Key breast cancer highlights from the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting

The 2025 American Society of Clinical Oncology (ASCO) Annual Meeting featured pivotal, practice-changing data in breast oncology. Three landmark phase III trials: DESTINY-Breast09, SERENA-6, and ASCENT-04/KEYNOTE-D19 are poised to redefine standard treatment algorithms for human epidermal growth factor receptor 2 (HER2)-positive, endocrine-resistant, and triple-negative breast cancer (TNBC). DESTINY-Breast09 demonstrated a striking improvement in progression-free survival (PFS) with trastuzumab deruxtecan (T-DXd) plus pertuzumab over standard first-line therapy in HER2-positive metastatic breast cancer. The SERENA-6 trial supported early intervention with camizestrant in estrogen receptor 1 (ESR1)-mutated disease to delay progression. In triple-negative disease, the combination of sacituzumab govitecan (SG) and pembrolizumab outperformed chemotherapy plus pembrolizumab in programmed death-ligand 1 (PD-L1)-positive advanced TNBC. Additional trials—such as INAVO120, VERITAC-2, FINER, EMBER-3, and DESTINY-Breast06—highlighted new agents and combinations that expand the therapeutic landscape across subtypes. These studies collectively mark a significant shift toward biomarker-driven and chemotherapy-sparing regimens in advanced breast cancer management.

HER2-positive breast cancer

DESTINY-Breast09 marks a paradigm shift in the first-line treatment of HER2-positive metastatic breast cancer. This randomized, open-label, phase III trial enrolled 1,074 patients with previously untreated HER2-positive [immunohistochemistry (IHC) 3⁺ or IHC 2⁺/in situ hybridization (ISH)⁺] metastatic or locally advanced unresectable breast cancer. Patients were randomized 1:1 to receive either T-DXd 5.4 mg/kg every 3 weeks plus pertuzumab 840 mg loading dose followed by 420 mg every 3 weeks, or standard therapy consisting of taxane (investigator’s choice of docetaxel, paclitaxel, or nab-paclitaxel) plus trastuzumab and pertuzumab (THP). The primary endpoint was PFS by blinded independent central review (1).

T-DXd plus pertuzumab significantly reduced the risk of disease progression or death by 44% compared to the current standard, achieving a median PFS of 40.7 vs. 26.9 months [hazard ratio =0.56; 95% confidence interval (CI): 0.45–0.70; P<0.00001]. The confirmed objective response rate (ORR) reached 85.1% with T-DXd plus pertuzumab vs. 76.8% with standard therapy, with a median duration of response (DOR) of 39.2 vs. 26.7 months, establishing the combination as the new benchmark in first-line HER2-positive metastatic breast cancer.

From a safety perspective, interstitial lung disease (ILD), a known adverse effect of T-DXd, was observed in approximately 12% of patients in the experimental arm. However, the majority of cases were mild to moderate in severity (grade 1–2: 8.2%, grade 3: 3.5%, grade 4: 0.2%). Other notable grade ≥3 adverse events included neutropenia (24.8%), thrombocytopenia (7.8%), and fatigue (6.1%). However, the T-DXd plus pertuzumab arm had a longer median treatment duration and higher rates of nausea, vomiting, and constipation.

Treatment discontinuation due to adverse events occurred in 19.8% of patients receiving T-DXd plus pertuzumab vs. 8.9% in the control arm.

Critical analysis and implementation challenges

While these results are practice-changing, several considerations merit attention. The study remains ongoing for final overall survival analysis, and the long-term cardiac safety profile of combining T-DXd with pertuzumab requires continued monitoring. The increased ILD risk necessitates enhanced patient education, monitoring protocols, and pulmonary specialist access. From a healthcare systems perspective, the cost implications of replacing standard chemotherapy with this antibody-drug conjugate (ADC) containing regimen will require careful economic evaluation and may influence adoption patterns globally.

