Neoadjuvant TIL- and Response-Adapted Chemoimmunotherapy for TNBC (NCT05645380) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Neoadjuvant TIL- and Response-Adapted Chemoimmunotherapy for TNBC
United States139 participantsStarted 2022-12-05
Plain-language summary
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.
Who can participate
Age range18 Years – 120 Years
SexFEMALE
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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 t…
What they're measuring
1
Pathological complete response (pCR) rate in high sTIL cohort with radiographic complete response