This study will assess if the presence of immune system cells in and around the tumor impacts tumor shrinkage in patients receiving neoadjuvant chemoimmunotherapy for triple-negative breast cancer.
Triple negative breast cancers (TNBC) with enrichment of immune system cells in and around the tumor are more sensitive to chemoimmunotherapy and have better prognosis. Imaging is often used during the course of neoadjuvant chemoimmunotherapy to monitor how the disease is responding to treatment, and disappearance of a patient's tumor on imaging after chemoimmunotherapy usually means that the tumor will have completely disappeared when the patient goes for surgery. This study will test whether the presence of immune system cells in and around the tumor and the response of the tumor on MRI can be used to personalize the type and amount of neoadjuvant chemoimmunotherapy for patients with TNBC.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
139
The University of Kansas Cancer Center - Clinical Research Center
Fairway, Kansas, United States
RECRUITINGThe University of Kansas Cancer Center - Main Hospital
Kansas City, Kansas, United States
RECRUITINGPathological complete response (pCR) rate in high sTIL cohort with radiographic complete response
Defined as percentage of participants who achieve pathological complete response in the breast and axilla. Pathological complete response is defined as no evidence of invasive disease in the breast (residual DCIS permitted) and axilla at the time of pathology review.
Time frame: Up to 26 weeks
Residual cancer burden (RCB) 0+1 rate in high sTIL cohort with radiographic complete response
Defined as summed percentage of participants with RCB=0 and RCB=1 in the breast and axilla. Residual cancer burden score for each patient is calculated using surgical pathology parameters using an online tool (http://www3.mdanderson.org/app/medcalc/index.cfm?pagename=jsconvert3).
Time frame: Up to 26 weeks
pCR and RCB 0+1 in intermediate sTIL cohort
Percentage of participants with intermediate sTILs who achieve pCR (RCB=0) and RCB=0+RCB=1.
Time frame: Up to 26 weeks
pCR and RCB 0+1 in low sTIL cohort
Percentage of participants with low sTILs who achieve pCR (RCB=0) and RCB=0+RCB=1.
Time frame: Up to 32 weeks
Recurrence-free, event-free, and overall survival
Recurrence-free survival is defined as the time from diagnosis to first recurrence (invasive ipsilateral breast, invasive local/regional, or distant), or to death as a result of any cause., event-free survival is defined as time from diagnosis to first recurrence (invasive ipsilateral breast, invasive local/regional, or distant), or to breast cancer related death, and overall survival is defined as time from diagnosis to death from any cause.
Time frame: Up to 5 years
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600 mg/m2, IV
200 mg, IV
The University of Kansas Cancer Center - Westwood
Kansas City, Kansas, United States
The University of Kansas Cancer Center - Overland Park
Overland Park, Kansas, United States
RECRUITINGThe University of Kansas Cancer Center - North
Kansas City, Missouri, United States
RECRUITINGThe University of Kansas Cancer Center - Lee's Summit
Lee's Summit, Missouri, United States
RECRUITINGUniversity of Kansas Cancer Center at North Kansas City Hospital
North Kansas City, Missouri, United States
RECRUITING