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PCI in Advanced Triple Negative Breast Cancer Patients Who Response to 1st Line Chemotherapy

Primary Purpose

Breast Cancer, Brain Metastasis

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
prophylactic cranial irradiation
Sponsored by
wang shusen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breast Cancer focused on measuring phase 3 randomized controlled trial, prophylactic cranial irradiation, triple negative breast cancer, brain metastasis, advanced breast cancer

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Signed informed consent;
  2. Age of 18 to 65 years;
  3. Documented advanced breast cancer, clinical and pathological confirmed;
  4. Immunohistochemical examination:ER<1%+, progestin receptor (PR)<1%+, HER-2 -/+ or HER-2(++)with negative result of FISH;
  5. A response after four to eight cycles of first line chemotherapy;
  6. Life expectancy longer than six months evaluated by investigator;
  7. A performance status of 0 to 2, according to the criteria of the World Health Organization (with a higher score indicating a poorer performance status)
  8. Less than grade 1( Common Terminology Criteria grade version 4.0) of treatment-related toxicities;
  9. Adequate baseline organ function.

Exclusion Criteria:

  1. History of another malignancy.
  2. Pregnancy or gestation
  3. Definite diagnosed of central nervous system (CNS)or leptomeningeal metastases
  4. Serious cardiac illness or medical condition
  5. Known history of related central nervous system or leptomeningeal disease
  6. Cognition impairment or suffering from mental illness
  7. Demand a long-term oral administration of psychotropic drugs
  8. Have a concurrent disease or condition that may interfere with study participation, or any serious medical disorder that would interfere with the subject's safety (for example, active or uncontrolled infection, currently active/requiring anti-viral therapy hepatic or biliary disease)

Sites / Locations

  • State Key Laboratory of Oncology in South China, Sun Yat-sen University Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

PCI group

observation group

Arm Description

Receiving prophylactic cranial irradiation after response to first line chemotherapy.

Patients in the observation group do not receive prophylactic cranial irradiation after response to first line chemotherapy.

Outcomes

Primary Outcome Measures

brain metastasis-free survival
time from randomization to brain metastasis

Secondary Outcome Measures

cumulative risk of brain metastases within 1 year
the percent of subjects occurring brain metastases with 1 year
progression-free survival
time from randomization to disease progression or death(upon which happen earlier)
overall survival
time from randomization to death
life quality score
quality of life measured by the EORTC-QLQ-C30 questionnaire score
central nervous function score
function of central nervous measured by the EORTC-QLQ-BN20 questionnaire score

Full Information

First Posted
May 5, 2015
Last Updated
May 30, 2017
Sponsor
wang shusen
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1. Study Identification

Unique Protocol Identification Number
NCT02448576
Brief Title
PCI in Advanced Triple Negative Breast Cancer Patients Who Response to 1st Line Chemotherapy
Official Title
A Phase III Randomized Controlled Trial of Prophylactic Cranial Irradiation in Patients With Advanced Triple Negative Breast Cancer Who Had a Response to First Line Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 2017 (Anticipated)
Primary Completion Date
August 2025 (Anticipated)
Study Completion Date
August 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
wang shusen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to compare whether prophylactic cranial irradiation in patients with advanced triple negative breast cancer who had a response to first line chemotherapy could prolong brain-metastasis free survival.
Detailed Description
This is a phase III, randomized, controlled, open, multicenter clinical trial, designed to assess the efficacy and safety of prophylactic cranial irradiation (PCI) in advanced triple negative breast cancer who response to the first line chemotherapy. Compare the PCI group with the observation group to evaluate brain metastasis-free survival,cumulative risk of brain metastases within 1 year,progression-free survival,overall survival,quality of life measured by the The Europe organization for research and treatment of cancer, Quality of life Questionnaire-cancer 30 (EORTC-QLQ-C30) questionnaire score and function of central nervous measured by the The Europe organization for research and treatment of cancer, Quality of life Questionnaire-brain cancer 20 (EORTC-QLQ-BN20) questionnaire score in women with advanced triple negative breast cancer who response to the first line chemotherapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Brain Metastasis
Keywords
phase 3 randomized controlled trial, prophylactic cranial irradiation, triple negative breast cancer, brain metastasis, advanced breast cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
326 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PCI group
Arm Type
Experimental
Arm Description
Receiving prophylactic cranial irradiation after response to first line chemotherapy.
Arm Title
observation group
Arm Type
No Intervention
Arm Description
Patients in the observation group do not receive prophylactic cranial irradiation after response to first line chemotherapy.
Intervention Type
Radiation
Intervention Name(s)
prophylactic cranial irradiation
Intervention Description
Prophylactic cranial irradiation in patients with advanced triple negative breast cancer who had a response to first line chemotherapy
Primary Outcome Measure Information:
Title
brain metastasis-free survival
Description
time from randomization to brain metastasis
Time Frame
eight years
Secondary Outcome Measure Information:
Title
cumulative risk of brain metastases within 1 year
Description
the percent of subjects occurring brain metastases with 1 year
Time Frame
one year
Title
progression-free survival
Description
time from randomization to disease progression or death(upon which happen earlier)
Time Frame
eight years
Title
overall survival
Description
time from randomization to death
Time Frame
eight years
Title
life quality score
Description
quality of life measured by the EORTC-QLQ-C30 questionnaire score
Time Frame
eight years
Title
central nervous function score
Description
function of central nervous measured by the EORTC-QLQ-BN20 questionnaire score
Time Frame
eight years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signed informed consent; Age of 18 to 65 years; Documented advanced breast cancer, clinical and pathological confirmed; Immunohistochemical examination:ER<1%+, progestin receptor (PR)<1%+, HER-2 -/+ or HER-2(++)with negative result of FISH; A response after four to eight cycles of first line chemotherapy; Life expectancy longer than six months evaluated by investigator; A performance status of 0 to 2, according to the criteria of the World Health Organization (with a higher score indicating a poorer performance status) Less than grade 1( Common Terminology Criteria grade version 4.0) of treatment-related toxicities; Adequate baseline organ function. Exclusion Criteria: History of another malignancy. Pregnancy or gestation Definite diagnosed of central nervous system (CNS)or leptomeningeal metastases Serious cardiac illness or medical condition Known history of related central nervous system or leptomeningeal disease Cognition impairment or suffering from mental illness Demand a long-term oral administration of psychotropic drugs Have a concurrent disease or condition that may interfere with study participation, or any serious medical disorder that would interfere with the subject's safety (for example, active or uncontrolled infection, currently active/requiring anti-viral therapy hepatic or biliary disease)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
fei Xu
Phone
862087342693
Email
xufei@sysucc.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shusen Wang
Organizational Affiliation
Sun Yat-sen University
Official's Role
Study Chair
Facility Information:
Facility Name
State Key Laboratory of Oncology in South China, Sun Yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
fei xu, M.D.
Phone
862087342693
Email
xufei@sysucc.org.cn

12. IPD Sharing Statement

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PCI in Advanced Triple Negative Breast Cancer Patients Who Response to 1st Line Chemotherapy

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