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Personalized chemoimmunotherapy for triple-negative breast cancer

Neoadjuvant TIL- and Response-Adapted Chemoimmunotherapy for TNBC

Phase 2 Interventional University of Kansas Medical Center · NCT05645380

This study is testing how the immune cells in triple-negative breast cancer tumors can help doctors personalize chemoimmunotherapy to improve treatment results for patients.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment139 (estimated)
Ages18 Years to 120 Years
SexFemale
SponsorUniversity of Kansas Medical Center Academic / other
Drugs / interventionspembrolizumab, chemotherapy, immunotherapy, cyclophosphamide, doxorubicin, prednisone
Locations7 sites (Fairway, Kansas and 6 other locations)
Trial IDNCT05645380 on ClinicalTrials.gov

What this trial studies

This study investigates how the presence of immune system cells in and around tumors affects the effectiveness of neoadjuvant chemoimmunotherapy in patients with triple-negative breast cancer (TNBC). It aims to personalize treatment based on the tumor's response to therapy as monitored by imaging techniques like MRI. By assessing the immune cell presence and tumor shrinkage, the study seeks to optimize the type and dosage of chemotherapy and immunotherapy administered to patients. The goal is to improve treatment outcomes and prognosis for those diagnosed with TNBC.

Who should consider this trial

Good fit: Ideal candidates are female patients aged 18 and older with histologically confirmed triple-negative breast cancer that meets specific criteria.

Not a fit: Patients with prior breast cancer treatments or those with hormone receptor-positive or HER2-positive tumors may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more effective and tailored treatment options for patients with triple-negative breast cancer.

How similar studies have performed: Other studies have shown promising results with personalized approaches in cancer treatment, indicating potential for success in this novel application.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Ability of participant OR Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent
* Female subjects 18 years of age or older
* Histologically confirmed cT1c-T3N0, cT1-T3N1-N2, cTxN1-2 TNBC

  * 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
* No previous ipsilateral breast surgery for the current breast cancer
* No previous chemotherapy, immunotherapy, endocrine therapy, or radiotherapy for the current breast cancer
* ECOG Performance Status 0 - 1 documented within 21 days prior to the start of study treatment
* Breast and axillary imaging (including ultrasound and MRI) within 42 days (6 weeks) prior to treatment initiation
* Subjects with clinically and/or radiographically abnormal axillary or internal mammary lymph nodes should have pathologic confirmation of disease status with image-guided biopsy or fine needle aspiration
* Archival breast tumor tissue has been obtained or has been requested for use
* No clinically apparent metastatic disease. Staging to rule out metastatic disease is suggested for patients with clinical TNM stage III disease
* Subjects with bilateral synchronous TNBC are eligible if they meet other eligibility criteria
* No baseline neuropathy greater than grade 2
* Patients are not pregnant, not breastfeeding, and either not a woman of childbearing potential or agrees to follow specific contraceptive guidelines during the treatment period and for at least 120 days after the last dose of study treatment
* Adequate hematologic, hepatic, and renal function assessed ≤ 21 days from treatment initiation
* Only if assigned to Regimen C, LVEF ≥ 50% by echocardiogram or MUGA scan, per standard of care (assessed within 120 days prior to receiving doxorubicin + cyclophosphamide)

Exclusion Criteria:

* Current or anticipated use of other investigational agents while participating in this study
* Subject has previously received chemotherapy, immunotherapy, endocrine therapy, radiotherapy, or surgery for this breast cancer
* Subject has clinically or radiographically detected metastatic disease
* Subject has inflammatory breast cancer
* Subject has a 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 doxorubicin, cyclophosphamide, carboplatin, or docetaxel
* History of severe (≥ grade 3) hypersensitivity to pembrolizumab or any of its excipients
* Prior treatment 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)
* If participant has received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment.
* Subject has received a live vaccine within 30 days prior to treatment initiation
* 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 pembrolizumab
* Active autoimmune disease that has required systemic treatment (e.g., disease-modifying agents, corticosteroids, immunosuppressive drugs) in the past two years. Note: Patients using replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid therapy) are eligible
* Currently has or has history of (within the past one year) non-infectious pneumonitis requiring steroids
* Active infection requiring systemic therapy
* Known history of human immunodeficiency virus (HIV) infection
* Active hepatitis B (defined as HBsAg reactive) or hepatitis C (detectable HCV RNA)
* 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
* Subject has known psychiatric or substance abuse disorder(s) that would interfere with cooperation with the requirements of the study
* Subject is pregnant or breastfeeding or expecting to conceive within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment
* Inadequate hematologic, renal, hepatic, or cardiac function.
* Myocardial infarction, unstable angina pectoris, an arterial thrombotic event, stroke, or transient ischemic attack within the past 12 months, uncontrolled hypertension (systolic BP \> 160 mmHg, diastolic BP \> 90 mmHg), uncontrolled or symptomatic arrhythmia, or greater than grade 2 peripheral vascular disease

Where this trial is running

Fairway, Kansas and 6 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Triple Negative Breast CancerBreast CancerTumor infiltrating lymphocytesNeoadjuvant chemotherapyNeoadjuvant immunotherapy
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.