Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00193206
Status:
COMPLETED
Last Update Posted:
2021-11-23
First Post:
2005-09-12
Brief Title:
Neo-adjuvant Gemcitabine Epirubicin ABI-007 GEA in Locally Advanced or Inflammatory Breast Cancer
Sponsor:
SCRI Development Innovations LLC
Organization:
SCRI Development Innovations LLC
Study Overview
Official Title:
Phase II Trial of Dose Dense Neo-adjuvant Gemcitabine Epirubicin ABI-007 GEA in Locally Advanced or Inflammatory Breast Cancer
Status:
COMPLETED
Status Verified Date:
2021-11
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:
None
Brief Summary:
In this trial we will evaluate ABI-007 with gemcitabine and epirubicin utilizing the biweekly pegfilgrastim support in order to further improve upon the effectiveness and favorable toxicity of this triplet
Detailed Description:
Upon determination of eligibility patients will be receive both induction neo-adjuvant regimen and a postoperative adjuvant regimen
Induction Neo-adjuvant Epirubicin Gemcitabine ABI-007 Pegfilgrastim
Postoperative Adjuvant Gemcitabine ABI-007 Pegfilgrastim
Upon completion of chemotherapy all ER andor PR patients will receive Tamoxifen or an aromatase inhibitor at physician discretion
Induction Neo-adjuvant Epirubicin Gemcitabine ABI-007 Pegfilgrastim
Postoperative Adjuvant Gemcitabine ABI-007 Pegfilgrastim
Upon completion of chemotherapy all ER andor PR patients will receive Tamoxifen or an aromatase inhibitor at physician discretion
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