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

NCT01928680 | Unknown Phase 2 Results DMC

• 2 other identifiers: LQ0001CAMS-LQ0001
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Breast Cancer

Keywords

Triple Negative Breast Cancer, Cisplatin, Capecitabine

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate

  6 months

Secondary Outcomes (3)

• Progression Free Survival

  2 years

• Overall Survival

  3 years

• Number and Severity of Adverse Events of Patients Enrolled in This Trial

  1 year

Study Arms (1)

Cisplatin/Capecitabine

EXPERIMENTAL

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

Interventions

Cisplatin/Capecitabine DRUG

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

Also known as: Xeloda

Cisplatin/Capecitabine

Eligibility Criteria

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

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead

Study Sites (1)

Cancer Hospital, ChineseAMS

Beijing, Beijing Municipality, 100021, China

Location

MeSH Terms

Conditions

Breast Neoplasms; Triple Negative Breast Neoplasms

Interventions

Cisplatin; Capecitabine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Dr. Qiao Li
• Organization: Chinese Academy of Medical Science

liqiaopumc@qq.com

86-18500027849

Study Officials

• Binghe XU, MD, PHD

  Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 1, 2013
• First Posted: August 27, 2013
• Study Start: November 1, 2012
• Primary Completion: October 1, 2015
• Study Completion: March 1, 2016
• Last Updated: February 23, 2015
• Results First Posted: February 23, 2015

Record last verified: 2015-02

Locations

CN (1)