Capecitabine In Combination With Cemiplimab In Patient With Metastatic Breast Cancer (NCT05064085) | Clinical Trial Compass
CompletedPhase 1
Capecitabine In Combination With Cemiplimab In Patient With Metastatic Breast Cancer
United States13 participantsStarted 2021-10-12
Plain-language summary
This is a single-center, open-label, phase I study to assess the safety and efficacy of the oral chemotherapy capecitabine in combination with cemiplimab in patients with hormone-receptor-positive (HR+) metastatic breast cancer.
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:
* Able to provide a written informed consent and any locally required authorization prior to performing any protocol-related procedures,including screening evaluations.
* Female or male, age 18 years or older
* Eastern Cooperative Oncology Group (EGOG) performance status 0 through 2
* Pathologic confirmation of noninvasive breast cancer that is Hormone-receptor positive (HR+) (ER \[estrogen-receptor\] and/or PR \[progesterone-receptor\] \>/= 1%, locally advanced, or metastatic disease.
* Invasive breast cancer is Human Epidermal Growth Factor Receptor 2 (HER2) negative defined as 0 or 1+ by immunohistochemistry (IHC) or with an in situ hybridization (ISH) ratio (HER2 gene copy/chromosome 17) \< 2 or as defined by ASCO/CAP guidelines
* Measurable or non-measurable disease
* Any line of prior endocrine therapy in the unresectable and /or metastatic setting
* Adequate organ and marrow function as defined in protocol
* Participants must be willing and able to comply with the protocol for the duration of the study. This compliance includes undergoing treatment, scheduled visits, and examinations, including follow-up.
* If taking herbal or natural remedies that may have immune modulatory effects, participants must be willing to discontinue them before first dose of cemiplimab
* Body weight greater than 30 kg
Exclusion Criteria:
* Participation in another clinical study with an investigational product during the last 4 weeks
* Concurrent enrollment in another …
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
Recommended Phase 2 Dose (RP2D)
Timeframe: Up to 24 months
Trial details
NCT IDNCT05064085
SponsorH. Lee Moffitt Cancer Center and Research Institute