- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02448576
PCI in Advanced Triple Negative Breast Cancer Patients Who Response to 1st Line Chemotherapy
May 30, 2017 updated by: wang shusen
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
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
326
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: fei Xu
- Phone Number: 862087342693
- Email: xufei@sysucc.org.cn
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510060
- State Key Laboratory of Oncology in South China, Sun Yat-sen University Cancer Center
-
Contact:
- fei xu, M.D.
- Phone Number: 862087342693
- Email: xufei@sysucc.org.cn
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PCI group
Receiving prophylactic cranial irradiation after response to first line chemotherapy.
|
Prophylactic cranial irradiation in patients with advanced triple negative breast cancer who had a response to first line chemotherapy
|
No Intervention: observation group
Patients in the observation group do not receive prophylactic cranial irradiation after response to first line chemotherapy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
brain metastasis-free survival
Time Frame: eight years
|
time from randomization to brain metastasis
|
eight years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
cumulative risk of brain metastases within 1 year
Time Frame: one year
|
the percent of subjects occurring brain metastases with 1 year
|
one year
|
progression-free survival
Time Frame: eight years
|
time from randomization to disease progression or death(upon which happen earlier)
|
eight years
|
overall survival
Time Frame: eight years
|
time from randomization to death
|
eight years
|
life quality score
Time Frame: eight years
|
quality of life measured by the EORTC-QLQ-C30 questionnaire score
|
eight years
|
central nervous function score
Time Frame: eight years
|
function of central nervous measured by the EORTC-QLQ-BN20 questionnaire score
|
eight years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Shusen Wang, Sun Yat-sen University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Lin NU, Bellon JR, Winer EP. CNS metastases in breast cancer. J Clin Oncol. 2004 Sep 1;22(17):3608-17. doi: 10.1200/JCO.2004.01.175.
- Auperin A, Arriagada R, Pignon JP, Le Pechoux C, Gregor A, Stephens RJ, Kristjansen PE, Johnson BE, Ueoka H, Wagner H, Aisner J. Prophylactic cranial irradiation for patients with small-cell lung cancer in complete remission. Prophylactic Cranial Irradiation Overview Collaborative Group. N Engl J Med. 1999 Aug 12;341(7):476-84. doi: 10.1056/NEJM199908123410703.
- Berghoff A, Bago-Horvath Z, De Vries C, Dubsky P, Pluschnig U, Rudas M, Rottenfusser A, Knauer M, Eiter H, Fitzal F, Dieckmann K, Mader RM, Gnant M, Zielinski CC, Steger GG, Preusser M, Bartsch R. Brain metastases free survival differs between breast cancer subtypes. Br J Cancer. 2012 Jan 31;106(3):440-6. doi: 10.1038/bjc.2011.597. Epub 2012 Jan 10.
- Saip P, Cicin I, Eralp Y, Karagol H, Kucucuk S, Cosar Alas R, Yavuz E, Dincer M, Saglam E, Topuz E. Identification of patients who may benefit from the prophylactic cranial radiotherapy among breast cancer patients with brain metastasis. J Neurooncol. 2009 Jun;93(2):243-51. doi: 10.1007/s11060-008-9769-0. Epub 2008 Dec 20.
- Le Scodan R, Jouanneau L, Massard C, Gutierrez M, Kirova Y, Cherel P, Gachet J, Labib A, Mouret-Fourme E. Brain metastases from breast cancer: prognostic significance of HER-2 overexpression, effect of trastuzumab and cause of death. BMC Cancer. 2011 Sep 19;11:395. doi: 10.1186/1471-2407-11-395.
- Huang F, Alrefae M, Langleben A, Roberge D. Prophylactic cranial irradiation in advanced breast cancer: a case for caution. Int J Radiat Oncol Biol Phys. 2009 Mar 1;73(3):752-8. doi: 10.1016/j.ijrobp.2008.05.031. Epub 2008 Oct 26.
- Tsukada Y, Fouad A, Pickren JW, Lane WW. Central nervous system metastasis from breast carcinoma. Autopsy study. Cancer. 1983 Dec 15;52(12):2349-54. doi: 10.1002/1097-0142(19831215)52:123.0.co;2-b.
- Slotman B, Faivre-Finn C, Kramer G, Rankin E, Snee M, Hatton M, Postmus P, Collette L, Musat E, Senan S; EORTC Radiation Oncology Group and Lung Cancer Group. Prophylactic cranial irradiation in extensive small-cell lung cancer. N Engl J Med. 2007 Aug 16;357(7):664-72. doi: 10.1056/NEJMoa071780.
- Ahn HK, Park YH, Lee SJ, Park S, Maeng CH, Park W, Choi DH, Hur SJ, Ahn JS, Im YH. Clinical implication of Time To Brain Metastasis (TTBM) according to breast cancer subtypes. Springerplus. 2013 Mar 28;2(1):136. doi: 10.1186/2193-1801-2-136. Print 2013 Dec.
- Bai B, Yuan ZY, Liu DG, Teng XY, Wang SS. Clinical features and survival analysis of different subtypes of patients with breast cancer brain metastases. Chin J Cancer. 2010 Apr;29(4):413-9. doi: 10.5732/cjc.009.10643.
- Paterson AH, Agarwal M, Lees A, Hanson J, Szafran O. Brain metastases in breast cancer patients receiving adjuvant chemotherapy. Cancer. 1982 Feb 15;49(4):651-4. doi: 10.1002/1097-0142(19820215)49:43.0.co;2-x.
