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

Hebei Medical University

Status and phase: Unknown; Phase 2

Conditions: Breast Cancer Metastatic

Treatments: Drug: Apatinib

Study type: Interventional

Funder types: Other

Identifiers

NCT03086785

HB-B001

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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<ULN if the transferanse elevation is due to liver 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

apatinib

Experimental group

Description:

apatinib 500mg qd po or combined Capecitabine 1000mg/m2 bid d1-d14 q3w

Treatment:

Drug: Apatinib