Study of High-dose Chemotherapy (HDC) Combined With Adoptive Cellular Therapy With DC-CIK Cells in Triple Negative Breast Cancer Patients

NCT01232062 | Completed DMC

• 1 other identifier: HD+DC-CIK
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

To access the effectiveness of High-dose Cyclophosphamide Combined Chemotherapy combined with adoptive cellular therapy with dentritic and cytokine-induced killer cells in triple negative metastatic breast cancer patients

Conditions

Breast Neoplasms; Neoplasm Metastasis

Keywords

breast neoplasm; Neoplasm Metastasis; Drug Therapy

Outcome Measures

Primary Outcomes (1)

• response to chemotherapy

  Response to chemotherapy is evaluated by Response Evaluation Criteria in Solid Tumors(RESIST).

  4months

Secondary Outcomes (3)

• Time to disease progression

  six months to one year

• survival rates

  one-year

• clinical benefit response

  six months to one year

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

female patients with metastatic breast cancer

You may qualify if:

• Failure to anthracycline and/or taxol chemotherapy;
• metastatic tumor is histologically confirmed by immunohistochemical staining to be ER-negative and PR-negative. FISH testing for her-2-negative;
• Metastatic tumor can not be removed through surgery procedure;
• Metastatic tumor measured by PET-CT scan is at least 1cm;
• An Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
• Normal cardiac, hepatic, renal and bone marrow functions;
• Life expectancy ≥3 months.

You may not qualify if:

• Do not finish twice PET-CT scan;
• Central nervous system metastases;
• Serious or uncontrolled concurrent medical illness;
• History of other malignancies;
• Having been enrolled in some other clinal trials within a month;

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, 100142, China

Location

Biospecimen

Retention: NONE RETAINED

about 4ml peripheral vein blood，paraffin section on metastatic tissue，

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• JING YU, MD, PhD

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

• CHAO YING WANG, MD, PhD

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

• JUN REN, MD, PhD

  Peking University Cancer Hospital & Institute

  STUDY CHAIR

• YU LIN ZHU, MD, PhD

  Bei jing Cancer Hospital

  PRINCIPAL INVESTIGATOR

• Jie Zhang, MD.

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: October 29, 2010
• First Posted: November 2, 2010
• Study Start: August 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: October 1, 2013
• Last Updated: July 23, 2015

Record last verified: 2015-07

Locations

CN (1)