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Phase II Study of Capecitabine and Cisplatin to Treat Metastatic Triple Negative Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01928680
Recruitment Status : Unknown
Verified February 2015 by Li Qiao, Chinese Academy of Medical Sciences.
Recruitment status was:  Active, not recruiting
First Posted : August 27, 2013
Results First Posted : February 23, 2015
Last Update Posted : February 23, 2015
Sponsor:
Information provided by (Responsible Party):
Li Qiao, Chinese Academy of Medical Sciences

Brief Summary:
It is a phase II trial to explore the efficacy and safety of cisplatin plus capecitabine in anthracycline and taxane-pretreated metastatic triple negative breast cancer patients.

Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Drug: Cisplatin/Capecitabine Phase 2

Detailed Description:
Cisplatin contained regimens have been demonstrated to be effective in metastatic triple negative breast cancer patients in some phase II clinical trials. Meanwhile, Capecitabine is also a highly effective choice for metastatic breast cancer with considerable duration of response. Combination of cisplatin and capecitabine have been proved effective in metastatic breast cancer in several phase II trials. This study is aimed to investigate the efficacy and safety of this combination in triple negative breast cancer patients.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Capecitabine and Cisplatin in Anthracycline and Taxanes-pretreated Metastatic Triple Negative Breast Cancer Patients
Study Start Date : November 2012
Estimated Primary Completion Date : October 2015
Estimated Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Cisplatin/Capecitabine

Capecitabine 1000mg/m2 orally Bid on day 1 to day 14 plus Cisplatin 75mg/m2 on day1 of each 21 day cycle, until progression or untolerable toxicity.

This is a single arm phase II clinical trial.

Drug: Cisplatin/Capecitabine
Cisplatin/Capecitabine: Capecitabine 1000mg/m2 orally Bid on day 1 to day 14 plus Cisplatin 75mg/m2 on day1 of each 21 day cycle, until progression or untolerable toxicity
Other Name: Xeloda




Primary Outcome Measures :
  1. Overall Response Rate [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Progression Free Survival [ Time Frame: 2 years ]
  2. Overall Survival [ Time Frame: 3 years ]
  3. Number and Severity of Adverse Events of Patients Enrolled in This Trial [ Time Frame: 1 year ]
    Number and severity of adverse events sufferred by patients who received capecitabine and cisplatin regimen.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written and signed informed consent prior to beginning specific protocol procedures.
  • Pathologically confirmed Estrogen Receptor(ER), Progesterone Receptor(PR) and Human Epidermal growth factor Receptor HER-2) negative ("triple negative") breast cancer and documented metastatic or locally advanced disease.

Measurable disease - with at least 1 lesion measurable by radiological method

  • KPS>=70
  • 18 to 70 years old women
  • Previously treated with an anthracycline and a taxane
  • Hormone therapy for early-stage or metastatic breast cancer was permitted if hormonal receptor positive.
  • Treatment with Herceptin for early-stage or metastatic breast cancer is permitted if HER2 positive
  • Laboratory requirements:

    • Hematology Absolute neutrophil count>=1,500 /μl; Platelets>=100,000 /μl; Hemoglobin>=10 g/dl
    • Liver function Total bilirubin<=2 times ULN ASAT (SGOT) and ALAT (SGPT)<=2.5 times UNL without liver metastasis or <=5.0 times if liver metastasis Glucose<=200 mg/dL
    • Renal function Serum creatinine<=140 mol/l
  • Life expectancy of at least 12 weeks
  • Patients must be accessible for treatment and follow-up.
  • Patients should have recovered from the acute reversible effects of prior treatment. This generally means at least 3 weeks should have elapsed since prior chemotherapy, adjuvant or Neoadjuvant treatment. and at least 4 weeks since prior (radical) radiotherapy or major surgery

Exclusion Criteria:

  • Women who are pregnant or breast feeding
  • History of brain and/or leptomeningeal metastases
  • Past or current history of malignant neoplasm other than breast carcinoma, except for curatively treated non melanoma skin cancer, in situ carcinoma of the cervix or other cancer curatively treated and with no evidence of disease for at least 5 years
  • Pre-existing neuropathy grade 1 according to the NCIC-CTC 3.0
  • Psychiatric disorders or other conditions which would prevent pt. compliance
  • Other serious illness or medical condition:
  • Congestive heart failure, or unstable angina pectoris, previous history of myocardial infarction within 6 month prior to study entry, uncontrolled hypertension as determined by the Investigator or high risk uncontrolled, arrhythmia.
  • History of significant neurological or psychiatric disorders including psychotic disorders, dementia of seizures that would prohibit the understanding and giving of informed consent.
  • Active uncontrolled infection.
  • Unstable peptic ulcer, unstable diabetes mellitus or other contraindication for the use of Corticosteroids.
  • Inability to take and/or absorb oral medicine
  • Prior treatment with capecitabine and/or cisplatin
  • Concurrent treatment with other experimental drugs, or participation in another clinical trial with any investigational drug within 30 days prior to study entry

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01928680


Locations
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China, Beijing
Cancer Hospital, ChineseAMS
Beijing, Beijing, China, 100021
Sponsors and Collaborators
Chinese Academy of Medical Sciences
Investigators
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Principal Investigator: Binghe XU, MD, PHD Chinese Academy of Medical Sciences
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Responsible Party: Li Qiao, MD, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT01928680    
Other Study ID Numbers: LQ0001
CAMS-LQ0001 ( Other Identifier: cams )
First Posted: August 27, 2013    Key Record Dates
Results First Posted: February 23, 2015
Last Update Posted: February 23, 2015
Last Verified: February 2015
Keywords provided by Li Qiao, Chinese Academy of Medical Sciences:
Triple Negative Breast Cancer, Cisplatin, Capecitabine
Additional relevant MeSH terms:
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Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Capecitabine
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action