Endocrine-resistant hormone receptor (HR)⁺/HER2^– breast cancer

The SERENA-6 trial provided strong evidence for early intervention based on real-time liquid biopsy monitoring. This randomized, open-label, phase III study enrolled 1,168 patients with HR⁺/HER2⁻ locally advanced or metastatic breast cancer who were receiving first-line or second-line aromatase inhibitor (AI) therapy. Eligible patients had rising ESR1 mutations detected via circulating tumor DNA (ctDNA) analysis during AI treatment. Patients were randomized 1:1 to switch to camizestrant 75 mg daily or continue current AI therapy. The primary endpoint was PFS by blinded independent central review (2).

In patients with confirmed ESR1 mutations detected during AI therapy, switching to camizestrant significantly prolonged PFS to 16.0 vs. 9.2 months with continued AI therapy (hazard ratio =0.44; 95% CI: 0.33–0.59; P<0.0001). The ORR was 16.3% with camizestrant vs. 7.2% with continued AI. The clinical benefit rate (CBR) was 61.8% vs. 47.6%, respectively. Treatment was generally well tolerated, with the most common adverse events being nausea (31.2%), fatigue (26.8%), and diarrhea (24.1%).

Critical analysis and implementation challenges

While the biological rationale is compelling, translating these findings into routine practice faces significant hurdles. The study’s success hinges on widespread availability of timely, standardized ctDNA testing—an area that still faces logistical, cost, and interpretive barriers. Many healthcare systems lack the infrastructure for serial liquid biopsy monitoring, and clinician familiarity with ctDNA interpretation remains limited. Questions remain about optimal testing frequency, the lead time required for mutation detection before clinical progression, and cost-effectiveness compared to empirical treatment switching strategies.

VERITAC-2

The VERITAC-2 trial evaluated the oral proteolysis targeting chimera (PROTAC) estrogen receptor (ER) degrader vepdegestrant vs. fulvestrant in patients with ER⁺/HER2⁻ advanced breast cancer. This randomized, open-label, phase III study enrolled 614 patients with ER⁺/HER2⁻ locally advanced or metastatic breast cancer who had received ≤1 prior line of endocrine therapy and ≤1 prior line of chemotherapy for advanced disease. Patients were randomized 2:1 to receive either vepdegestrant 200 mg daily or fulvestrant 500 mg intramuscularly every 28 days (with a loading dose on day 15 of cycle 1). The primary endpoint was PFS in the overall population (3).

In the overall population, median PFS was 3.9 months with vepdegestrant vs. 3.1 months with fulvestrant (hazard ratio =0.84; 95% CI: 0.70–1.01; P=0.059), failing to meet statistical significance. However, among patients with ESR1 mutations (43% of the population), PFS was 5.0 vs. 2.1 months (hazard ratio =0.60; 95% CI: 0.44–0.82), with higher CBRs (42.1% vs. 20.2%) and response rates (18.6% vs. 4.0%). Vepdegestrant was generally well tolerated, with mostly low-grade side effects including fatigue (41.2%), nausea (32.1%), and mild liver enzyme elevations [alanine aminotransferase (ALT) increase: 28.3%]. Treatment discontinuation due to adverse events was low (2.9%).

Critical analysis and implementation challenges

The lack of PFS benefit in the broader population underscores the critical need for biomarker-driven patient selection and likely combination approaches. The modest benefit even in ESR1-mutant patients suggests that oral selective estrogen receptor degraders (SERDs) may require combination with cyclin-dependent kinase (CDK)4/6 inhibitors, phosphoinositide 3-kinase (PI3K) inhibitors, or other targeted agents to achieve clinically meaningful outcomes. The positioning of vepdegestrant relative to other oral SERDs (elacestrant) and in the sequence of treatments after CDK4/6 inhibitor progression remains unclear.

