Trilaciclib in Patients Receiving Sacituzumab Govitecan-hziy for Triple Negative Breast Cancer (NCT05113966) | Clinical Trial Compass
TerminatedPhase 2
Trilaciclib in Patients Receiving Sacituzumab Govitecan-hziy for Triple Negative Breast Cancer
Stopped: The Sponsor decided to close enrollment to the study on Feb 14, 2023, in order to reallocate resources to other ongoing trilaciclib clinical trials.
United States30 participantsStarted 2021-12-08
Plain-language summary
This was a Phase 2, multicenter, open-label, single-arm study evaluating the safety and efficacy of trilaciclib administered prior to sacituzumab govitecan-hziy in participants with unresectable, locally advanced or metastatic triple-negative breast cancer (TNBC) who received at least 2 prior treatments, at least 1 in the metastatic setting.
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
. Adult ( ≥18 years of age), female or male participant with measurable (per RECIST v1.1), unresectable locally advanced or metastatic TNBC
. Documentation of histologically or cytologically confirmed ER-negative, PR-negative, and HER2-negative tumor per the American Society of Clinical Oncology (ASCO) and the College of American Pathologists (ASCO/CAP) criteria.
. Measurable disease as defined by RECIST v1.1.
. Considered to be eligible to receive sacituzumab govitecan-hziy treatment, in the Investigator's judgment.
. Participants must have received 2 or more prior lines of systemic therapy, at least one of them in the metastatic setting.
. Radiation therapy for metastatic disease is permitted as long as the participant has at least 1 measurable lesion that has not been irradiated. Participants should be sufficiently recovered from the effects of radiation as determined by the Investigator but must have completed radiotherapy at least 2 weeks prior to enrollment.
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.
. Adequate organ function as demonstrated by the following laboratory values:
Exclusion criteria
. Prior treatment with trilaciclib, sacituzumab govitecan-hziy, irinotecan, Trop-2 antibody drug conjugate, or any therapy with a topoisomerase-1 payload.
. Participants with known brain metastasis at enrollment.
. Participants with known Gilbert's disease or known homozygous for the UGT1A1\*28 allele.
. Participants with bone-only disease.
. Malignancies other than TNBC within 3 years prior to enrollment. Participants with malignancies of a negligible risk of metastasis or death (e.g., risk of metastasis or death \<5% at 5 years as determined by the Investigator) are eligible provided they meet all of the following criteria:
. Malignancy treated with expected curative intent (e.g., adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, or ductal carcinoma in situ treated surgically with curative intent);
. No evidence of recurrence or metastasis by follow-up imaging and any disease-specific tumor markers.
. History of clinically significant gastrointestinal bleeding, intestinal obstruction, or gastrointestinal perforation within 6 months of enrollment.