AzTrials
AzTrials

Metastatic Breast CancerPhase 1BOCISNCT06900647

Bortezomib Plus Cisplatin in Recurrent or Metastatic Breast Cancer

A Phase 1 study testing Bortezomib (B) and Cisplatin (CDDP) in people with Metastatic Breast Cancer and Recurrent Breast Cancer, run by Sun Yat-sen University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This a phase 1 study to evaluate the safety and preliminary efficacy of cisplatin combined with bortezomib in patients with recurrent or metastatic breast cancer. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Bortezomib (B) and Cisplatin (CDDP)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
1 Jan 2025to 30 Jun 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Women aged 18 years and above with pathologically confirmed recurrent or metastatic advanced breast cancer ;
  • The patient has tumor specimens (formalin-fixed, paraffin-embedded or fresh pre-treated recurrent tumor tissue);
  • Patients who have failed standard treatment in the late stage;
  • At least one measurable lesion;
  • ECOG PS : 0-2 points;
  • Estimated survival period ≥12 weeks;
Show all 9Show fewer
  • 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.

Who cannot join

  • Any of the following will be considered as meeting the exclusion criteria of the study:
  • Patients with acute active hepatitis B or acute active hepatitis C;
  • Any serious underlying disease, comorbidity and active infection
  • Currently receiving other anti-tumor treatments;
  • History of epilepsy or epileptic-induced condition;
  • Patients who are pregnant or breastfeeding;
Show all 10Show fewer
  • Those with poor compliance or unable to undergo normal follow-up;
  • Allergic to study drugs;
  • 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;
  • The researcher determines other situations that may affect the conduct of the clinical study and the determination of the study results.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yanxia Shi, Doctor contact

86-020-87343486

shiyx@sysucc.org.cn

China1 site, 1 recruiting

  • Sun Yat-Sen University Cancer Center

    Guangzhou, Guangdong, 510000

    Yanxia Shi, Doctor, 86-020-87343486, shiyx@sysucc.org.cn

    Yanxia Shi, Doctor

    Recruiting

Other trials in China

About this study

Official title: Phase I Study to Evaluate the Safety and Preliminary Efficacy of Bortezomib Combined With Cisplatin in Patients With Recurrent or Metastatic Breast Cancer

This a phase 1 study to evaluate the safety and preliminary efficacy of cisplatin combined with bortezomib in patients with recurrent or metastatic breast cancer.

Being tested
Bortezomib (B), Cisplatin (CDDP)
Keywords
Breast cancer, Bortezomib, Cisplatin
Medical subject headings
Breast Neoplasms

What participants receive

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

  • Bortezomib (B)Drug

    1.3mg/m2, IV, D1, D4, D8 and D11, every 3 weeks

  • Cisplatin (CDDP)Drug

    50mg/m2, IV, D1-3, every 3 weeks

  • Bortezomib (B)Drug

    1.5mg/m2, IV, D1, D4, D8 and D11, every 3 weeks

  • Bortezomib (B)Drug

    1.7mg/m2, IV, D1, D4, D8 and D11, every 3 weeks

  • Cisplatin (CDDP)Drug

    70mg/m2, IV, D1-3, every 3 weeks

Study groups in NCT06900647
Study groupRoleWhat they receive
Dose level 1ExperimentalIn this dose level, all subjects will receive a dose of 1.3m/m2 bortezomib combined with a dose of 50mg/m2 cisplatin.
Receives: Drug: Bortezomib (B); Drug: Cisplatin (CDDP)
Dose level 2ExperimentalIn this dose level, all subjects will receive a dose of 1.5m/m2 bortezomib combined with a dose of 50mg/m2 cisplatin.
Receives: Drug: Cisplatin (CDDP); Drug: Bortezomib (B)
Dose level 3ExperimentalIn this dose level, all subjects will receive a dose of 1.7m/m2 bortezomib combined with a dose of 50mg/m2 cisplatin.
Receives: Drug: Cisplatin (CDDP); Drug: Bortezomib (B)
Dose level 4ExperimentalIn this dose level, all subjects will receive a dose of 1.3m/m2 bortezomib combined with a dose of 75mg/m2 cisplatin.
Receives: Drug: Bortezomib (B); Drug: Cisplatin (CDDP)
Dose level 5ExperimentalIn this dose level, all subjects will receive a dose of 1.5m/m2 bortezomib combined with a dose of 75mg/m2 cisplatin.
Receives: Drug: Bortezomib (B); Drug: Cisplatin (CDDP)
Dose level 6ExperimentalIn this dose level, all subjects will receive a dose of 1.7m/m2 bortezomib combined with a dose of 75mg/m2 cisplatin.
Receives: Drug: Bortezomib (B); Drug: Cisplatin (CDDP)

What is being measured

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

  1. Dose-limiting toxicities (DLTs)

    The DLT assessment period is from day 1 to day 21 of the subject's first dose plus 24 hours after the second dose, that is, 22 days.

