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CompletedNCT00785291Updated Jun 23, 2026Results posted

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

A Phase 3 interventional study of Bevacizumab and Ixabepilone in Estrogen Receptor Negative, Estrogen Receptor Positive and HER2/Neu Negative, sponsored by National Cancer Institute (NCI). Completed at 704 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-23.

Sponsored by National Cancer Institute (NCI) · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
799
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This randomized phase III trial studies the side effects and how well different chemotherapy regimens with or without bevacizumab work in treating patients with stage IIIC or stage IV breast cancer. Drugs used in chemotherapy, such as paclitaxel, paclitaxel albumin-stabilized nanoparticle formulation (nab-paclitaxel), and ixabepilone, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Bevacizumab may block tumor growth by targeting certain cells and slowing the growth of blood vessels to the tumor. It is not yet known which treatment regimen is more effective in treating patients with breast cancer.

Read the detailed description

PRIMARY OBJECTIVES:

I. To compare the progression-free survival (PFS) in patients with metastatic breast cancer receiving nab-paclitaxel versus paclitaxel (control arm).

II. To compare PFS in patients receiving ixabepilone versus paclitaxel.

SECONDARY OBJECTIVES:

I. To compare the objective response rate, duration of response, and time to treatment failure in patients receiving nab-paclitaxel versus paclitaxel, and to separately compare these endpoints in patients receiving ixabepilone versus paclitaxel.

II. To compare the 12-month rate of progression in patients receiving nab-paclitaxel versus paclitaxel, and to separately compare this endpoint in patients receiving ixabepilone versus paclitaxel.

III. To determine toxicities in patients receiving nab-paclitaxel as compared to paclitaxel, and in patients receiving ixabepilone as compared to paclitaxel.

IV. To compare overall survival in patients receiving nab-paclitaxel versus paclitaxel, and to separately compare overall survival in patients receiving ixabepilone versus paclitaxel.

V. To evaluate the relationships between secreted protein, acidic, cysteine-rich (SPARC) overexpression and changes in blood levels of caveolin-1 (Cav-1) to PFS and secondary endpoints of response during treatment with nab-paclitaxel as compared to paclitaxel, and with ixabepilone as compared to paclitaxel.

VI. To evaluate the relationships between changes in blood levels of circulating tumor cells (CTCs) and circulating endothelial cells (CECs) to PFS and secondary endpoints of response during treatment with nab-paclitaxel as compared to paclitaxel, and with ixabepilone as compared to paclitaxel.

VII. To evaluate the association of expression levels of the microtubule associated proteins tau and beta-tubulin isotype composition with PFS and secondary endpoints of response during treatment with nab-paclitaxel as compared to paclitaxel, and with ixabepilone as compared to paclitaxel.

VIII. To investigate a potential cytochrome P450, family 2, subfamily C polypeptide 8, 2, 3 (CYP2C8*2/*3) by paclitaxel interaction with respect to progression-free survival (PFS).

IX. To determine if CYP2C8*2 and CPY2C8*3 are associated with paclitaxel-induced peripheral neuropathy.

X. To perform exploratory analysis of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4), cytochrome P450, family 3, subfamily A, polypeptide 5 (CYP3A5), ATP-binding cassette, sub-family B (MDR/TAP), member 1 (ABCB1) and ATP-binding cassette, sub-family C (CFTR/MRP), member 2 (ABCC2) polymorphisms with response and toxicity profiles.

XI. To prospectively collect data on sociodemographics, non-cancer morbidities, and receipt of post-trial therapy to evaluate the role of potential disparities on survival from cancer.

XII. To evaluate the relationship between physical activity behaviors at the time of enrollment in the protocol and progression-free and overall survival.

XIII. To identify baseline factors that predict the risk of grade 3, 4, or 5 toxicity in patients receiving treatment with weekly paclitaxel, nab-paclitaxel, or ixabepilone combined with or without bevacizumab.

XIV. To perform an exploratory analysis of whether other factors included in patient assessments (either individually or in combination) predict the risk of grade 3, 4, or 5 toxicity in patients receiving weekly paclitaxel, nab-paclitaxel, or ixabepilone combined with or without bevacizumab, with a specific focus on the relationship between pre-existing hypertension or neuropathy.

XV. To compare the associations of baseline factors to grade 3, 4, or 5 toxicity in patients receiving weekly paclitaxel, nab-paclitaxel, or ixabepilone combined with or without bevacizumab.

XVI. To explore whether longitudinal changes in factors are in association with the occurrence of grade 3, 4, or 5 toxicities in patients with weekly paclitaxel, nab-paclitaxel, or ixabepilone combined with or without bevacizumab.

