Neoadjuvant Angiogenesis-Targeting Bispecific Chemoimmunotherapy for TNBC

Starting soon · Phase 2

Conditions studied: Breast Cancer, Triple Negative Breast Cancer

In brief

This study will test the effectiveness of two standard neoadjuvant chemotherapy regimens plus an investigational drug (ivonescimab) that has dual action as both immunotherapy and therapy targeting the tumor's blood supply. This investigational drug is called ivonescimab.

Key facts

Study ID

NCT07743632

Run by

University of Kansas Medical Center

People needed

110

Starts

2026-09-01

Expected to finish

2033-12-01

Last updated by the study team

2026-08-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Ability of participant OR Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent
• 18 years of age or older
• Histologically confirmed cT1c-T3 N0 or cT1-T3 N1-N2 triple-negative breast cancer
• The invasive tumor must be hormone receptor poor, defined as both estrogen receptor (ER) and progesterone receptor staining in ≤ 10% of invasive cancer cells by IHC.
• The invasive tumor must be HER2-negative based on the current ASCO-CAP guidelines 79.
• Subjects with bilateral synchronous triple-negative breast cancer are eligible if they meet other eligibility criteria.
• No previous ipsilateral breast surgery for the current breast cancer
• No previous chemotherapy, immunotherapy, targeted therapy, endocrine therapy, or radiotherapy for the current breast cancer
• ECOG Performance Status 0 or 1, documented within 21 days prior to the start of study treatment (Appendix A)
• Breast and axillary imaging (including MRI and either mammogram and/or ultrasound, per standard of care) within 56 days (8 weeks) prior to treatment initiation
• Subjects with clinically and/or radiographically abnormal axillary or internal mammary lymph nodes should have pathologic assessment of disease status with image-guided biopsy or fine needle aspiration unless deemed medically unsafe
• Co-enrollment in the PROGECT (HSC #12614) observational registry protocol
• Archival breast tumor tissue has been obtained or has been requested for use, which should include either a formalin-fixed paraffin-embedded (FFPE) block, or sixteen slides (fourteen 5-micron uncharged unstained slides plus either two H\&E slides or two 5-micron charged unstained slides) - from primary breast tumor only.
• Neuropathy: No baseline grade 2 or above neuropathy
• Not pregnant, not breastfeeding, and at least one of the following applies:
• Not a woman of reproductive potential as defined by institutional standards and treating physician's discretion
• A woman of reproductive potential who agrees to follow contraceptive guidelines per institutional standards during the treatment period and for at least 3 months after the last dose of ivonescimab, or until 6 months after last dose of carboplatin or doxorubicin, 2 months after last dose of docetaxel, or 12 months after last dose of cyclophosphamide (whichever is longer).
• Adequate organ function, defined as follows:
• Hematologic (assessed ≤ 21 days of treatment initiation):
• Absolute neutrophil count ≥ 1,500/μL (with the exception of patients with documented Fy(a-/b-) (Duffy null) immunophenotype, in which case absolute neutrophil count ≥1,200/uL is allowed)
• Platelets ≥ 100,000/μL
• Leukocytes ≥ 3,000/μL
• Hemoglobin ≥ 9.0 g/dL or ≥ 5.6 mmol/L (must be met without erythropoietin dependency and without erythrocyte transfusion within the last two weeks)
• Coagulation (assessed ≤ 21 days of treatment initiation):
• For patients who are not on therapeutic anti-coagulation:

You may not qualify if…

• Current or anticipated use of other investigational agents while participating in this study
• Clinically or radiographically detected metastatic disease
• Inflammatory breast cancer
• Prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the treatment regimen.
• Note: Patients with squamous cell or basal cell carcinoma of the skin, ductal carcinoma in situ (DCIS) of the breast, or carcinoma in situ (CIS) of the uterine cervix who have undergone definitive therapy are not excluded from participation
• History of allergic reactions attributed to carboplatin, docetaxel, doxorubicin, or cyclophosphamide
• History of severe (≥ grade 3) hypersensitivity to ivonescimab or any of its excipients, or to any other monoclonal antibody
• Prior treatment with a VEGF inhibitor or with an anti-PD-1, anti-PD-L1, anti-PD-L2 inhibitor or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA4, OX40, CD137)
• History of bleeding tendencies or coagulopathy and/or clinically significant bleeding symptoms or risk within 4 weeks prior to starting study treatment, including but not limited to:
• Hemoptysis (defined as coughing up ≥ 0.5 teaspoon of fresh blood or small blood clots). Note: Transient hemoptysis associated with diagnostic bronchoscopy is allowed.
• Nasal bleeding /epistaxis (bloody nasal discharge is allowed)
• Current use of prophylactic or full-dose anticoagulants or anti-platelet agents for therapeutic purposes that is not stable prior to starting study treatment. The use of full-dose anticoagulants is permitted as long as the international normalized ratio (INR) or activated partial thromboplastin time (aPTT) is within therapeutic limits according to institutional guidelines.
• Poorly controlled hypertension with repeated systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg after oral antihypertensive therapy
• Major surgical procedures or serious trauma within 4 weeks prior to start of study treatment, major surgical procedures planned for within 4 weeks after the first dose of study treatment, or minor local procedures within 3 days prior to start of study treatment (as determined by the investigator).
• Note: Central venous catheterization and port implantation within 3 days prior to start of study treatment are allowed.
• Subject has received a live vaccine within 30 days prior to treatment initiation
• Live vaccines include (but are not limited to) measles, mumps, rubella, varicella/zoster (chicken pox and shingles), yellow fever, rabies, Bacillus-Calmette-Guérin (BCG), typhoid.
• Note: Seasonal injectable influenza vaccines are killed virus and are allowed
• Subject is currently receiving treatment or has received treatment with an investigational agent within four weeks prior to treatment initiation, or has used an investigational device within four weeks prior to treatment initiation
• Has a diagnosis of immunodeficiency or is receiving chronic steroid therapy (in doses exceeding 10 mg daily prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment
• Active autoimmune or lung disease that has required systemic treatment (e.g., disease-modifying agents, corticosteroids in doses exceeding 10 mg daily prednisone equivalent, immunosuppressive drugs) in the past two years.
• Note: Patients using replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid therapy) are eligible
• Note: Intermittent use of bronchodilators, inhaled corticosteroids, topical corticosteroids, or local corticosteroid injections is permitted
• History of major diseases before starting study treatment, specifically any of the following:
• Unstable angina, myocardial infarction, congestive heart failure (New York Heart Association [NYHA] classification ≥ grade 2) or unstable vascular disease (e.g., aortic aneurysm at risk of rupture, Moyamoya disease) that required hospitalization within 12 months prior to starting study treatment, or other cardiac impairment that may affect the safety evaluation of the study drug (e.g., poorly controlled arrhythmias, myocardial ischemia)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.