Paclitaxel, Nab-paclitaxel, or Ixabepilone With or Without Bevacizumab in Treating Patients With Stage IIIC or Stage IV Breast Cancer

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

National Cancer Institute (NCI)

ClinicalTrials.gov Identifier:

NCT00785291

First received: November 4, 2008

Last updated: June 1, 2016

Last verified: June 2016

History of Changes

Results First Received: June 5, 2015

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Estrogen Receptor Negative Estrogen Receptor Positive HER2/Neu Negative HER2/Neu Positive Male Breast Carcinoma Progesterone Receptor Negative Progesterone Receptor Positive Recurrent Breast Carcinoma Stage IIIC Breast Cancer AJCC v6 Stage IV Breast Cancer
Interventions:	Drug: Paclitaxel Drug: Paclitaxel Albumin-Stabilized Nanoparticle Formulation Drug: Ixabepilone Biological: Bevacizumab Other: Questionnaire Administration Other: Laboratory Biomarker Analysis

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Between October 2008 - November 2011, a total of 799 participants were recruited.

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
Arm A (Paclitaxel)	Patients receive 90 mg/m^2 paclitaxel IV over 1 hour on days 1, 8, and 15. Patients may receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.
Arm B (Nab-paclitaxel)	Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.
Arm C (Ixabepilone)	Patients receive ixabepilone IV over 60 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression. (closed to accrual as of 7/18/11)

Participant Flow: Overall Study

	Arm A (Paclitaxel)	Arm B (Nab-paclitaxel)	Arm C (Ixabepilone)
STARTED	283	271	245
COMPLETED	147	122	139
NOT COMPLETED	136	149	106
Never began treatment	8	4	4
Adverse Event	39	70	56
Death	7	4	3
Withdrawal by Subject	35	36	17
Alternative Therapy	12	6	7
Complicating illness	6	4	4
Other Medical Reasons	29	25	15

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All randomized participants are included in baseline characteristics.

Reporting Groups

	Description
Arm A (Paclitaxel)	Patients receive 90 mg/m^2 paclitaxel IV over 1 hour on days 1, 8, and 15. Patients may receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.
Arm B (Nab-paclitaxel)	Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.
Arm C (Ixabepilone)	Patients receive ixabepilone IV over 60 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression. (closed to accrual as of 7/18/11)
Total	Total of all reporting groups

Baseline Measures

	Arm A (Paclitaxel)	Arm B (Nab-paclitaxel)	Arm C (Ixabepilone)	Total
Number of Participants [units: participants]	283	271	245	799
Age, Customized [units: participants]
20-29	2	2	1	5
30-39	15	18	17	50
40-49	52	56	55	163
50-59	109	89	86	284
60-69	74	74	68	216
70-79	24	28	15	67
80+	7	4	3	14
Gender [units: participants]
Female	277	268	243	788
Male	6	3	2	11
Ethnicity (NIH/OMB) [units: participants]
Hispanic or Latino	19	15	13	47
Not Hispanic or Latino	252	239	221	712
Unknown or Not Reported	12	17	11	40
Race (NIH/OMB) [units: participants]
American Indian or Alaska Native	2	1	2	5
Asian	0	0	0	0
Native Hawaiian or Other Pacific Islander	3	0	1	4
Black or African American	42	45	26	113
White	220	214	206	640
More than one race	1	1	2	4
Unknown or Not Reported	15	10	8	33
Region of Enrollment [units: participants]
United States	283	271	245	799
Prior Adjuvant Taxane [units: participants]
Yes	125	120	107	352
No	158	151	138	447
Hormone Receptor Status [units: participants]
ER/PgR Positive	201	195	178	574
ER/PgR Negative	82	76	67	225
Physician's Decision to use Bevacizumab [units: participants]
Bevacizumab planned	51	44	15	110
Bevacizumab not planned	8	4	8	20
Bevacizumab required	224	223	222	669

Outcome Measures

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1. Primary:

Progression Free Survival [ Time Frame: Time from randomization to progression or death due to any cause, whichever occurs first (up to 5 years) ]

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2. Secondary:

Objective Tumor Response Rate [ Time Frame: Up to 5 years ]

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3. Secondary:

Time to Treatment Failure [ Time Frame: Time from randomization until progression, death, or yearly termination of protocol therapy (up to 5 years) ]

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4. Secondary:

12 Month Progression Free Survival [ Time Frame: 12 months ]

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5. Secondary:

Overall Survival [ Time Frame: Time from randomization to death or last follow-up (up to 5 years) ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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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
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More Information

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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.

Results Point of Contact:

Name/Title: Hope Rugo, M.D.
Organization: UCSF Comprehensive Cancer Center
e-mail: hrugo@medicine.ucsf.edu

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

Rugo HS, Barry WT, Moreno-Aspitia A, Lyss AP, Cirrincione C, Leung E, Mayer EL, Naughton M, Toppmeyer D, Carey LA, Perez EA, Hudis C, Winer EP. Randomized Phase III Trial of Paclitaxel Once Per Week Compared With Nanoparticle Albumin-Bound Nab-Paclitaxel Once Per Week or Ixabepilone With Bevacizumab As First-Line Chemotherapy for Locally Recurrent or Metastatic Breast Cancer: CALGB 40502/NCCTG N063H (Alliance). J Clin Oncol. 2015 Jul 20;33(21):2361-9. doi: 10.1200/JCO.2014.59.5298. Epub 2015 Jun 8.

Responsible Party:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00785291 History of Changes
Other Study ID Numbers:	NCI-2009-00476 NCI-2009-00476 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) CTSU 40502 NCCTG N063H CDR0000617539 CALGB 40502 ( Other Identifier: Alliance for Clinical Trials in Oncology ) CALGB-40502 ( Other Identifier: CTEP ) U10CA031946 ( US NIH Grant/Contract Award Number ) U10CA180821 ( US NIH Grant/Contract Award Number )
Study First Received:	November 4, 2008
Results First Received:	June 5, 2015
Last Updated:	June 1, 2016
Health Authority:	United States: Food and Drug Administration

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