A Phase 2 interventional study of Retlirafusp alfa+Nab-paclitaxel: and Retlirafusp alfa+Fluzoparib in Triple-Negative Breast Cancer (TNBC), sponsored by Harbin Medical University. Not yet recruiting at 1 site in China. Open to female participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-08-07.
Sponsored by Harbin Medical University · Phase 2, Interventional, and Treatment
To investigate the efficacy and safety of Retlirafusp alfa in combination with chemotherapy or fluzoparib for early-stage and advanced triple-negative breast cancer.
Triple-negative breast cancer (TNBC) is the molecular subtype with the poorest prognosis among breast cancers, characterized by high rates of early recurrence, rapid distant metastasis, and short overall survival. Due to the lack of estrogen receptor, progesterone receptor, and HER2 expression, TNBC is insensitive to endocrine therapy and targeted therapy, making chemotherapy the mainstay of systemic treatment for a long time. However, conventional chemotherapy offers limited efficacy, and treatment options become scarce after the development of drug resistance. In recent years, immune checkpoint inhibitors have shown promising prospects in TNBC, particularly in PD-L1-positive patients who may benefit from immunotherapy combined with chemotherapy; nevertheless, a substantial proportion of patients still fail to achieve durable responses. In addition, PARP inhibitors have provided a new therapeutic option for TNBC patients harboring gBRCA mutations, and they exhibit potential synergistic effects with immunotherapy. Retlirafusp alfa (SHR-1701) is a domestically developed bifunctional fusion protein targeting PD-L1 and TGF-β, which can simultaneously block the PD-1/PD-L1 pathway and neutralize TGF-β in the tumor microenvironment, thereby enhancing anti-tumor immune responses. It has demonstrated promising efficacy and manageable safety in tumor types such as gastric cancer. Based on the above background, this study aims to explore the efficacy and safety of Retlirafusp alfa combined with chemotherapy or fluzoparib in early-stage and advanced TNBC, in order to provide novel therapeutic strategies for TNBC patients.
1,219 studies on the registry are indexed under Triple Negative Breast Neoplasms; 446 are open to participants now.
This study's planned enrollment of 120 is above the median of 60 across 1,053 interventional studies indexed under Triple Negative Breast Neoplasms.
Browse Triple Negative Breast Neoplasms studies →Harbin Medical University is the lead sponsor of 88 studies on the registry; 30 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Advanced cohort:
Metastatic or unresectable locally advanced TNBC (no prior systemic therapy or completed /adjuvant therapy ≥12 months); positive with a Combined Positive Score (CPS) ≥1;
Neoadjuvant cohort:
Clinical stage II (T2N0-1M0/T3N0M0) or III (T2N2-3M0/T3N1-3M0) previously untreated breast cancer patients;
Adequate major organ function meeting the following criteria (no blood transfusion or use of granulocyte colony-stimulating factor or thrombopoietin within 2 weeks prior to screening):
Hematologic: (ANC) ≥1.5×10⁹/L; count (PLT) ≥90×10⁹/L; (Hb) ≥90 g/L; Biochemical: Total (TBIL) ≤1.5× (ULN); and AST ≤1.5× ULN (≤3× ULN for patients with liver metastases); alkaline phosphatase ≤2.5× ULN; BUN and creatinine ≤1.5× ULN with ≥50 mL/min (calculated by Cockcroft-Gault formula); Thyroid-stimulating hormone (TSH) ≤ULN (if abnormal, T3 and T4 levels should also be assessed; patients with normal T3 and T4 levels may be enrolled); Echocardiography: (LVEF) ≥50%; 18-lead : Fridericia- interval (QTcF) \<480 ms for females;
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HER2
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Leptomeningeal disease
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Retlirafusp alfa + nab-paclitaxel
Drug: Retlirafusp alfa+Nab-paclitaxel:
Retlirafusp alfa + fluzoparib
Drug: Retlirafusp alfa+Fluzoparib
Retlirafusp alfa+TP-AC
Drug: Retlirafusp alfa+TP-AC
Retlirafusp alfa+ Fluzoparib
Drug: Retlirafusp alfa+Fluzoparib
Drug pages: SHR-1701 · Albumin-Bound Paclitaxel
Retlirafusp alfa+Nab-paclitaxel
Drug pages: SHR-1701 · Fluzoparib
Retlirafusp alfa+Fluzoparib
Drug page: SHR-1701
Retlirafusp alfa+TP-AC
Drug pages: SHR-1701 · Fluzoparib
Retlirafusp alfa+Fluzoparib
Late-Stage Cohort-Objective Response Rate
Proportion of patients with best overall response of complete response (CR) or partial response (PR) from treatment initiation to disease progression.
