Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001250
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Effect of Preoperative Chemotherapy on Axillary Lymph Node Metastases in Stage II Breast Cancer A Prospective Randomized Trial
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Effect of Preoperative Chemotherapy on Axillary Lymph Node Metastases in Stage II Breast Cancer A Prospective Randomized Trial
Status:
COMPLETED
Status Verified Date:
2002-10
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:
Patients with untreated clinical stage II breast cancer are eligible An excisional biopsy of the primary tumor is acceptable but without definitive local therapy or prior chemotherapy Histologic confirmation of invasive carcinoma is required Patients are prospectively randomized to receive five 21-day cycles of dose-intense 5-fluorouracil adriamycin leucovorin cytoxan granuloctye-colony stimulating factor FLACG-CSF chemotherapy either before preoperative or after postoperative local therapy Chemotherapy is given as an outpatient For patients receiving preoperative chemotherapy local therapy modified radical mastectomy or breast segmentectomyaxillary dissectionbreast radiotherapy according to patient preference is performed 3-4 weeks after last chemotherapy For patients receiving postoperative chemotherapy chemotherapy will begin 2-3 weeks after local therapy Immediate reconstruction for mastectomy is acceptable Upon completion of local therapy and chemotherapy in either treatment group all estrogen receptor positive patients receive tamoxifen for 5 years Follow-up consists of history and physical examination each 3 months for first 3 years each six months for years 4 and 5 and yearly thereafter Mammogram bone scan chest x-ray and blood work are performed yearly
Detailed Description:
A prospective randomized trial evaluating the effect of preoperative dose intense chemotherapy FLACG-CSF on axillary lymph node metastases in women with clinical stage II T1N1 T2N0 T2N1 breast cancer Patients will be randomized to receive 5 cycles of combination chemotherapy 5-FU adriamycin leucovorin cytoxan G-CSF either as initial therapy preoperative or postoperatively after local therapy modified radical mastectomy or lumpectomyaxillary lymph node dissectionwhole breast radiotherapy Each chemotherapy cycle will be 21 days At the time of local therapy the incidence of axillary metastases in the axillary dissection specimen will be determined and compared in the preoperative chemotherapy vs postoperative chemotherapy treatment groups
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 |
|---|---|---|---|
| 90-C-0044 | None | None | None |