Clinical trial · Interventional
PCI in Advanced Triple Negative Breast Cancer Patients Who Response to 1st Line Chemotherapy
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
NCT02448576CI-TRIAL-00027934unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Metastasis | — | UNRESOLVED | — |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| prophylactic cranial irradiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- PCI group
- description
- Receiving prophylactic cranial irradiation after response to first line chemotherapy.
- interventionNames
- Radiation: prophylactic cranial irradiation
- type
- NO_INTERVENTION
- label
- observation group
- description
- Patients in the observation group do not receive prophylactic cranial irradiation after response to first line chemotherapy.
Primary outcomes (1)
- measure
- brain metastasis-free survival
- timeFrame
- eight years
- description
- time from randomization to brain metastasis
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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)
References
Publications (17)
- BACKGROUNDBerghoff 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
- BACKGROUNDSaip 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
- BACKGROUNDLe 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
- BACKGROUNDHuang 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
- BACKGROUNDTsukada 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
- BACKGROUNDSlotman 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