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

This research study is studying endostar in combination with chemotherapy as a possible treatment for HER-2 negative advanced breast cancer.

Study Overview

• Status: Unknown
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Endostar; Drug: Chemotherapy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310022
      • Recruiting
      • Zhejiang Cancer Hospital
      • Contact: Yuan Huang; Phone Number: 057188122072

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: endostar + chemotherapy; 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.	Drug: Endostar; an anti-angiogenesis drug; Other Names: Recombinant human endostatin; Drug: Chemotherapy; Physician's choice

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free Survival (PFS)	From enrollment to disease progression or death due to any cause	up to approximately 100 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	From enrollment to death due to any cause	up to approximately 100 months
Objective Response Rate (ORR）	Ratio of CR and PR in all subjects	up to approximately 100 months
Clinical Benefit Rate (CBR)	Ratio of CR,PR and SD more than or equal to 24 weeks	up to approximately 100 months
Adverse events (AEs)	Described in terms of CTC AE 4.0	from enrollment to 30 days after the last dose administration

Collaborators and Investigators

• Sponsor: Zhejiang Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2016
• Primary Completion (Anticipated): December 30, 2019
• Study Completion (Anticipated): June 30, 2020

Study Registration Dates

• First Submitted: March 29, 2019
• First Submitted That Met QC Criteria: April 5, 2019
• First Posted (Actual): April 8, 2019

Study Record Updates

• Last Update Posted (Actual): April 8, 2019
• Last Update Submitted That Met QC Criteria: April 5, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: breast cancer; endostar
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Endostar protein; Endostatins
• Other Study ID Numbers: ZJCHBC008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No