XVII. To explore the association between grade 2-4 neuropathy and longitudinal changes in the following functional status measures: a) Older Americans Resources and Services (OARS) Multidimensional Functional Assessment Questionnaire (MFAQ) (Instrumental Activities of Daily Living [IADL]); b) Medical Outcomes Study (MOS) Physical Functioning; c) Karnofsky Performance Status Rated Healthcare Professional; d) Timed "Up and Go"; e) OARS Physical Health Section.

OUTLINE: Patients are randomized to 1 of 3 treatment arms.

ARM A (WEEKLY PACLITAXEL): Patients receive paclitaxel intravenously (IV) over 1 hour on days 1, 8, and 15. Patients may also receive bevacizumab IV over 30-90 minutes on days 1 and 15.

ARM B (WEEKLY NAB-PACLITAXEL): Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Patients may also receive bevacizumab as in Arm A.

ARM C (WEEKLY IXABEPILONE): Patients receive ixabepilone IV over 60 minutes on days 1, 8, and 15. Patients may also receive bevacizumab as in Arm A. (closed to accrual as of 7/18/11)

In all arms, treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed every 6 months for 2 years and then annually for up to 3 years.

02

Conditions studied

  • Estrogen Receptor Negative
  • Estrogen Receptor Positive
  • HER2/Neu Negative
  • HER2/Neu Positive
  • Progesterone Receptor Negative
  • Progesterone Receptor Positive
  • Recurrent Breast Carcinoma
  • Stage IIIC Breast Cancer AJCC v6
  • Stage IV Breast Cancer AJCC v6 and v7

Browse trials for

03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 799 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.

Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  • Histologic confirmation of invasive cancer of the breast
  • Stage IV disease or stage IIIC disease (using American Joint Committee on Cancer [AJCC] criteria, 6th edition) not amenable to local therapy
  • Patients may not have a "currently active" second malignancy other than non-melanoma skin cancers; patients are not considered to have a "currently active" malignancy if they have completed therapy and are considered by their physician to be at less than 30% risk of relapse
  • Patients with human epidermal growth factor receptor 2 (HER2) negative disease are eligible; patients with HER2+ disease are eligible providing they have previously received trastuzumab or lapatinib; documentation of progression on HER2 directed therapy is not required; Her2/neu status must be known at the time of protocol registration
  • Estrogen receptor (ER) and progesterone receptor (PgR) status must be known at the time of registration; ER and/or PgR >= 1% cells will be considered positive
  • Prior treatment may include adjuvant or neoadjuvant taxane, however, the interval between completion of adjuvant or neoadjuvant therapy and disease recurrence must be >= 12 months
  • No prior chemotherapy for metastatic breast cancer
  • Any number of prior hormonal therapies are allowed; the last dose should have been administered at least 7 days prior to the initiation of protocol therapy
  • Prior radiotherapy must be completed at least 2 weeks prior to study entry
  • Treatment with bisphosphonates is allowed and recommended as per American Society of Clinical Oncology (ASCO) guidelines
  • Prior trastuzumab or lapatinib required for patients with HER2 overexpressing tumors
  • Prior treatment with bevacizumab is allowed

  • Patients must not have had a major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study registration, and must have fully recovered from any such procedure

    • The following are not considered to be major procedures: thoracentesis, paracentesis, port placement, laparoscopy, thoracoscopy, bronchoscopy, endoscopic ultrasonographic procedures, mediastinoscopy, skin biopsies, incisional biopsies and routine dental procedures
  • Patients must not have anticipation of need for a major surgical procedure during the course of the study

  • There are no restrictions on core biopsies, placement of a vascular access device or other minor procedures prior to registration

    • Placement of a vascular access device after starting study therapy should be performed between day 15 and 28 of a treatment cycle (but not less than 48 hours before the next dose of bevacizumab) to allow for sufficient healing

  • Patients must have measurable disease (target lesions): measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 2.0 cm with conventional techniques or as >= 1 cm with spiral computed tomography (CT) scan

    • Lesions that are considered non-measurable include the following:

      • Bone lesions
      • Leptomeningeal disease
      • Ascites
      • Pleural/pericardial effusion
      • Inflammatory breast disease
      • Lymphangitis cutis/pulmonitis
      • Abdominal masses that are not confirmed and followed by imaging techniques
      • Cystic lesions
  • Patients with pre-existing peripheral neuropathy >= grade 2 are not eligible for this study
  • Patients must have an Eastern Cooperative Oncology Group (ECOG) (Zubrod) performance status of =\< 1 to be eligible for this trial
  • Women must not be pregnant or breast feeding; premenopausal women must have a negative serum or urine beta-human chorionic gonadotropin (Hcg)
  • Patients with a history of Common Terminology Criteria for Adverse Events (CTCAE) grade >= 3 hypersensitivity to paclitaxel or Cremophor® EL are not eligible
  • Patients with a history of abdominal fistula, or intra-abdominal abscess within 6 months prior to study registration are not eligible
  • Patients with a history of gastrointestinal (GI) perforation within 12 months prior to registration are not eligible
  • Patients with a history of significant bleeding episodes (e.g., hemoptysis, upper or lower GI bleeding) within 6 months prior to registration are not eligible

