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

• Status: Completed
• Trial end date: 2011-10-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jungsil Ro
• Collaborators: CJ HealthCare Corporation; GlaxoSmithKline; HK inno.N Corporation
• Treatments: Albumin-Bound Paclitaxel; Gemcitabine; Lapatinib; Paclitaxel

Criteria

Inclusion Criteria:

• Histologically confirmed and newly diagnosed operable breast cancer

• Documented HER2 positive disease : 3+ overexpression by IHC or HER2 gene amplification by FISH

• ECOG performance status 0-2

• Age ≥ 18 years

• Clinical stage II or III operable breast cancer

• Axillary node positivity determined by cytology

• No prior hormonal, chemotherapy, or radiotherapy is allowed

• No breast operation other than biopsy to make diagnosis is allowed

• Negative urine pregnancy test within 7 days prior to registration in premenopausal patients

• Adequate hematopoietic function: Absolute granulocyte count ≥1,500/mm3, platelet ≥100,000/mm3, hemoglobin ≥10g/mm3

• Adequate hepatic function: total bilirubin ≤1.5mg/dL, AST/ALT ≤2 x UNL, alkaline phosphatase ≤2 x UNL

• Adequate renal function: Serum creatinine ≤1.5mg/dL

• Adequate cardiac function:

1. Normal or nonspecific EKG taken within 1 month of enrollment

2. LVEF ≥50% by MUGA or echocardiogram taken within 4 weeks of enrollment

• Ability to understand and comply with protocol during study period

• Patients should sign a written informed consent before study entry

Exclusion Criteria:

• Pregnant or lactating women

• Patients who received hormonal, chemotherapy or radiotherapy for breast cancer

• Patients with bilateral breast cancer

• Patients who underwent surgery for breast cancer

• Patients with node-negative stage IIA (T2N0) breast cancer

• Patients who have history of cancer other than in situ uterine cervix cancer or nonmelanotic skin cancer

• Patients with GI tract disease resulting in an inability to take oral medication, malabsorption syndrome, a requirement for IV alimentation, prior surgical procedures affecting absorption, uncontrolled GI disease (e.g., Crohn's disease, ulcerative colitis)