A Multicenter, Randomized Clinical Trail Evaluate Effectiveness and Security of Capecitabine or Endocrinotherapy as a Maintenance Therapy Regimen After the 1st-line Chemotherapy With Capecitabine Combine Regimen in Hormone Receptor Positive and HER2 Negative Metastatic Breast Cancer(Overstep)

March 26, 2016 updated by: Zhejiang Cancer Hospital
A multi-sites study about the efficacy of sequential monotherapy: Capecitabine vs. endocrine therapy, in metastatic breast cancer patients with HR-positive & HER2-negative after capecitabine-base chemotherapy.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

capecitabine-base chemotherapy must be first-line chemotherapy.

Study Type

Interventional

Enrollment (Anticipated)

132

Phase

  • Not Applicable

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
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Recruiting
        • Zhejiang Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Xiaojia Wang, PHD

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 to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Signed informed consent
  • The age is Above 18 years of age, <70 years old
  • HR-positive & HER2-negative
  • Metastatic breast cancer,incurable.
  • No prior chemotherapy for metastatic recurrence, if there is disease progression within 6 months after the end of the adjuvant chemotherapy, adjuvant chemotherapy as first-line treatment for metastatic lesions
  • Eastern Cooperative Oncology Group performance status (ECOG PS)=0~1
  • The basic function of normal bone marrow
  • Functions of liver and kidney is normal
  • Expectation of life is more than 3 months
  • Agreed to take contraceptive measures during treatment

Exclusion Criteria:

  • Previous toxicity was not recovered to 0-1 degrees
  • Central nervous system metastasis
  • Pregnancy or lactation
  • There are uncontrolled infection, myocardial infarction, thrombosis, etc.
  • There are uncontrolled chronic diseases such as diabetes, hypertension, peptic ulcer, chronic hepatitis, mental disease;
  • Researchers believe that is not suitable for the study
  • Patients with other malignant tumor history, except the healed skin basal cell carcinoma and carcinoma of uterine cervix;
  • Bilateral breast cancer

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
Active Comparator: Capecitabine
Capecitabine 1250mg per BSA by mouth twice per day for 14 days, per 21 days as a cycle, until disease progress or toxicity can not be tolerated.
Drug: Capecitabine
Capecitabine is be given as a sequential treatment in Metastatic breast cancer patients who are got benefit in chemo treatment.
Other Names:
  • Xeloda
Experimental: endocrine therapy
endocrine therapy is be gived as a sequential treatment in Metastatic breast cancer patients who are got benefit in chemotreatment,the medcine will be confirmed by the patient's past-treatment.
Procedure: endocrine therapy
endocrine therapy is be given as a sequential treatment in Metastatic breast cancer patients who are got benefit in chemo treatment,the medicine will be confirmed by the patient's past-treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival(PFS)
Time Frame: From date of enrolling until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years
Progression-free survival (PFS) is defined as the time elapsed between enrolling and tumor progression or death from any cause
From date of enrolling until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical benefit rate(CBR)
Time Frame: From date of enrolling until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years
the response is CR+PR+SD ≥ 24 weeks
From date of enrolling until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival(OS)
Time Frame: From date of enrolling until the date of death from any cause, assessed up to 3 years
the time elapsed between enrolling and death from any cause
From date of enrolling until the date of death from any cause, assessed up to 3 years
Number of participants with Grade 3/4 adverse events
Time Frame: From date of enrolling until the date of 1 month of stop treatment, assessed up to 3 years
Number of Participants with Grade 3/4 Adverse Events
From date of enrolling until the date of 1 month of stop treatment, assessed up to 3 years
QOL
Time Frame: From date of enrolling until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years
change from enrolling to progression disease or death according EORTC QLQ-C30 and EORTC BR23
From date of enrolling until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years

Collaborators and Investigators

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

Sponsor

Zhejiang Cancer Hospital

Collaborators

307 Hospital of PLA
Fudan University
Hangzhou Cancer Hospital
Zhejiang University
Sir Run Run Shaw Hospital
Jiangsu Provincial People's Hospital
Zhejiang Chinese Medical University
Fujian Province Tumor Hospital
The Tumor Hospital of Jiangsu Province

Investigators

  • Principal Investigator: Xiaojia Wang, PHD, Zhejiang Cance Hospital

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

January 1, 2013

Primary Completion (Anticipated)

July 1, 2016

Study Completion (Anticipated)

July 1, 2017

Study Registration Dates

First Submitted

March 9, 2014

First Submitted That Met QC Criteria

November 4, 2015

First Posted (Estimate)

November 5, 2015

Study Record Updates

Last Update Posted (Estimate)

March 29, 2016

Last Update Submitted That Met QC Criteria

March 26, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZJCH15003

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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