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Breast Cancer at ASCO 2025
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Top Breast Cancer Abstracts | ASCO 2025
The 2025 American Society of Clinical Oncology (ASCO) Annual Meeting promises to showcase data from several pivotal trials that could reshape treatment paradigms across various tumor types, including breast cancer.
Overall, the average risk of a woman in the United States developing breast cancer sometime in her life is about 13%. DelveInsight estimates that in 2024, there were approximately 686,000 new cases of breast cancer in the 7MM (the United States, Germany, France, Italy, Spain, the United Kingdom, and Japan).
Leading pharmaceutical companies, including AstraZeneca, Pfizer, Gilead Sciences, Eli Lilly, Janssen, Daiichi Sankyo, Sanofi, and Roche among others, are set to present clinical data from their ongoing breast cancer clinical studies. Detailed results from late breaking abstracts of phase III clinical trials such as ASCENT-04/KEYNOTE-D19 (NCT05382286), DESTINY-Breast09 (NCT04784715), and SERENA-6 (NCT04964934) are also set to be presented at ASCO 2025.
The ctDNA-guided SERENA-6 study is evaluating a proactive approach for treating HR-positive, HER2-negative breast cancer with emergent ESR1 mutations. Instead of waiting for the cancer to clearly progress, researchers are using blood tests (ctDNA) to spot emergent ESR1 mutations —before they cause problems. If detected, patients are switched to a new treatment combo: camizestrant (an oral SERD) plus a CDK4/6 inhibitor. Early findings showed that this approach might slow down disease progression more effectively than current therapies. Experts say positive findings from this study could change how breast cancer was historically monitored and treated.
Moving on to the ASCENT-04/KEYNOTE-D19 trial where a combination of TRODELVY (sacituzumab govitecan) and pembrolizumab is being investigated to check whether starting treatment for PD-L1–positive triple-negative breast cancer (TNBC) is better than the usual chemo-plus-immunotherapy option. So far, results show improved progression-free survival (PFS) and manageable side effects. Experts are hopeful this combo could become a new frontline standard and possibly expand to patients with PD-L1–negative TNBC in the future. Furthermore, in HER2-positive metastatic breast cancer, interim data showed that combining ENHERTU (T-DXd) with PERJETA works better than the established triplet in this setting, i.e., taxane plus trastuzumab plus pertuzumab.
List of Top-10 Key Breast Cancer Abstracts
|
Company/ Institute |
Drug Name |
Trial ID/ Acronym |
Patient Segment |
Phase |
Abstract ID |
Session type |
Abstract Title | |
|
Gilead Sciences |
TRODELVY |
NCT05382286 (ASCENT-04/KEYNOTE-D19) |
TNBC |
III |
#LBA109 |
Oral |
Sacituzumab govitecan (SG) + pembrolizumab (pembro) vs chemotherapy (chemo) + pembro in previously untreated PD-L1–positive advanced triple-negative breast cancer (TNBC): Primary results from the randomized Phase III ASCENT-04/KEYNOTE-D19 study. | |
|
AstraZeneca |
Trastuzumab Deruxtecan (T-DXd) |
NCT04784715 (DESTINY-Breast09) |
HER2+ metastatic breast cancer |
III |
#LBA1008 |
Oral |
Trastuzumab deruxtecan (T-DXd) + pertuzumab (P) vs taxane + trastuzumab + pertuzumab (THP) for first-line (1L) treatment of patients (pts) with human epidermal growth factor receptor 2–positive (HER2+) advanced/metastatic breast cancer (a/mBC): Interim results from DESTINY-Breast09. | |
|
AstraZeneca |
Camizestrant |
NCT04964934 (SERENA-6) |
HR+/HER2-metastatic breast cancer |
III |
#LBA4 |
Plenary |
Camizestrant + CDK4/6 inhibitor (CDK4/6i) for the treatment of emergent ESR1 mutations during first-line (1L) endocrine-based therapy (ET) and ahead of disease progression in patients (pts) with HR+/HER2– advanced breast cancer (ABC): Phase III, double-blind ctDNA-guided SERENA-6 trial. | |
|
Pfizer |
Vepdegestrant |
NCT05654623 (VERITAC-2) |
ER+/ HER2- advanced breast cancer |
III |
#LBA1000 |
Oral |
Vepdegestrant, a PROTAC estrogen receptor (ER) degrader, vs fulvestrant in ER-positive/human epidermal growth factor receptor 2 (HER2)–negative advanced breast cancer: Results of the global, randomized, Phase III VERITAC-2 study. | |
|
Eli Lilly |
Imlunestrant |
NCT04975308 (EMBER-3) |
ER+, HER2- advanced breast cancer |
III |
#1060 |
Poster |
Imlunestrant with or without abemaciclib in advanced breast cancer (ABC): Safety analyses from the phase III EMBER-3 trial. | |
|
Roche |
Fulvestrant and Ipatasertib |
NCT04650581 (FINER) |
ER+ breast cancer |
III |
#LBA1005 |
Oral |
A double-blind placebo controlled randomized Phase III trial of fulvestrant and ipatasertib as treatment for advanced HER2-negative and estrogen receptor positive (ER+) breast cancer following progression on first line CDK 4/6 inhibitor and aromatase inhibitor: The CCTG/BCT MA.40/FINER study (NCT04650581). | |
|
Daiichi Sankyo |
HER3-DXd |
NCT05865990 (TUXEDO-3) |
Metastatic breast cancer |
II |
#2005 |
Oral |
Patritumab deruxtecan (HER3-DXd) in active brain metastases (BM) from metastatic breast (mBC) and non–small cell lung cancers (aNSCLC), and leptomeningeal disease (LMD) from advanced solid tumors: Results from the TUXEDO-3 Phase II trial. | |
|
Roche |
ITOVEBI |
NCT04191499 (INAVO120) |
HR+/HER2- advanced or metastatic breast cancer |
II/III |
#1003 |
Oral |
INAVO120: Phase III trial final overall survival (OS) analysis of first-line inavolisib (INAVO)/placebo (PBO) + palbociclib (PALBO) + fulvestrant (FULV) in patients (pts) with PIK3CA-mutated, hormone receptor-positive (HR+), HER2-negative (HER2–), endocrine-resistant advanced breast cancer (aBC). | |
|
Gilead Sciences |
TRODELVY |
NCT04230109 (NeoSTAR) |
TNBC |
II |
#511 |
Rapid Oral |
A Phase II study of response-guided neoadjuvant sacituzumab govitecan and pembrolizumab (SG/P) in patients with early-stage triple-negative breast cancer: Results from the NeoSTAR trial. | |
|
Sichuan Kelun-Biotech Biopharmaceutical |
Sacituzumab tirumotecan |
NCT05445908 (OptiTROP-Breast05) |
HER2- breast cancer |
II |
#1019 |
Rapid Oral |
Sacituzumab tirumotecan (sac-TMT) as first-line treatment for unresectable locally advanced/metastatic triple-negative breast cancer (a/mTNBC): Initial results from the Phase II OptiTROP-Breast05 study. | |
Executive Summary
The 2025 American Society of Clinical Oncology (ASCO) Annual Meeting promises to showcase data from several pivotal trials that could reshape treatment paradigms across various tumor types, including breast cancer.