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Capecitabine or Endocrinotherapy as a Maintenance Therapy Regimen at Least 2nd Line in Hormone Receptor Positive and HER2 Negative Metastatic 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03204734
Recruitment Status : Recruiting
First Posted : July 2, 2017
Last Update Posted : July 2, 2017
Sponsor:
Information provided by (Responsible Party):
Zhengyabing, Zhejiang Cancer Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Capecitabine Drug: endocrine therapy Phase 2

Detailed Description:
Capecitabine-base chemotherapy must be ≥Second-line Therapy

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : January 1, 2016
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : December 30, 2021

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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



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

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

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): NCT03204734


Contacts
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Contact: Xiao-jia Wang, PHD,MD 86 13906500190 wxiaojia0803@163.com
Contact: Ya-bing Zheng, MD 13858065353 zhengyabing@sina.com

Locations
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China, Zhejiang
Zhejiang Cancer Hospital Recruiting
Hangzhou, Zhejiang, China, 310022
Contact: Xiaojia WANG, MD,PhD    +86 13906500190    wxiaojia0803@163.com   
Contact: Ya-bing Zheng, MD    +8613858065353    zhengyabing@sina.com   
Sponsors and Collaborators
Zhejiang Cancer Hospital
Investigators
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Principal Investigator: Xiao-jia Wang, PHD,MD Zhejiang Cance Hospital
Publications:
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Responsible Party: Zhengyabing, Chief Physician, Zhejiang Cancer Hospital
ClinicalTrials.gov Identifier: NCT03204734    
Other Study ID Numbers: ZJCH15009
First Posted: July 2, 2017    Key Record Dates
Last Update Posted: July 2, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zhengyabing, Zhejiang Cancer Hospital:
therapy
Capecitabine
breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Capecitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents