The incidence of stage IV breast cancer increased significantly overall, across ages, and for both sexes from 2010 through 2021, according to research from a Dana Farber-led team. The percentage of patients with stage IV breast cancers, versus those with stages I to III diagnoses also increased.
Notably, this increase was seen for all tumor subtypes in both sexes.
The researchers write, “These findings suggest that efforts are needed to determine factors contributing to these increases and to identify breast cancer before patients present with de novo stage IV disease.”
The study appears this week (May 12 issue) in JAMA Network Open. The senior author is José P. Leone, MD, department of medical oncology, Dana-Farber Cancer Institute and Harvard Medical School, Boston.
In their analysis of data from over 700,000 U.S. patients, the incidence of stage IV breast cancer increased significantly by 1.2% per year, and the percentage of people with stage IV also increased significantly. Stage IV incidence increased widely across all ages, races, sexes, and tumor subtypes. Still, survival improved significantly from 2010 through 2021.
Stage IV incidence increased across all tumor subtypes in both sexes. In women, those subtypes include hormone receptor (HR)–positive/ERBB2-negative, HR-positive/ERBB2-positive, HR-negative/ERBB2-positive, and triple-negative disease.
Trends in the incidence of de novo stage IV breast cancer “remain underreported,” these authors write. A previous study evaluating incidence of distant disease in the U.S. before 2010 showed a statistically significant increase in incidence for younger patients and a statistically significant decrease in older patients. But, this current study’s authors said, a meta-analysis reported a decreasing percentage of stage IV presentation over time.
Breast cancer is the second most common cancer in women, behind skin cancer. It is the most common cancer diagnosed in females worldwide and an estimated 30% of patients develop metastases. The American Cancer Society estimates 42,140 U.S. women will die from breast cancer in 2026.
The incidence of breast cancer in younger women, in particular, has been rising. In August 2025, the CDC reported that: “Most breast cancers occur in older women, but rates have been increasing slowly among women younger than 45 years in all racial and ethnic groups.” The agency added that survival from breast cancer is improving “among women in most racial and ethnic groups.”
Breast cancer in men remains rare, but the rate is increasing also.
This population-based cohort study used data from the Surveillance, Epidemiology, and End Results (SEER) program to identify patients diagnosed with de novo invasive breast cancer between January 1, 2010, and December 31, 2021. Data analyses were conducted from January 2024 to June 2025.
Of 761,471 breast cancer diagnoses, 43,934 (5.8%) were stage IV. Stage IV incidence increased from 9.5 cases per 100,000 females in 2010 to 11.2 cases per 100,000 females in 2021. The incidence of stages I to III disease also increased, from 163 cases per 100,000 females in 2010 to 177.4 cases per 100,000 females in 2021.
Among males, there was also a statistically significant increase in stage IV incidence.
The researchers noted that, “Although overall survival improved, research is warranted to determine factors contributing to increased incidence, including potential changes in natural history of breast cancer, disease screening, and incidence and mortality of other conditions.”
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