Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00193115
Status:
COMPLETED
Last Update Posted:
2010-08-04
First Post:
2005-09-12
Brief Title:
Docetaxel Followed by Doxorubicin Plus Cyclophosphamide for Node Positive or High-Risk Primary Breast Cancer
Sponsor:
SCRI Development Innovations LLC
Organization:
SCRI Development Innovations LLC
Study Overview
Official Title:
Phase II Pilot Trial of Dose-Dense Docetaxel Followed by Doxorubicin Plus Cyclophosphamide T-AC Given as Adjuvant or Neoadjuvant Treatment for Women With Node Positive or High-Risk Primary Breast Cancer
Status:
COMPLETED
Status Verified Date:
2009-01
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:
None
Brief Summary:
This protocol will evaluate the feasibility and toxicity of dose-dense docetaxel followed by doxorubicin and cyclophosphamide with support given as adjuvant or neoadjuvant treatment of women with node positive and high risk breast cancer
Detailed Description:
Upon determination of eligibility patients will receive
Neoadjuvant Docetaxel Doxorubicin Cyclophosphamide Surgery
Adjuvant patients will enter the study after surgery and receive Docetaxel Doxorubicin Cyclophosphamide Patients treated with lumpectomy will undergo postoperative radiation therapy after completion of chemotherapy Patients with positive estrogen andor progesterone receptors will begin anti-estrogen therapy after the last course of chemotherapy
Neoadjuvant Docetaxel Doxorubicin Cyclophosphamide Surgery
Adjuvant patients will enter the study after surgery and receive Docetaxel Doxorubicin Cyclophosphamide Patients treated with lumpectomy will undergo postoperative radiation therapy after completion of chemotherapy Patients with positive estrogen andor progesterone receptors will begin anti-estrogen therapy after the last course of 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 |
|---|---|---|---|
| 11251 | None | None | None |