Ignite Creation Date:
2024-05-05 @ 5:29 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00462865
Status:
TERMINATED
Last Update Posted:
2019-04-09
First Post:
2007-04-18
Brief Title:
Trial of Chemotherapy and Avastin as Treatment for Women With Breast Cancer at High Risk for Relapse
Sponsor:
Brown University
Organization:
Brown University
Study Overview
Official Title:
A Phase II Study of Adjuvant GemcitabineCapecitabine and Bevacizumab for Patients Treated Neoadjuvantly Chemotherapy for Early Stage Breast Cancer With High Risk for Relapse
Status:
TERMINATED
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
DSMB determined toxicity of regimen more than originally thought Slow accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Women with breast cancer who are not eligible for breast conserving surgery or who have node-involvement are sometimes treated with chemotherapy up front in hopes of allowing for a woman to keep her breast and decreasing the size of the excision for her breast cancer While current research has shown that survival is the same whether women are treated with chemotherapy first or surgery first for breast cancer the investigators do not yet know how to treat women with persistent breast cancer after she has received primary chemotherapy This study looks at the use of a combination regimen of two agents gemcitabine and capecitabine both of which are active in breast cancer and using Avastin to see if this regimen can be given to women treated with primary chemotherapy and then surgery considered to be at high risk of relapse
Detailed Description:
For patients with locally advanced breast cancers LABC primary or neoadjuvant chemotherapy NAC has become accepted as standard treatment Advantages of NAC include shrinking the primary tumor often rendering an unresectable cancer resectable and the theoretically concurrent treatment of occult metastatic disease prior to definitive local therapy surgery - radiation therapy NAC can reduce the extent of surgery required for the management of local breast cancer from mastectomy to lump- or segmentectomy without compromising major outcome measures such as overall and disease free survival At this time the current standard of care for women felt to be candidates for NAC is an anthracycline taxane regimen The intent is to induce a pCR which as noted above is a strong indicator of survival Yet in both large NSABP studies the proportion of women achieving this is less than 20 with these regimens raising a major challenge in clinical practice what is the appropriate treatment for women with persistent disease after NAC Given that gemcitabine and capecitabine are non-cross-resistant to anthracyclines and taxanes and use a different mechanism of action have an acceptable toxicity profile and in the absence of standard options for therapy we are interested in utilizing these agents coupled with bevacizumab as adjuvant treatment in women with residual breast cancer following primary chemotherapy
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 |
|---|---|---|---|
| AVF4173s | OTHER | Genentech | None |