Capecitabine (NX) Versus Docetaxel Plus Capecitabine (TX) as 1-line Chemotherapy on Metastatic Breast Cancer (MBC)

May 3, 2011 updated by: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

A Randomized Phase III Study to Investigate the Efficacy and Safety of Docetaxel + Capecitabine vs. Vinorelbine + Capecitabine Followed by Capecitabine Alone as 1st Therapy on Locally Advanced and Metastatic Breast Cancer Patients.

It is a phase III trial to explore the efficacy and safety of vinorelbine plus capecitabine (NX) and docetaxel plus capecitabine (TX) as first line treatment followed by capecitabine alone till Progressive Disease(PD). We plan to enroll 200 pts for limited budget and the non-inferior trend of the two curves is anticipated.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

We designed the randomized non-inferiority study. Main Inclusion& exclusion Criteria include: 1) Histologically or cytologically confirmed breast cancer with unresectable locally advanced and/or metastatic disease; 2) Untreated patients with unresectable locally advanced and/or metastatic disease; 3) with at least 1 lesion measurable by radiological method(RECIST criteria); 4) Karnofsky Performance Status(KPS)≥70; 5) normal Adequate hepatic, renal, and bone marrow function; 6) Life expectancy of at least 12 weeks; 7) No previous chemotherapy for metastatic breast cancer. Primary endpoint is Progression free survival(PFS), second endpoint are safety profiles (National Cancer Institute-Common Toxicity Criteria 3.0, NCI-CTC 3.0), overall survival and response rate. During Primary study treatment, Arm A: Capecitabine: 1,000 mg/m2 per ora(PO) twice daily (day 1-14), Vinorelbine 25 mg/m2 intravenous(IV) over 3 hours on day 1 and 8, every 3 weeks, 21 days as one cycle and 6-8 cycles are required; Arm B: Capecitabine: 1,000 mg/m2 PO twice daily (day 1-14), Docetaxel 75 mg/m2 IV over 3 hours on day 1, every 3 weeks, 21 days as one cycle and 6-8 cycles are required. Patients who are responding (complete or partial), or whose disease is stable followed by Capecitabine: 1,000 mg/m2 PO twice daily (day 1-14) 21 days as one cycle until progression or unacceptable toxicity

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100021
        • Recruiting
        • Cancer Institute and Hospital, Chinese Academy of Medical Sciences
        • Contact:
        • Principal Investigator:
          • Binghe Xu, MD, Ph.D
        • Contact:
        • Sub-Investigator:
          • Jiayu Wang, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Written and signed informed consent prior to beginning specific protocol procedures.
  • Pathologically confirmed breast cancer and documented metastatic or locally advanced disease.

Measurable disease (RECIST criteria) - with at least 1 lesion measurable by radiological method

  • KPS>=70
  • Adjuvant and/or Neoadjuvant chemotherapy, including an anthracycline was permitted
  • 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
  • Patients had to have concluded prior radiation therapy at least 14 days before enrollment.

  • 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
  • Previous chemotherapy for metastatic breast cancer
  • 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 an docetaxel and/or capecitabine and/or vinorbine
  • Concurrent treatment with other experimental drugs, or participation in another clinical trial with any investigational drug within 30 days prior to study entry

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Arm A
Vinorelbine plus Capecitabine
Drug: Vinorelbine plus Capecitabine for 6 cycles, followed by Capecitabine
Capecitabine: 1,000 mg/m2 PO twice daily (day 1-14) Vinorelbine: 25 mg/m2 IV over 3 hours on day 1 and 8, every 3 weeks 21 days as one cycle and 6 cycles are required
Other: Arm B
Docetaxel plus Capecitabine
Drug: Docetaxel plus Capecitabine for 6 cycles, followed by Capecitabine

Capecitabine: 1,000 mg/m2 PO twice daily (day 1-14), Docetaxel: 75 mg/m2 IV over 3 hours on day 1, every 3 weeks, 21 days as one cycle and 6 cycles are required.

Followed by Capecitabine: 1,000 mg/m2 PO twice daily (day 1-14) 21 days as one cycle until progression or unacceptable toxicity

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival(PFS)
Time Frame: Up to 2 years until disease progression or death

Progress free survival is defined as the time from first dose of test drug to the first recording of disease progression or the date of death in patients with no evidence of disease progression.

In addition to hazard ratios and associated 95% confidence intervals, the results from these analyses will, for each treatment arm, also be summarized by Kaplan-Meier plots, medians and 95% confidence intervals.
Up to 2 years until disease progression or death

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety Profiles
Time Frame: Up to 2 years until 28 days after last intake of study medication

All adverse events occurring up to 28 days after last intake of study medication are to be recorded in the case report form. Safety profile will be analyzed by tabulating its occurring frequency and percentage per patient using NCI-CTC version 3.0. χ2 statistics will be used to test the differences in toxicities between the two treatment arms.

SAEs will be reported according to ICH-GCP.
Up to 2 years until 28 days after last intake of study medication
Overall Survival
Time Frame: Up to 3 years after last intake of study medication
Survival will be measured from the date of first dose of test drug to the date of death (any cause) or to the date of last contact.
Up to 3 years after last intake of study medication
Response Rate
Time Frame: Up to 2 years until disease progression, unacceptable toxicity or death
Tumor responses were assessed on the basis of Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 at 6-week intervals then at 12-week intervals after disease progression.
Up to 2 years until disease progression, unacceptable toxicity or death

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Collaborators

Hoffmann-La Roche

Investigators

  • Principal Investigator: Binghe Xu, MD, Ph.D, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Anticipated)

May 1, 2015

Study Completion (Anticipated)

August 1, 2015

Study Registration Dates

First Submitted

May 18, 2010

First Submitted That Met QC Criteria

May 18, 2010

First Posted (Estimate)

May 19, 2010

Study Record Updates

Last Update Posted (Estimate)

May 4, 2011

Last Update Submitted That Met QC Criteria

May 3, 2011

Last Verified

May 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML25241

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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