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

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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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

Participant Flow: Overall Study

	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

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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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