    Each dose group must first enroll 3 subjects. If no DLT occurs in the first cycle (within 28 days after the first dose), the dose will be increased to the next cohort; if 1 subject develops DLT, 3 subjects will be added to the cohort, and if no DLT occurs in the last 3 subjects, the dose will be increased to the next dose. If 2 or more subjects in 3 or 6 subjects in a dose group develop DLT, the dose escalation will be stopped, and the previous dose of the dose will be the MTD. DLT is defined as a treatment-related adverse event of Grade 3 or higher, based on the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.

    Measured: Within 28 days after the first dose.

  2. Maximum Tolerated Dose (MTD)

    If 2 or more subjects in 3 or 6 subjects in a dose group develop DLT, the dose escalation will be stopped , and the previous dose of the dose will be the MTD. If the MTD is not reached in this trial, the researchers will discuss whether to continue the subsequent escalation trial.

    Measured: Within 28 days after the first dose.

Secondary outcomes (7)

  1. Progression- free survival ( PFS )

    PFS assessed by investigators according to RECIST version 1.1 criteria.

    Measured: Within approximately 48 months.

  2. Objective Response Rate (ORR)

    ORR assessed by investigators according to RECIST version 1.1 criteria.

    Measured: Within approximately 48 months

  3. Disease Control Rate (DCR)

    DCR assessed by investigators according to RECIST version 1.1 criteria.

    Measured: Within approximately 48 months

  4. Area Under the Curve (AUC)

    The area under the plasma concentration-time curve (AUC) will be measured to evaluate the systemic exposure of bortezomib and cisplatin. Blood samples will be collected at specified time points to calculate AUC using non-compartmental analysis.

    Measured: Blood samples for PK analysis were collected within 60 minutes before dosing, at 0.5, 2, 6, 24, 72 hours, and on days 8, 15, and 22 after the start of dosing.

  5. Maximum Plasma Concentration (Cmax)

    The maximum observed plasma concentration (Cmax) of bortezomib and cisplatin will be determined from the collected blood samples. Cmax reflects the peak concentration of the drug in plasma after administration.

    Measured: Blood samples for PK analysis were collected within 60 minutes before dosing, at 0.5, 2, 6, 24, 72 hours, and on days 8, 15, and 22 after the start of dosing.

  6. Time to Maximum Plasma Concentration (Tmax)

    The time to reach the maximum plasma concentration (Tmax) will be assessed for bortezomib and cisplatin. Tmax will be determined directly from the plasma concentration-time data.

    Measured: Blood samples for PK analysis were collected within 60 minutes before dosing, at 0.5, 2, 6, 24, 72 hours, and on days 8, 15, and 22 after the start of dosing.

  7. Half-Life (T1/2)

    The terminal elimination half-life (T1/2) of bortezomib and cisplatin will be calculated using non-compartmental analysis. T1/2 represents the time required for the plasma concentration of the drug to decrease by 50%.

    Measured: Blood samples for PK analysis were collected within 60 minutes before dosing, at 0.5, 2, 6, 24, 72 hours, and on days 8, 15, and 22 after the start of dosing.

Timeline

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

  1. First posted28 Mar 2025
  2. Study start1 Jan 2025
  3. Primary completion30 Jun 2026 (estimated)
  4. Study completion30 Jun 2028 (estimated)

Resources

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 1
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Sequential
Model description
Single-center, non-randomized, open-label, phase I study
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06900647
Sponsor's protocol ID
2024-FXY-300
Acronym
BOCIS
Status last verified
Mar 2025
First submitted
16 Mar 2025
Last updated
2 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data (IPD) will not be shared due to ethical and privacy concerns.

Publications

  • 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.

    PubMed 33304752

  • 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.

    PubMed 28117417

  • 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.

    PubMed 21147690

  • 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.

    PubMed 17952740

  • 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.

    PubMed 25530422

  • 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.

    PubMed 12867067

  • 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.

    PubMed 15016328

  • 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.

    PubMed 10363983

  • 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.

    PubMed 10471047

  • 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.

    PubMed 11250681

  • 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.

    PubMed 12559038

  • 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.

    PubMed 15929791

  • 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.

    PubMed 12738242

  • 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.

    PubMed 12738240

  • Adams J. Development of the proteasome inhibitor PS-341. Oncologist. 2002;7(1):9-16. doi: 10.1634/theoncologist.7-1-9.

    PubMed 11854543

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Bortezomib (B) and Cisplatin (CDDP) in people with Metastatic Breast Cancer and Recurrent Breast Cancer, run by Sun Yat-sen University 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 10 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: looking for participants now, as of the sponsor's last update on 2 Apr 2025. 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.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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

Contact Yanxia Shi, Doctor (86-020-87343486, shiyx@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-limiting toxicities (DLTs) (time frame: Within 28 days after the first dose.). The study lists 2 primary outcomes in all. 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 NCT06900647, 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 2 Apr 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in