Breast Cancer
Conditions
Keywords
breast cancer, endostar
Brief summary
This research study is studying endostar in combination with chemotherapy as a possible treatment for HER-2 negative advanced breast cancer.
Detailed description
This is a multi-center phase II open label single-arm study to assess the safety and efficacy of endostar in combination with chemotherapy for patients with locoregionally recurrent or metastatic HER-2 negative breast cancer. Endostar is an anti-angiogenesis drug. It is prepared by adding 9 amino acids to the N-terminal of the peptide chain on the basis of endostatin. Studies have shown that there may be a synergistic effect between endostar and chemotherapeutic agents.
Interventions
DRUGEndostar
an anti-angiogenesis drug
DRUGChemotherapy
Physician's choice
Sponsors
Zhejiang Cancer Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival (PFS) | up to approximately 100 months | From enrollment to disease progression or death due to any cause |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | up to approximately 100 months | From enrollment to death due to any cause |
| Objective Response Rate (ORR） | up to approximately 100 months | Ratio of CR and PR in all subjects |
| Clinical Benefit Rate (CBR) | up to approximately 100 months | Ratio of CR,PR and SD more than or equal to 24 weeks |
| Adverse events (AEs) | from enrollment to 30 days after the last dose administration | Described in terms of CTC AE 4.0 |
Countries
China
Contacts
Primary ContactXiaojia Wang, PhD
Backup ContactYuan Huang, PhD
Outcome results
None listed