Phase 3
N=799
Paclitaxel, Nab-paclitaxel, or Ixabepilone With or Without Bevacizumab in Treating Patients With Stage IIIC or Stage IV Breast Cancer
Estrogen Receptor Negative · Estrogen Receptor Positive · HER2/Neu Negative · HER2/Neu Positive · Progesterone Receptor Negative
Bottom Line
View on ClinicalTrials.gov: NCT00785291 ↗Enrolled (actual)
799
Serious AEs
26.4%
Results posted
Jul 2015
Primary outcome: Primary: Progression Free Survival — 10.97; 9.3; 7.36 months — p=0.054
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Bevacizumab (Biological); Ixabepilone (Drug); Laboratory Biomarker Analysis (Other); Nab-paclitaxel (Drug); Paclitaxel (Drug); Questionnaire Administration (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Cancer Institute (NCI)
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival |
10.97; 9.3; 7.36 | 0.054 |
| SECONDARY Objective Tumor Response Rate |
38.2; 34.1; 25.6 | — |
| SECONDARY Time to Treatment Failure |
6.6; 5.19; 4.93 | — |
| SECONDARY 12 Month Progression Free Survival |
45; 36; 28 | — |
| SECONDARY Overall Survival |
26.55; 23.52; 23.53 | 0.20 |
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.
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 = = 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
Data sourced from ClinicalTrials.gov (NCT00785291). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.