Clinical trial · Interventional
Primary Paclitaxel Plus Gemcitabine in Patients With Stage II and III Breast Cancer
Phase II Study of Primary Paclitaxel Plus Gemcitabine in Patients With Stage II and III Breast Cancer
NCT00532285CI-TRIAL-00005060terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): terminated
Summary
Brief summary (as posted)
This is an open labeled phase II single arm trial. The patients with clinical stage II and III will undergo core-needle biopsy of breast tumor for histologic diagnosis, immunohistochemical studies for estrogen receptor (ER), progesterone receptor(PR), HER-2/neu and others. PET or ultrasound results will determine the positivity of lymph node metastasis.
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 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Paclitaxel/Gemcitabine
- description
- paclitaxel 80 mg/m2 (day 1, 8) and gemcitabine 1200 mg/m2 (day1, 8) every 3 weeks, 4 cycles
- interventionNames
- Drug: Paclitaxel/Gemcitabine
Primary outcomes (1)
- measure
- To evaluate the clinical and pathologic responses to preoperative administration of Paclitaxel/Gemcitabine (PG)
- timeFrame
- two years
Secondary outcomes (1)
- measure
- To assess breast conserving rate To evaluate the disease free survival (DFS) and overall survival (OS) of patients who received preoperatively PG To investigate the toxicity profiles of PG
- timeFrame
- two years
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: * All patients must have histologically confirmed and newly diagnosed breast cancer: node-positive stage IIA and any stage IIB, III. PET results will determine node positivity. If PET was not utilized, sonographically positive node should be confirmed cytologically by fine needle aspiration. * 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: £ two times normal, Alkaline phosphatase: £ two times normal * Adequate cardiac function: normal or nonspecific EKG taken within 1 mo of enrollment * Adequate 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 node-negative stage IIA breast cancer * Patients who have history of cancer other than in situ uterine cervix cancer or nonmelanotic skin cancer
References
Publications (0)
Data not yet available
No reference posted for this study.