Preoperative Chemotherapy With Paclitaxel, Gemcitabine, and Lapatinib (Tykerb®) (PGT)

Sponsor
Jungsil Ro
Study ID
NCT01133912
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • paclitaxel, gemcitabine, lapatinib — DRUG
    Patients receive paclitaxel and gemcitabine intravenously (iv) on day 1 and 8, and oral lapatinib once daily. Lapatinib with fixed dose will be given once a day p.o. from day 1 without resting during each cycle. The starting doses of paclitaxel 80mg/m2 and gemcitabine 1000mg/m2 iv, on day 1 and 8, and lapatinib 1000mg p.o., daily (dose level 1) will be administered every 21 days.

Study Details

Primary objectives : 1\. To evaluate the recommended dose of the combination of paclitaxel, gemcitabine, and lapatinib (Tykerb®) (PGT) as preoperative chemotherapy in patients with HER2 positive operable breast cancer Secondary objectives : 1. To evaluate the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of PGT 2. To determine the safety profile 3. To assess pCR in primary tumor and axillary LN 4. To evaluate clinical response rate, disease free survival (DFS), and overall survival (OS) 5. To assess breast conserving rate after preoperative PGT

Key Dates

Start date
Mar 31, 2009
Status verified
Jan 2012
Primary completion
Jun 30, 2010
Completion
Oct 31, 2011

Study Design

Enrollment
13 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: paclitaxel, gemcitabine, lapatinib
    paclitaxel 80mg/m2 D1, D8 gemcitabine 1000mg/m2 D1, D8, every 3 weeks, 6 cycle lapatinib(Tykerb®)1000mg every day

Primary Outcome Measure

To evaluate the recommended dose of the combination of paclitaxel, gemcitabine, and lapatinib (Tykerb®) (PGT) as preoperative chemotherapy in patients with HER2 positive operable breast cancer [ Time Frame: two years ]

Related Studies