Radiotherapy in Combo With Chemo and Immunotherapy in Patients With PD-L1 Positive Metastatic TNBC (NCT05233696) | Clinical Trial Compass
WithdrawnPhase 2
Radiotherapy in Combo With Chemo and Immunotherapy in Patients With PD-L1 Positive Metastatic TNBC
Stopped: Low Accrual
United States0Started 2022-01-04
Plain-language summary
Patients with locally advanced unresectable or metastatic programmed cell death ligand (PD-L1) positive triple negative breast cancer (TNBC) will be treated with radiation to one-four sites of metastasis amenable to radiation (sites of disease to be selected at the discretion of the treating radiation oncologist) followed by initiation of systemic therapy with pembrolizumab plus nab-paclitaxel/paclitaxel. Patients will be treated with pembrolizumab plus nab-paclitaxel/paclitaxel within 7 days of completion of radiation. Repeat imaging of all sites of disease will be performed every 9 weeks and response will be assessed according to RECIST 1.1.
Who can participate
Age range
18 Years – 100 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
. Provision to sign and date the consent form including non-English speaking and non-reading participants.
. Stated willingness to comply with all study procedures and be available for the duration of the study.
. Male or female aged ≥ 18 years.
. Metastatic or locally advanced unresectable histologically documented TNBC as defined by absence of estrogen receptor (ER) and progesterone receptor (PR) expression and no HER2 amplification or over-expression by local pathology report.
. HER2 negativity is defined as either: in situ hybridization non-amplified (ratio of HER2 to CEP17 \< 2 or single probe average HER2 gene copy number \< 4 signals/cell OR IHC 0 or 1+).
. ER and PR negativity is defined as \< 1% positive by IHC.
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.
. Treatment with \< 1 prior line of systemic therapy in the metastatic setting or adjuvant/neoadjuvant setting if metastatic recurrence within 12 months of treatment.
. Confirmed PD-L1 positive as defined by Combined Positive Score (CPS) \> 10% by a CLIA-certified lab
Exclusion criteria
. Any of the following interventions within the specified time frame prior to radiation:
. Radiation therapy within 21 days.
. Cytotoxic chemotherapy within 21 days (capecitabine within 14 days).
. Monoclonal antibodies within 21 days.
. Administration of an investigational agent that is not expected to be cleared prior to initiation of radiation.
. More than one prior line of chemotherapy in the locally advanced unresectable or metastatic setting.
. Prior treatment with a taxane in the metastatic setting. Prior taxane in the curative setting is allowed if treatment was completed ≥ 6 months prior to metastatic recurrence.
. Prior receipt of immune checkpoint inhibitor (PD-L1, PD-1 or CTLA-4 inhibitors) less than 12 mos from metastatic recurrence.