NCT06900647 Bortezomib Plus Cisplatin in Recurrent or Metastatic Breast Cancer
| NCT ID | NCT06900647 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Sun Yat-sen University |
| Condition | Metastatic Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-01-01 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2025-01-01 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. Women aged 18 years and above with pathologically confirmed recurrent or metastatic advanced breast cancer ; 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: Any of the following will be considered as meeting the exclusion criteria of the study: 1. Patients with acute active hepatitis B or acute active hepatitis C; 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.
Contact & Investigator
Yan-xia Shi, Doctor
PRINCIPAL INVESTIGATOR
Sun Yat-sen University
Frequently Asked Questions
Who can join the NCT06900647 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Metastatic Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06900647 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06900647 currently recruiting?
Yes, NCT06900647 is actively recruiting participants. Contact the research team at shiyx@sysucc.org.cn for enrollment information.
Where is the NCT06900647 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT06900647 clinical trial?
NCT06900647 is sponsored by Sun Yat-sen University. The principal investigator is Yan-xia Shi, Doctor at Sun Yat-sen University. The trial plans to enroll 20 participants.
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