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Breast cancerJune 2026
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Breast Cancer — Monthly Compass
Jun 01–30, 2026 • Priority Updates • 3–5 minute read
 
A curated, practice-minded digest of what moved in breast cancer this month — regulatory signals, clinical development, and the most practice-relevant publications.
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breast cancer updates
Key Highlights
Key Highlights
  • Practice-Changing Updates
    • On June 24, 2026, the FDA approved sacituzumab govitecan-hziy (Trodelvy) as monotherapy and with pembrolizumab for first-line unresectable locally advanced or metastatic TNBC under Project Orbis one month ahead of the goal date, based on ASCENT-03 and ASCENT-04/KEYNOTE-D19 showing significant PFS improvements, with boxed warnings for diarrhea and neutropenia.
    • On June 24, 2026, the FDA approved palbociclib with trastuzumab, with or without pertuzumab, and endocrine therapy as maintenance for HR-positive, HER2-positive locally advanced or metastatic breast cancer based on PATINA’s statistically significant improvement in investigator-assessed PFS, with warnings for neutropenia, interstitial lung disease/pneumonitis, and embryo-fetal toxicity.
  • Important Drug Publication Updates
    • A Journal of Clinical Oncology Late-Breaking Abstract from I-SPY 2.2 reported that neoadjuvant rilvegostomig (anti–PD-1/TIGIT) plus trastuzumab deruxtecan achieved high pCR in immune-positive HER2-negative disease, enabling many patients to omit additional chemotherapy/anthracyclines under structured ILD monitoring.
    • JCO reports detailed that FHERAD used molecular imaging to predict outcomes on trastuzumab deruxtecan in HER2-low disease and that DESTINY-Breast05 secondary safety analyses differentiated ILD from radiation pneumonitis and identified demographic/radiotherapy risk factors without compromising efficacy.
  • Key Clinical Development Updates
    • The FDA accepted Genentech/Roche’s NDA for giredestrant under Priority Review as adjuvant therapy for ER-positive, HER2-negative stage I–III breast cancer with a PDUFA date of November 30, 2026, supported by lidERA phase III showing a 30% reduction in risk of invasive disease recurrence or death versus standard endocrine therapy, while a separate NDA for giredestrant plus everolimus in ESR1-mutated advanced disease is also under review.
    • AstraZeneca disclosed that the FDA extended the camizestrant first-line HR-positive, HER2-negative advanced breast cancer PDUFA date to review additional ctDNA-linked efficacy analyses presented June 2 at ASCO 2026, while the FDA granted Fast Track to TER-2013 (AKT1-selective inhibitor) for HR-positive/HER2-negative disease with AKT/PI3K/PTEN alterations post–endocrine plus CDK4/6 and to emiltatug ledatotin (B7-H4 ADC) in adult TNBC and HER2-low/HER2-negative post–topo-1 ADC exposure, and cleared INDs for IOV-5001 (IL-12–tethered TIL; TNBC and ER-low cohorts) and the MagSense HER2 imaging agent for a phase 1b/2 study in HER2-positive disease.
  • Key Conference Updates
    • At ASCO 2026, TROPION-Breast02 showed the TROP2-directed ADC datopotamab deruxtecan improved TFST (HR 0.49), PFS2 (HR 0.61) and TSST (HR 0.67) versus chemotherapy in IO-ineligible first-line metastatic TNBC, reinforcing ADC-first approaches.
    • In SERENA-6, early switching to camizestrant upon emergent ESR1 mutation improved PFS and PFS2, extended chemotherapy/ADC-free survival, and deepened ctDNA clearance, though the regulatory path remained uncertain after ODAC skepticism about PFS2 as an approval basis.
  • Emerging Themes & Macro-Trends
    • ADCs are consolidating as first-line backbones in metastatic TNBC while chemo-sparing neoadjuvant ADC–IO pathways advance for immune-positive HER2-negative disease and ctDNA-guided endocrine switches aim to delay escalation to ADCs or chemotherapy in ER-positive/HER2-negative advanced settings.
