Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003992
Status:
COMPLETED
Last Update Posted:
2013-06-03
First Post:
1999-11-01
Brief Title:
Chemotherapy Plus Monoclonal Antibody Therapy in Treating Women With Stage II or Stage IIIA Breast Cancer That Overexpresses HER2
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Pilot Trial of Paclitaxel-Herceptin Adjuvant Therapy for Early Stage Breast Cancer
Status:
COMPLETED
Status Verified Date:
2013-03
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:
Randomized phase II trial to study the effectiveness of chemotherapy with paclitaxel and the monoclonal antibody trastuzumab followed by chemotherapy in treating women who have stage II or stage IIIA breast cancer that overexpresses HER2 Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Monoclonal antibodies can locate tumor cells and deliver tumor-killing substances to them without harming normal cells Combining monoclonal antibody therapy with chemotherapy may kill more tumor cells
Detailed Description:
OBJECTIVES
I Evaluate the safety of paclitaxel plus trastuzumab Herceptin followed by adjuvant chemotherapy in women with node positive stage II or IIIa breast cancer with HER2 overexpression
II Evaluate the safety of long term trastuzumab Herceptin in this patient population
OUTLINE This is a randomized study Patients are stratified according to radiotherapy none planned vs planned to breast or chest wall Patients are randomized to one of two treatment arms
ARM I Patients receive paclitaxel IV over 3 hours immediately followed by trastuzumab Herceptin IV over 30-90 minutes on day 1 Paclitaxel repeats every 3 weeks for 4 courses and trastuzumab Herceptin repeats weekly for 10 courses At 3 weeks following paclitaxel and trastuzumab Herceptin patients receive doxorubicin IV and cyclophosphamide IV over 1 hour every 3 weeks for 4 courses Following chemotherapy estrogen receptor ER positive andor progesterone receptor PR positive patients receive oral tamoxifen twice daily for 5 years
ARM II Patients receive same therapy as in Arm I except for additional trastuzumab Herceptin IV weekly beginning within 3 weeks following completion of chemotherapy and local therapy and continuing for 1 year ER andor PR positive patients receive tamoxifen as in Arm I but may be concurrent with trastuzumab Herceptin Following completion of doxorubicin and cyclophosphamide post lumpectomy and post mastectomy patients may receive local radiotherapy daily for 5-6 weeks Treatment continues in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 1 year every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 200 patients 100 per treatment arm will be accrued for this study within 1 year
I Evaluate the safety of paclitaxel plus trastuzumab Herceptin followed by adjuvant chemotherapy in women with node positive stage II or IIIa breast cancer with HER2 overexpression
II Evaluate the safety of long term trastuzumab Herceptin in this patient population
OUTLINE This is a randomized study Patients are stratified according to radiotherapy none planned vs planned to breast or chest wall Patients are randomized to one of two treatment arms
ARM I Patients receive paclitaxel IV over 3 hours immediately followed by trastuzumab Herceptin IV over 30-90 minutes on day 1 Paclitaxel repeats every 3 weeks for 4 courses and trastuzumab Herceptin repeats weekly for 10 courses At 3 weeks following paclitaxel and trastuzumab Herceptin patients receive doxorubicin IV and cyclophosphamide IV over 1 hour every 3 weeks for 4 courses Following chemotherapy estrogen receptor ER positive andor progesterone receptor PR positive patients receive oral tamoxifen twice daily for 5 years
ARM II Patients receive same therapy as in Arm I except for additional trastuzumab Herceptin IV weekly beginning within 3 weeks following completion of chemotherapy and local therapy and continuing for 1 year ER andor PR positive patients receive tamoxifen as in Arm I but may be concurrent with trastuzumab Herceptin Following completion of doxorubicin and cyclophosphamide post lumpectomy and post mastectomy patients may receive local radiotherapy daily for 5-6 weeks Treatment continues in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 1 year every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 200 patients 100 per treatment arm will be accrued for this study within 1 year
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 |
|---|---|---|---|
| CDR0000067197 | REGISTRY | PDQ Physician Data Query | None |
| E-2198 | None | None | None |