  • Patients must not have a history of clinically significant cardiovascular disease that includes the following:

    • Uncontrolled hypertension defined as systolic blood pressure > 150 and/or diastolic blood pressure > 90 mmHg on antihypertensive medications or any prior history of hypertensive crisis or hypertensive encephalopathy
    • History of myocardial infarction or unstable angina within past 6 months
    • New York Heart Association (NYHA) congestive heart failure grade 2 or greater
    • Symptomatic peripheral vascular disease
    • Significant vascular disease (e.g., aortic aneurysm, aortic dissection) or arterial thrombotic events
  • Patients on full dose anticoagulants must be on a stable dose of warfarin, or be on a stable dose of low molecular weight (LMW) heparin; patients receiving anti-platelet or on daily prophylactic dose aspirin are eligible, as are patients receiving stable doses of anticoagulation for atrial fibrillation
  • Patients may not have a history of stroke or transient ischemic attack within 6 months prior to study registration
  • Patients with a history of seizures must be well controlled with standard medication
  • Patients must not have progressing or untreated central nervous system (CNS) metastases or leptomeningeal disease; patients with a history of resected brain metastases with stable magnetic resonance imaging (MRI) scans for 3 months including within 4 weeks of study start are eligible; patients with a history of gamma knife radiosurgery or whole brain radiation with stable MRI scans for 3 months including within 4 weeks of study start are eligible
  • No serious, non-healing wound, ulcer or bone fracture
  • Life expectancy of >= 12 weeks
  • Granulocytes >= 1,500/ul
  • Platelet count >= 100,000/ul
  • Creatinine =\< 2.0 mg/dL
  • Bilirubin \< 1.5 mg/dL (unless due to Gilbert's syndrome)
  • Transaminases (aspartate aminotransferase [AST], alanine aminotransferase [ALT]) =\< 2.5 x upper limit of normal (ULN)
  • Serum or urine beta-Hcg negative in premenopausal women of child-bearing potential

  • Urine protein =\< 1+ protein* or urine protein: creatinine ratio (UPC) \< 1

    • Patients discovered to have >= 2+ proteinuria at baseline must undergo a 24-hour urine collection that must demonstrate \< 1 g of protein/24 hr or UPC ratio =\< 1 to allow participation in the study
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
799 participants (actual)

Study arms

  • Active comparator
    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.

    Biological: Bevacizumab · Other: Laboratory Biomarker Analysis · Drug: Paclitaxel · Other: Questionnaire Administration

  • Experimental
    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.

    Biological: Bevacizumab · Other: Laboratory Biomarker Analysis · Drug: Nab-paclitaxel · Other: Questionnaire Administration

  • Experimental
    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. (closed to accrual as of 7/18/11)

    Biological: Bevacizumab · Drug: Ixabepilone · Other: Laboratory Biomarker Analysis · Other: Questionnaire Administration

Interventions

  • BiologicalBevacizumab

    Given IV

    Also known as: ABP 215, Anti-VEGF, Anti-VEGF Humanized Monoclonal Antibody, Anti-VEGF Monoclonal Antibody SIBP04, Anti-VEGF rhuMAb, Avastin, Bevacizumab awwb, Bevacizumab Biosimilar ABP 215, Bevacizumab Biosimilar BEVZ92, Bevacizumab Biosimilar BI 695502, Bevacizumab Biosimilar CBT 124, Bevacizumab Biosimilar CT-P16, Bevacizumab Biosimilar FKB238, Bevacizumab Biosimilar GB-222, Bevacizumab Biosimilar HD204, Bevacizumab Biosimilar HLX04, Bevacizumab Biosimilar IBI305, Bevacizumab Biosimilar LY01008, Bevacizumab Biosimilar MIL60, Bevacizumab Biosimilar Mvasi, Bevacizumab Biosimilar MYL-1402O, Bevacizumab Biosimilar QL 1101, Bevacizumab Biosimilar RPH-001, Bevacizumab Biosimilar SCT501, Bevacizumab Biosimilar Zirabev, Bevacizumab-awwb, Bevacizumab-bvzr, BP102, BP102 Biosimilar, HD204, Immunoglobulin G1 (Human-Mouse Monoclonal rhuMab-VEGF Gamma-Chain Anti-Human Vascular Endothelial Growth Factor), Disulfide With Human-Mouse Monoclonal rhuMab-VEGF Light Chain, Dimer, Mvasi, MYL-1402O, Recombinant Humanized Anti-VEGF Monoclonal Antibody, rhuMab-VEGF, SCT501, SIBP 04, SIBP-04, SIBP04, Zirabev