    • Strategic imperatives include defining sequencing frameworks between sacituzumab govitecan and datopotamab deruxtecan, payer strategies for earlier ADC adoption, companion diagnostics for immune-positive selection, and ILD surveillance infrastructure to sustain broad ADC utilization.
FDA Approvals/Withdrawals
FDA Approvals/Withdrawals
  • On June 24, 2026, the FDA approved sacituzumab govitecan-hziy (Trodelvy, Gilead Sciences, Inc.) for two new indications in adults with triple-negative breast cancer (TNBC), both as a monotherapy and in combination with pembrolizumab (Keytruda, Merck & Co., Inc.) for first-line treatment. These approvals were supported by data from the ASCENT-03 and ASCENT-04/KEYNOTE-D19 trials, demonstrating improved progression-free survival in patients with unresectable locally advanced or metastatic TNBC. The prescribing information includes boxed warnings for diarrhea and neutropenia, along with other warnings and precautions.¹ (read more)
  • On June 24, 2026, the FDA approved palbociclib (Ibrance, Pfizer Inc.) in combination with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance treatment of adults with HR-positive, HER2-positive locally advanced or metastatic breast cancer. This approval was based on the PATINA trial, which showed a statistically significant improvement in investigator-assessed progression-free survival. The prescribing information for palbociclib includes warnings and precautions for neutropenia, interstitial lung disease/pneumonitis, and embryo-fetal toxicity.² (read more)
Clinical Development Regulatory Updates
Clinical Development Regulatory Updates
  • Genentech announced FDA acceptance of its NDA under Priority Review for giredestrant as adjuvant therapy in ER-positive, HER2-negative stage I–III breast cancer, with a PDUFA decision date of November 30, 2026. The filing is supported by the phase III lidERA trial showing a 30% reduction in risk of invasive disease recurrence or death versus standard endocrine therapy. ¹ (read more)
  • Roche reported the FDA’s Priority Review acceptance of the NDA for giredestrant in early-stage ER-positive, HER2-negative breast cancer and confirmed a PDUFA date of November 30, 2026. The company highlighted lidERA phase III results and noted a separate NDA for giredestrant plus everolimus in ESR1-mutated advanced disease is also under review. ² (read more)
  • AstraZeneca shared updated SERENA-6 data for camizestrant combinations and disclosed that the FDA extended the PDUFA date to review additional analyses requested for the NDA in first-line HR-positive, HER2-negative advanced breast cancer with emergent ESR1 mutation. The company said it provided ctDNA-linked efficacy analyses that were presented June 2 at ASCO 2026. ³ (read more)
  • FDA approved sacituzumab govitecan-hziy (Trodelvy) as monotherapy and with pembrolizumab for first-line metastatic TNBC; the review was conducted under Project Orbis and was completed one month ahead of the FDA goal date. The approvals were based on ASCENT-03 and ASCENT-04/KEYNOTE-D19, which demonstrated significant progression-free survival improvements. ⁴ (read more)
  • Terremoto Biosciences received FDA Fast Track designation for TER-2013, an AKT1-selective inhibitor, for patients with locally advanced, unresectable or metastatic HR-positive/HER2-negative breast cancer harboring AKT/PI3K/PTEN alterations after endocrine therapy and a CDK4/6 inhibitor. Fast Track enables more frequent FDA interactions to expedite development and review. ⁵ (read more)
  • Servier highlighted ASCO 2026 phase 1 data for emiltatug ledatotin (Emi‑Le) and noted the FDA has granted Fast Track designations for the B7‑H4–targeted ADC in adult TNBC and in HER2-low/HER2-negative breast cancer post–topo-1 ADC exposure. The company’s update underscored the program’s expansion beyond ACC into breast cancer populations with high unmet need. ⁶ (read more)
