Clinical trial · Interventional
Endostar in Combination With Chemotherapy in HER-2 Negative Advanced Breast Cancer
A Phase II Study of Endostar in Combination With Chemotherapy in HER-2 Negative Advanced Breast Cancer
NCT03907098CI-TRIAL-00038002unknownPhase 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)
This research study is studying endostar in combination with chemotherapy as a possible treatment for HER-2 negative advanced 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 | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemotherapy | Drug | Chemotherapy | ALIAS |
| Endostar | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- endostar + chemotherapy
- description
- Endostar 15 mg per square of BSA, continuous intravenous infusion 24 hours a day, continuous administration for 7 days, every three weeks. Chemotherapy regimens are selected by physicians based on regular clinical decision.
- interventionNames
- Drug: Endostar
- Drug: Chemotherapy
Primary outcomes (1)
- measure
- Progression-free Survival (PFS)
- timeFrame
- up to approximately 100 months
- description
- From enrollment to disease progression or death due to any cause
Secondary outcomes (4)
- measure
- Overall Survival (OS)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * locoregionally Recurrent or metastatic breast cancer confirmed by histology. * HER-2 Negative Breast Cancer. * At least one measurable lesion according to RECIST 1.1.. * Chemotherapy for recurrent and metastatic lesions should be discontinued for more than 2 weeks. * 18-70 years old. * ECOG PS 0～1. * Participants must have normal organ and marrow function as defined below: ANC ≥ 1.5×109/L,PLT ≥ 75×109/L,Hb ≥ 100 g/L;TBIL≤1.0ULN；ALT and AST≤3×ULN（ALT and AST≤5×ULN if liver metastasis）;BUN and Cr≤1.5×ULN and CCr≥50 mL/min. * life expectancy is not less than 12 weeks. * Signed informed consent. Exclusion Criteria: * Uncontrolled central nervous system metastasis. * Not recovered to 0-1 degree (CTC AE 4.0) from toxic reactions of previous treatments.. * History of allergy to biological agents in the past. * Important organ dysfunction and severe heart disease, including congestive heart failure, uncontrollable arrhythmia, angina, valvular disease, myocardial infarction, and refractory hypertension. * Pregnant or lactating women.. * The patient had a history of other malignant tumors, except for the cured skin basal cell carcinoma and cervical cancer. * The risk of uncontrolled infection, thrombosis and bleeding exists. * A history of immunodeficiency, including HIV positive, HCV, active hepatitis B, or other acquired, congenital immunodeficiency disorders, or organ transplantation, is known. * Researchers consider it inappropriate to carry out the study.
References
Publications (0)
Data not yet available
No reference posted for this study.