Capecitabine or Endocrinotherapy as a Maintenance Therapy Regimen at Least 2nd Line in Hormone Receptor Positive and HER2 Negative Metastatic Breast Cancer

June 27, 2017 updated by: Zhengyabing, Zhejiang Cancer Hospital

Evaluate Effectiveness and Security of Capecitabine or Endocrinotherapy as a Maintenance Therapy Regimen After 2nd-line or Over 2nd-line Therapy With Capecitabine Combine Regimen in Hormone Receptor Positive and HER2 Negative Metastatic Breast Cancer

A single-site 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 ≥Second-line Therapy

Study Type

Interventional

Enrollment (Anticipated)

132

Phase

  • Phase 2

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:

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.
  • For recurrent or metastatic lesions has had at least 1 but no more than 3 kinds of chemotherapy, if there is disease progression within 6 months after the end of the adjuvant chemotherapy, adjuvant chemotherapy will been the first-line treatment for metastatic lesions
  • No prior use of capecitabine therapy or the use of capecitabine treatment was effective, and the efficacy evaluation was CR/PR/SD more than 6 months.
  • 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
  • Capecitabine was ineffective in past treatment

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Capecitabine
Capecitabine by mouth twice per day for 14 days, per 21 days as a cycle, until disease progress or toxicity can not be tolerated.Capecitabine starting dose was the dose used at the end of the combined chemotherapy regimen,eg:1000mg per BSA.
Drug: Capecitabine
Capecitabine will been given as a sequential treatment who are got benefit in capecitabine-base chemotherapy.
EXPERIMENTAL: endocrine therapy
endocrine therapy will been given as a sequential treatment in Metastatic breast cancer patients who are got benefit in capecitabine-base chemotherapy.The medicine will be confirmed by the patient's past-treatment.
Drug: endocrine therapy
endocrine therapy will been given as a sequential treatment who are got benefit in capecitabine-base chemotherapy.Endocrine therapy is determined by the doctor, including any kind of letrozole, anastrozole, exemestane, fulvestrant, tamoxifen, toremifene, combined with or without drugs or surgery in the inhibition of ovarian function.

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
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
overall survival
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
Quality of life(QOL)（1）
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
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
Quality of life(QOL)（2）
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 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

Investigators

  • Principal Investigator: Xiao-jia Wang, PHD,MD, Zhejiang Cance Hospital

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 (ACTUAL)

January 1, 2016

Primary Completion (ANTICIPATED)

December 30, 2020

Study Completion (ANTICIPATED)

December 30, 2021

Study Registration Dates

First Submitted

June 24, 2017

First Submitted That Met QC Criteria

June 27, 2017

First Posted (ACTUAL)

July 2, 2017

Study Record Updates

Last Update Posted (ACTUAL)

July 2, 2017

Last Update Submitted That Met QC Criteria

June 27, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZJCH15009

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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