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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03204734
• Other study ID #: ZJCH15009
• Status: Recruiting
• Phase: Phase 2
• First received: June 24, 2017
• Last updated: June 27, 2017
• Start date: January 1, 2016
• Est. completion date: December 30, 2021

Study information

• Verified date: June 2017
• Source: Zhejiang Cancer Hospital
• Contact: Xiao-jia Wang, PHD,MD
• Phone: 86 13906500190
• Email: wxiaojia0803[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Capecitabine-base chemotherapy must be ≥Second-line Therapy

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 132
• Est. completion date: December 30, 2021
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	clinical benefit rate(CBR)	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
Secondary	overall survival	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
Secondary	Number of participants with Grade 3/4 adverse events	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
Secondary	Quality of life(QOL)(1)	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
Secondary	Quality of life(QOL)(2)	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