Recruiting
Bortezomib Plus Cisplatin in 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.
ClinicalTrials.gov IDNCT06900647
PhasePHASE1
Enrollment20
SponsorSun Yat-sen University
Age18 Years
SexFEMALE
Conditions studied
Metastatic Breast Cancer, Recurrent Breast Cancer
About this study
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.
Interventions
- Drug: Bortezomib (B) — 1.3mg/m2, IV, D1, D4, D8 and D11, every 3 weeks
- Drug: Cisplatin (CDDP) — 50mg/m2, IV, D1-3, every 3 weeks
- Drug: Bortezomib (B) — 1.5mg/m2, IV, D1, D4, D8 and D11, every 3 weeks
- Drug: Bortezomib (B) — 1.7mg/m2, IV, D1, D4, D8 and D11, every 3 weeks
- Drug: Cisplatin (CDDP) — 70mg/m2, IV, D1-3, every 3 weeks
Primary outcomes
- Dose-limiting toxicities (DLTs) (Within 28 days after the first dose.)
- Maximum Tolerated Dose (MTD) (Within 28 days after the first dose.)
Eligibility information
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.
Study locations
- Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong 510000 China
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.