2025-06-04
minor
Study Identification, Study Status, Oversight, Contacts/Locations v16
Show 15 earlier versions
2024-09-04
minor
Study Identification, Study Status, Oversight, Contacts/Locations, IPDSharing v15
Study sitescontacts updated at 10 of 10 sites
2024-04-15
minor
Study Status v14
Primary completion date2024-04-01→2026-04-01
Completion date2027-04-01→2029-04-01
2023-08-10
minor
Study Status, Contacts/Locations v13
2023-07-24
minor
Study Status, Sponsor/Collaborators, Contacts/Locations v12
2022-11-14
minor
Study Status, Contacts/Locations v11
2022-11-02
minor
Study Status, Contacts/Locations v10
Study sitescontacts updated at 1 of 7 sites
2022-03-15
minor
Study Status, Contacts/Locations v9
2021-12-20
minor
Study Status, Sponsor/Collaborators, Study Description, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v8
Primary completion date2023-06-01→2024-04-01
Completion date2026-06-01→2027-04-01
Eligibility criteria-135 characters
[...] s must have evaluable or measurable disease per RECIST 1.1.
See Section 11 for the assessment of measurable disease.
For instance, patientsPatients with bone only disease will be allowed to participate.
Part [...] to CTCAE v5.0 grade 1 or lower, unless otherwise specified inper 3.1.13protocol, except alopecia can be any grade and neuropathy can be gra [...] to CTCAE v5.0 grade 1 or lower, unless otherwise specified inper 3.1.13protocol.
Prior radiation therapy: Patients may have received prior [...] ation therapy.
Radiation therapy must be completed at least 147 days prior to study treatment initiation, and all [...] [...]
Secondary endpointsdetails revised at 3 of 7 entries
Study description+65 characters
[...] ic disease.
The U.S. Food and Drug Administration (FDA) has not approved Pembrolizumab for metastatic triple-negative breast cancer, but it hasis beencurrently approved only for otherpatients useswith PD-L1-positive metastatic triple-negative breast cancer.
In this research study, we are:
Studying Sacituzumab Govit [...]
Study sitescontacts updated at 1 of 6 sites
2021-09-30
minor
Study Status, Contacts/Locations v7
2021-05-07
minor
Study Status, Study Description, Eligibility, Contacts/Locations v6
Eligibility criteria-169 characters
[...] infiltrating immune cells (IC) by the PD-L1 IHC SP142 assay or a Combined Positive Score (CPS) less than 10 by the PD-L1 IHC 22C3 assay measured with standard of care testing.
Participants must be [...] .
Note: Reimaging at baseline post-treatment is not required, but baseline scans should be after radiation or surgery or within 21 days of randomization.
Any corticosteroid use for brain metastases must have been [...] ed starting with the first dose of study medication through 150180 days (56 months) after the last dose of study medication.
Examples o [...] for the duration of study treatment with pembrolizumab [...]
2021-03-10
minor
Study Status, Contacts/Locations v5
2021-02-01
minor
Study Status, Contacts/Locations v4
Study sitesdetails revised at 1 of 2 sites
2020-12-29
minor
Study Status, Contacts/Locations v3
2020-10-14
minor
Study Identification, Study Status, Eligibility v2
Eligibility criteria+74 characters
[...] ve radiation (≤2 weeks of radiotherapy) to non-CNS disease.
Stable, previouslyPreviously treated brain metastases are permitted, with the following provisions:
Prior SRS should complete ≥ 7 days before study treatment initiation
Prior WBRT or SBRT should complete ≥ 14 days before study treatment initiation [...] articipants with creatinine levels above institutional ULN.
Note: Criteria must be met without erythropoietin dependency and without packed red blood cells.
Female subjects of childbearing potential must have a negati [...] ed risk for neutropenia and diarrhea related to irinotecan.
Note: Concurrent [...] [...]
2020-07-20
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2020-08→confirmed 2020-07-20
Study sitesdetails revised at 1 of 1 site