The Possible Efficacy and Safety of Lansoprazole Co-administration With Neoadjuvant Chemotherapy in Women With Breast Cancer

NCT04874935 | Completed Phase 3

• 1 other identifier: 34615/4/21
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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

Breast Cancer

Outcome Measures

Primary Outcomes (3)

• Tumor Response

  \- Tumor response evaluation will be assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

  6 months

• Change in ki67 level

  \- Assessment of the level of Ki-67 expression in cancer cells through a staining process (a marker of cancer cell proliferation).

  baseline and end of neoadjuvant chemotherapy cycles each cycle will be repeated every 21 days or may postponed according to patient condition and doctor instructions.

• Change in P-gp level

  \- Assessment of P-gp level by ELISA Kits according to manufacturer's instructions.

  baseline and end of neoadjuvant chemotherapy cycles each cycle will be repeated every 21 days or may postponed according to patient condition and doctor instructions.

Secondary Outcomes (4)

• Adverse events and toxicity

  6 months

• Follow up of kidney function

  baseline and monthly through study completion, an average of 4 to 6 months

• Follow up of liver function

  baseline and monthly through study completion, an average of 4 to 6 months

• Follow up of complete blood count

  baseline and monthly through study completion, an average of 4 to 6 months

Study Arms (2)

Lansoprazole arm

ACTIVE COMPARATOR

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

Drug: Lansoprazole

Placebo arm

PLACEBO COMPARATOR

33 patients who will receive neoadjuvant chemotherapy and placebo capsules.

Drug: Placebo

Interventions

Lansoprazole DRUG

administration of lansoprazole 60 mg twice daily 4 days before starting neoadjuvant chemotherapy regimen and continue till end of chemotherapy cycles

Lansoprazole arm

Placebo DRUG

administration of Placebo capsule twice daily 4 days before starting neoadjuvant chemotherapy regimen and continue till end of chemotherapy cycles

Placebo arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Females with age ≥ 18 years old.
• Newly diagnosed breast cancer patients.
• Planned neoadjuvant chemotherapy.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Faculty of Pharmacy

Tanta, 32511, Egypt

Location

Related Publications (6)

• Lee 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 BACKGROUND

• Whitton 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 BACKGROUND

• Ikemura 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 BACKGROUND

• Lu 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 BACKGROUND

• Wang 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 BACKGROUND

• da 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 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Lansoprazole

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: April 29, 2021
• First Posted: May 6, 2021
• Study Start: June 10, 2021
• Primary Completion: November 5, 2022
• Study Completion: November 5, 2022
• Last Updated: November 15, 2022

Record last verified: 2022-10

Locations

EG (1)