Metastatic Breast CancerPhase 2SPARKNCT04734262
A Phase II Study to Explore the Safety, Tolerability, and Preliminary Antitumor Activity of Sitravatinib Plus Tislelizumab or Combination With Nab-paclitaxel in Patients With Locally Recurrent or Metastatic Triple Negative Breast Cancer (TNBC)
A Phase 2 study testing Sitravatinib, Tislelizumab and Nab-paclitaxel in people with Metastatic Breast Cancer, run by Fudan University at 1 site in China.
Trial summary
The purpose of this study is to assess the efficacy and safety of sitravatinib plus tislelizumab or combination with nab-paclitaxel in locally recurrent or metastatic triple-negative breast cancer (TNBC) patients. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Sitravatinib, Tislelizumab and Nab-paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2021to 30 Jun 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to provide written informed consent and can understand and agree to comply with the requirements of the study and the schedule of assessments
- Age ≥ 18 years on the day of signing the ICF (or the legal age of consent in the jurisdiction in which the study is taking place)
- Histologically confirmed diagnosis of TNBC characterized by estrogen-receptor negative (ER-), progesterone receptor negative (PR-) and human epidermal growth factor-2 receptor negative (HER2-);
- ≤ 3 prior lines of systemic therapy
- For patients refractory/resistant to anti-PD-1/PD-L1 antibodies, there should be no anti-PD-1/PD-L1 treatment-related toxicity from prior therapies
- Previously untreated for metastatic setting or recurred/metastasized after surgery for locally recurrent or metastatic breast cancer (cohort C), and the time from previous neo-/adjuvant therapy to recurrence met the following requirements: ≥ 6 months interval between the end of neo-/adjuvant paclitaxel-based treatment and the onset of recurrence/metastasis; ≥ 6 months interval between the end of neo-/adjuvant anti-angiogenic treatment and the onset of recurrence/metastasis; ≥ 6 months interval between the end of neo-/adjuvant immunotherapy and recurrence/metastasis
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- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ function
- Females of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study, and ≥ 120 days after the last dose of study drug(s), and have a negative serum pregnancy test ≤ 7 days of first dose of study drug(s)
- Nonsterile males must be willing to use a highly effective method of birth control for the duration of the study and for ≥ 120 days after the last dose of study drug(s)
Who cannot join
- Active leptomeningeal disease or uncontrolled brain metastasis
- Active autoimmune diseases or history of autoimmune diseases that may relapse
- Any active malignancy ≤ 2 years
- Severe chronic or active infections (including tuberculosis infection, etc) requiring systemic antibacterial, antifungal, or antiviral therapy within 14 days prior to first dose of study drug(s)
- History of interstitial lung disease, noninfectious pneumonitis or uncontrolled diseases including pulmonary fibrosis, acute lung diseases, etc
- Known history of human immunodeficiency virus (HIV) infection
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- Untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers
- Any major surgical procedure requiring general anesthesia ≤ 28 days before the first dose of study drug(s)
- Prior allogeneic stem cell transplantation or organ transplantation
- Inadequately controlled hypertension (defined as systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 100 mmHg)
- Bleeding or thrombotic disorders or use of anticoagulants such as warfarin or similar agents requiring therapeutic international normalized ratio (INR) monitoring
- Any systemic chemotherapy within 28 days of the first dose of study drug(s) or hormone therapy, targeted therapy, or any investigational therapies Toxicities (as a result of prior anticancer therapy) that have not recovered to baseline or stabilized, except for AEs not considered a likely safety risk (eg, alopecia, neuropathy, and specific laboratory abnormalities)
- Inability to swallow capsules or disease significantly affecting gastrointestinal function
- Pregnant or breastfeeding woman NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
China1 site
Fudan University Shanghai Cancer
Shanghai, Shanghai Municipality, 200032
About this study
The purpose of this study is to assess the efficacy and safety of sitravatinib plus tislelizumab or combination with nab-paclitaxel in locally recurrent or metastatic triple-negative breast cancer (TNBC) patients.
Read the detailed description
This is a prospective, single-center, three cohorts, phase II clinical trial in locally recurrent or metastatic triple-negative breast cancer(TNBC) patients. Subjects will be divided into three cohorts by different treatment combination. Cohort A \& Cohort B aim to explore the two dosages of sitravatinib in combination with tislelizumab in TNBC with prior ≤ 3 treatment line. Cohort A patients will receive 70mg sitravatinib (QD PO) in combination with 200mg tislelizumab (Q3W IV); Cohort B patients will receive 100mg sitravatinib (QD PO) in combination with 200mg tislelizumab (Q3W IV). Cohort C aims to explore the sitravatinib (QD PO) plus 200mg tislelizumab (Q3W IV) and 100 mg/m2 nab-paclitaxel (D1, D8 Q3W IV) in TNBC previously untreated for metastatic setting or recurred/metastasized after surgery. Subjects in the three cohorts will be treated until disease progression, intolerable toxicity, informed consent withdrawn, or investigators-determined medication termination. Drug efficacy and safety data will be collected.
- Conditions
- Metastatic Breast Cancer
- Being tested
- Sitravatinib, Tislelizumab, Nab-paclitaxel
- Keywords
- Triple Negative Breast Cancer
- 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.
SitravatinibDrug
Also called MGCD516
Sitravatinib QD PO Sitravatinib is a small molecule inhibitor of receptor tyrosine kinases
TislelizumabDrug
Also called BGB-A317
Tislelizumab Q3W IV Tislelizumab is a programmed death receptor-1 (PD-1) blocking antibody
Nab-paclitaxelDrug
Also called Nanoparticle albumin-bound paclitaxel
Nab-paclitaxel D1, D8 Q3W IV Nab-paclitaxel is a chemotherapy drug which combines the chemotherapy drug paclitaxel with albumin
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Experimental | Subjects will receive 70mg sitravatinib in combination with 200mg tislelizumab until disease progression, unacceptable toxicity, withdrawal of consent or death, whichever occurs first. Receives: Drug: Sitravatinib; Drug: Tislelizumab |
| Cohort B | Experimental | Subjects will receive 100mg sitravatinib in combination with 200mg tislelizumab until disease progression, unacceptable toxicity, withdrawal of consent or death, whichever occurs first. Receives: Drug: Sitravatinib; Drug: Tislelizumab |
| Cohort C | Experimental | Subjects will receive sitravatinib in combination with 200mg tislelizumab and 100 mg/m2 nab-paclitaxel until disease progression, unacceptable toxicity, withdrawal of consent or death, whichever occurs first. Receives: Drug: Sitravatinib; Drug: Tislelizumab; Drug: Nab-paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR) by Investigator in Cohort A, Cohort B and Cohort C
The number of people with tumor responses according to RECIST (V1.1): the proportion of participants who achieves a best overall response of complete response (CR) or partial response (PR).
Measured: Up to 12 months
Number of participants experiencing ≥ Grade 3 TRAEs in Cohort B
TRAE are adverse events that occur during or after the first administration of the study drug until 30 days after the study drug is discontinued or the new anticancer treatment is initiated.
Measured: Up to 12 months
Secondary outcomes (7)
Duration of Response (DOR) by Investigator in Cohort A, Cohort B and Cohort C
The time from the date that response criteria are first met to the date that progressive disease (PD) is objectively documented or death, whichever occurs first.
Measured: Up to 12 months
Disease Control Rate (DCR) by Investigator in Cohort A, Cohort B and Cohort C
The proportion of participants who achieves a best overall response of CR, PR or stable disease(SD).
Measured: Up to 12 months
Progression-free Survival (PFS) by Investigator in Cohort A, Cohort B and Cohort C
Time from the date of randomization to the date of progressive disease (PD) or death, whichever occurs first.
Measured: Up to 12 months
One-year overall survival (OS) rate in Cohort A, Cohort B and Cohort C
OS defined as the time from the date of randomization to the date of death due to any reason. One-year survival rate (percentage of subjects alive at 1 year) was estimated from OS data.
Measured: Up to 12 months
Number of participants experiencing Adverse Events (AEs), Treatment-Related Adverse Events (TRAEs) or Serious Adverse Events (SAEs) in Cohort A, Cohort B and Cohort C
Adverse Events (AEs) according to CTCAE v5.0
Measured: Up to 12 months
Patient report outcomes (PROs) based on the EORTC QLQ-C30 (V.3) Quality of Life Questionnaire in Cohort B and Cohort C
Evaluating the Quality of Life of participants as assessed by EORTC QLQ-C30 Questionnaire
Measured: Through study completion, an average of 1 year
Potential biomarkers associated with efficacy, drug resistance, and/or disease progression (PD) in tumor tissues in Cohort A, Cohort B and Cohort C
Potential biomarkers in tumor tissues associated with efficacy
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2021
- Study start1 Apr 2021
- Primary completion1 Jun 2026
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Metastatic 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
- Non-randomised
- Intervention model
- Sequential
- Model description
- Cohort A Subjects will receive 70mg sitravatinib in combination with 200mg tislelizumab until disease progression, unacceptable toxicity, withdrawal of consent or death, whichever occurs first. Cohort B Subjects will receive 100mg sitravatinib in combination with 200mg tislelizumab until disease progression, unacceptable toxicity, withdrawal of consent or death, whichever occurs first. Cohort C Subjects will receive sitravatinib in combination with 200mg tislelizumab and 100 mg/m2 nab-paclitaxel until disease progression, unacceptable toxicity, withdrawal of consent or death, whichever occurs first.
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhimin Shao, Fudan University
- Investigators
- Zhimin Shao, MD, PhD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04734262
- Sponsor's protocol ID
- BGB-900-2001-IIT
- Acronym
- SPARK
- Status last verified
- Aug 2026
- First submitted
- 29 Jan 2021
- Last updated
- 21 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Liu XY, Sui XY, Xu Y, Yang F, Wu SY, Zhu XZ, Zuo K, Cao SW, Jin X, Chen L, Ma LX, Zhang WJ, Ye FG, Qu FL, Ma D, Xiao Y, Di GH, Liu GY, Yu KD, Wu J, Hu X, Jiang YZ, Wang ZH, Shao ZM, Fan L. Sitravatinib plus tislelizumab in locally recurrent or metastatic triple-negative breast cancer: a multi-cohort, single-arm, phase II clinical trial (SPARK Trial). Mol Cancer. 2025 Dec 19;25(1):15. doi: 10.1186/s12943-025-02505-5.
PubMed 41420248Xiyu Liu, Ying Xu, Xiuzhi Zhu, Wenjuan Zhang, Linxiaoxi Ma, Xi Jin, Songyang Wu, Han Wang, Shen Zhao, Yi Xiao, Li Chen, Min He, Wei Zhu, Zhigang Zhuang, Fengyi Hou, Ayong Cao, Genhong Di, Jiong Wu, Keda Yu, Guangyu Liu, Xin Hu, , Yizhou Jiang, Zhonghua Wang, Lei Fan, Zhiming Shao. Tislelizumab plus sitravatinib and nab-paclitaxel in patients with untreated locally recurrent or metastatic triple negative breast cancer (TNBC): updated efficacy and safety results [abstract]. In: Proceedings of the San Antonio Breast Cancer Symposium 2024; 2024 Dec 10-13; San Antonio, TX. Philadelphia (PA): AACR; Clin Cancer Res 2025;31(12 Suppl):Abstract nr PS3-01.
L. Liu, X. Jin, Y. Xu, S. Wu, Y. Yang, L. Chen, W. Zhang, L. Ma, X. Hu, Z. Wang, Y. Jiang, Z. Shao. The safety, tolerability, and preliminary antitumor activity of sitravatinib plus tislelizumab in patients (pts) with locally recurrent or metastatic triple negative breast cancer (TNBC): a multi-cohort, phase II trial. Annals of Oncology (2022) 16 (suppl_1): 100102-100102. 10.1016/iotech/iotech100102
Lei Fan, Xiyu Liu, Xi Jin, Yunsong Yang, Li Chen, Xin Hu, Zhonghua Wang, Yizhou Jiang, and Zhimin Shao. The safety, tolerability, and preliminary antitumor activity of sitravatinib plus tislelizumab in patients with locally recurrent or metastatic triple-negative breast cancer.Journal of Clinical Oncology 2022 40:16_suppl, 1070-1070
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study to Explore the Safety, Tolerability, and Preliminary Antitumor Activity of Sitravatinib Plus Tislelizumab or Combination With Nab-paclitaxel in Patients With Locally Recurrent or Metastatic Triple Negative Breast Cancer (TNBC)
- ClinicalTrials.gov ID
- NCT04734262
- Acronym / sponsor ID
- SPARK / BGB-900-2001-IIT
- Conditions
- Metastatic Breast Cancer
- Keywords
- Triple Negative Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 2 Feb 2021 (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.
The purpose of this study is to assess the efficacy and safety of sitravatinib plus tislelizumab or combination with nab-paclitaxel in locally recurrent or metastatic triple-negative breast cancer (TNBC) patients.
Detailed description
This is a prospective, single-center, three cohorts, phase II clinical trial in locally recurrent or metastatic triple-negative breast cancer(TNBC) patients. Subjects will be divided into three cohorts by different treatment combination. Cohort A \& Cohort B aim to explore the two dosages of sitravatinib in combination with tislelizumab in TNBC with prior ≤ 3 treatment line. Cohort A patients will receive 70mg sitravatinib (QD PO) in combination with 200mg tislelizumab (Q3W IV); Cohort B patients will receive 100mg sitravatinib (QD PO) in combination with 200mg tislelizumab (Q3W IV). Cohort C aims to explore the sitravatinib (QD PO) plus 200mg tislelizumab (Q3W IV) and 100 mg/m2 nab-paclitaxel (D1, D8 Q3W IV) in TNBC previously untreated for metastatic setting or recurred/metastasized after surgery. Subjects in the three cohorts will be treated until disease progression, intolerable toxicity, informed consent withdrawn, or investigators-determined medication termination. Drug efficacy and safety data will be collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Cohort A Subjects will receive 70mg sitravatinib in combination with 200mg tislelizumab until disease progression, unacceptable toxicity, withdrawal of consent or death, whichever occurs first. Cohort B Subjects will receive 100mg sitravatinib in combination with 200mg tislelizumab until disease progression, unacceptable toxicity, withdrawal of consent or death, whichever occurs first. Cohort C Subjects will receive sitravatinib in combination with 200mg tislelizumab and 100 mg/m2 nab-paclitaxel until disease progression, unacceptable toxicity, withdrawal of consent or death, whichever occurs first.
| Arm | Type | Receives |
|---|---|---|
| Cohort A | Experimental | Drug: Sitravatinib, Drug: TislelizumabSubjects will receive 70mg sitravatinib in combination with 200mg tislelizumab until disease progression, unacceptable toxicity, withdrawal of consent or death, whichever occurs first. |
| Cohort B | Experimental | Drug: Sitravatinib, Drug: TislelizumabSubjects will receive 100mg sitravatinib in combination with 200mg tislelizumab until disease progression, unacceptable toxicity, withdrawal of consent or death, whichever occurs first. |
| Cohort C | Experimental | Drug: Sitravatinib, Drug: Tislelizumab, Drug: Nab-paclitaxelSubjects will receive sitravatinib in combination with 200mg tislelizumab and 100 mg/m2 nab-paclitaxel until disease progression, unacceptable toxicity, withdrawal of consent or death, whichever occurs first. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Able to provide written informed consent and can understand and agree to comply with the requirements of the study and the schedule of assessments
- Age ≥ 18 years on the day of signing the ICF (or the legal age of consent in the jurisdiction in which the study is taking place)
- Histologically confirmed diagnosis of TNBC characterized by estrogen-receptor negative (ER-), progesterone receptor negative (PR-) and human epidermal growth factor-2 receptor negative (HER2-);
- ≤ 3 prior lines of systemic therapy
- For patients refractory/resistant to anti-PD-1/PD-L1 antibodies, there should be no anti-PD-1/PD-L1 treatment-related toxicity from prior therapies
Key exclusion criteria (14 listed)
- Active leptomeningeal disease or uncontrolled brain metastasis
- Active autoimmune diseases or history of autoimmune diseases that may relapse
- Any active malignancy ≤ 2 years
- Severe chronic or active infections (including tuberculosis infection, etc) requiring systemic antibacterial, antifungal, or antiviral therapy within 14 days prior to first dose of study drug(s)
- History of interstitial lung disease, noninfectious pneumonitis or uncontrolled diseases including pulmonary fibrosis, acute lung diseases, etc
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 |
|---|---|---|
| SitravatinibAlso: MGCD516Sitravatinib QD PO Sitravatinib is a small molecule inhibitor of receptor tyrosine kinases | Drug | Cohort A, Cohort B, Cohort C |
| TislelizumabAlso: BGB-A317Tislelizumab Q3W IV Tislelizumab is a programmed death receptor-1 (PD-1) blocking antibody | Drug | Cohort A, Cohort B, Cohort C |
| Nab-paclitaxelAlso: Nanoparticle albumin-bound paclitaxelNab-paclitaxel D1, D8 Q3W IV Nab-paclitaxel is a chemotherapy drug which combines the chemotherapy drug paclitaxel with albumin | Drug | Cohort C |
Primary outcome
Overall Response Rate (ORR) by Investigator in Cohort A, Cohort B and Cohort C
Time frame: Up to 12 months
The number of people with tumor responses according to RECIST (V1.1): the proportion of participants who achieves a best overall response of complete response (CR) or partial response (PR).