  • DrugIxabepilone

    Given IV

    Also known as: (1S,3S,7S,10R,11S,12S,16R)-7,11-Dihydroxy-8,8,10,12,16-pentamethyl-3-[(1E)-1-methyl-2-(2-methyl-4-thiazolyl)ethenyl]-17-oxa-4-azabicyclo[14.1.0]heptadecane-5,9-dione, Azaepothilone B, BMS 247550, BMS-247550, BMS247550, Epothilone, Epothilone-B BMS 247550, Ixempra

  • OtherLaboratory Biomarker Analysis

    Correlative studies

  • DrugNab-paclitaxel

    Given IV

    Also known as: ABI 007, ABI-007, Abraxane, Albumin-bound Paclitaxel, Albumin-Stabilized Nanoparticle Paclitaxel, Nanoparticle Albumin-bound Paclitaxel, Nanoparticle Paclitaxel, Paclitaxel Albumin, paclitaxel albumin-stabilized nanoparticle formulation, Protein-bound Paclitaxel

  • DrugPaclitaxel

    Given IV

    Also known as: Anzatax, Asotax, Bristaxol, Praxel, Taxol, Taxol Konzentrat

  • OtherQuestionnaire Administration

    Ancillary studies

06

What researchers measure

Primary outcomes

  1. Progression Free Survival

    Progression-free survival (PFS) is defined as the interval from registration until first disease progression, regardless of site, or death resulting from any cause, which ever occurred first. Distribution was estimated using the Kaplan Meier product-limit method. Progression is defined as a 20% increase in the sum of longest diameter of target lesions (per Response Evaluation Criteria in Solid Tumors \[RECIST\] criteria).

    Time frame: Time from randomization to progression or death due to any cause, whichever occurs first (up to 5 years)

Secondary outcomes

  1. Objective Tumor Response Rate

    Response was defined by the Response Evaluation Criteria in Solid Tumors (RECIST). A responding participant had either a Complete Response (disappearance of all target lesions) or Partial Response (30% decrease in sum of longest diameter of target lesions).

    Time frame: Up to 5 years

  2. Time to Treatment Failure

    Time from registration until treatment failure, defined as early termination of protocol therapy for any reason, first disease progression or death without progression. Surviving participants who were failure free were censored as date last known alive and failure free. Distribution was estimated using the Kaplan Meier product-limit method.

    Time frame: Time from randomization until progression, death, or yearly termination of protocol therapy (up to 5 years)

  3. 12 Month Progression Free Survival

    Percentage of participants who were alive and progression free at 12 months. The 12 month progression free survival, with 95% confidence interval, was estimated using the Kaplan Meier method.

    Time frame: 12 months

  4. Overall Survival

    Overall survival was measured as the interval from study entry until death, from any cause, or last contact. Distribution was estimated using the Kaplan Meier product-limit method.

    Time frame: Time from randomization to death or last follow-up (up to 5 years)

07

Results

Posted Jul 2, 2015

Participant flow

Between October 2008 - November 2011, a total of 799 participants were recruited.

Participant flow — Overall Study
MilestoneArm A (Paclitaxel)Arm B (Nab-paclitaxel)Arm C (Ixabepilone)
Started283271245
Completed147122139
Not completed136149106
Withdrew: Never began treatment844
Withdrew: Adverse event397056
Withdrew: Death743
Withdrew: Withdrawal by subject353617
Withdrew: Alternative therapy1267
Withdrew: Complicating illness644
Withdrew: Other medical reasons292515

Outcome measures

PrimaryProgression Free Survival

Progression-free survival (PFS) is defined as the interval from registration until first disease progression, regardless of site, or death resulting from any cause, which ever occurred first. Distribution was estimated using the Kaplan Meier product-limit method. Progression is defined as a 20% increase in the sum of longest diameter of target lesions (per Response Evaluation Criteria in Solid Tumors \[RECIST\] criteria).

