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

Breast Cancer Metastatic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03086785
• Other study ID #: HB-B001
• Status: Recruiting
• Phase: Phase 2
• First received: March 16, 2017
• Last updated: January 14, 2018
• Start date: November 24, 2016
• Est. completion date: May 2019

Study information

• Verified date: January 2018
• Source: Hebei Medical University Fourth Hospital
• Contact: cuizhi Geng, archiat
• Phone: 0311-66696310
• Email: gengcuizhi[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: May 2019
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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 class?and above coronary heart disease, unable to control arrhythmia (including QTc lengthened women > 470 ms) and class?-?cardiac 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.

Related Conditions & MeSH terms

• Breast Cancer Metastatic
• Breast Neoplasms

Intervention

Drug:
• Apatinib
apatinib 500mg qd po or combined capecitabine 1000mg/m2 bid d1-14 q3w

Locations

Country	Name	City	State
China	Fourth Hospital of Hebei Medical University	ShiJiazhuang	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
Hebei Medical University Fourth Hospital

Country where clinical trial is conducted

China, 

Outcome

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