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Trial record 1 of 3 for:    PCI brain breast cancer
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PCI in Advanced Triple Negative Breast Cancer Patients Who Response to 1st Line Chemotherapy

This study is not yet open for participant recruitment.
Verified May 2017 by wang shusen, Sun Yat-sen University
Sponsor:
ClinicalTrials.gov Identifier:
NCT02448576
First Posted: May 19, 2015
Last Update Posted: June 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
wang shusen, Sun Yat-sen University
  Purpose
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.

Condition Intervention
Breast Cancer Brain Metastasis Radiation: prophylactic cranial irradiation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by wang shusen, Sun Yat-sen University:

Primary Outcome Measures:
  • brain metastasis-free survival [ Time Frame: eight years ]
    time from randomization to brain metastasis


Secondary Outcome Measures:
  • cumulative risk of brain metastases within 1 year [ Time Frame: one year ]
    the percent of subjects occurring brain metastases with 1 year

  • progression-free survival [ Time Frame: eight years ]
    time from randomization to disease progression or death(upon which happen earlier)

  • overall survival [ Time Frame: eight years ]
    time from randomization to death

  • life quality score [ Time Frame: eight years ]
    quality of life measured by the EORTC-QLQ-C30 questionnaire score

  • central nervous function score [ Time Frame: eight years ]
    function of central nervous measured by the EORTC-QLQ-BN20 questionnaire score


Estimated Enrollment: 326
Anticipated Study Start Date: August 2017
Estimated Study Completion Date: August 2025
Estimated Primary Completion Date: August 2025 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PCI group
Receiving prophylactic cranial irradiation after response to first line chemotherapy.
Radiation: prophylactic cranial irradiation
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.

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02448576


Contacts
Contact: fei Xu 862087342693 xufei@sysucc.org.cn

Locations
China, Guangdong
State Key Laboratory of Oncology in South China, Sun Yat-sen University Cancer Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: fei xu, M.D.    862087342693    xufei@sysucc.org.cn   
Sponsors and Collaborators
wang shusen
Investigators
Study Chair: Shusen Wang Sun Yat-sen University
  More Information

Publications:
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.
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.
Aupérin A, Arriagada R, Pignon JP, Le Péchoux 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.
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.
Lin NU, Bellon JR, Winer EP. CNS metastases in breast cancer. J Clin Oncol. 2004 Sep 1;22(17):3608-17. Review.
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.
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.
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.
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. Review.
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.
Santarelli JG, Sarkissian V, Hou LC, Veeravagu A, Tse V. Molecular events of brain metastasis. Neurosurg Focus. 2007 Mar 15;22(3):E1. Review.
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. 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.

Responsible Party: wang shusen, Shusen Wang, M.D. Department of Medical Oncology, Sun Yat-sen University Cancer Center, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02448576     History of Changes
Other Study ID Numbers: SYSU-5010-TNBC-PCI
First Submitted: May 5, 2015
First Posted: May 19, 2015
Last Update Posted: June 1, 2017
Last Verified: May 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by wang shusen, Sun Yat-sen University:
phase 3 randomized controlled trial
prophylactic cranial irradiation
triple negative breast cancer
brain metastasis
advanced breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasm Metastasis
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes


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