  • Iovance Biotherapeutics announced FDA clearance of an IND for IOV‑5001, an IL‑12–tethered tumor-infiltrating lymphocyte therapy, enabling a phase 1/2 basket study that includes cohorts for triple‑negative and ER‑low breast cancers. The IND clearance allows U.S. trial initiation across multiple solid tumors, including specified breast cancer subsets. ⁷ (read more)
  • Imagion Biosystems reported the FDA issued a “Study May Proceed” letter for its IND supporting a phase 1b/2 study of the MagSense HER2 imaging agent in HER2‑positive breast cancer. The company plans to advance site activation and patient enrollment under the cleared IND. ⁸ (read more)
Conference
Major Conference Updates
Conference Information
  • 2026 ASCO Annual Meeting, Chicago, Illinois
  • Overall sentiment: ADCs solidified first-line roles in metastatic TNBC and pushed into earlier settings, while molecularly guided endocrine strategies aimed to delay cytotoxic/ADC exposure; safety management and response prediction for HER2-directed ADCs matured in parallel. (read more)
  • Theme 1: ADCs Reshape First-Line TNBC (Monotherapy and IO-Backbones)
    • Significance: Clear momentum toward ADC-first approaches in mTNBC, with combination IO regimens extending benefit and durability metrics (PFS2/TFST/TSST) beyond first progression. (read more)
    • Mechanism insights / clinical impact: TROP2-directed datopotamab deruxtecan-dlnk (Dato‑DXd; Datroway) in TROPION‑Breast02 improved TFST (HR 0.49), PFS2 (HR 0.61) and TSST (HR 0.67) vs chemotherapy in IO‑ineligible 1L mTNBC; sacituzumab govitecan‑hziy plus pembrolizumab in ASCENT‑04/KEYNOTE‑D19 prolonged PFS2 despite high crossover, with expected toxicity trade‑offs (more GI/neutropenia on SG, more neuropathy/thrombocytopenia on chemo). (read more)
    • Patient populations affected: 1L unresectable/metastatic TNBC—both PD‑L1‑positive (SG+pembrolizumab) and IO‑ineligible cohorts (Dato‑DXd). US patients gained immediate access via June 24, 2026 Trodelvy label expansion (mono and with pembrolizumab). (read more)
  • Theme 2: Chemo‑Sparing Neoadjuvant Strategies with ADC + Bispecific IO
    • Significance: Early‑setting de‑escalation emerges: high pCR with rilvegostomig (anti‑PD‑1/TIGIT) plus fam‑trastuzumab deruxtecan‑nxki (T‑DXd) enables many immune‑positive patients to omit additional chemotherapy/anthracyclines in I‑SPY 2.2. (read more)
    • Mechanism insights / clinical impact: Dual checkpoint (PD‑1/TIGIT) priming with T‑DXd cytotoxic delivery achieved pCR rates comparable to controls while reducing cytotoxic exposure; rigorous ILD monitoring framework supported safe delivery. (read more)
    • Patient populations affected: High‑risk, HER2‑negative, immune‑positive neoadjuvant cohorts; potential benefit for both HR‑positive and HR‑negative subgroups within immune‑positive RPS. (read more)
  • Theme 3: Molecularly Guided Endocrine Optimization (Delaying ADC/Chemo)
    • Significance: Early switch to next‑gen SERD aims to postpone escalation to ADCs/chemo, aligning with patient‑centric goals and cost/toxicity containment. (read more)
    • Mechanism insights / clinical impact: In SERENA‑6, switching to camizestrant upon emergent ESR1 mutation improved PFS and PFS2, extended chemotherapy/ADC‑free survival, and deepened ctDNA clearance; regulatory path remains uncertain after ODAC skepticism about PFS2 as a basis for approval. (read more)
    • Patient populations affected: ER+/HER2‑, ESR1‑mutated advanced disease on 1L AI+CDK4/6i across common co‑mutations (PIK3CA/TP53). (read more)
  • Theme 4: ADC Biomarker & Safety Optimization (Prediction and ILD Management)
    • Significance: Tools to select responders and mitigate ILD risk are becoming central to sustaining ADC leadership across HER2‑expressing spectrums. (read more)
    • Mechanism insights / clinical impact: FHERAD explored molecular imaging to predict outcomes on T‑DXd in HER2‑low disease; DESTINY‑Breast05 secondary safety analysis parsed interstitial lung disease vs radiation pneumonitis and identified demographic/RT factors without compromising efficacy. (read more)
    • Patient populations affected: HER2‑low/ultralow mBC on T‑DXd; HER2‑positive early‑stage patients receiving adjuvant T‑DXd with radiotherapy. (read more)
