Ignite Creation Date:
2025-12-24 @ 6:43 PM
Ignite Modification Date:
2026-01-02 @ 6:39 AM
Study NCT ID:
NCT00532857
Status:
COMPLETED
Last Update Posted:
2012-01-04
First Post:
2007-09-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase II Study of Primary Chemotherapy With Paclitaxel, Gemcitabine, and Trastuzumab
Sponsor:
Jungsil Ro
Organization:
Study Overview
Official Title:
Phase II Study of Primary Chemotherapy With Paclitaxel, Gemcitabine, and Trastuzumab in Patients With HER2 Positive Operable Breast Cancer
Status:
COMPLETED
Status Verified Date:
2012-01
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:
PGH
Brief Summary:
To evaluate the pathologic complete response rate to preoperative administration of Paclitaxel, Gemcitabine, and Trastuzumab (HerceptinÒ) (PGH)
Detailed Description:
Primary objectives: To evaluate the pathologic complete response rate to preoperative administration of Paclitaxel, Gemcitabine, and Trastuzumab (HerceptinÒ) (PGH) Secondary objectives: To assess breast conserving rate after preoperative chemotherapyTo evaluate clinical response rate, disease free survival (DFS), and overall survival (OS) To assess the safety profiles of PGH
Treatment will be delivered in the outpatient setting. Each three-week cycle consists of paclitaxel 80 mg/m2 (day 1, 8) and gemcitabine 1200 mg/m2 (day1, 8) in addition to trastuzumab, which is given at a dose of 4 mg/kg IV on day 1 of the first treatment cycle over 90 min, and subsequently given weekly at a dose of 2 mg/kg over 30 min. Patients will receive 6 cycles of therapy unless there is any evidence of no response suitable for operation(SD or PD) or unacceptable toxicity or noncompliance by patient with protocol requirements. Patients who are unsuitable for op due to SD or PD, will undergo XRT. However, when patients are still suitable for op even with SD or PD, these patients will undergo op.Such decision will be made at physician's discretion at each institution. Also, even though there is neither clear evidence of disease progression nor severe toxicity, if patient declines the treatment, study treatment can be discontinued. Response will be documented by physical examination, sonography and/or chest CT prior to treatment and every three cycles. Postoperatively within 1-3 week, trastuzumab 6 mg/kg every 3 weeks x 11 and tamoxifen or AI for 5 years will be given as indicated. Radiation therapy will be initiated postoperatively in 3-4 weeks according to the standard practice guidelines.
Treatment will be delivered in the outpatient setting. Each three-week cycle consists of paclitaxel 80 mg/m2 (day 1, 8) and gemcitabine 1200 mg/m2 (day1, 8) in addition to trastuzumab, which is given at a dose of 4 mg/kg IV on day 1 of the first treatment cycle over 90 min, and subsequently given weekly at a dose of 2 mg/kg over 30 min. Patients will receive 6 cycles of therapy unless there is any evidence of no response suitable for operation(SD or PD) or unacceptable toxicity or noncompliance by patient with protocol requirements. Patients who are unsuitable for op due to SD or PD, will undergo XRT. However, when patients are still suitable for op even with SD or PD, these patients will undergo op.Such decision will be made at physician's discretion at each institution. Also, even though there is neither clear evidence of disease progression nor severe toxicity, if patient declines the treatment, study treatment can be discontinued. Response will be documented by physical examination, sonography and/or chest CT prior to treatment and every three cycles. Postoperatively within 1-3 week, trastuzumab 6 mg/kg every 3 weeks x 11 and tamoxifen or AI for 5 years will be given as indicated. Radiation therapy will be initiated postoperatively in 3-4 weeks according to the standard practice guidelines.
Study Oversight
Has Oversight DMC:
False
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?: