Breast Cancer Clinical Trial
Official title:
A Phase II Study of Endostar in Combination With Chemotherapy in HER-2 Negative Advanced Breast Cancer
This research study is studying endostar in combination with chemotherapy as a possible treatment for HER-2 negative advanced breast cancer.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | June 30, 2020 |
Est. primary completion date | December 30, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
China | Zhejiang Cancer Hospital | Hangzhou | Zhejiang |
Lead Sponsor | Collaborator |
---|---|
Zhejiang Cancer Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression-free Survival (PFS) | From enrollment to disease progression or death due to any cause | up to approximately 100 months | |
Secondary | Overall Survival (OS) | From enrollment to death due to any cause | up to approximately 100 months | |
Secondary | Objective Response Rate (ORR) | Ratio of CR and PR in all subjects | up to approximately 100 months | |
Secondary | Clinical Benefit Rate (CBR) | Ratio of CR,PR and SD more than or equal to 24 weeks | up to approximately 100 months | |
Secondary | Adverse events (AEs) | Described in terms of CTC AE 4.0 | from enrollment to 30 days after the last dose administration |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04681911 -
Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer
|
Phase 2 | |
Completed |
NCT04890327 -
Web-based Family History Tool
|
N/A | |
Terminated |
NCT04066790 -
Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer
|
Phase 2 | |
Completed |
NCT03591848 -
Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility
|
N/A | |
Recruiting |
NCT03954197 -
Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients
|
N/A | |
Terminated |
NCT02202746 -
A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer
|
Phase 2 | |
Active, not recruiting |
NCT01472094 -
The Hurria Older PatiEnts (HOPE) With Breast Cancer Study
|
||
Recruiting |
NCT06049446 -
Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
|
||
Recruiting |
NCT06057636 -
Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study
|
N/A | |
Recruiting |
NCT05560334 -
A Single-Arm, Open, Exploratory Clinical Study of Pemigatinib in the Treatment of HER2-negative Advanced Breast Cancer Patients With FGFR Alterations
|
Phase 2 | |
Active, not recruiting |
NCT05501769 -
ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer
|
Phase 1 | |
Recruiting |
NCT04631835 -
Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer
|
Phase 1 | |
Completed |
NCT04307407 -
Exercise in Breast Cancer Survivors
|
N/A | |
Recruiting |
NCT03544762 -
Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation
|
Phase 3 | |
Terminated |
NCT02482389 -
Study of Preoperative Boost Radiotherapy
|
N/A | |
Enrolling by invitation |
NCT00068003 -
Harvesting Cells for Experimental Cancer Treatments
|
||
Completed |
NCT00226967 -
Stress, Diurnal Cortisol, and Breast Cancer Survival
|
||
Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A | |
Recruiting |
NCT06006390 -
CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT06019325 -
Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy
|
N/A |