Carboplatin, Paclitaxel, and Bevacizumab in Treating Patients With Locally Recurrent or Metastatic Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00654836|
Recruitment Status : Completed
First Posted : April 9, 2008
Results First Posted : September 14, 2017
Last Update Posted : September 14, 2017
RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry cancer-killing substances to them. Bevacizumab may also stop the growth of breast cancer by blocking blood flow to the tumor. Giving carboplatin and paclitaxel together with bevacizumab may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving carboplatin and paclitaxel together with bevacizumab works in treating patients with locally recurrent or metastatic breast cancer.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Biological: bevacizumab Drug: Carboplatin Drug: ABI-007||Phase 2|
- To determine the progression-free survival of patients with locally recurrent or metastatic breast cancer treated with carboplatin, paclitaxel albumin-stabilized nanoparticle formulation, and bevacizumab as first-line therapy.
- To determine the response rate in these patients.
- To determine the overall survival of these patients.
- To evaluate the toxicity profile of this regimen in these patients.
OUTLINE: Patients receive carboplatin IV over 1 hour and bevacizumab IV on days 1, 22 and 43. Patients also receive paclitaxel albumin-bound nanoparticle formulation IV over 30 minutes on days 1, 8 ,15, 22, 29, 36, 43, and 50. Treatment continues in the absence of disease progression or unacceptable toxicity.
Formalin-fixed paraffin-embedded archived tumor tissue samples are assessed by immunohistochemistry (IHC) for various biomarkers. Levels of Notch-1, Notch-4, cyclin A, cyclin B, Jagged-1, and DLL4 in tumor-associated endothelial cells are correlated with response in both estrogen- and progesterone-positive and negative tumors, and independently of p53 status.
After completion of study treatment, patients are followed for up to 2 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Carboplatin, Nanoparticle Albumin-Bound Paclitaxel (ABI-007) and Avastin as the First Line Therapy in Metastatic Breast Cancer.|
|Study Start Date :||October 2007|
|Actual Primary Completion Date :||February 2012|
|Actual Study Completion Date :||September 2015|
Experimental: Carboplatin, ABI-007 and Bevacizumab
Participants will receive combination carboplatin, nanoparticle albumin-bound paclitaxel (ABI-007-Abraxane), and bevacizumab (Avastin)
Participants will receive bevacizumab 15 mg/kg on days 1,22, and 43.
Other Name: Avastin
Participants will receive a standard carboplatin dose according to their area under the plasma drug concentration-time curve (AUC-6) on days 1, 22, and 43.
Other Name: Paraplatin
Participants will receive ABI-007 (Abraxane) 100mg/m2 on days 1,8, 15, 22, 29, 36,43,and 50.
Other Name: Abraxane
- Progression-free Survival [ Time Frame: 30 Months ]Progression-free survival was measured from treatment initiation to 30 months. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
- Response Rate at End of Treatment [ Time Frame: 30 Months ]Response to treatment was recorded 30 months following treatment initiation. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progressive Disease (PD); PD, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions .
- Overall Survival [ Time Frame: 80 Months ]Overall survival was measured from treatment initiation to 80 months
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00654836
|United States, Illinois|
|Good Samaritan Cancer Care Center at Advocate Good Samaritan Hospital|
|Downers Grove, Illinois, United States, 60515-1500|
|Delnor Community Hospital - Geneva|
|Geneva, Illinois, United States, 60134-4200|
|Cardinal Bernardin Cancer Center at Loyola University Medical Center|
|Maywood, Illinois, United States, 60153|
|Edward Hospital Cancer Center|
|Naperville, Illinois, United States, 60540|
|Swedish-American Regional Cancer Center|
|Rockford, Illinois, United States, 61104-2315|
|Central Dupage Cancer Center|
|Winfield, Illinois, United States, 60190-1295|
|Principal Investigator:||Shelly Lo, MD||Loyola University|