  • Significance
    • Expected clinical or translational readouts: Longer‑term OS from ASCENT‑04/03 and TROPION‑Breast02; prospective validation of immune‑positive RPS selection and ILD‑risk algorithms in neoadjuvant ADC+IO. (read more)
    • Regulatory or policy implications: June 24, 2026 Trodelvy approvals accelerate US adoption of 1L SG±pembrolizumab; camizestrant decision pending with FDA scrutiny of PFS2 endpoints. (read more)
    • Potential shifts in standard of care: ADCs favored as 1L backbones in mTNBC; chemo‑sparing neoadjuvant pathways for immune‑positive HER2‑negative disease; ctDNA‑guided endocrine switches in ER+/HER2‑ advanced settings. (read more)
    • Strategic implications: Urgent need for sequencing frameworks (SG vs Dato‑DXd), payer strategies for earlier ADC use, companion diagnostics for immune‑positive selection, and safety infrastructure (ILD surveillance) to protect broad ADC utilization. (read more)
Publications Related to Approved Drugs
PHASE2, PHASE3
inavolisib
Safety analyses of the INAVO120 randomised phase III trial of inavolisib or placebo with palbociclib-fulvestrant in patients with PIK3CA-mutated, hormone receptor-positive, HER2-negative, endocrine-resistant advanced breast cancer. This comprehensive safety analysis from the INAVO120 trial details the management of key adverse events associated with inavolisib plus palbociclib and fulvestrant in PIK3CA-mutated, HR+/HER2- advanced breast cancer. The study concludes that the safety profile, including hyperglycaemia, stomatitis, rash, and diarrhoea, is generally consistent, manageable, and tolerable with supportive therapies and dose modifications, reinforcing the viability of this combination regimen. ()
Phase 3
letrozole and ribociclib, ribociclib, fulvestrant
Quantitative Pharmacology Justifying Ribociclib Dose in Early Breast Cancer. This integrative analysis provides the quantitative pharmacology rationale for the 400 mg starting dose of ribociclib in early breast cancer (EBC), which is lower than the 600 mg dose used in advanced disease. The study identified a population-specific effect on drug pharmacokinetics and QTcF response, demonstrating that the 400 mg dose in EBC patients leads to lower rates of neutropenia and QTcF prolongation compared to the 600 mg dose in the advanced setting, thus justifying the dose reduction for the adjuvant setting. (, , , )
New Publications Related to Drugs in Clinical Trial Development
['PHASE1', 'PHASE2']
Quantitative Pharmacology Justifying Ribociclib Dose in Early Breast Cancer. This integrative analysis justifies the 400 mg dose of ribociclib in early breast cancer (EBC) by demonstrating population-specific differences in pharmacokinetics and QTcF response compared to the 600 mg dose in advanced breast cancer. The lower dose in EBC patients resulted in reduced rates of neutropenia and QTcF prolongation, highlighting the utility of quantitative pharmacology in optimizing oncology therapy doses for different patient populations. ()
['PHASE1', 'PHASE2']
First-line durvalumab in combination with trastuzumab deruxtecan in women with locally advanced unresectable or metastatic, hormone-receptor-negative, HER2-low breast cancer: multicenter, open-label, phase 1b/2 BEGONIA platform trial. In the BEGONIA platform trial, the first-line combination of durvalumab and trastuzumab deruxtecan (T-DXd) demonstrated clinically relevant efficacy in metastatic HR-negative, HER2-low breast cancer, achieving a 62.1% objective response rate and a median PFS of 12.6 months. Although the primary endpoint was not met, the safety profile was manageable and consistent with the known toxicities of each agent. ()
['NA']
18F-Fluorodeoxyglucose Positron Emission Tomography for Estimating Outcomes After Initial Treatment for Metastatic Breast Cancer: A Nonrandomized Clinical Cohort Trial. This trial demonstrates that an early FDG-PET scan after two weeks of first-line therapy for metastatic breast cancer can significantly improve outcome estimation compared to standard CT assessment. Non-progressive disease on early FDG-PET was highly predictive of longer progression-free and overall survival, suggesting its potential to identify patients with poor long-term outcomes much earlier. ()
