Overview

Prospective, Multicenter, Observational Study of Apatinib Single or Combined Capecitabine for Treatment of Patients With Metastatic Her-2 Negative Breast Cancer

Status:
Unknown status
Trial end date:
2019-05-01
Target enrollment:
0
Participant gender:
Female
Summary
The purpose of this study is to assess the efficacy and safety of patients who receive apatinib single or combined capecitabine for treatment of patients with metastatic her-2 negative breast cancer.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hebei Medical University Fourth Hospital
Treatments:
Apatinib
Capecitabine
Criteria
Inclusion Criteria:

- 18 to 70 years old (female)

- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

- Pathologically diagnosed with her-2 negative, ER/PR negative, ER/PR positive after the
failure of endocrine treatment, and had not more than three chemotherapy regimens
(must include anthracycline-based and yew class), and the final failure of
chemotherapy regimens in patients with advanced breast cancer; Note: treatment failure
include (1) during or after the completion of six months or less disease progress of
neoadjuvant or adjuvant therapy; (2) rescue treatment in progress within 3 months or
less

- Patients with at least one measurable lesions of the advanced breast cancer，
measurable lesions has not received radiotherapy or other treatment, unless progress
after treatment (measuring≥10mm on spiral CT scan, satisfying the criteria in
RECIST1.1 and WHO);

- Major organ function has to meet the following certeria:

1. For results of blood routine test (without blood transfusion within 14 days)

1. HB≥100g/L;

2. ANC≥1.5×109/L;

3. PLT≥75×109/L;

2. For results of blood biochemical test：

1. TBIL<1.5ULN；

2. ALTand AST<2.5ULN, but5 metastases；

3. Serum creatinine ≤1.25ULN , or calculated creatinine clearance>45 ml/min(per
the Cockcroft-Gault formula); 6.Participants were willing to join in this
study, and written informed consent.

Exclusion Criteria:

1. The patients with the failure of capecitabine treatment；

2. The patients with chest wall invasion, or chest wall large canker has a tendency to
transfer；

3. Have high blood pressure and antihypertensive drug treatment can not control (systolic
blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg), with classⅡand above
coronary heart disease, unable to control arrhythmia (including QTc lengthened women >
470 ms) and classⅢ-Ⅳcardiac insufficiency; or Left ventricular ejection fraction
(LVEF) < 50%；

4. A variety of factors influencing oral drugs (such as unable to swallow, after
resection of the gastrointestinal, chronic diarrhea and intestinal obstruction, etc.)；

5. Has a history of bleeding, the clinical significance of bleeding symptoms, patients
with definite bleeding tendency, such as gastrointestinal bleeding, bleeding ulcers,
baseline period （+ +）and above of defecate occult blood, vasculitis, etc；

6. Received a major surgery within 4 weeks or severe traumatic injury, fractures, or has
a poor healing wound；

7. Allergic to apatinib and supplementary material；

8. Patients with active brain metastases;

9. Patients with pregnant or planning a pregnancy;

10. The researchers think inappropriate.