NCT02491697

Brief Summary

The prognosis of advanced breast cancer does not improve much recently although varies of adjuvant drugs have been tried.Dendritic cells co-cultured with cytokine-induced killer cells(DC-CIK) immunotherapy has been proved to improve survival in several cancers, but its role in advanced breast cancer stains unclear. The purpose of this study is to evaluate the efficacy and safety of DC-CIK immunotherapy combined with capecitabine versus capecitabine monotherapy for the treatment of advanced breast cancer.

Trial Health

83
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for phase_2 breast-cancer

Timeline
88mo left

Started Feb 2016

Longer than P75 for phase_2 breast-cancer

Status
active not recruiting

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 Progress59%
Feb 2016Aug 2033

First Submitted

Initial submission to the registry

July 1, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 8, 2015

Completed
7 months until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
14.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2030

Expected
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2033

Last Updated

February 23, 2016

Status Verified

July 1, 2015

Enrollment Period

14.5 years

First QC Date

July 1, 2015

Last Update Submit

February 21, 2016

Conditions

Breast Cancer

Keywords

DC-CIKBreast cancerCapecitabine

Outcome Measures

Primary Outcomes (1)

  • Overall Survival(OS)

    1 year

Secondary Outcomes (1)

  • Disease-free survival

    6 months

Other Outcomes (2)

  • Number of participants with side effects

    1 week

  • Clinical benefit response ( composite)

    2 months

Study Arms (2)

Capecitabine Monotherapy

ACTIVE COMPARATOR

Patients with advanced breast cancer accept capecitabine monotherapy. Drug: Capecitabine

Drug: Capecitabine Monotherapy

DC-CIK Immunotherapy+Capecitabine

EXPERIMENTAL

Biological/Vaccine: DC-CIK DC-CIK immunotherapy combined with capecitabine are used to treat advanced breast cancer. Drug: Capecitabine

Biological: DC-CIK ImmunotherapyDrug: Capecitabine Monotherapy

Interventions

DC-CIK ImmunotherapyBIOLOGICAL

DC-CIK cells are used to treat advanced breast cancer with capecitabine.

Also known as: DC-CIK
DC-CIK Immunotherapy+Capecitabine
Capecitabine MonotherapyDRUG

All patients receive capecitabine monotherapy (2500 mg/m2 twice daily) for 2 weeks followed by a 1-week rest period.And the treatment is repeated every 3 weeks.

Also known as: Capecitabine
Capecitabine MonotherapyDC-CIK Immunotherapy+Capecitabine

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed with advanced breast cancer.
  • Eastern Cooperative Oncology Group (ECOG) performance status was 0 - 2.
  • Hemoglobin≥10.0g/dL, Neutrophil count≥1.5×10\^9/L, Platelet count≥75×10\^9/L; total bilirubin(TBIL)≤1.5×ULN; alkaline phosphatase(AKP), aspartate aminotransferase(AST),ALT≤2.5×ULN(without metastasis of the liver), AKP,AST,ALT≤5×ULN(with metastasis of the liver); BUN≤1.5×ULN, Cr≤1.5×ULN.
  • Patient received 1-2 kinds of cytotoxic chemotherapy previously.
  • Patient never received capecitabine or other oral fluorouracil.

You may not qualify if:

  • Patients who are suffering from serious organ dysfunction.
  • HIV positive or other immunodeficiency disease.
  • Patients who had used long time or are using immunosuppressant drugs.
  • Patients who had active infection.
  • Patients who were allergic to fluorouracil.
  • Pregnant or lactating women.
  • History of other malignancies.
  • Other situations that the researchers considered unsuitable for this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Capecitabine

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

DeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2015

First Posted

July 8, 2015

Study Start

February 1, 2016

Primary Completion (Estimated)

August 1, 2030

Study Completion (Estimated)

August 1, 2033

Last Updated

February 23, 2016

Record last verified: 2015-07