['NA']
Rationale and design of a CArdiac Rehabilitation program on the Prevention of CardioTOXicity in Breast Cancer patients undergoing treatment with anthracyclines and/or trastuzumab (CARPTOX-BC) trial: a randomized, active control group, open-label trial. The CARPTOX-BC trial is designed to assess if a structured cardiac rehabilitation program can prevent chemotherapy-induced cardiotoxicity in breast cancer patients receiving anthracyclines and/or trastuzumab. This study aims to provide evidence for a non-pharmacological intervention to protect cardiac function and improve quality of life during cancer treatment. ()
['PHASE2']
Anlotinib combined with neoadjuvant chemotherapy for HR+/HER2- breast cancer (ACNTBC): a prospective, single-arm, single-center phase II clinical study with real-world validation. This phase II study demonstrates that adding anlotinib to neoadjuvant chemotherapy for HR+/HER2- breast cancer results in a promising total pathological complete response (tpCR) rate of 14.3% and an objective response rate of 93.5%. The regimen showed manageable toxicity, with high baseline VEGFR2 expression identified as a potential biomarker for superior efficacy. ()
['PHASE3']
HER2CLIMB-05: A Phase III Study of Tucatinib Versus Placebo in Combination With Trastuzumab and Pertuzumab as First-Line Maintenance Therapy for HER2+ Metastatic Breast Cancer. The addition of tucatinib to trastuzumab and pertuzumab as first-line maintenance therapy for HER2+ metastatic breast cancer demonstrated a statistically significant improvement in progression-free survival (24.9 vs 16.3 months). With a manageable safety profile, this regimen presents a promising new treatment option, including for patients with brain metastases. ()
['PHASE3']
Dose-dense adjuvant chemotherapy in HER2-low breast cancer: An exploratory analysis of the GIM2 trial. This exploratory analysis of the GIM2 trial shows that the survival benefits of dose-dense adjuvant chemotherapy for high-risk early breast cancer are maintained in patients with HER2-low tumors. The findings support the use of this intensified chemotherapy schedule irrespective of HER2-low or HER2-zero status. ()
['PHASE1']
Intravenous Everolimus Formulation (Sapu003) for Clinical Trials. A novel intravenous formulation of everolimus, Sapu003, has been developed to overcome the poor bioavailability of the oral agent, showing scalable manufacturing and potent antitumor efficacy in preclinical models. This formulation is now advancing into a Phase 1b clinical study for patients with advanced mTOR-sensitive solid tumors, including breast cancer. ()
['NA']
Perceptions and lived experiences with abemaciclib and endocrine therapy for early breast cancer: a rapid communication. This qualitative study highlights that while diarrhea is a significant early side effect of adjuvant abemaciclib, patients generally find it manageable with proactive support from clinical teams. Patients' motivation to reduce recurrence risk is a key driver for treatment adherence, underscoring the need for regular follow-up to manage symptoms effectively. ()
['PHASE2']
Neoadjuvant stereotactic body radiation therapy with durvalumab and oleclumab in ER+/HER2- breast cancer: a randomized phase 2 trial. In the Neo-CheckRay trial, combining immune-modulating stereotactic body radiation (iSBRT) with neoadjuvant chemotherapy and durvalumab (anti-PD-L1) improved pathologic complete response rates in high-risk ER+/HER2- breast cancer. This effect was most pronounced in PD-L1-negative tumors, suggesting iSBRT can convert immune-cold tumors into a more inflamed phenotype responsive to immunotherapy. ()
['PHASE1']
