NCT02547961

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of HER2-CAR-T cell Infusion for advanced HER2 positive breast cancer.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2015

Shorter than P25 for phase_1 breast-cancer

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

September 4, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 14, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2016

Completed
Last Updated

July 16, 2020

Status Verified

July 1, 2020

Enrollment Period

12 months

First QC Date

September 4, 2015

Last Update Submit

July 14, 2020

Conditions

Breast Cancer

Keywords

breast cancerHER2CAR-T cell

Outcome Measures

Primary Outcomes (1)

  • Number of participants with Adverse events

    24weeks

Secondary Outcomes (1)

  • Tumor load

    24weeks

Other Outcomes (2)

  • Progress free disease (PFS)

    1 year

  • Overall survival (OS)

    3 years

Study Arms (2)

HER2-CAR-T

EXPERIMENTAL

In interventional studies, participants are assigned to accept HER-2-targeting CAR T Cells infusion so that researchers can evaluate the effects and safety of the CAR-T cell.

Biological: HER-2-targeting CAR T Cells infusion

No Intervention

NO INTERVENTION

Interventions

HER-2-targeting CAR T Cells infusionBIOLOGICAL

HER-2-targeting CAR t cells infusion in breast cancer

HER2-CAR-T

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chemotherapy refractory Her2 positive breast cancer；
  • Relapsed patients after anti-Her2 using antibody or kinase inhibitor therapy；
  • Patients must be 18 years of age or older；
  • Patients must have an ECOG (Eastern Cooperative Oncology Group )performance status of 0-2；
  • Patients must have evidence of adequate bone marrow reserve, hepatic and renal function as evidenced by the following laboratory parameters:
  • Absolute neutrophil count greater than 1500/mm3. Platelet count greater than 100,000/mm3. Hemoglobin greater than 10g/dl (patients may receive transfusions to meet this parameter).
  • Total bilirubin \< 1.5 times upper limits of normal. Serum creatinine less than or equal to 1.6 mg/ml or the creatinine clearance must be greater than 70 ml/min/1.73m(2).
  • Seronegative for HIV antibody.
  • Seronegative for active hepatitis B, and seronegative for hepatitis C antibody.
  • Patients must be willing to practice birth control during and for four months following treatment.NOTE:women of child-bearing age must have evidence of negative pregnancy test.
  • Patients must be willing to sign an informed consent.

You may not qualify if:

  • \. Patients with uncontrolled hypertension (\> 160/95), unstable coronary disease evidenced by uncontrolled arrhythmias, unstable angina, decompensated congestive heart failure (\> New York Heart Association Class II), or myocardial infarction within 6 months of study will be excluded.
  • Patients with any of the follo wing pulmonary function abnormalities will be excluded: FEV(forced expiratory volume), \< 30% predicted; DLCO (diffusing capacity of lung for carbon monoxide) \< 30% predicted (post-bronchodilator); Oxygen Saturation less than 90% on room air.
  • Patients with severe liver and kidney dysfunction or consciousness disorders will be excluded.
  • Pregnant and/or lactating women will be excluded. 5.Patients with active infections, including HIV, will be excluded, due to unknown effects of the vaccine on lymphoid precursors.
  • Patients with any type of primary immunodeficiencies will be excluded from the study.
  • Patients requiring corticosteroids (other than inhaled) will be excluded. 8.Patients with history of T cell tumors will be excluded. 9.Patients who are participating or participated any other clinical trials in latest 30 days will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Central laboratory in Fuda cancer hospital

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Lizhi Niu, PhD

    Fuda Cancer Hospital

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2015

First Posted

September 14, 2015

Study Start

September 1, 2015

Primary Completion

August 15, 2016

Study Completion

August 15, 2016

Last Updated

July 16, 2020

Record last verified: 2020-07

Locations

CN(1)