Neoadjuvant Angiogenesis-Targeting Bispecific Chemoimmunotherapy for TNBC
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Kansas Medical Center
About this trial
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.
Eligibility criteria
Qualifiers
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.
Not a woman of reproductive potential as defined by institutional standards and treating physician's discretion
Disqualifiers
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.
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.
Trial design
Treatments tested in this trial
- Carboplatin
- Docetaxel
- Doxorubicin
- Cyclophosphamide
- Ivonescimab
Treatment groups
110 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov