KEY TAKEAWAYS
- A Phase III, worldwide, multicenter, randomized GBG-AGO-B SASCIA trial tests iDFS in HER2-negative breast cancer patients with the remaining disease following NACT.
- SG has shown activity in extensively pretreated metastatic (HR)-positive/HER2-negative BC patients with metastatic TNBC.
- OS, distant disease-free survival, locoregional recurrence-free interval, safety, compliance, and patient-reported outcomes are the trial’s secondary aims.
- HR-positive breast cancer patients will receive local-guided endocrine treatment. Radiotherapy should precede study treatment.
The risk of recurrence is high for women with triple-negative breast cancer (TNBC) who have nodal involvement after neoadjuvant chemotherapy (NACT) or for those with hormone-receptor-positive/HER2-negative breast cancer(BC) who have a CPS (clinical and posttreatment pathological stage) +EG (estrogen receptor status and grade) score of 3 or score 2 and nodal involvement after NACT (ypN+).
Sacituzumab govitecan(SG) has shown activity in extensively pretreated patients with metastatic HR-positive/HER2-negative BC and has been licensed by the FDA to treat patients with metastatic TNBC who have received at least two prior therapies for the metastatic illness. After NACT, SG may offer a novel strategy for combating any remaining sickness. The GBG and the AGO-B are conducting a phase III randomized, multicenter, open-label, parallel-group trial (NCT04595565) called SASCIA. Patients must have had 16 weeks of NACT that included at least 6 weeks of a taxane to be considered. Patients should have centrally confirmed HER2-negative BC (IHC score 0-1 or FISH negative).
HR-negative (1%), with any residual invasive disease > ypT1mi, or HR-positive (1%), with a CPS+EG score ≥ 3 or CPS+EG score 2 and ypN+ using local ER and grade assessed on core biopsies taken before NACT. Before the start of the study’s treatment, radiotherapy should be administered. Participants are assigned a 1:1 chance to receive either standard care (observation), platinum-based chemotherapy (capecitabine 2000 mg/m² day 1-14 q21 or platinum-based chemotherapy, i.e., carboplatin AUC 5 q3w or AUC 1.5 weekly for eight 3 weekly cycles), or SG (10 mg/kg body weight, days 1, 8 q3w for eight cycles). Those with a positive or negative HR and no nodal involvement following NACT (ypN+, ypN-) are assigned to different groups. Patients diagnosed with HR-positive BC will receive endocrine-based treatment according to regional standards. Invasive disease-free survival (iDFS) is the key measure of success. To compare the two therapy groups regarding secondary objectives such as overall survival (OS, the primary endpoint), distant disease-free survival (iDFS), locoregional recurrence-free interval, safety, compliance, iDFS, and OS in designated subgroups. As of the 21st of June, 2021, 57/1200 patients in Germany have been assigned to a treatment group.
Source: http://app.core-apps.com/sabcs2021/abstract/a46bd879-0f91-4460-b98f-1bdc7b3724e2
Clinical Trial: https://clinicaltrials.gov/ct2/show/NCT04595565
Frederik Marmé, Marcus Schmidt, Jenny Furlanetto, Carsten Denkert, Anthony Goncalves, Elmar Stickeler, Mattea Reinisch, Silvia Antolín, Toralf Reimer, Wolfgang Janni, Philippe Aftimos, Michael Untch, Laura Michel, Marija Balic, Bruno Sinn, Volker Möbus, Patrick Morris, Laura Schöllhorn, Sabine Schmatloch, Julia Rey and Sibylle Loibl/Phase III postneoadjuvant study evaluating sacituzumab govitecan (SG), an antibody drug conjugate in primary HER2-negative breast cancer patients with high relapse risk after standard neoadjuvant treatment – SASCIA/2021 San Antonio Breast Cancer Symposium. (n.d.). App.core-Apps.com. Retrieved April 6, 2023, from http://app.core-apps.com/sabcs2021/abstract/a46bd879-0f91-4460-b98f-1bdc7b3724e2
