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)

NCT02597868 | Unknown DMC

• 1 other identifier: ZJCH15003
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Keywords

therapy; Capecitabine; breast cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free survival(PFS)

  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 Outcomes (1)

• clinical benefit rate(CBR)

  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 Outcomes (3)

• overall survival(OS)

  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

  From date of enrolling until the date of 1 month of stop treatment, assessed up to 3 years

• QOL

  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

Study Arms (2)

Capecitabine

ACTIVE COMPARATOR

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

endocrine therapy

EXPERIMENTAL

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

Interventions

Capecitabine DRUG

Capecitabine is be given as a sequential treatment in Metastatic breast cancer patients who are got benefit in chemo treatment.

Also known as: Xeloda

Capecitabine

endocrine therapy PROCEDURE

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.

endocrine therapy

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Capecitabine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Xiaojia Wang, PHD

  Zhejiang Cance Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaojia - wang, PHD

CONTACT

86 13906500190; wxiaojia0803@163.com

Jian Huang, Doctor

CONTACT

86 13588048995; huang_jian22@aliyun.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2014
• First Posted: November 5, 2015
• Study Start: January 1, 2013
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2017
• Last Updated: March 29, 2016

Record last verified: 2016-03

Locations

CN (1)