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Paclitaxel, Nab-paclitaxel, or Ixabepilone With or Without Bevacizumab in Treating Patients With Stage IIIC or Stage IV Breast Cancer
Overall Recruitment Status: Active, enrollment completed
 
Official Title
A Randomized Phase III Trial of Weekly Paclitaxel Compared to Weekly Nanoparticle Albumin Bound Nab-paclitaxel or Ixabepilone With or Without Bevacizumab as First-Line Therapy for Locally Recurrent or Metastatic Breast Cancer
 
Region Sponsors
California - Northern
Alliance for Clinical Trials in Oncology
Cancer Trials Support Unit
National Cancer Institute (NCI)
 
Acronym KP IRB No.
CN-09LFehr-15-B
 
Study Type Phase
Clinical Trial Phase III
 
Study Population Description
Patients who are Estrogen Receptor Negative or Positive, HER2/Neu Negative or Positive, Progesterone Receptor Negative or Positive, or who have Recurrent Breast Carcinoma, Stage IIIC Breast Cancer AJCC v6, or Stage IV Breast Cancer.
 
Purpose
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.
 
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. Please contact study team for SECONDARY OBJECTIVES. 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.
 
Gender Age Limit
Male & Female
 
Inclusion Criteria
  • Histologic confirmation of invasive cancer of the breast
  • Stage IV disease or stage IIIC disease not amenable to local therapy
  • 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
  • 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
  • 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) to allow for sufficient healing
  • Please contact study team for more eligibility criteria
 
Exclusion Criteria
  • 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
  • No prior chemotherapy for metastatic breast cancer
  • 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
  • Patients with pre-existing peripheral neuropathy >= grade 2 are not eligible for this study
  • Women must not be pregnant or breast feeding
  • 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
  • Please contact study team for more eligibility criteria

 
Keywords and/or Specific Medical Conditions
  • Albumin-Bound Paclitaxel
  • Mitosis Modulators
  • Angiogenesis Inhibitors
  • Molecular Mechanisms of Pharmacological Action
  • Angiogenesis Modulating Agents
  • Neoplasms
  • Antimitotic Agents
  • Neoplasms by Histologic Type
  • Antineoplastic Agents
  • Neoplasms by Site
  • Antineoplastic Agents, Phytogenic
  • Neoplasms, Glandular and Epithelial
  • Bevacizumab
  • Paclitaxel
  • Breast Diseases
  • Physiological Effects of Drugs
  • Breast Neoplasms
  • Progesterone Receptor Negative
  • Breast Neoplasms, Male
  • Progesterone Receptor Positive
  • Carcinoma
  • Recurrent Breast Carcinoma
  • Epothilones
  • Skin Diseases
  • Estrogen Receptor Positive
  • Stage IIIC Breast Cancer AJCC v6
  • Growth Inhibitors
  • Stage IV Breast Cancer
  • Growth Substances
  • Tubulin Modulators
  • HER2/Neu Negative
  • Estrogen Receptor Negative
  • HER2/Neu Positive
  • Oncology (Adult)
  • Male Breast Carcinoma
 
KP Clinical Facility
  • Central Valley-Stockton
  • Diablo Medical Center-Walnut Creek
  • Fremont Medical Center
  • Hayward Medical Center
  • Oakland Medical Center
  • Redwood City Medical Center
  • Richmond Medical Center
  • Roseville Medical Center
  • San Rafael Medical Center
  • Santa Clara Medical Center-Homestead
  • Santa Rosa Medical Center
  • Santa Teresa Medical Center-San Jose
  • South Sacramento Medical Center
  • South San Francisco Medical Center
  • Vallejo Medical Center
  • Vallejo Medical Center-Vacaville
 
Clinical Area
  • Oncology (Adult)


Principal Investigator:
Jennifer Suga, MD
Contact Information:
- Desiree Goldstein, RN
-Desiree.Goldstein@kp.org
-Vallejo Medical Center


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