Time frame: Assessed every 6 weeks (every 2 cycles) during treatment until disease progression, death, or loss to follow-up. Analysis cutoff at 6 months.
Neoadjuvant Cohort-tpCR (ypT0/is ypN0)
Pathologic complete response with no residual invasive carcinoma in breast and ipsilateral lymph nodes after neoadjuvant therapy and surgery.
Time frame: Surgery performed 2-6 weeks after completing 8 cycles (≈24 weeks) of neoadjuvant therapy; pathological assessment post-surgery. Analysis cutoff at 6 months.
Late-Stage Cohort-Disease Control Rate
Proportion of patients with best overall response of CR, PR, or stable disease (SD) from treatment initiation to disease progression.
Time frame: Assessed every 6 weeks (every 2 cycles) during treatment until disease progression, death, or loss to follow-up. Analysis cutoff at 6 months.
Late-Stage Cohort-Clinical Benefit Rate
Proportion of patients with confirmed CR, PR, or SD lasting ≥24 weeks.
Time frame: Assessed until disease progression, death, or loss to follow-up. Analysis cutoff at 6 months.
Late-Stage Cohort-Progression-Free Survival
Time from treatment initiation to first radiographic disease progression or death from any cause.
Time frame: Assessed every 3 months during treatment and follow-up until disease progression, death, or start of subsequent anticancer therapy. Analysis cutoff at 36 months.
Late-Stage Cohort-Overall Survival
Time from treatment initiation to death from any cause.
Time frame: Follow-up every 3 months via clinic visit or telephone call after treatment completion until death or study end. Analysis cutoff at 36 months.
Neoadjuvant Cohort-bpCR (ypT0/is)
Pathologic complete response with no residual invasive carcinoma in breast (lymph node status disregarded) after neoadjuvant therapy and surgery.
Time frame: Surgery performed 2-6 weeks after completing 8 cycles (≈24 weeks) of neoadjuvant therapy; pathological assessment post-surgery. Analysis cutoff at 6 months.
Neoadjuvant Cohort-Objective Response Rate
Proportion of patients with best overall response of CR or PR during neoadjuvant therapy.
Time frame: Assessed every 6 weeks (every 2 cycles) during neoadjuvant therapy until treatment completion. Analysis cutoff at 6 months.
Neoadjuvant Cohort-Event-Free Survival
Time from treatment initiation to first occurrence of preoperative disease progression, postoperative recurrence, or death from any cause.
Time frame: Follow-up every 3 months from treatment start until event or study end. Analysis cutoff at 36 months.
Neoadjuvant Cohort-Disease-Free Survival
Time from surgery to first postoperative recurrence or death from any cause.
Time frame: Follow-up every 3 months from surgery until recurrence, death, or study end. Analysis cutoff at 36 months.
Neoadjuvant Cohort-Distant Disease-Free Survival
Time from surgery to first distant metastasis or death from any cause.
Time frame: Follow-up every 3 months from surgery until distant metastasis, death, or study end. Analysis cutoff at 36 months.
Adverse Event (AE) Incidence
Incidence, severity, and drug-relatedness of AEs and SAEs, graded per NCI-CTCAE v6.0.
Time frame: Recorded from informed consent signing through 30 days after last dose (SAEs and immune-related AEs through 90 days after last dose); maximum follow-up of 36 months.
Biomarker Exploration
Collection of tumor tissue and peripheral blood samples to analyze potential biomarkers associated with efficacy, resistance, and safety.
Time frame: Blood samples collected at baseline, Cycle 5 Day 1, and Cycle 8 Day 1 (21-day cycle); tumor tissue collected at baseline from archived FFPE blocks or fresh biopsy. Analysis cutoff at 6 months.
Plan to share: No
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This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: SHR-1701 · Albumin-Bound Paclitaxel · Fluzoparib
Triple Negative Breast Neoplasms →
Harbin Medical University