EMBER-3

EMBER-3 demonstrated that imlunestrant, another oral SERD, improved patient-reported outcomes compared to standard endocrine therapy. This randomized, open-label, phase III trial enrolled 842 patients with ER⁺/HER2⁻ locally advanced or metastatic breast cancer who had received ≤1 prior line of endocrine therapy for advanced disease. Patients were randomized 1:1 to receive imlunestrant 400 mg daily or investigator’s choice of endocrine therapy. The co-primary endpoints were PFS in the overall population and in patients with ESR1 mutations (4).

In patients with ESR1 mutations, imlunestrant delayed deterioration in global health status (5.6 vs. 3.8 months; hazard ratio =0.76; 95% CI: 0.59–0.98) and improved functional scores. The ORR was 18.1% with imlunestrant vs. 9.1% with control therapy in ESR1-mutant patients. However, the PFS benefit was modest (5.6 vs. 3.9 months; hazard ratio =0.79; 95% CI: 0.65–0.96) and the overall population showed no significant PFS improvement.

Critical analysis and implementation challenges

While patient-reported outcome improvements are clinically relevant, the modest PFS benefit raises questions about the cost-effectiveness and positioning of imlunestrant in treatment algorithms. Direct comparative data with other oral SERDs are lacking, making treatment selection challenging. The mechanism of resistance to oral SERDs and strategies for combination therapy require further investigation.

FINER

The FINER trial evaluated adding the protein kinase B (AKT) inhibitor ipatasertib to fulvestrant in post-CDK4/6 inhibitor settings. This randomized, double-blind, placebo-controlled, phase II study enrolled 309 patients with ER⁺/HER2⁻ metastatic breast cancer who had progressed on prior CDK4/6 inhibitor therapy. Patients were randomized 1:1 to receive ipatasertib 400 mg daily plus fulvestrant 500 mg or placebo plus fulvestrant. The primary endpoint was PFS (5).

The combination improved median PFS from 1.94 to 5.32 months (hazard ratio =0.61; 95% CI: 0.43–0.86; P=0.0007), with particular benefit in patients with AKT pathway alterations (PIK3CA/AKT1/PTEN mutations). The ORR was 13.5% with ipatasertib vs. 3.9% with placebo. However, the combination was associated with increased toxicity, including grade ≥3 diarrhea (19.4% vs. 1.3%), hyperglycemia (12.3% vs. 0%), and skin rash (11.0% vs. 0%).

Critical analysis and implementation challenges

The unusually short median PFS in the control arm (1.94 months) raises concerns about patient selection or the appropriateness of fulvestrant monotherapy as a comparator in this setting. The substantial toxicity burden of AKT inhibition requires careful patient selection and monitoring. The biomarker-driven approach shows promise, but broader validation and optimal patient selection criteria need refinement.

PI3K pathway and HR⁺/HER2^– breast cancer

INAVO120 was a practice-changing trial evaluating the addition of inavolisib—a PI3Kα inhibitor that also degrades mutant p110α—to palbociclib and fulvestrant. This randomized, double-blind, placebo-controlled, phase III study enrolled 325 patients with PIK3CA-mutant HR⁺/HER2⁻ locally advanced or metastatic breast cancer who had not received prior treatment for advanced disease. Patients were randomized 2:1 to receive inavolisib 9 mg daily or placebo, both in combination with palbociclib 125 mg daily (21 days on, 7 days off) and fulvestrant 500 mg every 28 days. The primary endpoint was PFS, with overall survival as a key secondary endpoint (6).

In patients with PIK3CA-mutant HR⁺/HER2⁻ advanced breast cancer, median overall survival improved to 34.0 vs. 27.0 months (hazard ratio =0.67; 95% CI: 0.46–0.97; P=0.019), and PFS more than doubled (17.2 vs. 7.3 months; hazard ratio =0.42; 95% CI: 0.30–0.59; P<0.001). The ORR significantly increased to 62.7% vs. 28.0% (P<0.001). Time to chemotherapy was delayed by nearly 2 years (35.6 vs. 12.6 months), establishing this triplet as a potential new standard in the PIK3CA-mutant setting.

The most common grade ≥3 adverse events with inavolisib included stomatitis or mucosal inflammation (in 55.3% and 28.8%, respectively), neutropenia (53.8% vs. 42.7%), diarrhea (16.7% vs. 0.9%), hyperglycemia (14.4% vs. 0%), rash (in 26.7% and 19.6%), and ocular toxic effects (in 29.2% and 16.0%).

Treatment discontinuation due to adverse events occurred in 22.1% of patients receiving inavolisib vs. 11.7% in the control arm.

Critical analysis and implementation challenges

While the efficacy results are compelling, several factors may influence clinical adoption. A limitation of this analysis is the small number of patients and deaths in subgroups, resulting in underpowered subgroup analyses. In several subgroups, inavolisib plus palbociclib-fulvestrant showed either less benefit than placebo plus palbociclib-fulvestrant or none at all. Further analyses are planned for underrepresented groups, such as patients over 65 years, where no benefit was seen. Another limitation is that CDK4/6 inhibitors other than palbociclib were not evaluated in INAVO120; however, the MORPHEUS-panBC trial (NCT03424005) is assessing inavolisib with other CDK4/6 inhibitors.

The long-term safety profile of triple combination therapy requires continued monitoring, particularly regarding potential cumulative toxicities. Cost considerations and the need for PIK3CA mutation testing infrastructure may influence implementation patterns globally.

HER2-low and HR⁺ breast cancer

DESTINY-Breast06 confirmed that T-DXd outperforms chemotherapy in patients with HR⁺/HER2-low or HER2-ultralow metastatic breast cancer who progressed on endocrine therapy. This randomized, open-label, phase III trial enrolled 866 patients with HR⁺/HER2-low (IHC 1⁺ or IHC 2⁺/ISH⁻) or HER2-ultralow (IHC 0 with detectable HER2 protein) metastatic breast cancer who had received 1–2 prior lines of chemotherapy for metastatic disease. Patients were randomized 1:1 to receive T-DXd 5.4 mg/kg every 3 weeks or investigator’s choice of chemotherapy. The primary endpoint was PFS (7).

In the biomarker-evaluable population, T-DXd improved PFS (13.9 vs. 8.2 months; hazard ratio =0.63; 95% CI: 0.51–0.78; P<0.001) and ORR (59.4% vs. 33.9%). Benefits were consistent across PI3K, ESR1, and BRCA1/2 mutation subgroups. The median DOR was 18.7 months with T-DXd vs. 7.1 months with chemotherapy.

From a safety perspective, ILD occurred in 12.1% of patients receiving T-DXd, with most cases being grade 1–2 (8.9%). Other notable grade ≥3 adverse events included neutropenia (13.7%), anemia (8.9%), and fatigue (7.8%). Treatment discontinuation due to adverse events occurred in 16.2% of patients receiving T-DXd vs. 8.3% in the chemotherapy arm.

Critical analysis and implementation challenges

While efficacy was impressive, several considerations warrant attention. ILD remains a significant safety concern, particularly with longer treatment durations, requiring enhanced monitoring protocols and pulmonary specialist availability. The benefit in HER2-ultralow tumors, while encouraging, warrants longer follow-up and external validation given the minimal protein expression levels. This trial challenges the traditional binary HER2 classification and supports a continuum-based model, potentially requiring pathology practice changes and updated testing guidelines. DESTINY-Breast06 is the first study to assess a HER2-directed therapy in HER2-ultralow tumors (IHC 0 with membrane staining). Further research is needed to refine HER2 detection, define the minimal threshold for T-DXd activity, and standardize assays for very low HER2 levels. The ongoing DESTINY-Breast15 trial (NCT05950945) will include patients with HER2 IHC 0 (without membrane staining), and its results are awaited.

