Clinical trial NCT01069081: Docetaxel and Cisplatin Chemotherapy With or Without High Dose Proton Pump Inhibitor in Metastatic Breast Cancer
Official title: Phase II Study of Docetaxel and Cisplatin Chemotherapy Versus Docetaxel and Cisplatin Chemotherapy Combined With High Dose Proton Pump Inhibitor in Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Metastasis, Neoplasm
Keywords: Metastasis Breast Cancer
Proton Pump Inhibitor
Chemotherapy
Phase II study
TTP
Lead sponsor: Fudan University
Sponsor class: OTHER
Collaborators: name: Istituto Superiore di Sanità
First posted: 2010-02-17
Enrollment: 94
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: High dose proton pump inhibitor (PPI) has been proved beneficial and it improved efficacy when combined with chemotherapy in preclinical and clinical trials.This study was designed to explore whether adding a proton pump inhibitor into docetaxel and cisplatin chemotherapy improves efficacy and does not affect tolerability in metastatic breast cancer.

Eligibility criteria: 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.

Primary outcomes:
measure: Time to progression
timeFrame: six weeks
Secondary outcomes:
measure: Time to treatment failure,Objective response,Overall survival,Safety
timeFrame: six weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Cancer Hospital
state: Shanghai
Study officials:
affiliation: Fudan University
name: XiChun Hu, MD,Ph. D
role: PRINCIPAL_INVESTIGATOR
affiliation: Istituto Superiore di Sanità
name: Antonio Chiesi
role: PRINCIPAL_INVESTIGATOR
affiliation: Istituto Superiore di Sanità
name: Stefano Fais, MD PHD
role: STUDY_DIRECTOR
References:
citation: 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.