Clinical trial · Interventional
Phase II Study of Primary Chemotherapy With Paclitaxel, Gemcitabine, and Trastuzumab
Phase II Study of Primary Chemotherapy With Paclitaxel, Gemcitabine, and Trastuzumab in Patients With HER2 Positive Operable Breast Cancer
NCT00532857CI-TRIAL-00005999PGHcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
To evaluate the pathologic complete response rate to preoperative administration of Paclitaxel, Gemcitabine, and Trastuzumab (HerceptinÒ) (PGH)
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/Trastuzumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Paclitaxel/Gemcitabine/Trastuzumab
- interventionNames
- Drug: Paclitaxel/Gemcitabine/Trastuzumab
Primary outcomes (1)
- measure
- To evaluate the pathologic complete response rate To assess breast conserving rate after preoperative chemotherapy To evaluate clinical response rate, disease free survival (DFS), and overall survival (OS) To assess the safety profiles of PGH
- timeFrame
- Prospective: a protocol that observes events in real time (may occur in the future)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * All patients must have histologically confirmed and newly diagnosed operable breast cancer * HER2 positive (all FISH +) * Axillary node positive (by PET or cytologically determine node by sonography) and/or tumor size \> 5 cm -No prior hormonal, chemotherapy or radiotherapy is allowed. * No breast operation other than biopsy to make diagnosis is allowed. * Age: 18-years and older, not pregnant pre-, and postmenopausal women with good performance status (ECOG 0-1) * Adequate hematopoietic function: Absolute granulocyte count ³1500/mm3, * platelet ³100,000/mm3, Hemoglobin ³ 10 g/mm3 * Adequate renal function: Serum creatinine £ 1.5 mg/dl * Adequate hepatic function: total bilirubin: £ 1.5 mg/dl, AST/ALT: £ 2 times normal, Alkaline phosphatase: £ 2 times normal-Adequate cardiac function: 1. normal or nonspecific EKG taken within 1 mo of enrollment 2. LVEF ³ 50% by MUGA or Echocardiogram taken within 1 mo of enrollment * Normal mental function to understand and sign the consent Exclusion Criteria: * patients who received hormonal, chemotherapy or radiotherapy for breast cancer * patients who underwent surgery for breast cancer * patients with a history of uncompensated congestive heart failure * 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
References
Publications (1)
- DERIVEDIm SA, Lee KS, Ro J, Lee ES, Kwon Y, Ahn JH, Ahn JS, Kim JH, Kang HS, Shin KH, Noh DY, Park IA, Kim SB, Im YH, Ha SW. Phase II trial of preoperative paclitaxel, gemcitabine, and trastuzumab combination therapy in HER2 positive stage II/III breast cancer: the Korean Cancer Study Group BR 07-01. Breast Cancer Res Treat. 2012 Apr;132(2):589-600. doi: 10.1007/s10549-011-1852-0. Epub 2011 Nov 18. PMID 22094934