TNBC

The phase III ASCENT-04/KEYNOTE-D19 trial demonstrated that SG plus pembrolizumab significantly improved outcomes compared to chemotherapy plus pembrolizumab in previously untreated, PD-L1-positive advanced TNBC. This randomized, open-label study enrolled 794 patients with previously untreated PD-L1-positive [combined positive score (CPS) ≥10] metastatic or locally advanced unresectable TNBC. Patients were randomized 1:1 to receive either SG 10 mg/kg on days 1 and 8 plus pembrolizumab 200 mg on day 1 every 21 days, or investigator’s choice of chemotherapy (carboplatin, nab-paclitaxel, paclitaxel, or gemcitabine/carboplatin) plus pembrolizumab 200 mg every 21 days. The primary endpoint was PFS (8).

SG plus pembrolizumab significantly prolonged PFS compared to chemotherapy plus pembrolizumab (median PFS: 11.2 vs. 7.8 months; hazard ratio =0.65; 95% CI: 0.53–0.81; P=0.0009). The combination also doubled the DOR (16.5 vs. 9.2 months) and demonstrated a higher ORR (46.4% vs. 38.5%). Overall survival showed a favorable trend (hazard ratio =0.87; 95% CI: 0.69–1.09) though not yet statistically significant.

The safety profile showed that SG plus pembrolizumab was associated with grade ≥3 neutropenia (43.2% vs. 39.1%), diarrhea (10.1% vs. 2.8%), and febrile neutropenia (8.1% vs. 7.6%). Treatment discontinuation due to adverse events occurred less frequently with SG plus pembrolizumab (15.6% vs. 20.8%).

Critical analysis and implementation challenges

While these results are practice-changing for PD-L1-positive TNBC, several factors may influence adoption. Key limitations include the open-label design, which may introduce bias; immature overall survival data (only ~26% maturity) limiting survival conclusions; a high crossover rate (~43% of control arm patients switched to SG after progression), confounding OS interpretation; and potential underpowering for subgroup or safety analyses—especially given emerging safety signals such as higher serious adverse event rates in the experimental arm despite consistent treatment-emergent adverse events (TEAEs) profiles

The substantial rates of grade ≥3 neutropenia require careful monitoring and supportive care measures. The restriction to PD-L1-positive patients (CPS ≥10) limits applicability to approximately 40–50% of TNBC patients. Widespread implementation may be influenced by drug availability, pricing, reimbursement policies, and healthcare infrastructure capacity for managing ADC-related toxicities.

Other notable data

The updated NATALEE trial showed that ribociclib plus AI continued to improve invasive disease-free survival (iDFS), distant DFS, and recurrence-free survival in early-stage HR⁺/HER2⁻ breast cancer across all age groups, including those <40 and >60 years. At 42 months median follow-up, iDFS was 90.7% with ribociclib vs. 87.6% with placebo (hazard ratio =0.76; 95% CI: 0.63–0.93). The benefit was maintained regardless of menopausal status, nodal involvement, or risk category (9).

A real-world analysis using the Surveillance, Epidemiology, and End Results (SEER)-Medicare Health Outcomes Survey (MHOS) database reported lower mortality among older breast cancer survivors using vaginal estrogen, suggesting safety and potential survival benefit in well-selected patients. Among 1,364 breast cancer survivors, vaginal estrogen use was associated with reduced all-cause mortality (hazard ratio =0.70; 95% CI: 0.51–0.95) and breast cancer-specific mortality (hazard ratio =0.52; 95% CI: 0.28–0.97) (10). While promising, women using local estrogen may differ from nonusers in health status, healthcare access, or treatment adherence, potentially confounding results. Prospective validation is needed before changing practice patterns.

An analysis from the FLEX registry demonstrated that when Black women with HR⁺/HER2⁻ early breast cancer receive appropriate treatment guided by genomic risk assessment, survival outcomes become comparable to those of White women. Among 3,986 patients, 5-year overall survival was 94.8% for Black women vs. 95.7% for White women when receiving guideline-concordant care (P=0.34), highlighting the critical importance of addressing healthcare disparities (11).