Time frame:
Time from randomization to progression or death due to any cause, whichever occurs first (up to 5 years)
Reported as:
Median · months
Progression Free Survival
monthsArm A (Paclitaxel)Arm B (Nab-paclitaxel)Arm C (Ixabepilone)
Progression Free Survival10.97 (9.79 to 12.42)9.3 (8.15 to 10.45)7.36 (6.21 to 8.18)
Statistical analysis
  • Arm A (Paclitaxel) vs Arm B (Nab-paclitaxel) · Log Rank · p = 0.054 (Tests were stratified by prior taxane therapy (yes/no) and hormone receptor status (positive/negative). P-values are for a test of inferiority 2-sided and are unadjusted for multiple comparisons.) · Hazard ratio (hr): 1.20 · 95% CI 1.00 to 1.45
  • Arm A (Paclitaxel) vs Arm C (Ixabepilone) · Log Rank · p = <0.0001 (Tests were stratified by prior taxane therapy (yes/no) and hormone receptor status (positive/negative). P-values are for a test of inferiority 2-sided and are unadjusted for multiple comparisons.) · Hazard ratio (hr): 1.55 · 95% CI 1.28 to 1.87
SecondaryObjective Tumor Response Rate

Response was defined by the Response Evaluation Criteria in Solid Tumors (RECIST). A responding participant had either a Complete Response (disappearance of all target lesions) or Partial Response (30% decrease in sum of longest diameter of target lesions).

Time frame:
Up to 5 years
Reported as:
Number · percentage of participants
Objective Tumor Response Rate
percentage of participantsArm A (Paclitaxel)Arm B (Nab-paclitaxel)Arm C (Ixabepilone)
Objective Tumor Response Rate38.234.125.6
SecondaryTime to Treatment Failure

Time from registration until treatment failure, defined as early termination of protocol therapy for any reason, first disease progression or death without progression. Surviving participants who were failure free were censored as date last known alive and failure free. Distribution was estimated using the Kaplan Meier product-limit method.

Time frame:
Time from randomization until progression, death, or yearly termination of protocol therapy (up to 5 years)
Reported as:
Median · months
Time to Treatment Failure
monthsArm A (Paclitaxel)Arm B (Nab-paclitaxel)Arm C (Ixabepilone)
Time to Treatment Failure6.6 (5.62 to 7.2)5.19 (4.83 to 5.55)4.93 (4.21 to 5.29)
Secondary12 Month Progression Free Survival

Percentage of participants who were alive and progression free at 12 months. The 12 month progression free survival, with 95% confidence interval, was estimated using the Kaplan Meier method.

Time frame:
12 months
Reported as:
Number · percentage of participants
12 Month Progression Free Survival
percentage of participantsArm A (Paclitaxel)Arm B (Nab-paclitaxel)Arm C (Ixabepilone)
12 Month Progression Free Survival45 (39 to 51)36 (30 to 42)28 (23 to 35)
SecondaryOverall Survival

Overall survival was measured as the interval from study entry until death, from any cause, or last contact. Distribution was estimated using the Kaplan Meier product-limit method.

Time frame:
Time from randomization to death or last follow-up (up to 5 years)
Reported as:
Median · months
Overall Survival
monthsArm A (Paclitaxel)Arm B (Nab-paclitaxel)Arm C (Ixabepilone)
Overall Survival26.55 (23.8 to 32.9)23.52 (20.4 to 28.2)23.53 (19.9 to 25.6)
Statistical analysis
  • Arm A (Paclitaxel) vs Arm B (Nab-paclitaxel) · Log Rank · p = 0.20 (Tests were stratified by prior taxane therapy (yes/no) and hormone receptor status (positive/negative).) · Hazard ratio (hr): 1.17 · 95% CI 0.92 to 1.47
  • Arm A (Paclitaxel) vs Arm C (Ixabepilone) · Log Rank · p = 0.038 (Tests were stratified by prior taxane therapy (yes/no) and hormone receptor status (positive/negative).) · Hazard ratio (hr): 1.28 · 95% CI 1.01 to 1.61

