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Breast CancerPhase 2NeoASPECTNCT07743632

Neoadjuvant Angiogenesis-Targeting Bispecific Chemoimmunotherapy for TNBC

A Phase 2 study testing Carboplatin, Docetaxel and Doxorubicin in people with Breast Cancer and Triple Negative Breast Cancer, run by University of Kansas Medical Center.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer, Triple Negative Breast Cancer
What is being tested?
Carboplatin, Docetaxel and Doxorubicin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
No sites listed yet
Study dates
Sep 2026to Dec 2033
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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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:
  • Prothrombin time (PT) or international normalized ratio (INR) ≤ 1.5x ULN
  • Partial prothrombin time (PTT) or activated partial prothrombin time (aPTT) ≤ 1.5x ULN (unless abnormalities are unrelated to coagulopathy). Patients receiving therapeutic anti-coagulation should be on a stable dose.
  • Renal (assessed ≤ 21 days of treatment initiation):
  • Creatinine ≤ 1.5 mg/dL and/or creatinine clearance ≥ 60 mL/min
  • Urine protein test <2+ or 24-hour urine protein quantification <1.0 g
  • Hepatic (assessed ≤ 21 days of treatment initiation):
  • Total bilirubin ≤ 1.5x ULN
  • AST(SGOT) and ALT(SPGT) ≤ 2x ULN
  • Serum albumin ≥ 3.0 g/dL
  • Cardiac (assessed ≤ 56 days of treatment initiation):
  • Subjects with heart failure are not eligible, nor are patients with myocardial infarction, unstable angina pectoris, an arterial thrombotic event, stroke, or transient ischemic attack within the past 12 months, uncontrolled hypertension (systolic BP > 150 mmHg, diastolic BP > 100 mmHg), uncontrolled or symptomatic arrythmia, or greater than grade 2 peripheral vascular disease
  • LVEF ≥ 50% by echocardiogram or MUGA scan, per standard of care

Who cannot join

  • 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
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  • 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)
  • History of esophageal gastric varices, severe ulcers, wounds that do not heal, abdominal fistula, intra-abdominal abscesses, or acute gastrointestinal bleeding within 6 months before starting study treatment
  • History of any grade arterial thromboembolic event, Grade 3 and above venous thromboembolic event, as specified in National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 5.0, transient ischemic attack, cerebrovascular accident, hypertensive crisis, or hypertensive encephalopathy within 12 months prior to starting study treatment
  • Acute exacerbation of chronic obstructive pulmonary disease within 4 weeks before starting study treatment
  • History of perforation of the gastrointestinal tract and/or fistula, history of gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive bowel resection (partial colectomy or extensive small bowel resection) within 6 months prior to starting study treatment
  • Currently has or has history of (within the past one year) non-infectious pneumonitis requiring steroids
  • Non-infectious pneumonia requiring systemic corticosteroids within the past 30 days, or current interstitial lung disease
  • Infection requiring systemic therapy within 2 weeks prior to starting study treatment (excluding antiviral therapy for hepatitis B or C)
  • Peripheral neuropathy grade 2 or higher by CTCAE version 6
  • Current or history of inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis)
  • Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation
  • Known history of human immunodeficiency virus (HIV) infection.
  • Note: Patients with controlled viral load are eligible.
  • Active hepatitis B (defined as HBsAg reactive) or hepatitis C (detectable HCV RNA or positive for HCV antibody)
  • Note: Patients with active hepatitis B are eligible if on appropriate antiviral therapy with acceptable tolerability for 4 weeks prior to starting study treatment, with stable or declining levels of hepatitis B DNA by polymerase chain reaction testing.
  • Note: Testing for hepatitis B and C is not required unless mandated by local health authority
  • History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of this study, interfere with the subject's participation for the full duration of the study, or it is not in the best interest of the subject to participate, in the opinion of the treating investigator
  • Pregnancy, breastfeeding or planning to breastfeed during study treatment, or expecting to conceive within the projected duration of the study, starting with the screening visit through 90 days after the last dose of trial treatment. There is a potential for congenital abnormalities and for this regimen to harm breastfeeding infants.
  • Subject is a female of reproductive potential per institutional guidelines and treating physician's discretion and within 24 hours of starting treatment:
  • Serum pregnancy test is positive, or
  • Urine pregnancy test is positive or cannot be confirmed as negative, and serum pregnancy test has not been done or is positive
  • Note: In the event that 24 hours have elapsed between the screening pregnancy test and the first dose of study treatment, another pregnancy test (urine or serum) must be performed and must be negative in order for subject to start receiving study medication.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

KUCC Navigation contact

913-588-3671

kucc_navigation@kumc.edu

About this study

Official title: Neoadjuvant Angiogenesis-Targeting Bispecific Chemoimmunotherapy for TNBC (NeoASPECT)

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.

