2026-06-29
minor
Study Status, Study Design, Outcome Measures, Document Section, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events, More Information v20
Enrollment targetestimated 62→confirmed 66
Secondary endpoints4 entries, revised
pCR rateRate (in ER+/HER2- BCBreast patients)Cancer
ChangesTILs inand TILspCR
Rate of Residual Cancer Burden (RCB)-0/1 responseResponse
Number of Participants With Treatment-Related NCI Common Terminology Criteria forrelated Adverse Events (CTCAE) version 5.0
Primary endpoints2 entries, revised
TheChange numberin andTumor-infiltrating proportionLymphocytes of participants achieving (TILs)
Pathologic Complete Response (pCR)
Tumor-infiltrating lymphocytesRate (TILs)in TNBC
Show 16 earlier versions
2025-04-23
notable
Recruiting→Active, Not Recruiting Study Identification, Study Status, Contacts/Locations v16
Trial statusRecruiting→Active, Not Recruiting
Study sites9→8
Study titlerevised
Niraparib + Dostarlimab inIn BRCA Mutated Breast Cancer
2024-09-04
minor
Study Identification, Study Status, Contacts/Locations, IPDSharing v15
Study sitescontacts updated at 8 of 9 sites
Study titlerevised
Niraparib + Dostarlimab Inin BRCA Mutated Breast Cancer
2024-05-28
minor
Study Status, Eligibility v14
Primary completion date2024-07-17→2025-07-17
Eligibility criteriarevised
[...] st cancer Stage I to III with primary tumor size at least 1.50 cm defined by physical exam or imaging (whichever is larger [...] ntric, or bilateral disease, the largest lesion must be ≥ 1.50 cm and designated as the "index" lesion for tumor evaluatio [...] ergone any major surgery within 3 weeks prior to study entry:
, patients must have recovered to baseline from any effects of [...]
2023-10-13
minor
Study Status, Contacts/Locations v13
2023-08-07
minor
Study Status, Contacts/Locations v12
2023-02-13
minor
Study Status, Contacts/Locations v11
Study sitesdetails revised at 1 of 7 sites
2022-11-11
minor
Study Status, Contacts/Locations v10
Study sitesdetails revised at 1 of 7 sites
2022-09-15
minor
Study Status, Contacts/Locations v9
2022-08-15
minor
Study Status, Contacts/Locations v8
2022-06-27
minor
Study Identification, Study Status, Study Description, Conditions v7
Study title+5 characters
Niraparib + TSR042Dostarlimab In BRCA Mutated Breast Cancer
2022-03-16
minor
Study Status, Contacts/Locations v6
Study sitesdetails revised at 1 of 7 sites
2022-03-04
minor
Study Status, Contacts/Locations v5
2021-11-15
minor
Study Status, Eligibility v4
Eligibility criteria+7 characters
[...] Participants must have documented germline mutation in BRCA1, BRCA2 or BRCA2PALB2 that is deleterious or suspected to be deleterious (known o [...]
2021-05-13
minor
Study Status v3
Start dateestimated 2021-03→confirmed 2020-12-18
2020-12-31
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Study sitesdetails revised at 3 of 3 sites
2020-12-07
minor
Study Status, Study Description, Arms and Interventions, Outcome Measures, Eligibility v1
Eligibility criteria+59 characters
[...] a are not eligible.
Participants must have documentation of estrogen receptor (ER) and progesterone receptor (PR) testing by IHC according to local institutional guidelines [...] R status is not required.
All tumors must be HER2 negative.
-- Arms A and B: Target lesion must be ER and PR negative (<10% [...] acquisition (a needle aspiration, core biopsy) is required.
Sentinel Lymph Node (SLN) biopsy before neoadjuvant therapy is not allowed.
ECOG perf [...] ry tumor and/or excision of axillary lymph nodes, including sentinel lymph node biopsy (SLNB), prior to study treatment.
Participants with a history of m [...] hin 12 [...]
Secondary endpoints4 entries, revised
Rate of Residual Cancer Burden (RCB) 0/1 response
Study description-4 characters
[...] and if it is effective in treating this type of cancer.
The FDA (the U.S. Food and Drug Administration (FDA) has not yet approved either of the drugs in this study for [...]