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Arm A (Paclitaxel)—65/272 (23.9%)263/272 (96.7%)
Arm B (Nab-paclitaxel)—80/264 (30.3%)248/264 (93.9%)
Arm C (Ixabepilone)—59/238 (24.8%)230/238 (96.6%)
Most frequent serious events
Showing 10 of 215
Most frequent serious events
EventArm A (Paclitaxel)Arm B (Nab-paclitaxel)Arm C (Ixabepilone)
FatigueGeneral disorders43/27256/26440/238
Peripheral sensory neuropathyNervous system disorders35/27243/26432/238
Neutrophil count decreasedInvestigations16/27236/26414/238
NauseaGastrointestinal disorders6/27219/26421/238
HypertensionVascular disorders15/27217/26417/238
Hemoglobin decreasedBlood and lymphatic system disorders14/27218/26412/238
Leukocyte count decreasedInvestigations7/27217/2647/238
VomitingGastrointestinal disorders6/27212/26415/238
DyspneaRespiratory, thoracic and mediastinal disorders12/27213/26415/238
Platelet count decreasedInvestigations3/27213/26410/238
Most frequent other events
Showing 10 of 293
Most frequent other events
EventArm A (Paclitaxel)Arm B (Nab-paclitaxel)Arm C (Ixabepilone)
FatigueGeneral disorders208/272213/264205/238
Peripheral sensory neuropathyNervous system disorders216/272206/264175/238
Neutrophil count decreasedInvestigations116/272178/26464/238
HypertensionVascular disorders127/27297/26490/238
MyalgiaMusculoskeletal and connective tissue disorders92/27299/26477/238
Leukocyte count decreasedInvestigations55/27287/26441/238
NauseaGastrointestinal disorders48/27252/26475/238
Peripheral motor neuropathyNervous system disorders46/27266/26447/238
EpistaxisRespiratory, thoracic and mediastinal disorders68/27256/26447/238
ProteinuriaRenal and urinary disorders58/27264/26450/238

Baseline characteristics

All randomized participants are included in baseline characteristics.

Age, Customized
Age, Customized(participants)Arm A (Paclitaxel)Arm B (Nab-paclitaxel)Arm C (Ixabepilone)Total
20-292215
30-3915181750
40-49525655163
50-591098986284
60-69747468216
70-7924281567
80+74314
Sex: Female, Male
Sex: Female, Male(Participants)Arm A (Paclitaxel)Arm B (Nab-paclitaxel)Arm C (Ixabepilone)Total
Female277268243788
Male63211
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Arm A (Paclitaxel)Arm B (Nab-paclitaxel)Arm C (Ixabepilone)Total
Hispanic or Latino19151347
Not Hispanic or Latino252239221712
Unknown or Not Reported12171140
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Arm A (Paclitaxel)Arm B (Nab-paclitaxel)Arm C (Ixabepilone)Total
American Indian or Alaska Native2125
Asian0000
Native Hawaiian or Other Pacific Islander3014
Black or African American424526113
White220214206640
More than one race1124
Unknown or Not Reported1510833
Region of Enrollment
Region of Enrollment(participants)Arm A (Paclitaxel)Arm B (Nab-paclitaxel)Arm C (Ixabepilone)Total
United States283271245799
Prior Adjuvant Taxane
Prior Adjuvant Taxane(participants)Arm A (Paclitaxel)Arm B (Nab-paclitaxel)Arm C (Ixabepilone)Total
Yes125120107352
No158151138447
Hormone Receptor Status
Hormone Receptor Status(participants)Arm A (Paclitaxel)Arm B (Nab-paclitaxel)Arm C (Ixabepilone)Total
ER/PgR Positive201195178574
ER/PgR Negative827667225
Physician's Decision to use Bevacizumab
Physician's Decision to use Bevacizumab(participants)Arm A (Paclitaxel)Arm B (Nab-paclitaxel)Arm C (Ixabepilone)Total
Bevacizumab planned514415110
Bevacizumab not planned84820
Bevacizumab required224223222669
08

