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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02448576
• Other study ID #: SYSU-5010-TNBC-PCI
• Status: Not yet recruiting
• Phase: N/A
• First received: May 5, 2015
• Last updated: May 30, 2017
• Start date: August 2017
• Est. completion date: August 2025

Study information

• Verified date: May 2017
• Source: Sun Yat-sen University
• Contact: fei Xu
• Phone: 862087342693
• Email: xufei[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 326
• Est. completion date: August 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Brain Metastasis
• Breast Cancer
• Breast Neoplasms
• Neoplasm Metastasis
• Triple Negative Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	State Key Laboratory of Oncology in South China, Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
wang shusen

Country where clinical trial is conducted

China, 

References & Publications (17)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Lin NU, Bellon JR, Winer EP. CNS metastases in breast cancer. J Clin Oncol. 2004 Sep 1;22(17):3608-17. Review. — View Citation

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. — View Citation

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. — View Citation

Santarelli JG, Sarkissian V, Hou LC, Veeravagu A, Tse V. Molecular events of brain metastasis. Neurosurg Focus. 2007 Mar 15;22(3):E1. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	brain metastasis-free survival	time from randomization to brain metastasis	eight years
Secondary	cumulative risk of brain metastases within 1 year	the percent of subjects occurring brain metastases with 1 year	one year
Secondary	progression-free survival	time from randomization to disease progression or death(upon which happen earlier)	eight years
Secondary	overall survival	time from randomization to death	eight years
Secondary	life quality score	quality of life measured by the EORTC-QLQ-C30 questionnaire score	eight years
Secondary	central nervous function score	function of central nervous measured by the EORTC-QLQ-BN20 questionnaire score	eight years