Combination treatment for advanced triple-negative breast cancer

A Prospective, Single-arm, Open-Label, Phase II Study of Nab-paclitaxel Plus Cisplatin Plus Carilizumab as First-line Treatment in Patients With Metastatic Triple-negative Breast Cancer

This study is testing a new combination treatment for people with advanced triple-negative breast cancer to see if it works better than current options.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 18 Years to 70 Years
• Sex: Female
• Sponsor: Fudan University (Academic / other)
• Drugs / interventions: chemotherapy, Radiation, prednisone, carilizumab
• Locations: 1 site (Shanghai, Shanghai)
• Trial ID: NCT04537286 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of a combination therapy using nab-paclitaxel, cisplatin, and carilizumab as a first-line treatment for patients with metastatic triple-negative breast cancer (mTNBC). The study aims to determine how well this treatment works compared to existing options, focusing on measurable outcomes in patients who have not previously received chemotherapy for their metastatic condition. Participants will be closely monitored for both effectiveness and safety throughout the trial.

Who should consider this trial

Good fit: Ideal candidates are female patients aged 18-70 with confirmed metastatic triple-negative breast cancer who have not received prior chemotherapy for their condition.

Not a fit: Patients who have previously been treated with PD-1 or PD-L1 antibodies, or those with certain recent radiation therapy, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with metastatic triple-negative breast cancer.

How similar studies have performed: While this specific combination has not been widely tested, similar approaches using chemotherapy and immunotherapy have shown promise in other studies.

Eligibility criteria

Inclusion Criteria:

1. Female patients aged 18-70 years who had
2. Metastatic TNBC. ER, PgR, and HER2 status were determined locally by immunohistochemistry (IHC) of patient primary or metastatic tumor sections. Metastatic disease was confirmed by clinical, imaging, histological or cytological measures.
3. Patients were required to receive no previous chemotherapy or targeted therapy for metastatic triple-negative breast cancer.
4. Patients who had received adjuvant/neoadjuvant therapy were required an interval for at least 6 months after stop of chemotherapy before the enrollment.
5. At least one measurable lesion according to RECIST 1.1,
6. ECOG performance status ≤ 1
7. Life expectancy of more than 12 weeks
8. Adequate organ and bone marrow function.

Exclusion Criteria:

1. Patient of childbearing potential but unwilling to receive contraception.
2. Radiation therapy of axial bone within 4 weeks before enrollment.
3. Previous treatment with PD-1 antibody, PD-L1 antibody and CTLA-4 antibody.
4. Patients have active autoimmune diseases.
5. Patients who need systemic corticosteroids (\> 10 mg prednisone/d) or other immunosuppressive drugs within 14 days before enrollment or during the study period.
6. Symptomatic central nervous system (CNS) disease (patients with asymptomatic treated CNS metastases were permitted)
7. Other malignant diseases within the past 5 years (patients with basal cell skin carcinoma and cervical carcinoma in situ were permitted)
8. Uncontrolled infection.

Where this trial is running

Shanghai, Shanghai

• Fudan University Shanghai Cancer Center — Shanghai, Shanghai, China (Recruiting)

Study contacts

• Principal investigator: Biyun Wang, Professor — Fudan University
• Study coordinator: Biyun Wang, Professor

Conditions Breast Cancer