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

NCT03086785 | Unknown Phase 2

• 1 other identifier: HB-B001
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer Metastatic

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  Baseline to measured date of progression or death from any cause

  evaluated in 24 months since the treatment began

Secondary Outcomes (4)

• Overall survival

  the first day of treatment to death or last survival confirm date,up to 24 months

• Disease control rate

  tumor assessment every 6 weeks since the treatment began，up to 24 months

• Objective response rate

  tumor assessment every 6 weeks since the treatment began，up to 24 months

• Side effects

  evaluated in the 24th month since the treatment began according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0

Study Arms (1)

apatinib

EXPERIMENTAL

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

Drug: Apatinib

Interventions

Apatinib DRUG

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

apatinib

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• For results of blood routine test (without blood transfusion within 14 days)
• HB≥100g/L;
• ANC≥1.5×109/L;
• PLT≥75×109/L;
• For results of blood biochemical test：
• TBIL\<1.5ULN；
• ALTand AST\<2.5ULN, but5\<ULN if the transferanse elevation is due to liver metastases；
• 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.

You may not qualify if:

• The patients with the failure of capecitabine treatment；
• The patients with chest wall invasion, or chest wall large canker has a tendency to transfer；
• 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%；
• A variety of factors influencing oral drugs (such as unable to swallow, after resection of the gastrointestinal, chronic diarrhea and intestinal obstruction, etc.)；
• 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；
• Received a major surgery within 4 weeks or severe traumatic injury, fractures, or has a poor healing wound；
• Allergic to apatinib and supplementary material；
• Patients with active brain metastases;
• Patients with pregnant or planning a pregnancy;
• The researchers think inappropriate.

Sponsors & Collaborators

• Hebei Medical University Fourth Hospital: lead

Study Sites (1)

Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050019, China

RECRUITING

MeSH Terms

Interventions

apatinib

Study Officials

• cuizhi Geng, archiat

  Hebei Medical University Fourth Hospital

  PRINCIPAL INVESTIGATOR

• zefei Jiang, archiat

  The 307th Hospital of Chinese Peoples' Liberation Army

  PRINCIPAL INVESTIGATOR

Central Study Contacts

cuizhi Geng, archiat

CONTACT

0311-66696310; gengcuizhi@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2017
• First Posted: March 22, 2017
• Study Start: November 24, 2016
• Primary Completion: November 1, 2018
• Study Completion: May 1, 2019
• Last Updated: January 17, 2018

Record last verified: 2018-01

Locations

CN (1)