Immunotherapy Combined With Capecitabine Versus Capecitabine Monotherapy in Advanced Breast Cancer

Breast Cancer Clinical Trial

Official title:

Randomized Controlled Trial Comparing Dendritic Cells Co-cultured With Cytokine-induced Killer Cells Immunotherapy Combined With Capecitabine Versus Capecitabine Monotherapy in Advanced Breast Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02491697
• Other study ID #: CZ1H-BC-001
• Status: Active, not recruiting
• Phase: Phase 2
• First received: July 1, 2015
• Last updated: February 21, 2016
• Start date: February 2016
• Est. completion date: August 2033

Study information

• Verified date: July 2015
• Source: The First People's Hospital of Changzhou
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Health and Family Planning Commission of Changzhou
• Study type: Interventional

Clinical Trial 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.

Description:

1.400 patients with advanced breast cancer should be definitively diagnosis based on histopathology, according to the 7th American Joint Committee on Cancer(AJCC) Cancer Staging Manual.

2.All patients will be randomly divided into group A（DC-CIK immunotherapy combined with capecitabine ) or group B（capecitabine monotherapy).

3.Patients in group A will receive 4 cycles of DC-CIK treatment (every 1 year) and capecitabine(continuous).Patients in group B will receive only capecitabine monotherapy(continuous) .

4.The response is assessed using Response Evaluation Criteria in Solid Tumor Group (RECIST) guidelines.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 400
• Est. completion date: August 2033
• Est. primary completion date: August 2030
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Biological:
• DC-CIK Immunotherapy
DC-CIK cells are used to treat advanced breast cancer with capecitabine.

Drug:
• Capecitabine Monotherapy
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The First People's Hospital of Changzhou

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of participants with side effects	The side effect was evaluated according to WHO standards, including diarrhea, nausea, vomiting, hand-foot syndrome and neutropenia.	1 week	Yes
Other	Clinical benefit response ( composite)	complete response(CR),partial response(PR),stable disease(SD)and progressive disease(PD).	2 months	Yes
Primary	Overall Survival(OS)		1 year	Yes
Secondary	Disease-free survival		6 months	Yes