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June 2026 brought 5 FDA firsts across infectious disease, oncology, and rare disease, expanding treatment options and addressing unmet patient needs.

AI-guided breast screening is advancing faster than coverage policy, guidelines, and imaging capacity—raising questions about who qualifies and who pays.

Approval is granted for patients with PIK3CA wild-type disease who progressed after endocrine therapy, based on VIKTORIA-1's improved survival results.

Jennifer Sheng, MD, discusses how consistent follow-up, patient education, and lifestyle interventions improve breast cancer survivorship care.

Kazia Therapeutics advances paxalisib, a dual PI3K/mTOR inhibitor, into triple-negative breast cancer, boosting immunotherapy responses with early promising data.

Breast density raises cancer risk and masks tumors on mammography. Danielle Holt, MD, MSS, explains why density alone shouldn't trigger more imaging.

The FDA approved sacituzumab govitecan-hziy alone or with pembrolizumab as first-line therapy for metastatic triple-negative breast cancer.

FDA approves palbociclib (Ibrance) for HR+, HER2+ metastatic breast cancer maintenance, based on phase 3 PATINA data showing a 24% reduction in progression risk.

Investigators described the combinations as a potential new standard of care in second-line HR+/HER2− advanced breast cancer.

OPTIMA shows Prosigna guides chemo decisions in high‑risk HR+ early breast cancer, sparing two‑thirds without raising 5‑year recurrence risk.

I-SPY 2.2 of rilvegostomig plus trastuzumab deruxtecan in breast cancer treatment cut chemo use while exposing access issues and disparities.

Nancy Lin, MD, explores MMAI validation needs, turnaround advantages, equity implications, and how payers should approach AI-based diagnostics.

Rilvegostomig plus T-DXd achieved 57% pCR in HR+/immune+ HER2-negative breast cancer in I-SPY 2.2, potentially enabling surgery without chemotherapy.

Nancy Lin, MD, explains how an AI model compares with genomic classifiers in HR+/HER2- early breast cancer, with implications for cost and access.

By controlling for ovarian suppression, OPTIMA shows Prosigna works equally well in pre and postmenopausal high-risk early breast cancer.

OPTIMA trial data show genomic testing helps many patients with high‑risk breast cancer skip chemotherapy safely and start endocrine therapy sooner.

FDA decisions in May 2026 included 5 major oncology approvals, including first-in-class therapies for breast cancer, AML, MCL, and NMIBC.

Chemotherapy decisions for young women with HR+ breast cancer and low recurrence scores reveal testing disparities that health systems must address.

From biased trial enrollment to the emotional weight of a young diagnosis, Rani Bansal, MD, speaks to the gaps we need to close.

Rising ER-positive breast cancer in young women: risk factors, subtype differences, and when to push for screening and imaging.

Ontada finds that EHR-based education boosts NCCN guideline-concordant care for patients with HER2-low metastatic cancer, raising targeted treatment use among providers who took part in the education activities.

The FDA approves Datroway for first-line metastatic triple-negative breast cancer in immunotherapy-ineligible patients.

Breast cancer incidence climbs in young women under 40 and risk-based screening earlier may help reduce this, explains Rani Bansai, MD.

FDA approval brings Enhertu into early breast cancer treatment, boosting response before surgery and cutting recurrence risk after, reshaping care.

Deep learning model beats breast density for 5-year breast cancer risk, informing supplemental screening decisions and personalized care.


















