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UNKNOWNPHASE2

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

NCT03086785•Hebei Medical University Fourth Hospital

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.

Eligibility

Age

18 - 70 years

Sex

FEMALE

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：
+3 more criteria

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.

Locations (1)

Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Key Dates

Start Date

November 24, 2016

Primary Completion Date

November 1, 2018

Completion Date

May 1, 2019

Last Updated

January 17, 2018

Enrollment

120

ESTIMATED participants

Conditions

Breast Cancer Metastatic

Interventions

Apatinib

DRUG

Contacts

cuizhi Geng, archiat

CONTACT

0311-66696310 gengcuizhi@hotmail.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 17, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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