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Phase II Study of Docetaxel and Cisplatin Chemotherapy Versus Docetaxel and Cisplatin Chemotherapy Combined With High Dose Proton Pump Inhibitor in Metastatic Breast Cancer


Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Cancer, Metastasis, Neoplasm

Thank you

Trial Information

Phase II Study of Docetaxel and Cisplatin Chemotherapy Versus Docetaxel and Cisplatin Chemotherapy Combined With High Dose Proton Pump Inhibitor in Metastatic Breast Cancer


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to progression

Outcome Time Frame:

six weeks

Safety Issue:

Yes

Principal Investigator

XiChun Hu, MD,Ph. D

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fudan University

Authority:

China: Ethics Committee

Study ID:

Fudan BR2010-01

NCT ID:

NCT01069081

Start Date:

August 2009

Completion Date:

February 2012

Related Keywords:

  • Breast Cancer
  • Metastasis, Neoplasm
  • Metastasis Breast Cancer
  • Proton Pump Inhibitor
  • Chemotherapy
  • Phase II study
  • TTP
  • Breast Neoplasms
  • Neoplasms
  • Neoplasm Metastasis

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