A Phase II Study of Neoadjuvant Sacituzumab Govitecan and Pembrolizumab Therapy for Immunochemoth… (NCT05675579) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Phase II Study of Neoadjuvant Sacituzumab Govitecan and Pembrolizumab Therapy for Immunochemotherapy-resistant Early-stage Triple-negative Breast Cancer (TNBC)
United States27 participantsStarted 2023-05-23
Plain-language summary
To learn if sacituzumab govitecan and pembrolizumab, when given before surgery, can help to control early-stage triple negative breast cancer that has not responded well to other treatments.
Who can participate
Age range
18 Years
Sex
ALL
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
. Female or male patients 18 years of age or older.
. Histologically or cytologically confirmed breast cancer
. T1c N1-2 or T2-4 N0-2 early-stage disease
. ER/PR negative (ER/PR \<1%) or ER/PR low positive (1%≤ER/PR≤10%), and HER2 negative as per institutional and ASCO-CAP guidelines)
. Initiated the NAC with the first regimen of KN-522 regimen (i.e., pembrolizumab 200 mg Q3W, given with 4 cycles of paclitaxel + carboplatin).
. ECOG performance score of 0 or 1.
. The volumetric change of primary tumor = 0% or increase in volumetric size by US or MRI after completing the first part of the KN-522 regimen.
. Negative serum pregnancy test within 72 hours of receiving the first dose of the study medication for women of childbearing potential as per institutional guidelines. Postmenopausal women (defined as no menses for at least 1 year) and surgically sterilized women are not required to undergo pregnancy tests.
Exclusion criteria
. Stage IV disease
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
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Timeframe: through study completion; an average of 1 year.
. Any other previous antitumor therapies for the current cancer event.
. Pregnant or planning to become pregnant during therapy.
. Gastrointestinal tract disease or defect or previous history of colitis.
. Has an active autoimmune disease that requires systemic therapy within two years of treatment or a medical condition that requires immunosuppression.
. Myocardial infarction within 6 months before starting therapy, symptomatic congestive heart failure (New York Heart Association \> class II), unstable angina, or unstable cardiac arrhythmia requiring medication.
. Has known human immunodeficiency virus (HIV) infection or active hepatitis B or C infection (screen test is not required). Subjects positive for hepatitis C (HCV) antibody are eligible only if the polymerase chain reaction is negative for HCV RNA.