NCT01232062

Completed

Study of High-dose Chemotherapy (HDC) Combined With Adoptive...

Peking University Cancer Hospital & Institute Source

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Other study identifiers

Sponsor study identifier

HD+DC-CIK

Study Type

observational

Actual enrollment (reported)

46

Locations

1 country

Sites

1

Timeline

Study Start

August 2010

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

May 2011

Actual (reported)

Study Completion

October 2013

Actual (reported)

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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 46 participants
Study completion date: October 2013
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
August 2010
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
October 29, 2010
Actual (reported)
First Posted
November 2, 2010
Actual (reported)
Primary Completion
May 2011
Actual (reported)
Study Completion
October 2013
Actual (reported)

Last Updated: July 23, 2015
Status Verified: July 2015
Last Update Submitted: July 22, 2015

Conditions

Breast Neoplasms Neoplasm Metastasis

Keywords

breast neoplasmNeoplasm MetastasisDrug 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

Age18 Years - 45 Years

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64)

Sampling MethodProbability Sample

Study Population

female patients with metastatic breast cancer

You may qualify if:

Failure to anthracycline and/or taxol chemotherapy;

Sponsors & Collaborators

Peking University Cancer Hospital & Institute
Otherlead

Study Sites (1)

Beijing Cancer Hospital

Beijing, 100142, China

Biospecimen

Retention: NONE RETAINED

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

MeSH Terms

Conditions

Breast NeoplasmsNeoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNeoplastic ProcessesPathologic ProcessesPathological 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

Enrollment

46 participants (actual enrollment reported by the registry).

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 2010

Date type not reported

This date has not been verified as actual or estimated.

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Phase 1/2Terminated

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;

Contact the study team to confirm eligibility.

Jie Zhang, MD.

Peking University Cancer Hospital & Institute

PRINCIPAL INVESTIGATOR

Primary Completion

May 2011

Actual (reported)

Study Completion

October 2013

Actual (reported)

Last Updated

July 23, 2015

Record last verified: 2015-07

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT01232062
Data provider: ClinicalTrials.gov
Source updated: 2015-07-23
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:37:13 UTC

Locations

CN(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations