Dr Barot on the FDA Approval of Palbociclib/Trastuzumab ± Pertuzumab in HER2+ Breast Cancer

“This [regimen] will help [us] target multiple pathways that are driving cancer at the same time and delay more cytotoxic…treatments for later lines by extending the PFS by doing this maintenance targeted strategy.”

Shimoli Barot, MD, a breast medical oncologist at Cleveland Clinic, discussed the significance of the June 2026 FDA approval of palbociclib (Ibrance) in combination with trastuzumab (Herceptin), with or without pertuzumab (Perjeta), and endocrine therapy for the maintenance treatment of adult patients with hormone receptor–positive, HER2-positive locally advanced or metastatic breast cancer following induction therapy, an indication supported by data from the phase 3 PATINA trial (NCT02947685).

Barot began by explaining that PATINA evaluated the addition of palbociclib to a maintenance strategy of trastuzumab, with or without pertuzumab, plus endocrine therapy—the prior standard of care in the first-line metastatic setting—following the completion of 4 to 8 cycles of induction chemotherapy plus HER2-targeted therapy. Barot emphasized that this approach led to an improvement in progression-free survival (PFS) vs the same regimen without palbociclib. The median PFS was 44.3 months (95% CI, 32.4-60.9) with the addition of palbociclib (n = 261) compared with 29.1 months (95% CI, 23.3-38.6) in the control arm (n = 257), representing an improvement of 15.2 months (HR, 0.74; 95% CI, 0.58-0.94; P = .0074). She noted that these exciting data emerged over the past year at conferences, and that the field had been eagerly awaiting the approval of the combination, which arrived as welcome news.

Barot emphasized the broader therapeutic rationale for the PATINA regimen, explaining that it simultaneously targets multiple pathways that drive hormone receptor–positive, HER2-positive breast cancer. By extending PFS through a maintenance targeted strategy, the approach allows the delay of more cytotoxic treatments until later lines of therapy, she noted. Barot concluded that these are exciting data with meaningful implications for patient care in this setting.