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Phase Ib/II Study of Primary Chemotherapy With Paclitaxel, Gemcitabine, and Sunitinib

NCT01070706 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2012-01-04

No results posted yet for this study

Summary

Phase Ib part:

▪ Primary objective: To demonstrate the recommended dose of the combination of paclitaxel, gemcitabine, and sunitinib (sutene®) (PGS) as preoperative chemotherapy in patients with HER2-negative operable breast cancer

* Secondary objective:

1. To demonstrate the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of this regimen
2. To determine the safety profile

Phase II part
* Primary objective:

To evaluate the pathologic complete response rate (pCR) to preoperative administration of PGS

▪ Secondary objective:

1. To assess breast conserving rate after preoperative PGS
2. To evaluate clinical response rate, disease free survival (DFS), and overall survival (OS)
3. To assess the safety profiles of PGS

Conditions

Interventions

DRUG

Paclitaxel,Gemcitabine,Sunitinib

To determine the MTD, only DLT occurring during the first cycle of treatment will be considered. And MTD is defined as the dose level at which at least one-third of patients experience a DLT during their first treatment course. The recommended dose level for the subsequent phase II study is defined as the preceding dose level before the MTD is attained. If MTD is not reached, the recommended initial dose of the phase II part will be at the dose of paclitaxel 80 mg/m2 and gemcitabine 1200 mg/m2 (days 1, 8) with sunitinib 37.5 mg qd D2-D15.

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • HK inno.N Corporation

    collaborator INDUSTRY

  • Jungsil Ro

    lead OTHER_GOV

Principal Investigators

  • Jungsil Ro · Chief, Center for Breast Cancer, National Cancer Center, Korea

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2009-12-31
Completion
2010-11-30

Countries

  • South Korea

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01070706 on ClinicalTrials.gov