Just a simple update...though Dr Sara does make mention of impressive cabozantinib results wrt bone mets. Both ER pos & Triple neg studies are touched on... No results, but I wouldn't expect any short of an appropriate delivery forum. We're due... I believe Drs Sara Tolaney and Michaela Higgins are conducting this IST out of Mass Gen.
Triple negative breast cancer will be good comparison of Cabo and Foretinib. Foretinb ASCO 2012 data didn't include bone met data unfortunately. The conclusion described pretreated bone biopsy, and CTC collection for stage 2 enrollment of 15 patients though. 7% tumor response rate by recist criteria.
Odd that the lone response by recist was MET negative, and all other 4 MET negative progressed as best response. Of MET positive 5/8 had stable disease as best response.
Results: Accrual is 29 pts to date; 24 are eligible, 22 evaluable for toxicity and 15 for response. Median age is 56 y (43-81), ECOG PS 0-1 in 23/24. Grade 3 laboratory adverse events were: lymphopenia (9%), elevations in ALT (5%), GGT (5%) and INR (5%). Treatment-related non-hematologic toxicities included (all/grade 3-4) fatigue (64%/5%), nausea (55%/5%), diarrhea (41%/5%), hypertension (32%/14%), vomiting (27%/0%), anorexia (23%/5%) and rash (14%/0%). Three SAEs possibly related to foretinib included; asymptomatic pulmonary embolism, reversible CHF and pleural effusion with QTc prolongation. One PR (7%), 8 early PD (53%) and 6 SD (40%) have been observed to date with median SD duration of 5.4 months (range 2.7-5.5). Preliminary correlative results (IHC): 5/8 (62.5%) evaluable Met positive cases had SD and 4/5 (80%) Met negative cases had PD as best response. Met IHC was negative in the pt with PR. Conclusions: Foretinib shows preliminary evidence of activity and tolerability in metastatic, TN breast cancer. Stage 2 of accrual will include 15 pts with pre-treatment biopsies of metastases and circulating tumor cell collection.