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

NCT02448576 | Unknown DMC

• 1 other identifier: SYSU-5010-TNBC-PCI
• Study Type: interventional
• Target: 326
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Brain Metastasis

Keywords

phase 3 randomized controlled trial; prophylactic cranial irradiation; triple negative breast cancer; brain metastasis; advanced breast cancer

Outcome Measures

Primary Outcomes (1)

• brain metastasis-free survival

  time from randomization to brain metastasis

  eight years

Secondary Outcomes (5)

• cumulative risk of brain metastases within 1 year

  one year

• progression-free survival

  eight years

• overall survival

  eight years

• life quality score

  eight years

• central nervous function score

  eight years

Study Arms (2)

PCI group

EXPERIMENTAL

Receiving prophylactic cranial irradiation after response to first line chemotherapy.

Radiation: prophylactic cranial irradiation

observation group

NO INTERVENTION

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

Interventions

prophylactic cranial irradiation RADIATION

Prophylactic cranial irradiation in patients with advanced triple negative breast cancer who had a response to first line chemotherapy

PCI group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• wang shusen: lead

Study Sites (1)

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

Guangzhou, Guangdong, 510060, China

Location

Related Publications (17)

• 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.

  PMID: 22233926 BACKGROUND

• 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.

  PMID: 19099196 BACKGROUND

• 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.

  PMID: 21929800 BACKGROUND

• 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.

  PMID: 18954943 BACKGROUND

• 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.

  PMID: 6640506 BACKGROUND

• 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.

  PMID: 17699816 BACKGROUND

• 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.

  PMID: 10441603 BACKGROUND

• 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.

  PMID: 23667803 BACKGROUND

• 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.

  PMID: 15337811 BACKGROUND

• 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.

  PMID: 20346218 BACKGROUND

• 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.

  PMID: 7055779 BACKGROUND

• 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.

  PMID: 15609130 BACKGROUND

• 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.

  PMID: 19357955 BACKGROUND

• 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.

  PMID: 11072785 BACKGROUND

• 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.

  PMID: 17608351 BACKGROUND

• 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.

  PMID: 17102066 BACKGROUND

• 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.

  PMID: 16826579 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Brain Neoplasms; Triple Negative Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Shusen Wang

  Sun Yat-sen University

  STUDY CHAIR

Central Study Contacts

fei Xu

CONTACT

862087342693; xufei@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Shusen Wang, M.D. Department of Medical Oncology, Sun Yat-sen University Cancer Center

Study Record Dates

• First Submitted: May 5, 2015
• First Posted: May 19, 2015
• Study Start: August 1, 2017
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: June 1, 2017

Record last verified: 2017-05

Locations

CN (1)