Study locations

704 sites
  • Mayo Clinic in Arizona
    Scottsdale, Arizona 85259, United States
  • Sparks Regional Medical Center
    Fort Smith, Arkansas 72901, United States
  • Mercy Hospital Fort Smith
    Fort Smith, Arkansas 72903, United States
  • NEA Baptist Memorial Hospital
    Jonesboro, Arkansas 72401, United States
  • Kaiser Permanente-Anaheim
    Anaheim, California 92806, United States
  • Kaiser Permanente-Deer Valley Medical Center
    Antioch, California 94531, United States
  • PCR Oncology
    Arroyo Grande, California 93420, United States
  • Kaiser Permanente-Baldwin Park
    Baldwin Park, California 91706, United States
  • Kaiser Permanente-Bellflower
    Bellflower, California 90706, United States
  • Alta Bates Summit Medical Center-Herrick Campus
    Berkeley, California 94704, United States
  • Providence Saint Joseph Medical Center/Disney Family Cancer Center
    Burbank, California 91505, United States
  • Mills-Peninsula Medical Center
    Burlingame, California 94010, United States
  • East Bay Radiation Oncology Center
    Castro Valley, California 94546, United States
  • Eden Hospital Medical Center
    Castro Valley, California 94546, United States
  • Valley Medical Oncology Consultants-Castro Valley
    Castro Valley, California 94546, United States
  • City of Hope Comprehensive Cancer Center
    Duarte, California 91010, United States
  • Bay Area Breast Surgeons Inc
    Emeryville, California 94608, United States
  • Kaiser Permanente-Fontana
    Fontana, California 92335, United States
  • Kaiser Permanente-Fremont
    Fremont, California 94538, United States
  • Valley Medical Oncology Consultants-Fremont
    Fremont, California 94538, United States
  • Kaiser Permanente-Fresno
    Fresno, California 93720, United States
  • Marin Cancer Care Inc
    Greenbrae, California 94904, United States
  • Marin General Hospital
    Greenbrae, California 94904, United States
  • Kaiser Permanente - Harbor City
    Harbor City, California 90710, United States
  • Kaiser Permanente-Irvine
    Irvine, California 92618, United States
  • Loma Linda University Medical Center
    Loma Linda, California 92354, United States
  • Kaiser Permanente Los Angeles Medical Center
    Los Angeles, California 90027, United States
  • Kaiser Permanente West Los Angeles
    Los Angeles, California 90034, United States
  • Contra Costa Regional Medical Center
    Martinez, California 94553-3156, United States
  • El Camino Hospital
    Mountain View, California 94040, United States
  • Sutter Cancer Research Consortium
    Novato, California 94945, United States
  • Highland General Hospital
    Oakland, California 94602, United States
  • Alta Bates Summit Medical Center - Summit Campus
    Oakland, California 94609, United States
  • Bay Area Tumor Institute
    Oakland, California 94609, United States
  • Hematology and Oncology Associates-Oakland
    Oakland, California 94609, United States
  • Tom K Lee Inc
    Oakland, California 94609, United States
  • Kaiser Permanente-Oakland
    Oakland, California 94611, United States
  • Kaiser Permanente - Panorama City
    Panorama City, California 91402, United States
  • Valley Care Health System - Pleasanton
    Pleasanton, California 94588, United States
  • Valley Medical Oncology Consultants
    Pleasanton, California 94588, United States
  • Kaiser Permanente-Redwood City
    Redwood City, California 94063, United States
  • Kaiser Permanente-Richmond
    Richmond, California 94801, United States
  • Kaiser Permanente-Riverside
    Riverside, California 92505, United States
  • Kaiser Permanente-Roseville
    Roseville, California 95661, United States
  • Kaiser Permanente-South Sacramento
    Sacramento, California 95823, United States
  • Kaiser Permanente - Sacramento
    Sacramento, California 95825, United States
  • Salinas Valley Memorial
    Salinas, California 93901, United States
  • UC San Diego Medical Center - Hillcrest
    San Diego, California 92103, United States
  • Kaiser Permanente-San Diego Mission
    San Diego, California 92108, United States
  • Kaiser Permanente-San Diego Zion
    San Diego, California 92120, United States
  • Naval Medical Center -San Diego
    San Diego, California 92134, United States
  • Zuckerberg San Francisco General Hospital
    San Francisco, California 94110, United States
  • California Pacific Medical Center-Pacific Campus
    San Francisco, California 94115, United States
  • Kaiser Permanente-San Francisco
    San Francisco, California 94115, United States
  • UCSF Medical Center-Mount Zion
    San Francisco, California 94115, United States
  • Kaiser Permanente-Santa Teresa-San Jose
    San Jose, California 95119, United States
  • Kaiser Permanente San Leandro
    San Leandro, California 94577, United States
  • Kaiser Permanente-San Marcos
    San Marcos, California 92078, United States
  • Doctors Medical Center- JC Robinson Regional Cancer Center
    San Pablo, California 94806, United States
  • Kaiser Permanente-San Rafael
    San Rafael, California 94903, United States
  • Kaiser Permanente Medical Center - Santa Clara
    Santa Clara, California 95051, United States
  • Kaiser Permanente-Santa Rosa
    Santa Rosa, California 95403, United States
  • Kaiser Permanente-South San Francisco
    South San Francisco, California 94080, United States
  • Saint Helena Hospital
    St. Helena, California 94574, United States
  • Kaiser Permanente-Stockton
    Stockton, California 95210, United States
  • Kaiser Permanente Medical Center-Vacaville
    Vacaville, California 95688, United States
  • Kaiser Permanente-Vallejo
    Vallejo, California 94589, United States
  • Sutter Solano Medical Center/Cancer Center
    Vallejo, California 94589, United States
  • Kaiser Permanente-Walnut Creek
    Walnut Creek, California 94596, United States
  • Kaiser Permanente-Woodland Hills
    Woodland Hills, California 91367, United States
  • The Medical Center of Aurora
    Aurora, Colorado 80012, United States
  • Boulder Community Hospital
    Boulder, Colorado 80301, United States
  • Penrose-Saint Francis Healthcare
    Colorado Springs, Colorado 80907, United States
  • UCHealth Memorial Hospital Central
    Colorado Springs, Colorado 80909, United States
  • Kaiser Permanente-Franklin
    Denver, Colorado 80205, United States
  • Porter Adventist Hospital
    Denver, Colorado 80210, United States
  • Presbyterian - Saint Lukes Medical Center - Health One
    Denver, Colorado 80218, United States
  • SCL Health Saint Joseph Hospital
    Denver, Colorado 80218, United States
  • Rose Medical Center
    Denver, Colorado 80220, United States
  • Western States Cancer Research NCORP
    Denver, Colorado 80222, United States
  • Swedish Medical Center
    Englewood, Colorado 80113, United States
  • Poudre Valley Hospital
    Fort Collins, Colorado 80524, United States
  • Saint Mary's Hospital and Regional Medical Center
    Grand Junction, Colorado 81501, United States
  • North Colorado Medical Center
    Greeley, Colorado 80631, United States
  • Kaiser Permanente-Rock Creek
    Lafayette, Colorado 80026, United States
  • Saint Anthony Hospital
    Lakewood, Colorado 80228, United States
  • Littleton Adventist Hospital
    Littleton, Colorado 80122, United States
  • Sky Ridge Medical Center
    Lone Tree, Colorado 80124, United States
  • Longmont United Hospital
    Longmont, Colorado 80501, United States
  • McKee Medical Center
    Loveland, Colorado 80539, United States
  • Saint Mary Corwin Medical Center
    Pueblo, Colorado 81004, United States
  • North Suburban Medical Center
    Thornton, Colorado 80229, United States
  • SCL Health Lutheran Medical Center
    Wheat Ridge, Colorado 80033, United States
  • Smilow Cancer Hospital Care Center at Saint Francis
    Hartford, Connecticut 06105, United States
  • Middlesex Hospital
    Middletown, Connecticut 06457, United States
  • Yale University
    New Haven, Connecticut 06520, United States
  • Bayhealth Hospital Kent Campus
    Dover, Delaware 19901, United States
  • Beebe Medical Center
    Lewes, Delaware 19958, United States
  • Christiana Care Health System-Christiana Hospital
    Newark, Delaware 19718, United States
  • MedStar Georgetown University Hospital
    Washington D.C., District of Columbia 20007, United States

