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

University of Chinese Academy Sciences

Status and phase: Unknown; Phase 2

Conditions: Breast Cancer

Treatments: Drug: endocrine therapy; Drug: Capecitabine

Study type: Interventional

Funder types: Other

Identifiers

NCT03204734

ZJCH15009

Details and patient eligibility

About

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.

Full description

Capecitabine-base chemotherapy must be ≥Second-line Therapy

Enrollment: 132 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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132 participants in 2 patient groups

Capecitabine

Experimental group

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.

Treatment:

Drug: Capecitabine

endocrine therapy

Experimental group

Description:

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.

Treatment:

Drug: endocrine therapy