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Atezolizumab + Sacituzumab Govitecan to Prevent Recurrence in TNBC (ASPRIA)

StatusRecruiting
PhasePhase 2
Started2020-07-02
View on ClinicalTrials.gov ↗

Amendment history

2026-04-28
Study Status, Contacts/Locations v16
Study sitesdetails revised at 4 of 7 sites
2025-08-14
Active, Not Recruiting→Recruiting Study Status, Study Description, Study Design, Contacts/Locations v15
Trial statusActive, Not Recruiting→Recruiting
Primary completion date2025-12-30→2026-12-30
Study sites9→7
2024-10-08
Study Status v14
Re-verified, no change to tracked fields
2024-01-22
Study Status v13
Primary completion date2023-12-30→2025-12-30
Completion date2025-12-30→2027-12-30
2023-06-19
Recruiting→Active, Not Recruiting Study Status, Sponsor/Collaborators, Study Design, Contacts/Locations v12
Trial statusRecruiting→Active, Not Recruiting
Study sitesdetails revised at 9 of 9 sites
Show 11 earlier versions
2022-05-25
Study Status, Contacts/Locations v11
Study sites8→9
2022-05-02
Study Status, Contacts/Locations v10
Study sites5→8
2022-04-20
Study Status, Eligibility, Contacts/Locations v9
Study sites3→5
Eligibility criteria-58 characters
[...] Cockcroft-Gault equation Serum albumin ≥ 25 g/L (2.5 g/dL) Fasting glucose < 150 mg/dL and hemoglobin (HBA1c) < 7.5% For patients not receiving therapeutic anticoagulation: INR [...]
2022-03-15
Study Status, Contacts/Locations v8
Study sites2→3
2022-03-07
Study Status, Contacts/Locations v7
Study sites1→2
2021-10-20
Suspended→Recruiting Study Status, Contacts/Locations v6
Trial statusSuspended→Recruiting
Reason stoppedStudy team plans to revise one of the agents used in the treatment plan of the study.→not stated
Study sitesdetails revised at 1 of 1 site
2021-09-06
Study Identification, Study Status, Study Description, Arms and Interventions, Outcome Measures, Eligibility v5
Primary completion date2022-04-30→2023-12-30
Completion date2024-04-30→2025-12-30
InterventionsAtezolizumab (Drug), Ipatasertib (Drug)→Atezolizumab (Drug), Sacituzumab govitecan (Drug)
Eligibility criteria+664 characters
[...] must contain at least 2mm of invasive disease. HER2 negative in primary tumor pre-treatment by local pathology assessed according to current ASCO/CAP g [...] pal Investigator to establish eligibility ER and PR negative in primary tumor pre-treatment defined as < 10% of cells expressing hormonal receptors via [...] emotherapy prior to breast surgery. Patients must be within 124 months of lastcompletion of all locoregional therapy (definitiveeither breastlast surgery or last dose of radiation, radiationwhichever and/oris alllater) intended adjuvant therapy). Definitive breast surgery must have been performed [...] [...]
Secondary endpoints7 entries, revised
NumberRate of Participantsundetectable Withcirculating Treatmenttumor cfDNA -Related Adverse1 EventsCycle
Study description+261 characters
This is an open label single-arm phase II study to evaluate the combination therapy of the AKTantibody inhibitordrug conjugate, ipatasertibsacituzumab govitecan, and the anti-PD-L1 antibody, atezolizumab, in patients wit [...] esearch study involves the following investigational drugs: IpatasertibSacituzumab govitecan Atezolizumab Participants will receive study treatment for 2418 weeks and will be followed for every 6 months for 3 years. [...] he U.S. Food and Drug Administration (FDA) has not approved ipatasertibsacituzumab asgovitecan (Trodelvy) for your specific disease, but it has been approved for pa [...] [...]
Study title+19 characters
IpatasertibAtezolizumab + AtezolizumabSacituzumab Govitecan to Prevent Recurrence in TNBC (ASPRIA)
2020-10-19
Recruiting→Suspended Study Status, Contacts/Locations v4
Trial statusRecruiting→Suspended
Reason stoppednot stated→Study team plans to revise one of the agents used in the treatment plan of the study.
Study sitesdetails revised at 1 of 1 site
2020-09-18
Study Status, Eligibility v3
Eligibility criteria-96 characters
[...] or to establish eligibility ER and PR negative defined as < 110% of cells expressing hormonal receptors via IHC analysis by [...] received neoadjuvant chemotherapy prior to breast surgery. Investigational agents as part of the neoadjuvant regimen are allowed, with the exception of PI3K/Akt/mTor inhibitors and/or immune checkpoint inhibitors. Patients must be within 12 months of last therapy (definitiv [...] ents (bisphosphonates or rank-ligand inhibitors)is allowed. Prior treatment with an immune checkpoint inhibitor in the neoadjuvant or adjuvant setting is permitted. ECOG Performance Status of 0 or 1 Men [...] [...]
2020-08-17
Study Status v2
Start dateestimated 2020-07→confirmed 2020-07-02
2020-07-07
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start date2020-06→2020-07
Study sitesdetails revised at 1 of 1 site
2020-06-14
Original filing
The purpose of this study is to determine if a combination of two drugs sacituzumab govitecan and atezolizumab works as a treatment for residual cancer in the breast or lymph nodes and have circulating tumor DNA in the blood. This research study involves the following investigational drugs: * Sacituzumab govitecan * Atezolizumab
Trial Details
NCT Number NCT04434040
Lead Sponsor Dana-Farber Cancer Institute
Collaborators: Genentech, Inc., Stand Up To Cancer
Conditions Breast Cancer, Triple Negative Breast Cancer, Residual Cancer, Circulating Tumor DNA
Enrollment 40 participants
Start Date 2020-07-02
Primary Completion 2026-12-30 (estimated)
Study Completion 2027-12-30 (estimated)
Updated on ClinicalTrials.gov 2026-05-04