Showing the first 100 of 704 sites across 2 countries.

09

References and documents

Publications

  • Stover DG, Salgado R, Savenkov O, Ballman K, Mayer EL, Magbanua MJM, Loi S, Vater M, Glover K, Watson M, Wen Y, Symmans WF, Perou C, Carey LA, Partridge AH, Rugo HS. Association between tumor-infiltrating lymphocytes and survival in patients with metastatic breast cancer receiving first-line chemotherapy: analysis of CALGB 40502. NPJ Breast Cancer. 2024 Aug 21;10(1):75. doi: 10.1038/s41523-024-00683-x. PubMed 39169033 ↗
  • Quintanilha JCF, Wang J, Sibley AB, Jiang C, Etheridge AS, Shen F, Jiang G, Mulkey F, Patel JN, Hertz DL, Dees EC, McLeod HL, Bertagnolli M, Rugo H, Kindler HL, Kelly WK, Ratain MJ, Kroetz DL, Owzar K, Schneider BP, Lin D, Innocenti F. Bevacizumab-induced hypertension and proteinuria: a genome-wide study of more than 1000 patients. Br J Cancer. 2022 Feb;126(2):265-274. doi: 10.1038/s41416-021-01557-w. Epub 2021 Oct 6. PubMed 34616010 ↗
  • Mehrotra S, Sharma MR, Gray E, Wu K, Barry WT, Hudis C, Winer EP, Lyss AP, Toppmeyer DL, Moreno-Aspitia A, Lad TE, Valasco M, Overmoyer B, Rugo H, Ratain MJ, Gobburu JV. Kinetic-Pharmacodynamic Model of Chemotherapy-Induced Peripheral Neuropathy in Patients with Metastatic Breast Cancer Treated with Paclitaxel, Nab-Paclitaxel, or Ixabepilone: CALGB 40502 (Alliance). AAPS J. 2017 Sep;19(5):1411-1423. doi: 10.1208/s12248-017-0101-9. Epub 2017 Jun 15. PubMed 28620884 ↗
  • 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. PubMed 26056183 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00785291
Lead sponsor
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Nov 5, 2008
Start date
Oct 13, 2008
Primary completion
Dec 31, 2013
Completion
Jun 15, 2017
Results posted
Jul 2, 2015
Last update
Jun 23, 2026

Study contacts

Hope S Rugo
principal investigator · Alliance for Clinical Trials in Oncology

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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