Clinical trial NCT03907098: Endostar in Combination With Chemotherapy in HER-2 Negative Advanced Breast Cancer
Official title: A Phase II Study of Endostar in Combination With Chemotherapy in HER-2 Negative Advanced Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Breast Cancer
Keywords: breast cancer
endostar
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2019-04-08
Enrollment: 50
Sex: ALL
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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Progression-free Survival (PFS)
timeFrame: up to approximately 100 months
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: up to approximately 100 months
measure: Objective Response Rate (ORR）
timeFrame: up to approximately 100 months
measure: Clinical Benefit Rate (CBR)
timeFrame: up to approximately 100 months
measure: Adverse events (AEs)
timeFrame: from enrollment to 30 days after the last dose administration
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
References: