Can a Three-Drug combo crack Triple-Negative breast cancer?
NCT ID NCT04734262
First seen Sep 21, 2026 · Last updated Sep 21, 2026
Summary
Researchers are testing whether combining sitravatinib and tislelizumab, with or without nab-paclitaxel, can shrink tumors in people with locally recurrent or metastatic triple-negative breast cancer. The trial enrolls about 98 adults whose cancer is estrogen-receptor, progesterone-receptor, and HER2-negative. Participants receive the drug combinations by mouth or infusion, and the study measures tumor response and side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- sitravatinib plus tislelizumab, with or without nab-paclitaxel
- What this could lead to
- If the combinations work, they could offer new treatment options for people with locally recurrent or metastatic triple-negative breast cancer, a form with few targeted therapies.
- What could go wrong
- This is a phase II trial with 98 participants, so it cannot prove the combinations work better than standard care. The drugs can cause serious side effects, and the results may not apply to everyone with TNBC.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
98 people
The number who actually took part.
- Started
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Apr 2021
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 * 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) Exclusion Criteria: * 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 * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Fudan University Shanghai Cancer
Shanghai, Shanghai Municipality, 200032, China
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