Onvansertib + Paclitaxel In TNBC (NCT05383196) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Onvansertib + Paclitaxel In TNBC
United States50 participantsStarted 2022-09-30
Plain-language summary
This research is being done to evaluate the safety and effectiveness of Onvansertib in combination with Paclitaxel in triple-negative breast cancer (TNBC) that has spread to other parts of the body.
The names of the study interventions involved in this study are:
* Onvansertib
* Paclitaxel
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:
* Histologically confirmed invasive breast cancer with unresectable locally advanced or metastatic disease, included inflammatory breast cancer
* Histologically or cytologically-confirmed triple negative breast cancer (defined as ER ≤ 10%, PR ≤ 10%, Her-2-neu negative per ASCO/CAP 2018 guidelines: 0-1+ by IHC or FISH-negative)
* Concurrent endocrine therapy will not be allowed for patients with ER/PR ≥1%
* Age ≥ 18 years
* ECOG Performance Status of 0 or 1.
* Subjects must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
* Subject is not receiving any other cancer therapy. Subjects participating in surveys or observational studies are allowed.
* Subjects with treated brain metastases that are stable on imaging for at least four weeks prior to registration and who are off steroid therapy are eligible. Subjects with small, asymptomatic incidental brain metastases that require no immediate treatment, including steroids, are also eligible.
* For a male or a woman of child-bearing potential (WOCBP): Must agree to use contraception or take measures to avoid pregnancy during the study and for 180 days of the final dose of any study drug.
* Adequate contraception is defined as follows:
* Complete true abstinence.
* Consistent and correct use of one of the following methods of birth control:
* Male partner who is sterile prior to the female …
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
Dose-Limiting Toxicity (DLT)-Phase Ib
Timeframe: during the first cycle of therapy (28 days).
2
Incidence of Grade 3 or Higher Treatment-Related Toxicity- Phase Ib
Timeframe: during the first cycle of therapy (28 days).
3
Overall Response Rate (ORR) Phase II
Timeframe: Every 8 weeks until disease progression, in average 24 weeks