Ataraxis AI has published details of a two-stage artificial intelligence framework designed to predict pathological complete response (pCR) to neoadjuvant therapy in breast cancer patients using routine pre-treatment biopsy slides. The system, described in a technical report from the company, pairs two AI models (MORPHEUS, which estimates gene expression from histology images, and NEO, which […]
The FDA has approved palbociclib (Ibrance) in combination with trastuzumab, with or without pertuzumab, and endocrine therapy for maintenance treatment of HR-positive, HER2-positive locally advanced or metastatic breast cancer. Supported by the phase 3 PATINA trial, the regimen becomes the first CDK4/6 inhibitor-based maintenance option approved for this patient population.
The FDA has granted approval for fam-trastuzumab deruxtecan-nxki (T-DXd, Enhertu) for two indications in HER2-positive early-stage breast cancer, expanding treatment options in both neoadjuvant and adjuvant settings. The approvals are based on clinical trial data demonstrating improved efficacy outcomes compared with standard-of-care regimens. Clinical Takeaway T-DXd is now approved for neoadjuvant treatment followed by taxane, […]
In the phase 3 PATINA trial, adding the CDK4/6 inhibitor palbociclib to maintenance HER2-targeted and endocrine therapy significantly prolonged progression-free survival in patients with HR-positive, HER2-positive metastatic breast cancer following initial chemotherapy. The findings support CDK4/6 inhibition as a maintenance strategy, though increased rates of grade 3–4 neutropenia highlight the need for careful toxicity management.
The FDA has approved fam-trastuzumab deruxtecan-nxki (T-DXd; Enhertu) plus pertuzumab for first-line treatment of unresectable or metastatic HER2-positive breast cancer. Supported by Phase 3 DESTINY-Breast09 results, the regimen significantly improved progression-free survival and objective response rates compared with standard THP therapy, establishing a new frontline treatment option for HER2-positive disease.
This article reviews recent pivotal HER2+ breast cancer trials, highlighting oral TKIs, antibody-drug conjugates, and chemotherapy-sparing strategies. Key studies—including HER2CLIMB-05, DESTINY-Breast11, DESTINY-Breast09, and PHILA—demonstrate improved progression-free survival, higher pathologic complete responses, and durable disease control. These findings support innovative, biology-driven therapies that may reshape first-line and maintenance treatment paradigms in both early and metastatic HER2+ disease.
TUKYSA combo improves PFS in first-line HER2+ metastatic breast cancer maintenance, the first update to treatment paradigm since 2012.
Two years of Verzenio plus endocrine therapy shows OS benefit in high-risk HR+, HER2- early breast cancer at seven-year follow-up.