Ignite Creation Date:
2024-05-05 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00479674
Status:
COMPLETED
Last Update Posted:
2015-02-18
First Post:
2007-05-25
Brief Title:
Phase II Study With Abraxane Bevacizumab and Carboplatin in Triple Negative Metastatic Breast Cancer
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
A Phase II Study of Abraxane Carboplatin and Bevacizumab in Triple Negative Demonstrating No Expression for Estrogen Progesterone or Her2 Receptors Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2015-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ABC
Brief Summary:
Taxanes such as paclitaxel are highly active to treat breast cancer Abraxane nanoparticle albumin-bound paclitaxel compared to standard paclitaxel improves efficacy and tolerability When combined with a taxane platinum agents improve response in metastatic breast cancer with carboplatin conferring less toxicity than cisplatin Monoclonal antibodies including bevacizumab target vascular endothelial growth factor VEGF to reduce angiogenesis We hypothesize that the previously-untested combination of weekly Abraxane and carboplatin plus biweekly bevacizumab will lengthen time to progression without producing intolerable toxicity
Detailed Description:
Anthracycline-based chemotherapy is widely used as adjuvant treatment for breast cancer In addition to the challenge posed by anthracycline-induced cardiotoxicity there are issues surrounding previous treatment with anthracyclines which limit its utility in the metastatic disease setting Many patients with advanced disease will have had prior anthracycline-based adjuvant therapy may have reached a maximum cumulative lifetime dose or developed refractory disease creating an obvious need for non-anthracycline treatment strategies3 Platinum- and taxane-based chemotherapies as first-line therapy for metastatic breast cancer have demonstrated significant activity producing single-agent response rates 50 in combination these rates increased to 60 in both previously untreated and in patients who previously received anthracyclines3 However overall survival has remained relatively unchanged4 As there is currently no standard of care for patients with metastatic breast cancer various physical and psychological factors must be considered when evaluating chemotherapy treatment options including the patients tumor biology and growth rate presence and extent of metastases history of prior treatment and response sensitivity and tolerance to therapy and quality of life2 Strategies to develop combination higher dose or sequential regimens using these active agents while improving response rates andor time to progression may produce increased toxicity without increased survival2 Because metastatic breast cancer remains essentially incurable using cytotoxic therapy alone the study of targeted biologics offers new opportunities to enhance drug delivery via their ability to regulate specific receptors that are associated with clinically aggressive disease processes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| AVF3962s | None | None | None |