Breast CancerPhase 2NCT04537286
First-line Nab-paclitaxel Plus Cisplatin Plus Camrelizumab in mTNBC Patients
A Phase 2 study testing nab-paclitaxel plus cisplatin plus carilizumab (AP+PD-1) in people with Breast Cancer and TNBC - Triple-Negative Breast Cancer, run by Fudan University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer, TNBC - Triple-Negative Breast Cancer
- What is being tested?
- nab-paclitaxel plus cisplatin plus carilizumab (AP+PD-1)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 25 Aug 2020to 10 Jul 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patient of childbearing potential but unwilling to receive contraception.
- Radiation therapy of axial bone within 4 weeks before enrollment.
- Previous treatment with PD-1 antibody, PD-L1 antibody and CTLA-4 antibody.
- Patients have active autoimmune diseases.
- Patients who need systemic corticosteroids (> 10 mg prednisone/d) or other immunosuppressive drugs within 14 days before enrollment or during the study period.
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
About this study
Official title: 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
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.
- Being tested
- nab-paclitaxel plus cisplatin plus carilizumab (AP+PD-1)
- Medical subject headings
- Breast Neoplasms, Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nab-paclitaxel plus cisplatin plus carilizumab (AP+PD-1)Drug
Nab-paclitaxel 125 mg/m2，ivgtt，d1, 8 Cisplatin 75 mg/m2，ivgtt，d1 Carilizumab 200mg, ivgtt，d1，q3w
| Study group | Role | What they receive |
|---|---|---|
| nab-paclitaxel plus cisplatin plus Camrelizumab (AP+PD-1) | Experimental | Nab-paclitaxel 125 mg/m2，ivgtt，d1, 8 Cisplatin 75 mg/m2，ivgtt，d1 Camrelizumab 200mg, ivgtt，d1，q3w Receives: Drug: nab-paclitaxel plus cisplatin plus carilizumab (AP+PD-1) |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Progression free survival
Measured: 6 weeks
Adverse events
Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0)
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2020
- Study start25 Aug 2020
- Primary completion30 Mar 2023
- Study completion10 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Biyun Wang, MD, Fudan University
- Investigators
- Biyun Wang, Professor, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04537286
- Sponsor's protocol ID
- YOUNGBC-11
- Status last verified
- Feb 2024
- First submitted
- 29 Aug 2020
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Shared patient information is not allowed by study center.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04537286
- Acronym / sponsor ID
- YOUNGBC-11
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 25 Aug 2020 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 10 Jul 2024 (actual)
- First posted
- 3 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| nab-paclitaxel plus cisplatin plus Camrelizumab (AP+PD-1) | Experimental | Drug: nab-paclitaxel plus cisplatin plus carilizumab (AP+PD-1)Nab-paclitaxel 125 mg/m2，ivgtt，d1, 8 Cisplatin 75 mg/m2，ivgtt，d1 Camrelizumab 200mg, ivgtt，d1，q3w |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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,
Key exclusion criteria (8 listed)
- Patient of childbearing potential but unwilling to receive contraception.
- Radiation therapy of axial bone within 4 weeks before enrollment.
- Previous treatment with PD-1 antibody, PD-L1 antibody and CTLA-4 antibody.
- Patients have active autoimmune diseases.
- Patients who need systemic corticosteroids (> 10 mg prednisone/d) or other immunosuppressive drugs within 14 days before enrollment or during the study period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nab-paclitaxel plus cisplatin plus carilizumab (AP+PD-1)Nab-paclitaxel 125 mg/m2，ivgtt，d1, 8 Cisplatin 75 mg/m2，ivgtt，d1 Carilizumab 200mg, ivgtt，d1，q3w | Drug | nab-paclitaxel plus cisplatin plus Camrelizumab (AP+PD-1) |
Primary outcome
PFS
Time frame: 6 weeks
Progression free survival
Adverse events
Time frame: 6 weeks
Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Individual participant dataSharing planned: No. Shared patient information is not allowed by study center.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Biyun Wang, Professor principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing nab-paclitaxel plus cisplatin plus carilizumab (AP+PD-1) in people with Breast Cancer and TNBC - Triple-Negative Breast Cancer, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.