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)

Breast Cancer Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02597868
• Other study ID #: ZJCH15003
• Status: Recruiting
• Phase: N/A
• First received: March 9, 2014
• Last updated: March 26, 2016
• Start date: January 2013
• Est. completion date: July 2017

Study information

• Verified date: March 2016
• Source: Zhejiang Cancer Hospital
• Contact: Xiaojia - wang, PHD
• Phone: 86 13906500190
• Email: wxiaojia0803[@]163.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Description:

capecitabine-base chemotherapy must be first-line chemotherapy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 132
• Est. completion date: July 2017
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• 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.

• 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

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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

Procedure:
• endocrine therapy
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.

Locations

Country	Name	City	State
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang

Sponsors (10)

Lead Sponsor	Collaborator
Zhejiang Cancer Hospital	307 Hospital of PLA, Fudan University, Fujian Province Tumor Hospital, Hangzhou Cancer Hospital, Jiangsu Provincial People's Hospital, Sir Run Run Shaw Hospital, The Tumor Hospital of Jiangsu Province, Zhejiang Chinese Medical University, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	overall survival(OS)	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	No
Other	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	Yes
Other	QOL	change from enrolling to progression disease or death according EORTC QLQ-C30 and 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	No
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	No
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	No