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Endostar in Combination With Chemotherapy in HER-2 Negative Advanced Breast Cancer

Primary Purpose

Breast Cancer

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Endostar

Chemotherapy

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring breast cancer, endostar

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Zhejiang Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

endostar + chemotherapy

Arm 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.

Outcomes

Primary Outcome Measures

Progression-free Survival (PFS)

From enrollment to disease progression or death due to any cause

Secondary Outcome Measures

Overall Survival (OS)

From enrollment to death due to any cause

Objective Response Rate (ORR）

Ratio of CR and PR in all subjects

Clinical Benefit Rate (CBR)

Ratio of CR,PR and SD more than or equal to 24 weeks

Adverse events (AEs)

Described in terms of CTC AE 4.0

Full Information

NCT ID

NCT03907098

First Posted

March 29, 2019

Last Updated

April 5, 2019

Sponsor

Zhejiang Cancer Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03907098

Brief Title

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

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Unknown status

Study Start Date

June 30, 2016 (Actual)

Primary Completion Date

December 30, 2019 (Anticipated)

Study Completion Date

June 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Zhejiang Cancer Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

breast cancer, endostar

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

endostar + chemotherapy

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Endostar

Other Intervention Name(s)

Recombinant human endostatin

Intervention Description

an anti-angiogenesis drug

Intervention Type

Drug

Intervention Name(s)

Chemotherapy

Intervention Description

Physician's choice

Primary Outcome Measure Information:

Title

Progression-free Survival (PFS)

Description

From enrollment to disease progression or death due to any cause

Time Frame

up to approximately 100 months

Secondary Outcome Measure Information:

Title

Overall Survival (OS)

Description

From enrollment to death due to any cause

Time Frame

up to approximately 100 months

Title

Objective Response Rate (ORR）

Description

Ratio of CR and PR in all subjects

Time Frame

up to approximately 100 months

Title

Clinical Benefit Rate (CBR)

Description

Ratio of CR,PR and SD more than or equal to 24 weeks

Time Frame

up to approximately 100 months

Title

Adverse events (AEs)

Description

Described in terms of CTC AE 4.0

Time Frame

from enrollment to 30 days after the last dose administration

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xiaojia Wang, PhD

Phone

86 13906500190

wxiaojia0803@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Yuan Huang, PhD

Phone

86 13588747179

hy415@163.com

Facility Information:

Facility Name

Zhejiang Cancer Hospital

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310022

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yuan Huang

Phone

057188122072

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Endostar in Combination With Chemotherapy in HER-2 Negative Advanced Breast Cancer

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