Clinical trial · Interventional
Preoperative Chemotherapy With Paclitaxel, Gemcitabine, and Lapatinib (Tykerb®) (PGT)
Phase Ib Study of Preoperative Chemotherapy With Paclitaxel, Gemcitabine, and Lapatinib (Tykerb®) (PGT) in Patients With HER2 Positive Operable Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| paclitaxel, gemcitabine, lapatinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- paclitaxel, gemcitabine, lapatinib
- description
- paclitaxel 80mg/m2 D1, D8 gemcitabine 1000mg/m2 D1, D8, every 3 weeks, 6 cycle lapatinib(Tykerb®)1000mg every day
- interventionNames
- Drug: paclitaxel, gemcitabine, lapatinib
Primary outcomes (1)
- 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
- timeFrame
- two years
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
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