A new report from leading global contract research organization Novotech examines the triple-negative breast cancer global clinical trial landscape in 2025, offering valuable insights into novel therapies, ongoing clinical trials, and future innovations shaping the treatment of triple-negative breast cancer, an aggressive and heterogeneous subtype of breast cancer, accounting for 10 to 15% of all breast cancer cases globally. Triple-negative breast cancer is characterized by the absence of estrogen receptors (ER), progesterone receptors (PR), and HER2 expression, limiting the effectiveness of targeted hormonal or HER2-directed therapies. The basal-like subtype dominates (~70%), associated with aggressive tumor biology.
According to the report, triple-negative breast cancer disproportionately affects younger women, individuals of African descent, and those with BRCA1 mutations. Its aggressive nature leads to early recurrence and metastasis to the lungs, liver, brain, and bones, resulting in poor outcomes. The five-year survival rate is <12% for metastatic triple-negative breast cancer and 50 to 60% for early-stage triple-negative breast cancer with timely treatment. Globally, an estimated 300 thousand triple-negative breast cancer cases were documented in 2022, with Asia reporting the highest burden, followed by Europe, North America, and the rest of the world, reflecting regional variations in incidence.
Treatment landscape
The report outlines how the treatment landscape for triple-negative breast cancer has evolved with biomarker-driven therapies supplementing traditional chemotherapy. First-line therapies include pembrolizumab combined with chemotherapy for PD-L1 positive tumors or PARP inhibitors for BRCA1/2 mutations. For relapsed cases, treatments like sacituzumab govitecan, trastuzumab deruxtecan, and platinum-based regimens are utilized. NCCN, ESMO, and Pan-Asian guidelines provide personalized treatment options, highlighting the role of biomarkers in therapy selection
Building on these established treatment strategies, the global clinical trial landscape is increasingly focused on developing innovative therapies for triple-negative breast cancer. Since 2019, over 1,500 clinical trials have been initiated globally for triple-negative breast cancer, representing approximately 30% of all breast cancer trials.
North America leads in the number of clinical trials conducted, followed by the Asia-Pacific region, Europe, and the rest of the world. China leads APAC, while the United States leads North America. Spain and France are key contributors in Europe, and Israel contributes moderately to the rest of the world’s trials. In terms of patient recruitment trends, Asia-Pacific has shown shorter median recruitment durations and faster recruitment rates compared to the United States.
Marketed and pipeline drugs
Shifting focus to the current landscape of marketed and pipeline drugs for triple-negative breast cancer, the report highlights how immune checkpoint inhibitors like pembrolizumab and atezolizumab, and antibody-drug conjugates such as sacituzumab govitecan, are playing vital roles. Promising therapies under investigation include datopotamab deruxtecan and adagloxad simolenin, showing innovation in triple-negative breast cancer treatment. Novel approaches, including PARP inhibitors and combination regimens, are transforming the therapeutic landscape.
Advancements in triple-negative breast cancer treatment focus on personalized medicine, leveraging immune checkpoint inhibitors, antibody-drug conjugates, and PARP inhibitors. Meanwhile, emerging biomarkers such as BRCA mutations, PD-L1 expression, and PI3K/AKT pathway alterations are guiding precision medicine approaches in triple-negative breast cancer clinical research. Leading biotech and biopharma companies such as Roche, and Merck & Co., are driving research to address triple-negative breast cancer’s aggressive nature and high recurrence rates. Despite challenges like drug resistance and limited long-term outcomes, innovative therapies are offering new hope for patients.
About Novotech
Novotech is a globally recognized full-service clinical research organization (CRO) and scientific advisory company that provides biotech and small- to mid-sized pharma companies an accelerated path to market since 1997. With a global footprint spanning 30+ offices across the Asia-Pacific region, North America, and Europe, and partnerships with 5,000+ trial sites, Novotech offers unparalleled access to key clinical trial destinations and diverse patient populations.
Novotech leverages its therapeutic and regulatory expertise, client-centric service model, local market insights, and advanced analytical tools to expedite patient recruitment, enhance trial efficiencies, and bring life-changing therapies to market faster. This work has been recognized by awards such as the Frost & Sullivan CRO Company of the Year, which Novotech has received for 19 consecutive years.
Discover more about triple-negative breast cancer research by downloading the comprehensive disease report below.
