 76.0 )	52.0 ( 25.0 to 79.0 )	53.0 ( 25.0 to 79.0 )
Gender [units: participants]
Female	375	376	751
Male	0	1	1
Race/Ethnicity, Customized [units: 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 [units: 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 [units: 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] [units: Units on a scale]
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
Menopausal Status [units: participants]
Premenopausal	54	51	105
Perimenopausal	19	23	42
Postmenopausal	288	289	577
Not reported	14	14	28
Number of Disease Sites [units: 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 [units: participants]
Subjects with at least 1 lesion	371	375	746
Subjects with no lesions	4	2	6
Visceral Disease in Liver and/or Lung [units: participants]
Yes	316	315	631
No	55	60	115
Missing	4	2	6

[1]	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.

Outcome Measures

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1. Primary:

Progression-free Survival (PFS) Per Independent Radiology Review Committee (IRRC) [ based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity ]

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2. Secondary:

Overall Response Rate (ORR) Per IRRC [ based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity ]

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3. Secondary:

Duration of Response Per IRRC [ based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity ]

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4. Secondary:

Time to Response Per IRRC [ based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity ]

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5. Secondary:

Overall Survival (OS) [ from date of randomization until death ]

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6. Secondary:

Treatment-related Safety Summary [ 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. ]

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7. Secondary:

Symptom Assessment Score Changes From Baseline for Functional Assessment of Cancer Therapy-Breast Symptom Index (FBSI) [ Baseline and prior to each 21-day cycle of treatment, and at first posttreatment follow-up assessment. ]

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Serious Adverse Events

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Other Adverse Events

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Time Frame	No text entered.
Additional Description	No text entered.

Frequency Threshold

Threshold above which other adverse events are reported	5%

Reporting Groups

	Description
Capecitabine	No text entered.
Ixabepilone + Capecitabine	No text entered.

