Clinical trial NCT03204734: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Breast Cancer
Keywords: therapy
Capecitabine
breast cancer
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2017-07-02
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Progression-free survival(PFS)
timeFrame: 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:
measure: clinical benefit rate(CBR)
timeFrame: 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
measure: overall survival
timeFrame: From date of enrolling until the date of death from any cause, assessed up to 3 years
measure: Number of participants with Grade 3/4 adverse events
timeFrame: From date of enrolling until the date of 1 month of stop treatment, assessed up to 3 years
measure: Quality of life(QOL)（1）
timeFrame: 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
measure: Quality of life(QOL)（2）
timeFrame: 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:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
affiliation: Zhejiang Cance Hospital
name: Xiao-jia Wang, PHD,MD
role: PRINCIPAL_INVESTIGATOR
References:
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.