The neoCARHP phase III trial assessed whether carboplatin could be safely omitted from neoadjuvant therapy in patients with HER2-positive early breast cancer receiving THP. This multicenter study involving 766 patients showed that pathological complete response (pCR) rates were similar between THP (64.1%) and standard TCbHP (taxane + carboplatin + trastuzumab + pertuzumab) (65.9%), meeting non-inferiority criteria (absolute difference −1.8%; 95% CI: −8.5 to 5.0; P=0.0089). The THP regimen was associated with fewer grade 3–4 and serious adverse events (12).

While toxicity reduction is valuable, long-term survival outcomes are needed to fully endorse this de-escalation approach, particularly in high-risk subgroups.

The I-SPY2 trial subanalysis investigated the relationship between ctDNA and residual nodal burden after neoadjuvant chemotherapy in stage II–III breast cancer. Among 495 evaluable patients, ctDNA negativity post-treatment was significantly associated with lower residual nodal disease, particularly ypN2 (9.8% in ctDNA⁻ vs. 35.6% in ctDNA⁺; P<0.0001), suggesting potential utility for guiding axillary surgical decisions (13).

A presentation of early results from the SHARE trial showed that accelerated partial breast irradiation (APBI) significantly reduced overall and skin-related toxicities compared to whole breast irradiation (WBI) in postmenopausal women with early-stage, low-risk breast cancer. Grade ≥2 skin toxicity was 12.3% with APBI vs. 31.2% with WBI (P<0.001). Cosmetic outcomes were comparable, though WBI showed fewer non-skin toxicities, particularly breast fibrosis (14).

The Phase III OASIS 4 trial evaluated elinzanetant, a dual neurokinin-1 and -3 receptor antagonist, for treating vasomotor symptoms in women undergoing adjuvant endocrine therapy for HR⁺ breast cancer.

At week 4, women taking elinzanetant experienced a significantly greater drop in symptoms than women on placebo (mean change, −6.5 vs. −3.0 episodes). The results remained significant at week 12 (−7.8 vs. −4.2 episodes). Elinzanetant was associated with improved sleep and quality of life (15). The modest benefit magnitude, lack of active comparator (venlafaxine), and likely high cost limit immediate clinical impact, though it may benefit women intolerant of existing alternatives. It would be interesting to see whether this drug improves breast cancer outcomes, as neurokinin-1 receptor (NK1R), the receptor for substance P, is linked to pain, inflammation, stress, and cell proliferation. It would be prudent to assess long-term outcomes in patients taking elinzanetant.

Conclusions

ASCO 2025 showcased transformative data across all breast cancer subtypes, fundamentally shifting treatment paradigms toward biomarker-driven, personalized approaches. The landmark trials DESTINY-Breast09, SERENA-6, and ASCENT-04/KEYNOTE-D19 establish new standards of care that prioritize efficacy while moving away from traditional chemotherapy backbones. However, successful implementation of these advances requires addressing significant challenges including healthcare infrastructure development for biomarker testing, cost considerations, safety monitoring protocols, and clinician education. The growing emphasis on oral SERDs, targeted combination therapies, and patient-reported outcomes reflects a broader evolution toward precision medicine that balances clinical efficacy with quality of life considerations. While these developments represent major progress, their ultimate impact will depend on equitable access, real-world effectiveness validation, and continued efforts to address healthcare disparities in breast cancer care.

Acknowledgments

None.

Footnote

Provenance and Peer Review: This article was a standard submission to the journal. The article has undergone external peer review.

Peer Review File: Available at https://tbcr.amegroups.com/article/view/10.21037/tbcr-25-26/prf

Funding: None.

Conflicts of Interest: Both authors have completed the ICMJE uniform disclosure form (available at https://tbcr.amegroups.com/article/view/10.21037/tbcr-25-26/coif). K.M. serves as an unpaid editorial board member of Translational Breast Cancer Research from May 2025 to June 2027. The other author has no conflicts of interest to declare.

Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.

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