NCT04537286CompletedPhase 2
First-line Nab-paclitaxel Plus Cisplatin Plus Camrelizumab in mTNBC Patients
A Prospective, Single-arm, Open-Label, Phase II Study of Nab-paclitaxel Plus Cisplatin Plus Camrelizumab as First-line Treatment in Patients With Metastatic Triple-negative Breast Cancer
Source: ClinicalTrials.gov · Last updated 21 Jul 2026
Brief summary (registry, in English)
To evaluate the efficacy and safety of nab-paclitaxel plus cisplatin plus carilizumab as first-line treatment in patients with metastatic triple-negative breast cancer.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 90 (actual)
- First submitted
- 29 Aug 2020
- Start date
- 25 Aug 2020
- Primary completion date
- 30 Mar 2023
- Lead sponsor
- Fudan University
- Diseases
- Triple-negative breast cancer
- NCT number
- NCT04537286
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 90
- From 25 Aug 2020 to the primary completion date, 30 Mar 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Radiation therapy of axial bone within 4 weeks before enrollment.
- Previous treatment with PD-1 antibody, PD-L1 antibody and CTLA-4 antibody.
- Patients who need systemic corticosteroids (\> 10 mg prednisone/d) or other immunosuppressive drugs within 14 days before enrollment or during the study period.
Other illness
- Patients have active autoimmune diseases.
- Symptomatic central nervous system (CNS) disease (patients with asymptomatic treated CNS metastases were permitted)
- Other malignant diseases within the past 5 years (patients with basal cell skin carcinoma and cervical carcinoma in situ were permitted)
- Uncontrolled infection.
Other
- Patient of childbearing potential but unwilling to receive contraception.
Who the study is looking for
- Female patients aged 18-70 years who had
- 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.
- Patients were required to receive no previous chemotherapy or targeted therapy for metastatic triple-negative breast cancer.
- Patients who had received adjuvant/neoadjuvant therapy were required an interval for at least 6 months after stop of chemotherapy before the enrollment.
- At least one measurable lesion according to RECIST 1.1,
- ECOG performance status ≤ 1
- Life expectancy of more than 12 weeks
- Adequate organ and bone marrow function.
Age in the registry: 18 years to 70 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fudan University Shanghai Cancer Center Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.