Breast CancerNCT02448576

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

A study testing prophylactic cranial irradiation in people with Breast Cancer and Brain Metastasis, run by wang shusen at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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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. Read more about this study

Who is it for?: Ages 18 to 65 years, women only
Conditions the study is for: Breast Cancer, Brain Metastasis
What is being tested?: prophylactic cranial irradiation
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 326 participants
Where: 1 siteChina
Study dates: Aug 2017to Aug 2025
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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;

Show all 9Show fewer

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.

Who cannot join

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)

Trial locations and contacts

1 site in 1 country.

fei Xu contact

862087342693

xufei@sysucc.org.cn

China1 site

State Key Laboratory of Oncology in South China, Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
fei xu, M.D., 862087342693, xufei@sysucc.org.cn

Other trials in China

About this study

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

Read the 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.

Conditions: Breast Cancer, Brain Metastasis
Being tested: prophylactic cranial irradiation
Keywords: phase 3 randomized controlled trial, prophylactic cranial irradiation, triple negative breast cancer, brain metastasis, advanced breast cancer
Medical subject headings: Breast Neoplasms, Brain Neoplasms, Triple Negative Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT02448576
Study group	Role	What they receive
PCI group	Experimental	Receiving prophylactic cranial irradiation after response to first line chemotherapy. Receives: 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

brain metastasis-free survival
time from randomization to brain metastasis
Measured: eight years

Secondary outcomes (5)

cumulative risk of brain metastases within 1 year
the percent of subjects occurring brain metastases with 1 year
Measured: one year
progression-free survival
time from randomization to disease progression or death(upon which happen earlier)
Measured: eight years
overall survival
time from randomization to death
Measured: eight years
life quality score
quality of life measured by the EORTC-QLQ-C30 questionnaire score
Measured: eight years
central nervous function score
function of central nervous measured by the EORTC-QLQ-BN20 questionnaire score
Measured: eight years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2017Aug 2025

First posted19 May 2015 (estimated)
Study startAug 2017 (estimated)
Primary completionAug 2025 (estimated)
Study completionAug 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (17)Papers the sponsor has linked to this study.
Other trials for Breast CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 326 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02448576
Sponsor's protocol ID: SYSU-5010-TNBC-PCI
Status last verified: May 2017
First submitted: 5 May 2015
Last updated: 1 Jun 2017
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

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.
PubMed 22233926
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.
PubMed 19099196
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.
PubMed 21929800
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.
PubMed 18954943
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.
PubMed 6640506
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.
PubMed 17699816
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.
PubMed 10441603
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.
PubMed 23667803
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.
PubMed 15337811
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.
PubMed 20346218
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.
PubMed 7055779
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.
PubMed 15609130
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.
PubMed 19357955
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.
PubMed 11072785
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.
PubMed 17608351

Want to know more?

fei Xu

862087342693

xufei@sysucc.org.cn

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 1 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02448576
Acronym / sponsor ID: SYSU-5010-TNBC-PCI
Conditions: Breast Cancer, Brain Metastasis
Keywords: phase 3 randomized controlled trial, prophylactic cranial irradiation, triple negative breast cancer, brain metastasis, advanced breast cancer
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 326 participants (estimated)
Lead sponsor: wang shusenUniversity, hospital or other
Study start: Aug 2017 (estimated)
Primary completion: Aug 2025 (estimated)
Study completion: Aug 2025 (estimated)
First posted: 19 May 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
PCI group	Experimental	Radiation: prophylactic cranial irradiationReceiving prophylactic cranial irradiation after response to first line chemotherapy.
observation group	No intervention	–Patients in the observation group do not receive prophylactic cranial irradiation after response to first line chemotherapy.

Who may qualify

Ages: 18 to 65 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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;

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
prophylactic cranial irradiationProphylactic cranial irradiation in patients with advanced triple negative breast cancer who had a response to first line chemotherapy	Radiation	PCI group

Primary outcome

brain metastasis-free survival
Time frame: eight years
time from randomization to brain metastasis

5 secondary outcomes

cumulative risk of brain metastases within 1 year
Time frame: one year
progression-free survival
Time frame: eight years
overall survival
Time frame: eight years
life quality score
Time frame: eight years
central nervous function score
Time frame: eight years

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2017.
Background: PubMed 22233926Berghoff 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.
Background: PubMed 19099196Saip 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.
Background: PubMed 21929800Le 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.
Background: PubMed 18954943Huang 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.
Background: PubMed 6640506Tsukada 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.
Background: PubMed 17699816Slotman 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.
Background: PubMed 10441603Auperin 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.
Background: PubMed 23667803Ahn 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.
Background: PubMed 15337811Lin 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.
Background: PubMed 20346218Bai 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.
Background: PubMed 7055779Paterson 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.
Background: PubMed 15609130Carey 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

fei Xu contact

862087342693

xufei@sysucc.org.cn

Shusen Wang study chair

Sun Yat-Sen University Cancer Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing prophylactic cranial irradiation in people with Breast Cancer and Brain Metastasis, run by wang shusen at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact fei Xu (862087342693, xufei@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

brain metastasis-free survival (time frame: eight years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02448576, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2017.