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

NCT01133912 | Completed Phase 1

• 1 other identifier: NCCCTS-08-370
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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. 1.To evaluate the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of PGT
2. 2.To determine the safety profile
3. 3.To assess pCR in primary tumor and axillary LN
4. 4.To evaluate clinical response rate, disease free survival (DFS), and overall survival (OS)
5. 5.To assess breast conserving rate after preoperative PGT

Conditions

Breast Cancer

Keywords

Patients with HER2 Positive Operable Breast Cancer

Outcome Measures

Primary Outcomes (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

  two years

Study Arms (1)

paclitaxel, gemcitabine, lapatinib

EXPERIMENTAL

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

Drug: paclitaxel, gemcitabine, lapatinib

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.

Also known as: Paclitaxel, Gemzar, Tykerb

paclitaxel, gemcitabine, lapatinib

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Normal or nonspecific EKG taken within 1 month of enrollment
• LVEF ≥50% by MUGA or echocardiogram taken within 4 weeks of enrollment

You may not qualify if:

• 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)

Sponsors & Collaborators

• Jungsil Ro: lead
• GlaxoSmithKline: collaborator
• HK inno.N Corporation: collaborator

Study Sites (1)

National Cancer Center

Goyang-si, Gyeonggi-do, 410-769, South Korea

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Paclitaxel; Gemcitabine; Lapatinib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Jungsil Ro, MD

  National Cencer Center, Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief, Center for Clinical Trials, National Cancer Center, Korea

Study Record Dates

• First Submitted: February 17, 2010
• First Posted: May 31, 2010
• Study Start: March 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: October 1, 2011
• Last Updated: January 4, 2012

Record last verified: 2012-01

Locations

KR (1)