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

NCT03204734 | Unknown Phase 2 DMC

• 1 other identifier: ZJCH15009
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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.

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 (5)

• 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

• overall survival

  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

• Quality of life(QOL)（1）

  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）

  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

EXPERIMENTAL

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

endocrine therapy

EXPERIMENTAL

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

Interventions

Capecitabine DRUG

Capecitabine will been given as a sequential treatment who are got benefit in capecitabine-base chemotherapy.

Capecitabine

endocrine therapy DRUG

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.

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.
• 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

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
• Capecitabine was ineffective in past treatment

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

Related Publications (1)

• Muss HB, Case LD, Richards F 2nd, White DR, Cooper MR, Cruz JM, Powell BL, Spurr CL, Capizzi RL. Interrupted versus continuous chemotherapy in patients with metastatic breast cancer. The Piedmont Oncology Association. N Engl J Med. 1991 Nov 7;325(19):1342-8. doi: 10.1056/NEJM199111073251904.

  PMID: 1922236 BACKGROUND

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

• Xiao-jia Wang, PHD,MD

  Zhejiang Cance Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiao-jia Wang, PHD,MD

CONTACT

86 13906500190; wxiaojia0803@163.com

Ya-bing Zheng, MD

CONTACT

13858065353; zhengyabing@sina.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: June 24, 2017
• First Posted: July 2, 2017
• Study Start: January 1, 2016
• Primary Completion: December 30, 2020
• Study Completion: December 30, 2021
• Last Updated: July 2, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)