Other Adverse Events

	Capecitabine	Ixabepilone + Capecitabine
Total, other (not including serious) adverse events
# participants affected / at risk	350	360
Blood and lymphatic system disorders
ANAEMIA ^†^A # participants affected / at risk	10/368 (2.72%)	19/369 (5.15%)
LEUKOPENIA ^†^A # participants affected / at risk	1/368 (0.27%)	22/369 (5.96%)
NEUTROPENIA ^†^A # participants affected / at risk	9/368 (2.45%)	51/369 (13.82%)
Eye disorders
LACRIMATION INCREASED ^†^A # participants affected / at risk	21/368 (5.71%)	21/369 (5.69%)
Gastrointestinal disorders
NAUSEA ^†^A # participants affected / at risk	164/368 (44.57%)	209/369 (56.64%)
VOMITING ^†^A # participants affected / at risk	106/368 (28.80%)	158/369 (42.82%)
DIARRHOEA ^†^A # participants affected / at risk	147/368 (39.95%)	179/369 (48.51%)
DYSPEPSIA ^†^A # participants affected / at risk	35/368 (9.51%)	34/369 (9.21%)
STOMATITIS ^†^A # participants affected / at risk	39/368 (10.60%)	61/369 (16.53%)
CONSTIPATION ^†^A # participants affected / at risk	57/368 (15.49%)	120/369 (32.52%)
ABDOMINAL PAIN ^†^A # participants affected / at risk	51/368 (13.86%)	68/369 (18.43%)
ABDOMINAL DISTENSION ^†^A # participants affected / at risk	12/368 (3.26%)	19/369 (5.15%)
ABDOMINAL PAIN UPPER ^†^A # participants affected / at risk	31/368 (8.42%)	45/369 (12.20%)
General disorders
PAIN ^†^A # participants affected / at risk	8/368 (2.17%)	27/369 (7.32%)
FATIGUE ^†^A # participants affected / at risk	97/368 (26.36%)	160/369 (43.36%)
PYREXIA ^†^A # participants affected / at risk	47/368 (12.77%)	56/369 (15.18%)
ASTHENIA ^†^A # participants affected / at risk	57/368 (15.49%)	101/369 (27.37%)
CHEST PAIN ^†^A # participants affected / at risk	19/368 (5.16%)	22/369 (5.96%)
OEDEMA PERIPHERAL ^†^A # participants affected / at risk	46/368 (12.50%)	51/369 (13.82%)
MUCOSAL INFLAMMATION ^†^A # participants affected / at risk	39/368 (10.60%)	59/369 (15.99%)
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION ^†^A # participants affected / at risk	16/368 (4.35%)	23/369 (6.23%)
Investigations
WEIGHT DECREASED ^†^A # participants affected / at risk	43/368 (11.68%)	88/369 (23.85%)
HAEMOGLOBIN DECREASED ^†^A # participants affected / at risk	4/368 (1.09%)	21/369 (5.69%)
NEUTROPHIL COUNT DECREASED ^†^A # participants affected / at risk	6/368 (1.63%)	27/369 (7.32%)
WHITE BLOOD CELL COUNT DECREASED ^†^A # participants affected / at risk	3/368 (0.82%)	23/369 (6.23%)
Metabolism and nutrition disorders
ANOREXIA ^†^A # participants affected / at risk	69/368 (18.75%)	127/369 (34.42%)
DECREASED APPETITE ^†^A # participants affected / at risk	8/368 (2.17%)	21/369 (5.69%)
Musculoskeletal and connective tissue disorders
MYALGIA ^†^A # participants affected / at risk	24/368 (6.52%)	130/369 (35.23%)
BACK PAIN ^†^A # participants affected / at risk	53/368 (14.40%)	46/369 (12.47%)
BONE PAIN ^†^A # participants affected / at risk	19/368 (5.16%)	26/369 (7.05%)
ARTHRALGIA ^†^A # participants affected / at risk	25/368 (6.79%)	87/369 (23.58%)
PAIN IN EXTREMITY ^†^A # participants affected / at risk	30/368 (8.15%)	70/369 (18.97%)
MUSCULOSKELETAL PAIN ^†^A # participants affected / at risk	16/368 (4.35%)	41/369 (11.11%)
MUSCULOSKELETAL CHEST PAIN ^†^A # participants affected / at risk	20/368 (5.43%)	20/369 (5.42%)
Nervous system disorders
HEADACHE ^†^A # participants affected / at risk	41/368 (11.14%)	63/369 (17.07%)
DIZZINESS ^†^A # participants affected / at risk	36/368 (9.78%)	48/369 (13.01%)
DYSGEUSIA ^†^A # participants affected / at risk	14/368 (3.80%)	42/369 (11.38%)
PARAESTHESIA ^†^A # participants affected / at risk	22/368 (5.98%)	71/369 (19.24%)
HYPOAESTHESIA ^†^A # participants affected / at risk	9/368 (2.45%)	29/369 (7.86%)
NEUROPATHY PERIPHERAL ^†^A # participants affected / at risk	5/368 (1.36%)	29/369 (7.86%)
PERIPHERAL MOTOR NEUROPATHY ^†^A # participants affected / at risk	8/368 (2.17%)	68/369 (18.43%)
PERIPHERAL SENSORY NEUROPATHY ^†^A # participants affected / at risk	30/368 (8.15%)	139/369 (37.67%)
Psychiatric disorders
INSOMNIA ^†^A # participants affected / at risk	25/368 (6.79%)	61/369 (16.53%)
Respiratory, thoracic and mediastinal disorders
COUGH ^†^A # participants affected / at risk	59/368 (16.03%)	73/369 (19.78%)
DYSPNOEA ^†^A # participants affected / at risk	67/368 (18.21%)	61/369 (16.53%)
Skin and subcutaneous tissue disorders
RASH ^†^A # participants affected / at risk	27/368 (7.34%)	45/369 (12.20%)
ALOPECIA ^†^A # participants affected / at risk	16/368 (4.35%)	121/369 (32.79%)
DRY SKIN ^†^A # participants affected / at risk	25/368 (6.79%)	23/369 (6.23%)
ERYTHEMA ^†^A # participants affected / at risk	17/368 (4.62%)	25/369 (6.78%)
PRURITUS ^†^A # participants affected / at risk	15/368 (4.08%)	21/369 (5.69%)
NAIL DISORDER ^†^A # participants affected / at risk	36/368 (9.78%)	76/369 (20.60%)
SKIN HYPERPIGMENTATION ^†^A # participants affected / at risk	53/368 (14.40%)	41/369 (11.11%)
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME ^†^A # participants affected / at risk	228/368 (61.96%)	235/369 (63.69%)

^†	Indicates events were collected by systematic assessment.
^A	Term from vocabulary, MedDRA 9.1

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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.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

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

No publications provided

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	CA163-046
Study First Received:	March 26, 2004
Results First Received:	May 1, 2009
Last Updated:	November 16, 2009
ClinicalTrials.gov Identifier:	NCT00080301 History of Changes
Health Authority:	United States: Food and Drug Administration