Breast Cancer, Metastasis, Neoplasm
Conditions
Keywords
Metastasis Breast Cancer, Proton Pump Inhibitor, Chemotherapy, Phase II study, TTP
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.
Interventions
DRUGArm C
Docetaxel and cisplatin chemotherapy combined with high dose PPI. Docetaxel 75mg/m2 intravenous d1, cisplatin 75mg/m2 intravenous d1,repeated every 3 weeks.Each patient is designed to receive no more than 6 cycles of chemotherapy.PPI 200mg p.o. d1-3 every week for 66 weeks.
DRUGArm B
Docetaxel and cisplatin chemotherapy combined with lower dose PPI. Docetaxel 75mg/m2 intravenous d1, cisplatin 75mg/m2 intravenous d1,repeated every 3 weeks.Each patient is designed to receive no more than 6 cycles of chemotherapy.PPI 160mg p.o. d1-3 every week for 66 weeks.
DRUGArm A
Docetaxel and cisplatin chemotherapy. Docetaxel 75mg/m2 intravenous d1, cisplatin 75mg/m2 intravenous d1,repeated every 3 weeks.Each patient is designed to receive no more than 6 cycles of chemotherapy.
Sponsors
Istituto Superiore di Sanità
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to progression | six weeks |
Secondary
| Measure | Time frame |
|---|---|
| Time to treatment failure,Objective response,Overall survival,Safety | six weeks |
Countries
China
Outcome results
None listed