Clinical trial · Interventional
Docetaxel and Cisplatin Chemotherapy With or Without High Dose Proton Pump Inhibitor in Metastatic Breast Cancer
Phase II Study of Docetaxel and Cisplatin Chemotherapy Versus Docetaxel and Cisplatin Chemotherapy Combined With High Dose Proton Pump Inhibitor in Metastatic Breast Cancer
NCT01069081CI-TRIAL-00017020completedPhase 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)
The objectives of this study are to evaluate the efficacy and tolerability of high dose proton pump inhibitor combined with chemotherapy in metastatic breast cancer.
Conditions
Conditions (2)
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 |
| Metastasis, Neoplasm | Breast Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Arm A | Drug | — | UNRESOLVED |
| Arm B | Drug | — | UNRESOLVED |
| Arm C | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- arm A
- description
- docetaxel and cisplatin chemotherapy
- interventionNames
- Drug: Arm A
- type
- EXPERIMENTAL
- label
- arm B
- description
- docetaxel and cisplatin chemotherapy combined with PPI 160mg per day.
- interventionNames
- Drug: Arm B
- type
- EXPERIMENTAL
- label
- arm C
- description
- docetaxel and cisplatin chemotherapy combined with PPI 200mg per day.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Signed informed consent. * Female, ≥ 18 years. * Histologically confirmed invasive breast cancer. * Metastatic breast cancer. * Karnofsky Performance Status ≥60. * Life expectancy of more than 3 months. * Subject must have adequate organ function. * Normal laboratory values: hemoglobin \> 80g/dl, neutrophils \> 2.0×10\^9/L, platelets \> 80×10\^9/L, serum creatinine \< upper limit of normal (ULN), serum bilirubin \< ULN, ALT and AST \< 2.5×ULN, AKP \< 5×ULN. * Negative serum pregnancy test for women with childbearing potential. * Good conditions for infusion and willing to have phlebotomy throughout whole study. * Have ceased anti-tumor treatments including endocrinotherapy and bio-targeted therapy for more than 28 days. * Have at least one target lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. * No prior use of docetaxel or has used docetaxel in adjuvant/neo-adjuvant chemotherapy and has a relapse free survival of at least 12 months. Exclusion Criteria: * Pregnant or lactating females. * History of other malignancy. However, subjects who have been disease-free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible. * Concurrent disease or condition that would make the subject inappropriate for study participation, or any serious medical disorder that would interfere with the subject's safety. * Active or uncontrolled infection. * Known history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure. * Concomitant with brain metastases. * Have received chemotherapy after metastasis.
References
Publications (1)
- DERIVEDWang BY, Zhang J, Wang JL, Sun S, Wang ZH, Wang LP, Zhang QL, Lv FF, Cao EY, Shao ZM, Fais S, Hu XC. Intermittent high dose proton pump inhibitor enhances the antitumor effects of chemotherapy in metastatic breast cancer. J Exp Clin Cancer Res. 2015 Aug 22;34(1):85. doi: 10.1186/s13046-015-0194-x. PMID 26297142