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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

Primary Purpose

Breast Cancer

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Capecitabine

endocrine therapy

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring therapy, Capecitabine, breast cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Zhejiang Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Capecitabine

endocrine therapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Progression-free survival(PFS)

Progression-free survival (PFS) is defined as the time elapsed between enrolling and tumor progression or death from any cause

Secondary Outcome Measures

clinical benefit rate(CBR)

the response is CR+PR+SD ≥ 24 weeks

overall survival

the time elapsed between enrolling and death from any cause

Number of participants with Grade 3/4 adverse events

Number of Participants with Grade 3/4 Adverse Events

Quality of life(QOL)（1）

change from enrolling to progression disease or death according EORTC QLQ-C30

Quality of life(QOL)（2）

change from enrolling to progression disease or death according EORTC BR23

Full Information

NCT ID

NCT03204734

First Posted

June 24, 2017

Last Updated

June 27, 2017

Sponsor

Zhejiang Cancer Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03204734

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Unknown status

Study Start Date

January 1, 2016 (Actual)

Primary Completion Date

December 30, 2020 (Anticipated)

Study Completion Date

December 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Zhejiang Cancer Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

Capecitabine-base chemotherapy must be ≥Second-line Therapy

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

therapy, Capecitabine, breast cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

132 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Capecitabine

Arm Type

Experimental

Arm Description

Arm Title

endocrine therapy

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Capecitabine

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

endocrine therapy

Intervention Description

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 Measure Information:

Title

Progression-free survival(PFS)

Description

Progression-free survival (PFS) is defined as the time elapsed between enrolling and tumor progression or death from any cause

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

Secondary Outcome Measure Information:

Title

clinical benefit rate(CBR)

Description

the response is CR+PR+SD ≥ 24 weeks

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

Title

overall survival

Description

the time elapsed between enrolling and death from any cause

Time Frame

From date of enrolling until the date of death from any cause, assessed up to 3 years

Title

Number of participants with Grade 3/4 adverse events

Description

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

Title

Quality of life(QOL)（1）

Description

change from enrolling to progression disease or death according EORTC QLQ-C30

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

Title

Quality of life(QOL)（2）

Description

change from enrolling to progression disease or death according EORTC BR23

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xiao-jia Wang, PHD,MD

Phone

86 13906500190

wxiaojia0803@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Ya-bing Zheng, MD

Phone

13858065353

zhengyabing@sina.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xiao-jia Wang, PHD,MD

Organizational Affiliation

Zhejiang Cance Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Zhejiang Cancer Hospital

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310022

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xiaojia WANG, MD,PhD

Phone

+86 13906500190

wxiaojia0803@163.com

First Name & Middle Initial & Last Name & Degree

Ya-bing Zheng, MD

Phone

+8613858065353

zhengyabing@sina.com

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

1922236

Citation

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.

Results Reference

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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

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