Clinical trial · Interventional
Effectiveness and Toxicity of Gemcitabine/Lobaplatin Versus Gemcitabine/Cisplatin as Second-line Treatment in Metastatic 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)
Gemcitabine plus cisplatin has been proved to be an effective regimen as second-line treatment for metastatic breast cancer patients, especially for those previously treated with anthracyclines and taxanes. Lobaplatin, as the third generation of new cancer drug platinum, has a similar anticancer activity to cisplatin, but less kidney toxicity and gastrointestinal reaction. The purpose of the study is to compare the efficacy and safety of gemcitabine/lobaplatin versus gemcitabine/cisplatin in patients with metastatic breast cancer.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin | Drug | Cisplatin | ALIAS |
| lobaplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- lobaplatin
- description
- gemcitabine plus lobaplatin
- interventionNames
- Drug: lobaplatin
- type
- ACTIVE_COMPARATOR
- label
- cisplatin
- description
- gemcitabine plus cisplatin
- interventionNames
- Drug: cisplatin
Primary outcomes (1)
- measure
- Overall response rate
- timeFrame
- 4 weeks after chemotherapy
- description
- Overall response rate (ORR) defined as complete response(CR) + partial response(PR) + stable disease (SD)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed metastatic breast cancer * Disease progression during or after previous 1st line chemotherapy * Scheduled to receive 2nd line chemotherapy. * Measurable disease, defined as a least one lesion that can be accurately measured in at least one dimension * 18 years of age or older * ECOG performance status of 0-2 * Life expectancy of greater than 6 months Exclusion Criteria: * Previous treatment with one of the study drugs * Application of other cytotoxic chemotherapy or radiotherapy * Insufficent renal function (creatinine clearance \< 60ml/min) * Clinically unstable brain metastasis * Pregancy or lactation * History of other malignancy within last 5 years.
References
Publications (0)
Data not yet available