Breast cancer
Conditions
Interventions
Experimental group:Eribulin mesilate 1.4 mg/m^2 intravenously over 2-5 minutes on days 1 and 8 of every 21-day cycle, in combine with Capecitabine tablet 1000 mg/m^2 orally bid for days 1 to 14 of eve
Control group:Capecitabine tablet 1250 mg/m^2 orally bid for days 1 to 14 of every 21-day cycle
Sponsors
Cancer Hospital Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-70 years; 2. Histologically or cytologically confirmed adenocarcinoma of the breast with locally advanced or metastatic disease; 3. HER2-negative confirmed by a local laboratory; 4. Patients with estrogen receptor (ER) negative and progesterone receptor (PR) negative; or patients with estrogen receptor (ER) positive and/or progesterone receptor (PR) positive who are resistant or unsuitable to endocrine therapy; 5. Have received chemotherapy with anthracyclines and taxanes, either in the (neo)adjuvant setting or for locally advanced or metastatic disease; 6. Previously received = 6 months; 9. Patients with at least one measurable disease by Response Evaluation Criteria in Solid Tumors 1.1(RECIST 1.1) criteria; 10. Resolution of all chemotherapy or radiation-related toxicities to less than grade 2 severity by NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 within 4 weeks before the randomization, including sensory neuropathy and alopecia; 11. For women of childbearing potential, agreement to use an effective form of contraception (patient and/or partner, e.g., surgical sterilization, a reliable barrier method, birth control pills, or contraceptive hormone implants) and to continue its use for the duration of study treatment and for 6 months after the last dose of study treatment; 12. Adequate organ and marrow function defined as follows: ANC >= 1,500/mm^3 (1.5 x 10^9 /L); platelets >= 100,000/mm^3 (100 x 10^9 /L); hemoglobin >= 10 g/dL (90 g/L); serum creatinine = 60 mL/min as calculated using the method standard for the institution; total serum bilirubin <= 1.5 x ULN; AST and ALT <= 3 x ULN (<= 5.0 x ULN if liver metastases present); alkaline phosphatase <= 2.5 x ULN (<= 5.0 x ULN if bone or liver metastases present); 13. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures; 14. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legal representative) has been informed of all pertinent aspects of the study before any study-specific activity is performed.
Exclusion criteria
Exclusion criteria: 1. Patients treated with chemotherapy or radiation therapy within the last 4 weeks prior to randomization; 2. Patients treated with endocrine or target therapy within the last 2 weeks prior to randomization; 3. Prior treatment with eribulin; 4. Prior treatment with capecitabine, and withdraw from it within 12 months before present; 5. Patients who have had a prior malignancy, unless the prior malignancy was diagnosed and definitively treated >= 5 years previously with no subsequent evidence of recurrence; 6. The patients are not permitted to participate in additional parallel investigational drug or device studies; 7. Pregnant or breast-feeding females; 8. Patients have any other concurrent severe or uncontrolled medical conditions, such as: severe heart, lung, liver, or kidney disease; severe hypertension or diabetes mellitus; severe gastrointestinal ulcer; serious active infection requiring antibiotics or hospitalization; psychiatric or addictive disorders; congenital or acquired immune function deficiency; and other conditions which would prevent the patient from meeting the study requirements in the opinion of the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR);Duration of Response (DoR);Overall Survival (OS);Safety;Quality of Life (QoL); | — |
Countries
China
Contacts
Public ContactXu Binghe
Cancer Hospital Chinese Academy of Medical Sciences
Outcome results
None listed