Clinical trial · Interventional
Prospective, Multicenter, Observational Study of Apatinib Single or Combined Capecitabine for Treatment of Patients With Metastatic Her-2 Negative Breast Cancer
NCT03086785CI-TRIAL-00031191unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Metastatic | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Apatinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- apatinib
- description
- apatinib 500mg qd po or combined Capecitabine 1000mg/m2 bid d1-d14 q3w
- interventionNames
- Drug: Apatinib
Primary outcomes (1)
- measure
- Progression free survival
- timeFrame
- evaluated in 24 months since the treatment began
- description
- Baseline to measured date of progression or death from any cause
Secondary outcomes (4)
- measure
- Overall survival
- timeFrame
- the first day of treatment to death or last survival confirm date,up to 24 months
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.References
Publications (0)
Data not yet available
No reference posted for this study.