Number of participants experiencing ≥ Grade 3 TRAEs in Cohort B
Time frame: Up to 12 months
TRAE are adverse events that occur during or after the first administration of the study drug until 30 days after the study drug is discontinued or the new anticancer treatment is initiated.
7 secondary outcomes
Duration of Response (DOR) by Investigator in Cohort A, Cohort B and Cohort C
Time frame: Up to 12 months
Disease Control Rate (DCR) by Investigator in Cohort A, Cohort B and Cohort C
Time frame: Up to 12 months
Progression-free Survival (PFS) by Investigator in Cohort A, Cohort B and Cohort C
Time frame: Up to 12 months
One-year overall survival (OS) rate in Cohort A, Cohort B and Cohort C
Time frame: Up to 12 months
Number of participants experiencing Adverse Events (AEs), Treatment-Related Adverse Events (TRAEs) or Serious Adverse Events (SAEs) in Cohort A, Cohort B and Cohort C
Time frame: Up to 12 months
Patient report outcomes (PROs) based on the EORTC QLQ-C30 (V.3) Quality of Life Questionnaire in Cohort B and Cohort C
Time frame: Through study completion, an average of 1 year
Potential biomarkers associated with efficacy, drug resistance, and/or disease progression (PD) in tumor tissues in Cohort A, Cohort B and Cohort C
Time frame: Through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Background: PubMed 41420248Liu XY, Sui XY, Xu Y, Yang F, Wu SY, Zhu XZ, Zuo K, Cao SW, Jin X, Chen L, Ma LX, Zhang WJ, Ye FG, Qu FL, Ma D, Xiao Y, Di GH, Liu GY, Yu KD, Wu J, Hu X, Jiang YZ, Wang ZH, Shao ZM, Fan L. Sitravatinib plus tislelizumab in locally recurrent or metastatic triple-negative breast cancer: a multi-cohort, single-arm, phase II clinical trial (SPARK Trial). Mol Cancer. 2025 Dec 19;25(1):15. doi: 10.1186/s12943-025-02505-5.
- BackgroundXiyu Liu, Ying Xu, Xiuzhi Zhu, Wenjuan Zhang, Linxiaoxi Ma, Xi Jin, Songyang Wu, Han Wang, Shen Zhao, Yi Xiao, Li Chen, Min He, Wei Zhu, Zhigang Zhuang, Fengyi Hou, Ayong Cao, Genhong Di, Jiong Wu, Keda Yu, Guangyu Liu, Xin Hu, , Yizhou Jiang, Zhonghua Wang, Lei Fan, Zhiming Shao. Tislelizumab plus sitravatinib and nab-paclitaxel in patients with untreated locally recurrent or metastatic triple negative breast cancer (TNBC): updated efficacy and safety results [abstract]. In: Proceedings of the San Antonio Breast Cancer Symposium 2024; 2024 Dec 10-13; San Antonio, TX. Philadelphia (PA): AACR; Clin Cancer Res 2025;31(12 Suppl):Abstract nr PS3-01.
- BackgroundL. Liu, X. Jin, Y. Xu, S. Wu, Y. Yang, L. Chen, W. Zhang, L. Ma, X. Hu, Z. Wang, Y. Jiang, Z. Shao. The safety, tolerability, and preliminary antitumor activity of sitravatinib plus tislelizumab in patients (pts) with locally recurrent or metastatic triple negative breast cancer (TNBC): a multi-cohort, phase II trial. Annals of Oncology (2022) 16 (suppl_1): 100102-100102. 10.1016/iotech/iotech100102
- Results publicationLei Fan, Xiyu Liu, Xi Jin, Yunsong Yang, Li Chen, Xin Hu, Zhonghua Wang, Yizhou Jiang, and Zhimin Shao. The safety, tolerability, and preliminary antitumor activity of sitravatinib plus tislelizumab in patients with locally recurrent or metastatic triple-negative breast cancer.Journal of Clinical Oncology 2022 40:16_suppl, 1070-1070
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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.
Zhimin Shao, MD, PhD 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 Sitravatinib, Tislelizumab and Nab-paclitaxel in people with Metastatic 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 10 inclusion and 14 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: under way, not looking for participants, as of the sponsor's last update on 21 Sep 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?
This study is still under way. Results are not available in the source record yet.
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?
Overall Response Rate (ORR) by Investigator in Cohort A, Cohort B and Cohort C (time frame: Up to 12 months). 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?
On the ClinicalTrials.gov record for NCT04734262, which also lists 4 linked publications.
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 Sep 2026.