Phase 1 study of ceralasertib, an ATR kinase inhibitor, in combination with durvalumab in patients with recurrent or metastatic NSCLC or HNSCC. This first-in-human study established a tolerable safety profile and recommended Phase 2 dose for the combination of the ATR inhibitor ceralasertib with durvalumab. The regimen demonstrated preliminary antitumor activity in heavily pretreated patients with advanced NSCLC and HNSCC, supporting the strategic combination of DNA damage response inhibitors with immunotherapy. ()
['NA']
Fluorescence imaging using indocyanine green to identify sentinel lymph nodes during surgery for breast cancer (INFINITE): protocol for a hybrid effectiveness-implementation trial using a stepped-wedge cluster design. The INFINITE trial is designed to evaluate the real-world effectiveness and guide the implementation of indocyanine green (ICG) fluorescence imaging for sentinel lymph node biopsy in breast cancer. This study aims to establish ICG as a safe, effective, and non-radioactive alternative to the current standard of care, potentially streamlining surgical workflow and reducing patient burden. ()
['PHASE1', 'PHASE2']
Efficacy of selpercatinib as a first-line treatment for RET-fusion positive non-small-cell lung cancer: a novel two-stage Bayesian network meta-analysis. This study presents a novel Bayesian network meta-analysis method to integrate single-arm trial data, demonstrating the significant efficacy of selpercatinib in first-line RET-fusion positive NSCLC compared to standard chemotherapy. The methodology provides a robust framework for health technology assessments to evaluate promising therapies from single-arm studies before Phase III data are available. ()
['NA']
Preliminary Effectiveness of the Comprehensive Oncology Rehabilitation and Exercise (CORE) Clinical Workflow Algorithm on Health Outcomes During Nonmetastatic Breast Cancer Care. The CORE pilot trial demonstrated that a clinical workflow integrating rehabilitation and exercise services for early-stage breast cancer patients is feasible and shows promise for improving exercise engagement. Although the primary endpoint for physical function was not met, these findings support further investigation in a larger trial to confirm the benefits of structured exercise programs during cancer care. ()
['PHASE3']
Primary results from EL1SSAR, a prospective phase IIIb study of first-line atezolizumab plus nab-paclitaxel therapy for patients with PD-L1-positive advanced triple-negative breast cancer. The EL1SSAR study confirms the efficacy and safety of first-line atezolizumab plus nab-paclitaxel for PD-L1-positive advanced TNBC in a broader, real-world patient population, mirroring the results of the pivotal IMpassion130 trial. The findings support this combination's use in routine clinical practice and underscore the importance of standardized PD-L1 testing, as concordance between local and central labs was only 67%. ()
['PHASE3']
Outcomes in KEYNOTE-355 after chemotherapy discontinuation before pembrolizumab discontinuation and with immune-mediated adverse events. This analysis of KEYNOTE-355 shows that for patients with advanced PD-L1-positive TNBC, discontinuing chemotherapy while continuing pembrolizumab maintenance does not negatively impact survival. Furthermore, the development of immune-mediated adverse events was associated with a numerical improvement in efficacy, providing additional confidence in the management and outcomes of this standard-of-care regimen. ()
['PHASE3']
Impact of Germline BRCA Status on Pathologic Complete Response (pCR) and Outcomes in Early TNBC Treated with Pembrolizumab-Based Neoadjuvant Chemotherapy (KEYNOTE-522 Regimen): A Real-World Study. In a real-world cohort of early TNBC patients treated with the KEYNOTE-522 regimen, germline BRCA mutation carriers showed a numerically higher pCR rate and excellent survival outcomes. Recurrences were primarily seen in BRCA-negative patients who did not achieve pCR, highlighting a key population for future post-neoadjuvant escalation strategies. ()
['PHASE3']
