HER2 Breast Cancer

NCCN recommends ribociclib as a preferred CDK4/6 inhibitor adjuvant therapy for patients with HR+/HER2- EBC in combination with an aromatase inhibitor.

Multiple P13K inhibitors have showed promise in treating genetically-mutated forms of breast cancer.

The KEYNOTE-756 and CheckMate 7FL trials show this combination improves pathological complete response rates in this patient population.

The FDA also approved the FoundationOne Liquid CDx assay as a companion diagnostic device to identify patients who would benefit from the treatment.

The designation was based on results from the DESTINY-Breast06 trial, evaluating fam-trastuzumab deruxtecan-nxki (Enhertu; AstraZeneca, Daiichi Sankyo) compared with chemotherapy.

Pharmacists play a crucial role in supporting patients with HR+/HER2– breast cancer.

AC699 is being evaluated for patients with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2 negative (HER2–), estrogen receptor 1-mutated advanced or metastatic breast cancer with disease progression on or after at least 1 line of endocrine-based therapy.

Data presented at ASCO 2024 show fam-trastuzumab deruxtecan-nxki (T-DXd) delayed cancer growth in patients with hormone receptor-positive (HR+), HER2-low or -ultralow disease that progressed following endocrine therapy (ET).

The priority review of inavolisib is for treatment of patients with advanced hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation.

The investigators note that additional research is needed to confirm positive overall survival trends in this patient population.

Trastuzumab is indicated for adjuvant breast cancer, metastatic breast cancer, and gastric cancer.

The decision follows phase 3 trial results that demonstrated improved progression-free survival and confirmed the safety of Dato-DXd in patients with breast cancer.

Tucatinib significantly improved median PFS in the overall population and those with brain metastases.

pCR rates improve regardless of whether patients received full chemotherapy doses.

The combination resulted in numerically longer OS compared with an NSAI alone.

The candidate has already demonstrated anti-tumor activity in chemotherapy-naïve patients.

There is a prognostic impact of clinical and immunohistochemistry markers.

Improvements in PFS were also seen among patients with brain metastases.

pCR rates were improved with the addition of pembrolizumab regardless of whether patients received the full chemotherapy doses.

MONARCH 3 final OS data show that the combination of abemaciclib and a NSAI in the first-line resulted in numerically longer OS compared to an NSAI alone.

Patients with an estrogen receptor measure greater than 8% and those with little to no TIL expression showed no benefit with the addition of nivolumab.

Although PFS was improved in patients with unresectable locally advanced or metastatic HER2-positive breast cancer, OS data were immature, requiring further research.

Datopotamab deruxtecan (Dato-DXd; AstraZeneca, Daiichi Sankyo) also demonstrated improved overall survival compared to chemotherapy.

The combination regimen showed positive progression-free survival results among patients with HER2-positive breast cancer in the phase 3 HER2CLIMB-02 trial, but overall survival data have yet to mature.

There are currently no HER2-directed therapies for many HER2-expressing solid tumors that are refractory.

The trial was recommended to continue to analyze event-free survival rates, but current results are encouraging for treating estrogen receptor-positive, human epidermal growth factor receptor 2-negative breast cancer.

Because of its prevalence in approximately 50% of breast cancers, the outcomes of HER2-low treatment have a significant impact on patient outcomes.

Indication for abemaciclib (Verzenio; Eli Lilly and Company) in combination with endocrine therapy expanded for the adjuvant treatment of adults with hormone receptor–positive, human epidermal growth factor receptor 2-negative, node-positive, early breast cancer with a high risk of recurrence.

HER2-low disease demands a different approach from that of HER2-negative disease.

Sacituzumab govitecan-hziy (Trodelvy) is a conjugated Trop-2-directed antibody and topoisomerase inhibitor previously approved for patients with triple-negative breast cancer.