2026-08-17
minor
Study Status, Study Description, Arms and Interventions, Eligibility, Baseline Characteristics, Outcome Measures (Results), Adverse Events v25
Completion pushed: 2026-06-30 → 2026-12-30
Eligibility criteria-77 characters
Inclusion Criteria: -
Participants must have histologically confirmed hormone rec [...] ical Oncology/College of American Pathologists) guidelines.
-Men and pre- and postmenopausal women are eligible.
Ongoing [...] ale participants for at least 4 weeks prior to study entry.
-Participants must have radiological or objective evidence of [...] crine and CDK4/6 inhibitor regimen in the adjuvant setting.
--Participants must have previously been exposed to CDK4/6 inh [...] after combination endocrine and CDK4/6 inhibitor exposure.
--Participants must have remained on prior endocrine and CDK4/ [...] out progression for at least 6 mo [...]
2025-09-25
minor
Study Status, Study Description, Arms and Interventions, Eligibility, Baseline Characteristics, Outcome Measures (Results), Adverse Events v24
Eligibility criteria+77 characters
Inclusion Criteria: -Participants must have histologically confirmed hormone rece [...] ical Oncology/College of American Pathologists) guidelines.
-Men and pre- and postmenopausal women are eligible.
Ongoing [...] ale participants for at least 4 weeks prior to study entry.
-Participants must have radiological or objective evidence of [...] crine and CDK4/6 inhibitor regimen in the adjuvant setting.
--Participants must have previously been exposed to CDK4/6 inh [...] after combination endocrine and CDK4/6 inhibitor exposure.
--Participants must have remained on prior endocrine and CDK4/ [...] out progression for at least 6 mo [...]
Show 20 earlier versions
2023-11-21
minor
Study Status, Outcome Measures, Baseline Characteristics, Outcome Measures (Results), Adverse Events v20
Start date2017-08-09→2017-09-05
Results first postednot stated→2023-12-12
Secondary endpoints2 entries, revised
Overall Response Rate, According to RECIST v1.1 Criteria (Investigator Assessment)
2023-10-24
minor
Study Status, Outcome Measures, Document Section, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events, More Information v19
Secondary endpointsdetails revised at 2 of 2 entries
Primary endpoints1 entry, revised
Progression-Free Survival (PFS), According to RECIST v1.1 Criteria (Investigator Assessment)
2023-02-15
minor
Study Status v18
Re-verified, no change to tracked fields
2022-09-19
minor
Study Status v17
Primary completion date2022-08-31→2022-12-31
2022-03-18
minor
Study Status v16
Primary completion date2022-04-30→2022-08-31
2022-03-01
notable
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v15
Trial statusRecruiting→Active, Not Recruiting
Study sites23→22
2021-08-19
minor
Study Status v14
Primary completion date2021-12-31→2022-04-30
2021-05-20
minor
Study Status, Contacts/Locations v13
Study sitescontacts updated at 1 of 23 sites
2021-01-08
minor
Study Status, Contacts/Locations v12
Primary completion date2020-12-31→2021-12-31
Study sites22→23
2020-10-06
minor
Study Status v11
Re-verified, no change to tracked fields
2020-07-02
minor
Study Status, Contacts/Locations v10
Study sitesdetails revised at 2 of 22 sites
2020-03-31
minor
Study Status, Contacts/Locations v9
2020-02-04
minor
Study Status, Contacts/Locations v8
2019-11-05
minor
Study Status, Contacts/Locations v7
2019-07-01
minor
Study Status, Contacts/Locations v6
2019-05-24
minor
Study Status, Contacts/Locations v5
2019-02-06
minor
Study Status, Contacts/Locations v4
2018-06-25
minor
Study Status, Contacts/Locations v3
2017-08-13
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2017-08→confirmed 2017-08-09
Study sites1 entry, revised
Dana-Farber Cancer Institute
2017-07-27
minor
Study Status v1
Start date2017-06-30→2017-08