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FDA Approves Palbociclib Plus Trastuzumab, With/Without Pertuzumab, and ET as Maintenance in HR+, HER2+ Metastatic Breast Cancer
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Drs Park and Iyengar discuss the evolving treatment paradigm for TNBC, the integration of metabolic health strategies, and the clinical emergence of ADCs.

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Megan Kruse, MD, discusses CDK4/6 inhibitor decision-making for patients with HR-positive breast cancer and future directions for oral SERD and ADC use.

Read a refresh of the top FDA news in breast cancer from May 2026, including several key approvals across ER-positive and triple-negative disease.

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Breast cancer data from ASCO 2026 confirm the clinical benefits of several investigational treatment approaches across disease subtypes.

The FDA will review data for adjuvant giredestrant in ER-positive, HER2-negative early-stage breast cancer after positive iDFS data from LidERA.

The FDA has approved the FoundationOne CDx as a companion diagnostic for inavolisib in HR-positive/HER2-negative, PIK3CA-mutated breast cancer.

HER3-DXd is being evaluated in the ongoing phase 3 HERTHENA-Breast04 trial in locally advanced or metastatic HR-positive, HER2-negative breast cancer.

A switch to camizestrant upon emergence of an ESR1 mutation improved PFS2 in ER-positive, HER2-negative advanced breast cancer.

Sacituzumab govitecan plus pembrolizumab improved PFS2 and delayed subsequent therapy vs chemo/pembrolizumab in PD-L1+ mTNBC.

Prespecified biomarker analyses of ASCENT-03 and ASCENT-04 showed longer PFS with sacituzumab govitecan–based regimens vs comparators in TNBC.

Rilvegostomig plus T-DXd yielded high pCR rates in immune-positive HER2-negative breast cancer.

Ahead of the 2026 ASCO Annual Meeting, results from the final analysis of the phase 3 KEYNOTE-522 study have been released.

Analyses from the evERA trial showed PFS2 and chemotherapy-free survival gains with giredestrant plus everolimus in ER+ breast cancer subgroups.

A prespecified subgroup analysis of the phase 3 lidERA trial showed an iDFS benefit with adjuvant giredestrant over SOC endocrine therapy in this population.

Roughly two-thirds of high-risk patients had low Prosigna scores and could safely omit adjuvant chemotherapy without compromising 5-year IBCFS.

Kelly Elizabeth McCann, MD, PhD, discusses the need for breast cancer research that encompasses drugs with different payloads.

Kelly Elizabeth McCann, MD, PhD, discusses the TROP2-directed ADCs that are clinically available for metastatic TNBC management.

The FDA extended the review period for camizestrant plus a CDK4/6 inhibitor in hormone receptor–positive breast cancer with an emergent ESR1 mutation.

A DSMB has recommended the continuation of the BRIA-ABC trial evaluating Bria-IMT in patients with metastatic breast cancer, with no safety concerns.

The FDA has published new sets of product-specific guidelines for investigating generic cancer treatments to guide proper evaluation of bioequivalence.

The top 5 OncLive TV videos of the week cover insights in breast cancer, ovarian cancer, prostate cancer, acute myeloid leukemia, and mantle cell lymphoma.

Yelena Novik, MD, notes the use of CDK4/6 inhibitors in ER-positive breast cancer and the role of oral SERDs in the management of select metastatic cases.













































































