Clinical trial NCT03086785: Prospective, Multicenter, Observational Study of Apatinib Single or Combined Capecitabine for Treatment of Patients With Metastatic Her-2 Negative Breast Cancer
Official title: Prospective, Multicenter, Observational Study of Apatinib Single or Combined Capecitabine for Treatment of Patients With Metastatic Her-2 Negative Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Breast Cancer Metastatic
Lead sponsor: Hebei Medical University Fourth Hospital
Sponsor class: OTHER
First posted: 2017-03-22
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Progression free survival
timeFrame: evaluated in 24 months since the treatment began
Secondary outcomes:
measure: Overall survival
timeFrame: the first day of treatment to death or last survival confirm date,up to 24 months
measure: Disease control rate
timeFrame: tumor assessment every 6 weeks since the treatment began，up to 24 months
measure: Objective response rate
timeFrame: tumor assessment every 6 weeks since the treatment began，up to 24 months
measure: Side effects
timeFrame: evaluated in the 24th month since the treatment began according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Other outcomes:
Locations:
city: ShiJiazhuang
country: China
facility: Fourth Hospital of Hebei Medical University
state: Hebei
Study officials:
affiliation: Hebei Medical University Fourth Hospital
name: cuizhi Geng, archiat
role: PRINCIPAL_INVESTIGATOR
affiliation: The 307th Hospital of Chinese Peoples' Liberation Army
name: zefei Jiang, archiat
role: PRINCIPAL_INVESTIGATOR
References: