Bortezomib Plus Cisplatin in Recurrent or Metastatic Breast Cancer
NCT ID: NCT06900647
Last Updated: 2025-04-02
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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RECRUITING
PHASE1
20 participants
INTERVENTIONAL
2025-01-01
2028-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
PREVENTION
NONE
Study Groups
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Dose level 1
In this dose level, all subjects will receive a dose of 1.3m/m2 bortezomib combined with a dose of 50mg/m2 cisplatin.
Bortezomib (B)
1.3mg/m2, IV, D1, D4, D8 and D11, every 3 weeks
Cisplatin (CDDP)
50mg/m2, IV, D1-3, every 3 weeks
Dose level 2
In this dose level, all subjects will receive a dose of 1.5m/m2 bortezomib combined with a dose of 50mg/m2 cisplatin.
Cisplatin (CDDP)
50mg/m2, IV, D1-3, every 3 weeks
Bortezomib (B)
1.5mg/m2, IV, D1, D4, D8 and D11, every 3 weeks
Dose level 3
In this dose level, all subjects will receive a dose of 1.7m/m2 bortezomib combined with a dose of 50mg/m2 cisplatin.
Cisplatin (CDDP)
50mg/m2, IV, D1-3, every 3 weeks
Bortezomib (B)
1.7mg/m2, IV, D1, D4, D8 and D11, every 3 weeks
Dose level 4
In this dose level, all subjects will receive a dose of 1.3m/m2 bortezomib combined with a dose of 75mg/m2 cisplatin.
Bortezomib (B)
1.3mg/m2, IV, D1, D4, D8 and D11, every 3 weeks
Cisplatin (CDDP)
70mg/m2, IV, D1-3, every 3 weeks
Dose level 5
In this dose level, all subjects will receive a dose of 1.5m/m2 bortezomib combined with a dose of 75mg/m2 cisplatin.
Bortezomib (B)
1.5mg/m2, IV, D1, D4, D8 and D11, every 3 weeks
Cisplatin (CDDP)
70mg/m2, IV, D1-3, every 3 weeks
Dose level 6
In this dose level, all subjects will receive a dose of 1.7m/m2 bortezomib combined with a dose of 75mg/m2 cisplatin.
Bortezomib (B)
1.7mg/m2, IV, D1, D4, D8 and D11, every 3 weeks
Cisplatin (CDDP)
70mg/m2, IV, D1-3, every 3 weeks
Interventions
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Bortezomib (B)
1.3mg/m2, IV, D1, D4, D8 and D11, every 3 weeks
Cisplatin (CDDP)
50mg/m2, IV, D1-3, every 3 weeks
Bortezomib (B)
1.5mg/m2, IV, D1, D4, D8 and D11, every 3 weeks
Bortezomib (B)
1.7mg/m2, IV, D1, D4, D8 and D11, every 3 weeks
Cisplatin (CDDP)
70mg/m2, IV, D1-3, every 3 weeks
Eligibility Criteria
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Inclusion Criteria
2. The patient has tumor specimens (formalin-fixed, paraffin-embedded or fresh pre-treated recurrent tumor tissue);
3. Patients who have failed standard treatment in the late stage;
4. At least one measurable lesion;
5. ECOG PS : 0-2 points;
6. Estimated survival period ≥12 weeks;
7. The function level of major organs meets the following standards:
1\) The blood routine examination standards must meet: ANC ≥1.5×109/L, PLT ≥75×109/L, Hb ≥85g/L (no blood transfusion and blood products within 14 days, no use of G-CSF and other hematopoietic stimulating factors for correction) 2) Biochemical examinations must meet the following standards: TBIL \<1.5×ULN, ALT, AST \<2.5×ULN, ALT, AST \<5×ULN for patients with liver metastasis, BUN and Cr ≤1×ULN or endogenous creatinine clearance ≥50ml/min (Cockcroft-Gault formula); 8. Women of childbearing age must have taken reliable contraceptive measures, or have undergone a pregnancy test (serum or urine) within 7 days before enrollment, with a negative result, and are willing to use appropriate contraceptive methods during the trial and 8 weeks after the last administration of the trial drug.
9\. The subjects voluntarily join this study, have good compliance, and cooperate with follow-up.
Exclusion Criteria
2. Any serious underlying disease, comorbidity and active infection
3. Currently receiving other anti-tumor treatments;
4. History of epilepsy or epileptic-induced condition;
5. Patients who are pregnant or breastfeeding;
6. Those with poor compliance or unable to undergo normal follow-up;
7. Allergic to study drugs;
8. Patients diagnosed with other malignant tumors within 5 years, except for the following: surgically resected non-melanoma skin cancer, adequately treated cervical carcinoma in situ, surgically radically treated ductal carcinoma in situ, or malignant tumors diagnosed 2 years ago with no current evidence of disease and untreated ≤ 2 years before randomization;
9. The researcher determines other situations that may affect the conduct of the clinical study and the determination of the study results.
18 Years
FEMALE
No
Sponsors
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Sun Yat-sen University
OTHER
Responsible Party
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Shi Yanxia
Professor
Principal Investigators
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Yan-xia Shi, Doctor
Role: PRINCIPAL_INVESTIGATOR
Sun Yat-sen University
Locations
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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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Shao F, Lyu X, Miao K, Xie L, Wang H, Xiao H, Li J, Chen Q, Ding R, Chen P, Xing F, Zhang X, Luo GH, Zhu W, Cheng G, Lon NW, Martin SE, Wang G, Chen G, Dai Y, Deng CX. Enhanced Protein Damage Clearance Induces Broad Drug Resistance in Multitype of Cancers Revealed by an Evolution Drug-Resistant Model and Genome-Wide siRNA Screening. Adv Sci (Weinh). 2020 Oct 11;7(23):2001914. doi: 10.1002/advs.202001914. eCollection 2020 Dec.