Read the detailed description

The standard treatment for women with high-risk early-stage triple-negative breast cancer (TNBC) includes chemotherapy plus immunotherapy (chemo-immunotherapy) given before surgery, followed by surgery, with or without radiation therapy. Patients whose tumor have low immune cell infiltration have lower response to chemoimmunotherapy and higher cancer recurrence rates. On the other hand, patients whose tumors have high immune infiltration have high response to chemoimmunotherapy and low rates of cancer recurrence and thus may not need 6 months of neoadjuvant therapy with multiple drugs. To improve outcomes for TNBC patients, we need better treatment agents, as well as ways to tailor treatment to minimize side effects.

Keywords
Tumor-infiltrating lymphocytes, Neoadjuvant chemotherapy, Neoadjuvant immunotherapy, Angiogenesis, VEGF
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.

  • CarboplatinDrug

    Also called Paraplatin

    Commercially available

  • DocetaxelDrug

    Also called Taxotere

    Commercially available

  • DoxorubicinDrug

    Also called Adriamycin

    Commercially available.

  • CyclophosphamideDrug

    Also called Cytoxan

    Commercially available.

  • IvonescimabDrug

    Also called SMT112, AK112

    Ivonescimab is a bispecific antibody targeting PD-1 and VEGF. Ivonescimab will be supplied for participants by Summit Therapeutics.

Study groups in NCT07743632
Study groupRoleWhat they receive
Low-sTILs cohort (sTILs <30%)Other4 cycles of carboplatin AUC 6 plus docetaxel 75mg/m2 plus ivonescimab 20mg/kg every 21 days, followed by 4 cycles of doxorubicin + cyclophosphamide + ivonescimab 20mg/kg every 21 days.
Receives: Drug: Carboplatin; Drug: Docetaxel; Drug: Doxorubicin; Drug: Cyclophosphamide; Drug: Ivonescimab
High-sTILs cohort (sTILs ≥30%)Other4 cycles of carboplatin AUC 6 plus docetaxel 75mg/m2 plus ivonescimab 20mg/kg every 21 days. Patients with lack of complete imaging response (by MRI) after 4 cycles will receive two additional cycles of carboplatin AUC 6 plus docetaxel 75mg/m2 plus ivonescimab 20mg/kg every 21 days.
Receives: Drug: Carboplatin; Drug: Docetaxel; Drug: Ivonescimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pathologic complete response (pCR) rate in the breast and axilla in the two treatment arms.

    Determine the rates of pathologic complete response (pCR) with ivonescimab-containing neoadjuvant systemic therapy among patients with low and high stromal tumor-infiltrating lymphocytes (sTILs), as evidenced by absence of invasive disease in breast and axillary lymph nodes (ypT0/Tis ypN0) determined by histopathological examination.

    Measured: At time of definitive breast surgery

Secondary outcomes (3)

  1. Treatment-related adverse events

    Assess toxicity of ivonescimab in combination with chemotherapy. Toxicity will be assessed according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE), version 6.0.

    Measured: Start of study treatment (cycle 1 day 1) until 30 days after last dose of study treatment (90 days for serious and immune-related adverse events)

  2. Event-free survival (EFS)

    3- and 5-year event-free survival (defined as the time from diagnosis to first recurrence [invasive ipsilateral breast, invasive local/regional, or distant] or to breast cancer-related death)

    Measured: Up to 5 years after enrollment

  3. Overall survival (OS)

    3- and 5-year overall survival (defined as the time from diagnosis to death from any cause)

    Measured: Up to 5 years after enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Aug 2026
  2. Study startSep 2026 (estimated)
  3. Primary completionDec 2032 (estimated)
  4. Study completionDec 2033 (estimated)

Resources

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
Parallel groups
Masking
None (open label)
Enrolment
110 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07743632
Sponsor's protocol ID
IIT-2026-NeoASPECT
Acronym
NeoASPECT
Status last verified
Jul 2026
First submitted
30 Jul 2026
Last updated
4 Aug 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Carboplatin, Docetaxel and Doxorubicin in people with Breast Cancer and Triple Negative Breast Cancer, run by University of Kansas Medical Center.

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 37 inclusion and 46 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: opening soon, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

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?

Contact KUCC Navigation (913-588-3671, kucc_navigation@kumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathologic complete response (pCR) rate in the breast and axilla in the two treatment arms. (time frame: At time of definitive breast surgery). 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 NCT07743632.

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 4 Aug 2026.

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