Bortezomib Plus Cisplatin in Recurrent or Metastatic Breast...

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.

Condition: Metastatic Breast Cancer, Recurrent Breast Cancer
Tested: Bortezomib (B), Cisplatin (CDDP), Bortezomib (B), Bortezomib (B), Cisplatin (CDDP)
Sponsor: Sun Yat-sen University

Who can join

Age: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted

Inclusion 13

Minimum age: 18 years
Eligible sex: Female
Study condition: Metastatic Breast Cancer, Recurrent Breast Cancer
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;
The function level of major organs meets the following standards:
\) 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.
\. The subjects voluntarily join this study, have good compliance, and cooperate with follow-up.

Exclusion 10

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;
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.

Where

1 site, 1 recruiting

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, China

Recruiting

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