Manasanch EE, Orlowski RZ. Proteasome inhibitors in cancer therapy. Nat Rev Clin Oncol. 2017 Jul;14(7):417-433. doi: 10.1038/nrclinonc.2016.206. Epub 2017 Jan 24.
Irvin WJ Jr, Orlowski RZ, Chiu WK, Carey LA, Collichio FA, Bernard PS, Stijleman IJ, Perou C, Ivanova A, Dees EC. Phase II study of bortezomib and pegylated liposomal doxorubicin in the treatment of metastatic breast cancer. Clin Breast Cancer. 2010 Dec 1;10(6):465-70. doi: 10.3816/CBC.2010.n.061.
Engel RH, Brown JA, Von Roenn JH, O'Regan RM, Bergan R, Badve S, Rademaker A, Gradishar WJ. A phase II study of single agent bortezomib in patients with metastatic breast cancer: a single institution experience. Cancer Invest. 2007 Dec;25(8):733-7. doi: 10.1080/07357900701506573. Epub 2007 Oct 18.
Thaler S, Thiede G, Hengstler JG, Schad A, Schmidt M, Sleeman JP. The proteasome inhibitor Bortezomib (Velcade) as potential inhibitor of estrogen receptor-positive breast cancer. Int J Cancer. 2015 Aug 1;137(3):686-97. doi: 10.1002/ijc.29404. Epub 2015 Jan 8.
Mack PC, Davies AM, Lara PN, Gumerlock PH, Gandara DR. Integration of the proteasome inhibitor PS-341 (Velcade) into the therapeutic approach to lung cancer. Lung Cancer. 2003 Aug;41 Suppl 1:S89-96. doi: 10.1016/s0169-5002(03)00149-1.
Ikezoe T, Yang Y, Saito T, Koeffler HP, Taguchi H. Proteasome inhibitor PS-341 down-regulates prostate-specific antigen (PSA) and induces growth arrest and apoptosis of androgen-dependent human prostate cancer LNCaP cells. Cancer Sci. 2004 Mar;95(3):271-5. doi: 10.1111/j.1349-7006.2004.tb02215.x.
Adams J, Palombella VJ, Sausville EA, Johnson J, Destree A, Lazarus DD, Maas J, Pien CS, Prakash S, Elliott PJ. Proteasome inhibitors: a novel class of potent and effective antitumor agents. Cancer Res. 1999 Jun 1;59(11):2615-22.
Pharoah PD, Day NE, Caldas C. Somatic mutations in the p53 gene and prognosis in breast cancer: a meta-analysis. Br J Cancer. 1999 Aug;80(12):1968-73. doi: 10.1038/sj.bjc.6690628.
Osin PP, Lakhani SR. The pathology of familial breast cancer: Immunohistochemistry and molecular analysis. Breast Cancer Res. 1999;1(1):36-40. doi: 10.1186/bcr11. Epub 1999 Oct 27.
Orlowski RZ, Dees EC. The role of the ubiquitination-proteasome pathway in breast cancer: applying drugs that affect the ubiquitin-proteasome pathway to the therapy of breast cancer. Breast Cancer Res. 2003;5(1):1-7. doi: 10.1186/bcr460. Epub 2002 Aug 14.
Boccadoro M, Morgan G, Cavenagh J. Preclinical evaluation of the proteasome inhibitor bortezomib in cancer therapy. Cancer Cell Int. 2005 Jun 1;5(1):18. doi: 10.1186/1475-2867-5-18.
Lenz HJ. Clinical update: proteasome inhibitors in solid tumors. Cancer Treat Rev. 2003 May;29 Suppl 1:41-8. doi: 10.1016/s0305-7372(03)00082-3.
Cusack JC. Rationale for the treatment of solid tumors with the proteasome inhibitor bortezomib. Cancer Treat Rev. 2003 May;29 Suppl 1:21-31. doi: 10.1016/s0305-7372(03)00079-3.
Adams J. Development of the proteasome inhibitor PS-341. Oncologist. 2002;7(1):9-16. doi: 10.1634/theoncologist.7-1-9.
Kane RC, Farrell AT, Sridhara R, Pazdur R. United States Food and Drug Administration approval summary: bortezomib for the treatment of progressive multiple myeloma after one prior therapy. Clin Cancer Res. 2006 May 15;12(10):2955-60. doi: 10.1158/1078-0432.CCR-06-0170.
Awada A, Albanell J, Canney PA, Dirix LY, Gil T, Cardoso F, Gascon P, Piccart MJ, Baselga J. Bortezomib/docetaxel combination therapy in patients with anthracycline-pretreated advanced/metastatic breast cancer: a phase I/II dose-escalation study. Br J Cancer. 2008 May 6;98(9):1500-7. doi: 10.1038/sj.bjc.6604347. Epub 2008 Apr 29.
Provided Documents
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Document Type: Study Protocol
Other Identifiers
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2024-FXY-300
Identifier Type: -
Identifier Source: org_study_id
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