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 range
18 Years – 120 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pathological complete response (pCR) rate in high sTIL cohort with radiographic complete response