PHARE

Incomplete

Pivot X, et al. "6 months versus 12 months of adjuvant trastuzumab in early breast cancer: final analysis of a multicentre,open-label, phase 3 randomised trial". The Lancet. 2019. :1979-1987.
PubMed • Full text • PDF

Clinical Question

In patients with Early Breast Cancer with HER2 overexpression, is 6-months adjuvant Trastuzumab non-inferior to the standard 12-months treatment ?

Major Points

Several small and large randomized trials in diabetics had previously suggested a sizable benefit of tight glycemic control in reducing cardiovascular risk. The ACCORD trial was the largest study of its kind and demonstrated that not only does euglycemia (ie, HbA1c <6%) not reduce cardiovascular risk, it also is associated with a trend towards increased mortality.

Outcomes

Comparisons are intensive therapy vs. standard therapy.

Primary Outcomes

Annual rate of nonfatal MI or nonfatal stroke or cardiovascular death

2.11% vs. 2.29% (HR 0.90; 95% CI 0.78-1.04; P=0.16)

Secondary Outcomes

Annual rate of death from any cause

1.41% vs. 1.14% (HR 1.22; 95% CI 1.01-1.46; P=0.04)

Annual rate of cardiovascular death

0.79% vs. 0.56% (HR 1.35; 95% CI 1.04-1.76; P=0.02)