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

Phase 2

• Conditions: Breast Cancer Metastatic
• Interventions: Drug: Apatinib

• Registration Number: NCT03086785
• Lead Sponsor: Hebei Medical University Fourth Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11-24
• Study First Submitted: 2017-03-16
• Study First Submitted QC: 2017-03-21
• Study First Posted: 2017-03-22
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-14
• Last Update Posted: 2018-01-17
• Primary Completion: 2018-11
• Study Completion: 2019-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Progression free survival	evaluated in 24 months since the treatment began	Baseline to measured date of progression or death from any cause

Secondary Outcome Measures

Name	Time	Method
Disease control rate	tumor assessment every 6 weeks since the treatment began，up to 24 months	Baseline to measured progressive disease
Side effects	evaluated in the 24th month since the treatment began according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0	throughout study
Overall survival	the first day of treatment to death or last survival confirm date,up to 24 months	Baseline to measured date of death from any cause
Objective response rate	tumor assessment every 6 weeks since the treatment began，up to 24 months	Baseline to measured stable disease

Trial Locations

Locations (1)

Fourth Hospital of Hebei Medical University; 🇨🇳 ShiJiazhuang, Hebei, China