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Sacituzumab Govitecan in Primary HER2-negative Breast Cancer

Study acronym: SASCIA
StatusActive, Not Recruiting
PhasePhase 3
Started2020-10-28
View on ClinicalTrials.gov ↗

Amendment history

2026-04-17
Study Status, Contacts/Locations v11
Study sites163 entries, revised
GemeinschaftspraxisMVZ Dr.InnMed-Filiale U.Traunstein Knappschaft Kronawitter/Kliniken Dr. C. Jung Marienhospital Bottrop gGmbHGmbH, Klinik für Gynäkologie und Geburtshilfe
2025-11-24
Study Status, Contacts/Locations v10
Study sites163 entries, revised
InstitutMVZ fürHämatologie-Onkologie VersorgungsforschungMayen/Koblenz GmbH
2025-03-27
Study Identification, Study Status, Oversight, Contacts/Locations, IPDSharing, References v9
Study sitesdetails revised at 3 of 163 sites
Publicationsdetails revised at 1 of 1 entry
2024-11-20
Study Identification, Study Status, Oversight, Contacts/Locations, IPDSharing, References v8
Study sites163 entries, revised
StudienzentrumMVZ für Hämatologie und Onkologie Ravensburg GmbH
Publicationsdetails revised at 1 of 1 entry
2024-06-14
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v7
Trial statusRecruiting→Active, Not Recruiting
Study sites179→163
Show 6 earlier versions
2023-02-28
Study Status, Study Description, Study Design, Outcome Measures, Eligibility, Contacts/Locations, References v6
Primary completion date2026-12-01→2027-03-30
Completion date2028-12-01→2029-03-30
Enrollment target1200→1332
Study sites162→179
Eligibility criteria+726 characters
[...] her: For HR-negative: any residual invasive disease > ypT1mi and/or ypN1>1mm For HR-positive disease: a CPS+EG score ≥ 3 or CPS+EG score [...] core biopsies taken before start of neoadjuvant treatment. Germline BRCA1/2 mutated or wildtype/unknown. Adequate surgical treatment including resection of clinicall [...] dissection before NACT is not permitted. Axillary dissection, isincluding notTargeted requiredAxillary in patients with a negative sentinel-node biopsy beforeDissection (pN0, pN+(mic)TAD) orshould afterbe (ypN0,performed ypN+(mic))according neoadjuvantto chemotherapyguidelines. Histologic complete [...] [...]
Secondary endpoints12 to 13 entries
To compare the invasive breast cancer-free survival (iBCFS) between both groups.
Study description+962 characters
[...] a pCR have a 5-year event free survival rate of about 50%. , , The association between pCR and prognosis is less pronounced [...] h T-DM1, an antibody-drug-conjugate compared to trastuzumab. Sacituzumab govitecan has demonstrated unprecedented activity in heavily pretreated patients with metastatic triple-negative and HR-positive/HER2-negative breast cancer, even after prior immune-checkpoint inhibitors or CDK4/6 and mTOR inhibitors. Based on the results of the phase I/II study, sacitu [...]
Publications+360 characters
Marmé F, Hanusch C, Furlanetto J, et al. Safety interim analysis (SIA) of the phase III postneoadjuvant SASCIA study evaluating sacituzumab govitecan (SG) in patients with primary HER2-negative breast cancer (BC) at high relapse risk after neoadjuvant treatment. ESMO Breast 2022; 58O, proffered pape [...]
2022-11-02
Study Status, Contacts/Locations v5
Study sites107→162
2022-04-13
Study Identification, Study Status, Sponsor/Collaborators, Oversight v4
Collaborators1 to 6 entries
Austrian Breast & Colorectal Cancer Study Group Spanish Breast Cancer Research Group (GEICAM) ETOP IBCSG Partners Foundation Cancer Trials Ireland UNICANCER
2021-11-16
Study Status, Contacts/Locations v3
Study sites32→107
2020-12-11
Study Status, Contacts/Locations v2
Study sites30→32
2020-11-17
Not Yet Recruiting→Recruiting Study Status, Outcome Measures, Eligibility, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2020-10-16→confirmed 2020-10-28
Study sites0→30
Eligibility criteria+1 characters
[...] n in the study, including Gilbert´s disease, Crigler-Najjar-SyndromSyndrome, known hepatitis B, hepatitis C, known HIV positivity or kn [...]
Secondary endpoints10 to 12 entries
Patient reported outcomesoutcome: QualityFunctional Assessment of lifeCancer Therapy - Breast Cancer (FACT-B) Patient Qualityreported outcome: Functional Assessment of lifeCancer Therapy - Cognitive function issues (FACT-Cog) Patient Qualityreported ofoutcome: lifeHealth Questionnaire 5-Level EQ-5D (EQ-5D-5L)
2020-10-14
Original filing
Phase III, prospective, multi-center, randomized, open label, parallel group, study in patients with HER2-negative breast cancer with residual disease after neoadjuvant chemotherapy with 1:1 allocation to: * Arm A: Sacituzumab govitecan (days 1, 8 q3w for eight cycles); * Arm B: treatment of physician´s choice (TPC, defined as capecitabine or platinum-based chemotherapy for eight cycles or observation. Treatment in either arm will be given for eight cycles. In patients with HR-positive breast cancer, endocrine-based therapy, which includes the use of CDK4/6 inhibitors, will be administered according to local guidelines. The start of endocrine therapy will be at the discretion of the investigator; however, it will be encouraged to start after surgery/radiotherapy in patients without additional cytotoxic agents. Adjuvant pembrolizumab can be given until the completion of radiotherapy before randomization. Within the study the use of pembrolizumab in patients with TNBC who received pembrolizumab as neoadjuvant therapy is allowed as monotherapy in the TPC arm, according to the approval of pembrolizumab in this setting.
Trial Details
NCT Number NCT04595565
Lead Sponsor GBG Forschungs GmbH
Collaborators: Gilead Sciences, Austrian Breast & Colorectal Cancer Study Group, Spanish Breast Cancer Research Group (GEICAM), ETOP IBCSG Partners Foundation, Cancer Trials Ireland, UNICANCER
Conditions HER2-negative Breast Cancer, Triple Negative Breast Cancer
Enrollment 1,332 participants
Start Date 2020-10-28
Primary Completion 2027-03-30 (estimated)
Study Completion 2029-03-30 (estimated)
Updated on ClinicalTrials.gov 2026-04-22