Surgical Outcomes After Neoadjuvant Pembrolizumab Plus Chemotherapy for Triple-Negative Breast Cancer: Results from the Randomized, Placebo-Controlled Phase 3 KEYNOTE-522 Study. Data from the pivotal KEYNOTE-522 trial confirm that the addition of neoadjuvant pembrolizumab to chemotherapy for early-stage TNBC does not negatively impact surgical feasibility, timing, or safety. This provides reassurance that the integration of immunotherapy into the neoadjuvant setting does not compromise definitive surgical management. ()
['PHASE1']
Discovery of Dual A2A/A2B Adenosine Receptor Antagonist and Clinical Candidate INCB106385. This publication details the discovery of INCB106385, a potent, peripherally-restricted dual A2A/A2B adenosine receptor antagonist designed to overcome immune suppression in the tumor microenvironment. Strong preclinical efficacy and favorable drug-like properties have propelled this candidate into Phase 1 clinical trials for cancer immunotherapy. ()
['PHASE3']
Quality-of-life assessment in the randomized JBCRG-M06/EMERALD study of eribulin plus dual HER2 blockade in HER2-positive locally advanced or metastatic breast cancer. The EMERALD study demonstrated that for patients with HER2-positive metastatic breast cancer, an eribulin-based regimen maintained quality of life longer than a taxane-based regimen. This finding positions eribulin as a favorable therapeutic choice to avoid the early and significant QoL deterioration often associated with taxane therapy. ()
['PHASE2']
Body mass index in postmenopausal women with estrogen receptor-positive, HER2-negative early breast cancer: An exploratory analysis of the LORELEI trial. This analysis of the LORELEI trial suggests that obesity is associated with a reduced response to neoadjuvant letrozole in ER+/HER2- early breast cancer. Importantly, the addition of the PI3K inhibitor taselisib appeared to mitigate this negative effect, indicating a potential role for PI3K pathway inhibition in overcoming obesity-related endocrine resistance. ()
['PHASE2']
Lenvatinib Plus Pembrolizumab for Patients With Previously Treated Advanced Colorectal Cancer: Results From the Phase II LEAP-005 Study. In the LEAP-005 study, the combination of lenvatinib and pembrolizumab demonstrated modest antitumor activity in patients with heavily pretreated advanced colorectal cancer, achieving a 14% objective response rate. The safety profile was manageable and consistent with the known effects of each drug. ()
['NA']
Development and feasibility testing of a conversational chatbot supporting genetic education and testing for hereditary cancer. A conversational chatbot was shown to be a feasible and acceptable tool for promoting genetic education and testing among cancer survivors, leading to a nearly tenfold increase in testing uptake compared to enhanced usual care. This digital health guide also reduced decisional conflict and regret, highlighting its potential to streamline access to genetic services. ()
['PHASE3']
Clinical and Molecular Evaluation of HER2-Low and HER2-Ultralow Breast Cancer in the Penelope-B Clinical Trial Cohort. This molecular analysis of the Penelope-B cohort confirms that HER2-low is a distinct group with increased HER2 mRNA expression, but finds no molecular distinction between HER2-ultralow and HER2-0 tumors. These findings suggest that despite the clinical activity of T-DXd in the ultralow setting, additional biomarkers are needed to better identify patients who will benefit. ()
['PHASE1']
First-in-human evidence of multidrug resistance reversal in solid tumors: a cohort analysis of carbon nanoparticles‑Fe(II) complex trials. This Phase I study provides the first clinical evidence that intratumoral injection of a carbon nanoparticles-Fe(II) complex can reverse multidrug resistance in advanced solid tumors. A subset of patients achieved long-term survival by demonstrating renewed sensitivity to previously failed systemic therapies, warranting further investigation of this novel ferroptosis-inducing agent. ()
['PHASE1']
