Clinical trial · Interventional
The Possible Efficacy and Safety of Lansoprazole Co-administration With Neoadjuvant Chemotherapy in Women With Breast Cancer
NCT04874935CI-TRIAL-00062193completedPhase 3ClinicalTrials.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)
Investigation of the possible efficacy and safety of lansoprazole co-administration with neoadjuvant chemotherapy in tumor response in women with breast cancer who will be planned for surgery.
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 |
|---|---|---|---|
| Lansoprazole | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Lansoprazole arm
- description
- 33 patients who will receive neoadjuvant chemotherapy and lansoprazole 60 mg twice daily four days before starting chemotherapy regimen and then the same dose will be used during chemotherapy cycles
- interventionNames
- Drug: Lansoprazole
- type
- PLACEBO_COMPARATOR
- label
- Placebo arm
- description
- 33 patients who will receive neoadjuvant chemotherapy and placebo capsules.
- interventionNames
- Drug: Placebo
Primary outcomes (3)
- measure
- Tumor Response
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Females with age ≥ 18 years old. * Newly diagnosed breast cancer patients. * Planned neoadjuvant chemotherapy. Exclusion Criteria: * Pregnancy. * Nursing mothers. * Active or uncontrolled infection. * Presence of another malignancies. * Inadequate blood picture. * Serum Creatinine more than 1.5 mg /dl. * AST and ALT more than 2.5 upper limit. * History of known hypersensitivity to lansoprazole.
References
Publications (6)
- BACKGROUNDLee YY, Jeon HK, Hong JE, Cho YJ, Ryu JY, Choi JJ, Lee SH, Yoon G, Kim WY, Do IG, Kim MK, Kim TJ, Choi CH, Lee JW, Bae DS, Kim BG. Proton pump inhibitors enhance the effects of cytotoxic agents in chemoresistant epithelial ovarian carcinoma. Oncotarget. 2015 Oct 27;6(33):35040-50. doi: 10.18632/oncotarget.5319. PMID 26418900
- BACKGROUNDWhitton B, Okamoto H, Packham G, Crabb SJ. Vacuolar ATPase as a potential therapeutic target and mediator of treatment resistance in cancer. Cancer Med. 2018 Aug;7(8):3800-3811. doi: 10.1002/cam4.1594. Epub 2018 Jun 21. PMID 29926527
- BACKGROUNDIkemura K, Hiramatsu S, Okuda M. Drug Repositioning of Proton Pump Inhibitors for Enhanced Efficacy and Safety of Cancer Chemotherapy. Front Pharmacol. 2017 Dec 12;8:911. doi: 10.3389/fphar.2017.00911. eCollection 2017. PMID 29311921
- BACKGROUNDLu ZN, Tian B, Guo XL. Repositioning of proton pump inhibitors in cancer therapy. Cancer Chemother Pharmacol. 2017 Nov;80(5):925-937. doi: 10.1007/s00280-017-3426-2. Epub 2017 Aug 31. PMID 28861639
- BACKGROUNDWang 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
- BACKGROUNDda Silva VP, Mesquita CB, Nunes JS, de Bem Prunes B, Rados PV, Visioli F. Effects of extracellular acidity on resistance to chemotherapy treatment: a systematic review. Med Oncol. 2018 Oct 30;35(12):161. doi: 10.1007/s12032-018-1214-4. PMID 30377828