- Carey LA, Ewend MG, Metzger R, Sawyer L, Dees EC, Sartor CI, Moore DT, Graham ML. Central nervous system metastases in women after multimodality therapy for high risk breast cancer. Breast Cancer Res Treat. 2004 Dec;88(3):273-80. doi: 10.1007/s10549-004-0999-3.
- Al-Shamy G, Sawaya R. Management of brain metastases: the indispensable role of surgery. J Neurooncol. 2009 May;92(3):275-82. doi: 10.1007/s11060-009-9839-y. Epub 2009 Apr 9.
- Fokstuen T, Wilking N, Rutqvist LE, Wolke J, Liedberg A, Signomklao T, Fernberg JO. Radiation therapy in the management of brain metastases from breast cancer. Breast Cancer Res Treat. 2000 Aug;62(3):211-6. doi: 10.1023/a:1006486423827.
- Santarelli JG, Sarkissian V, Hou LC, Veeravagu A, Tse V. Molecular events of brain metastasis. Neurosurg Focus. 2007 Mar 15;22(3):E1. doi: 10.3171/foc.2007.22.3.2.
- Gabos Z, Sinha R, Hanson J, Chauhan N, Hugh J, Mackey JR, Abdulkarim B. Prognostic significance of human epidermal growth factor receptor positivity for the development of brain metastasis after newly diagnosed breast cancer. J Clin Oncol. 2006 Dec 20;24(36):5658-63. doi: 10.1200/JCO.2006.07.0250. Epub 2006 Nov 13.
- Tham YL, Sexton K, Kramer R, Hilsenbeck S, Elledge R. Primary breast cancer phenotypes associated with propensity for central nervous system metastases. Cancer. 2006 Aug 15;107(4):696-704. doi: 10.1002/cncr.22041.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
August 1, 2017
Primary Completion (Anticipated)
August 1, 2025
Study Completion (Anticipated)
August 1, 2025
Study Registration Dates
First Submitted
May 5, 2015
First Submitted That Met QC Criteria
May 14, 2015
First Posted (Estimate)
May 19, 2015
Study Record Updates
Last Update Posted (Actual)
June 1, 2017
Last Update Submitted That Met QC Criteria
May 30, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Neoplastic Processes
- Central Nervous System Neoplasms
- Nervous System Neoplasms
- Breast Neoplasms
- Neoplasm Metastasis
- Brain Neoplasms
- Triple Negative Breast Neoplasms
Other Study ID Numbers
- SYSU-5010-TNBC-PCI
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Breast Cancer
-
Northwestern UniversityEisai Inc.UnknownMale Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative...United States
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI); Rutgers Cancer Institute of New JerseyActive, not recruitingStage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative Breast CancerUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedMale Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
University of WashingtonTerminatedBreast Cancer | Breast Cancer Stage I | Breast Cancer Stage II | Breast Cancer Stage III | Breast Cancer Stage IIB | Breast Cancer Stage IIA | Breast Cancer Stage IIIA | Breast Cancer Stage IIIB | Breast Cancer Stage IIIcUnited States
-
CelgeneCompletedBreast Cancer | Metastatic Breast Cancer | Stage IV Breast Cancer | Triple-negative Breast Cancer | Recurrent Breast Cancer | Breast Tumor | Cancer of the Breast | Triple-negative Metastatic Breast Cancer | Estrogen Receptor- Negative Breast Cancer | HER2- Negative Breast Cancer | Progesterone Receptor- Negative...United States, United Kingdom, Italy, Germany, Spain, Canada, Portugal, Australia, Austria, Greece, Brazil, France
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedHER2-positive Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Estrogen Receptor-negative Breast Cancer | Estrogen Receptor-positive Breast Cancer | Progesterone Receptor-negative Breast Cancer | Progesterone Receptor-positive Breast...United States
-
University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Male Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
Sidney Kimmel Cancer Center at Thomas Jefferson...Susan G. Komen Breast Cancer FoundationCompletedStage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative Breast CancerUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)WithdrawnStage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast Cancer
Clinical Trials on prophylactic cranial irradiation
-
Radiation Therapy Oncology GroupNational Cancer Institute (NCI)CompletedLung CancerUnited States, Canada
-
European Organisation for Research and Treatment...UNICANCERRecruitingExtensive-stage Small-cell Lung Cancer | Limited Stage Small Cell Lung CancerUnited Kingdom, Belgium, Switzerland, Italy, France, Germany, Poland, Spain, Austria
-
Instituto Nacional de Cancerologia de MexicoCompleted
-
Maastricht Radiation OncologyUniversity Medical Center Groningen; The Netherlands Cancer InstituteCompletedNon Small Cell Lung Cancer (NSCLC) | Stage III Non-Small Cell Lung Cancer | Radical TreatmentNetherlands
-
Cancer Institute and Hospital, Chinese Academy...Unknown
-
Alberta Health servicesCompleted
-
Cancer Institute and Hospital, Chinese Academy...RecruitingExtensive-stage Small-cell Lung CancerChina
-
M.D. Anderson Cancer CenterActive, not recruitingBladder CancerUnited States
-
Sidney Kimmel Comprehensive Cancer Center at Johns...CompletedSCLC | Small-cell Lung Cancer | Small Cell Lung Cancer Limited StageUnited States
-
Zhejiang Cancer HospitalSun Yat-sen University; First Affiliated Hospital, Sun Yat-Sen UniversityRecruitingSmall Cell Lung Cancer Limited StageChina