Zanidatamab, a Dual HER2-Targeted Bispecific Antibody, in Patients with Unresectable Locally Advanced or Metastatic HER2-Positive Salivary Gland Cancer: A Combined Analysis of Early-Phase Studies. The dual HER2-targeted bispecific antibody zanidatamab demonstrated meaningful and durable clinical activity in patients with heavily pretreated HER2-positive salivary gland cancer, achieving a 44% objective response rate. These findings support the potential of zanidatamab as a new therapeutic option for this challenging-to-treat cancer. ()
['PHASE3']
Association of cancer antigen 15-3 with distant recurrence in immunohistochemically defined breast cancer subtypes in Canadian Cancer Trials Group MA.32. This analysis of the MA.32 trial shows that a rising CA 15-3 level at 6 months post-diagnosis is a strong predictor of distant recurrence in patients with luminal and triple-negative breast cancer. This finding highlights the potential utility of monitoring CA 15-3 as a prognostic biomarker in non-HER2-positive subtypes. ()
['PHASE3']
Main factors associated with variability in the assessment of the objective response rate. A re-analysis of the PHEREXA phase 3 clinical trial. A re-analysis of the PHEREXA trial confirms that local investigators overestimate objective response rates, with the probability of discrepancy increasing with the number and location of target lesions evaluated. This underscores the critical importance of blinded independent central review in uncontrolled trials to provide an accurate assessment of tumor response. ()
Clinical Trials
Clinical Trials Summary
Number of Clinical Trials in breast cancer updated from 2026-06-01 to 2026-06-30:
Phase 1Phase 1/2Phase 2Phase 2/3Phase 3Phase 4Total
Enrolling by Invitation1-2---3
Not Yet Recruiting1211-2-16
Recruiting22935-11178
Available-------
Approved for Marketing-------
Active, Not Recruiting13327213260
Completed2-1-1-4
Total3914762273161
Phase 1 Clinical Trials within 3 Months of Primary Completion Date:
DRUGNCTIDStatusClinical Trial NameCompletion Date
Letrozole, BGB-43395, Fulvestrant NCT06253195 COMPLETED A Phase 1a/1b Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of the CDK4 Inhibitor BGB-43395, Alone or as Part of Combination Therapies in Chinese Patients With Advanced or Metastatic HR+/HER2- Breast Cancer and Other Solid Tumors 2026-04-23
ONO-4578, letrozole, abemaciclib, Palbociclib NCT06570031 COMPLETED ONO-4578-06: Phase I , Open-label, Non-blind, First-line Endocrine Therapy With ONO-4578 and Standard Treatment Letrozole and CDK4/6 Inhibitors (Palbociclib or Abemaciclib) in Patients With Metastatic or Recurrent Postmenopausal Hormone Receptor-positive HER2-negative Breast Cancer 2026-04-30
BG-68501, BGB-43395, Fulvestrant NCT06257264 ACTIVE_NOT_RECRUITING A Phase 1a/1b Study of BG-68501, a Selective CDK2 Inhibitor, in Participants With Advanced Solid Tumors 2026-08-31
Phase 2 Clinical Trials within 3 Months of Primary Completion Date:
DRUGNCTIDStatusClinical Trial NameCompletion Date
paclitaxel albumin-stabilized nanoparticle formulation, : pertuzumab, : trastuzumab NCT01730833 COMPLETED Phase II Prospective Open Label Study of Pertuzumab, Trastuzumab, and Nab-Paclitaxel in Patients With HER-2 Positive Advanced Breast Cancer 2026-04-20
Cyclophosphamide, : Multi-epitope Folate Receptor Alpha Peptide Vaccine, : Sargramostim NCT03012100 ACTIVE_NOT_RECRUITING Double Blind, Parallel Groups, Controlled, Randomized Phase II Trial to Evaluate Vaccination With Folate Receptor Alpha Peptide Vaccine With GM-CSF as Vaccine Adjuvant Following Oral Cyclophosphamide Versus GM-CSF/Placebo to Prevent Recurrence in Patients With Triple Negative Breast Cancer 2026-07-31
Phase 3 Clinical Trials within 3 Months of Primary Completion Date:
DRUGNCTIDStatusClinical Trial NameCompletion Date
Nuvastatic ™ NCT07669506 COMPLETED Phase III Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of NuvastaticTM in Reducing Cancer-Related Fatigue in Breast Cancer Patients Undergoing Chemotherapy 2026-06-15
Phase 4 Clinical Trials within 3 Months of Primary Completion Date:
No phase 4 trials completing within the next three months.
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