Bortezomib Plus Cisplatin in Recurrent or Metastatic Breast Cancer (BOCIS)

Sun Yat-sen University

Status and phase: Enrolling; Phase 1

Conditions: Metastatic Breast Cancer; Recurrent Breast Cancer

Treatments: Drug: Bortezomib (B); Drug: Cisplatin (CDDP)

Study type: Interventional

Funder types: Other

Identifiers

NCT06900647

2024-FXY-300

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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20 participants in 6 patient groups

Dose level 1

Experimental group

Description:

In this dose level, all subjects will receive a dose of 1.3m/m2 bortezomib combined with a dose of 50mg/m2 cisplatin.

Treatment:

Drug: Cisplatin (CDDP)

Drug: Bortezomib (B)

Drug: Bortezomib (B)

Drug: Cisplatin (CDDP)

Drug: Bortezomib (B)

Dose level 2

Experimental group

Description:

In this dose level, all subjects will receive a dose of 1.5m/m2 bortezomib combined with a dose of 50mg/m2 cisplatin.

Treatment:

Drug: Cisplatin (CDDP)

Drug: Bortezomib (B)

Drug: Bortezomib (B)

Drug: Cisplatin (CDDP)

Drug: Bortezomib (B)

Dose level 3

Experimental group

Description:

In this dose level, all subjects will receive a dose of 1.7m/m2 bortezomib combined with a dose of 50mg/m2 cisplatin.

Treatment:

Drug: Cisplatin (CDDP)

Drug: Bortezomib (B)

Drug: Bortezomib (B)

Drug: Cisplatin (CDDP)

Drug: Bortezomib (B)

Dose level 4

Experimental group

Description:

In this dose level, all subjects will receive a dose of 1.3m/m2 bortezomib combined with a dose of 75mg/m2 cisplatin.

Treatment:

Drug: Cisplatin (CDDP)

Drug: Bortezomib (B)

Drug: Bortezomib (B)

Drug: Cisplatin (CDDP)

Drug: Bortezomib (B)

Dose level 5

Experimental group

Description:

In this dose level, all subjects will receive a dose of 1.5m/m2 bortezomib combined with a dose of 75mg/m2 cisplatin.

Treatment:

Drug: Cisplatin (CDDP)

Drug: Bortezomib (B)

Drug: Bortezomib (B)

Drug: Cisplatin (CDDP)

Drug: Bortezomib (B)

Dose level 6

Experimental group

Description:

In this dose level, all subjects will receive a dose of 1.7m/m2 bortezomib combined with a dose of 75mg/m2 cisplatin.

Treatment:

Drug: Cisplatin (CDDP)

Drug: Bortezomib (B)

Drug: Bortezomib (B)

Drug: Cisplatin (CDDP)

Drug: Bortezomib (B)