PCI in Advanced Triple Negative Breast Cancer Patients Who Response to 1st Line Chemotherapy
NCT ID: NCT02448576
Last Updated: 2017-06-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
326 participants
INTERVENTIONAL
2017-08-31
2025-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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PCI group
Receiving prophylactic cranial irradiation after response to first line chemotherapy.
prophylactic cranial irradiation
Prophylactic cranial irradiation in patients with advanced triple negative breast cancer who had a response to first line chemotherapy
observation group
Patients in the observation group do not receive prophylactic cranial irradiation after response to first line chemotherapy.
No interventions assigned to this group
Interventions
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prophylactic cranial irradiation
Prophylactic cranial irradiation in patients with advanced triple negative breast cancer who had a response to first line chemotherapy
Eligibility Criteria
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Inclusion Criteria
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
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)
18 Years
65 Years
FEMALE
No
Sponsors
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wang shusen
OTHER
Responsible Party
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wang shusen
Shusen Wang, M.D. Department of Medical Oncology, Sun Yat-sen University Cancer Center
Principal Investigators
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Shusen Wang
Role: STUDY_CHAIR
Sun Yat-sen University
Locations
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State Key Laboratory of Oncology in South China, Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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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.
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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.
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Other Identifiers
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SYSU-5010-TNBC-PCI
Identifier Type: -
Identifier Source: org_study_id
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