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Breast cancerJuly 2026
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Breast Cancer — Monthly Compass
Jul 01–31, 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 July 14, 2026, the FDA approved gedatolisib (Revtorpyk) with fulvestrant, with or without palbociclib, for adults with HR‑positive/HER2‑negative locally advanced or metastatic breast cancer lacking a PIK3CA mutation after ≥1 line of metastatic endocrine therapy, based on VIKTORIA‑1 PFS benefit and reviewed via RTOR and the Assessment Aid.
    • First‑line sacituzumab govitecan plus pembrolizumab received FDA approval in July 2026 for PD‑L1–positive triple‑negative breast cancer, establishing an ADC+IO anchor in 1L TNBC care.
  • Key Clinical Development Updates
    • The FDA accepted Roche’s giredestrant NDA for ER‑positive early‑stage breast cancer under Priority Review with a PDUFA target action date of November 30, 2026, supported by lidERA phase III data.
    • The FDA cleared CoRegen’s IND for CRG‑150, enabling a first‑in‑human phase 1/2a study of this adoptive cell therapy in metastatic triple‑negative and HR+/HER2‑ breast cancers (and prostate cancer).
  • Key Conference Updates
    • ASCO 2026 highlighted ADCs consolidating first‑line roles, with T‑DXd’s bystander effect supporting combination with pertuzumab (DESTINY‑Breast09), sacituzumab govitecan plus pembrolizumab improving PFS vs chemo+pembro (ASCENT‑04/KEYNOTE‑D19), and updated safety clarifying ILD vs radiation pneumonitis (DESTINY‑Breast05).
    • AAPM 2026 showcased AI‑enabled DIBH triage using deep‑learning heart‑dose prediction and surface‑guided manual gating on Ethos/Halcyon yielding consistent dosimetry and responsive beam holds, enabling individualized and efficient breast RT planning.
  • Emerging Themes & Macro-Trends
    • ADC+IO combinations are moving into first‑line settings and intensifying PD‑L1 testing and payer pressures, while PAM50‑guided de‑escalation in early HR+/HER2− disease and AI‑guided DIBH selection signal a shift toward precision‑driven therapy intensity and standardized RT workflows.
FDA Approvals/Withdrawals
FDA Approvals/Withdrawals
  • On July 14, 2026, the FDA approved gedatolisib (Revtorpyk, Celcuity Inc.) in combination with fulvestrant, with or without palbociclib, for adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer. This approval is for patients who have progressed on or after treatment with at least one line of endocrine therapy in the metastatic setting and do not have a PIK3CA mutation. The efficacy and safety were evaluated in Study 1 of VIKTORIA-1, an open-label, randomized, multicenter trial. Results showed a statistically significant improvement in progression-free survival for gedatolisib combinations compared to fulvestrant alone.¹ (read more)
Clinical Development Regulatory Updates
Clinical Development Regulatory Updates
  • FDA approved Celcuity’s gedatolisib (Revtorpyk) NDA on July 14, 2026 for HR-positive, HER2-negative, PIK3CA wild-type locally advanced/metastatic breast cancer in combination with fulvestrant, with or without palbociclib; the review utilized Real-Time Oncology Review (RTOR) and the Assessment Aid to streamline assessment. The decision was supported by VIKTORIA-1 data showing significant PFS improvements versus fulvestrant alone. ¹ (read more)
  • Celcuity announced the FDA approval of REVTORPYK and stated it plans to submit a supplemental NDA in Q3 2026 to extend use to PIK3CA‑mutated HR+/HER2‑ advanced breast cancer based on additional VIKTORIA‑1 cohort results. The company also noted commercial launch timelines and patient access plans. ² (read more)
  • Roche reported in its July 23, 2026 half‑year update that the FDA accepted the giredestrant NDA for ER‑positive early‑stage breast cancer under Priority Review, assigning a PDUFA target action date of November 30, 2026. The company highlighted that lidERA phase III data support the submission. ³ (read more)
  • Greenwich LifeSciences provided a FLAMINGO‑01 phase 3 update for GLSI‑100 in HER2‑positive breast cancer, noting FDA and EMA review of protocol modifications and reiterating GLSI‑100’s FDA Fast Track designation. The company stated that positive interim analyses could support a future BLA filing strategy. ⁴ (read more)
  • CoRegen announced FDA clearance of its IND for CRG‑150, an adoptive cell therapy targeting immune checkpoints, enabling initiation of a phase 1/2a trial in metastatic triple‑negative breast cancer and HR+/HER2‑ breast cancer (as well as prostate cancer). The IND clearance transitions the program into first‑in‑human testing. ⁵ (read more)
  • OncLive published a July 10 regulatory roundup noting that FDA granted Priority Review to Roche/Genentech’s giredestrant NDA in early‑stage ER‑positive breast cancer (with a November 30, 2026 PDUFA) and Fast Track designation to Terremoto Biosciences’ AKT1‑selective inhibitor TER‑2013 for HR+/HER2‑ disease. The article also recapped late‑June FDA breast cancer decisions and diagnostics updates. ⁶ (read more)
Conference
Major Conference Updates
Conference Information
  • 2026 ASCO Annual Meeting (Chicago, IL; hybrid) — peer-expert July coverage of plenary breast cancer data and practice implications. Overall sentiment: ADCs are consolidating front-line roles while biologically guided de-escalation gains traction. (read more)
  • 43rd Annual Miami Breast Cancer Conference — Abstracts Supplement (posted July 2, 2026). Signal for imaging-enabled triage and procedure de-escalation. (read more)
  • 2026 Joint AAPM | COMP Annual Meeting (July 19–22, 2026) — physics/RT innovation spotlight with multiple breast-focused abstracts. (read more)
  • Theme 1: ADCs Move Upfront and Pair With IO
    • Significance: ADCs are reshaping first-line standards in HER2+ and PD-L1+ TNBC, creating new efficacy and sequencing benchmarks. (read more)
    • Mechanism insights / clinical impact: T-DXd’s high DAR and bystander effect underpin activity when combined with pertuzumab (DESTINY-Breast09), while TROP2-directed sacituzumab govitecan plus pembrolizumab (ASCENT-04/KEYNOTE-D19) improved PFS vs chemo+pembro; DESTINY-Breast05 safety signals clarify ILD vs radiation pneumonitis management. (read more)
    • Patient populations affected: 1L HER2+ metastatic (T-DXd+pertuzumab under evaluation); 1L PD-L1+ TNBC (sacituzumab govitecan+pembrolizumab, FDA-approved July 2026). (read more)
  • Theme 2: Biology-Guided De-escalation in Early HR+/HER2− Disease
    • Significance: Multigene signatures aim to spare chemotherapy where benefit is unlikely, shifting value toward precise risk tools and supportive care. (read more)
    • Mechanism insights / clinical impact: OPTIMA indicates PAM50 can identify subgroups with limited chemo benefit, supporting endocrine-focused strategies and toxicity reduction without sacrificing outcomes. (read more)
    • Patient populations affected: Early-stage ER+/HER2− (node-positive/selected node-negative) candidates for adjuvant therapy where genomic classifiers refine treatment intensity. (read more)
  • Theme 3: AI-Enabled Radiotherapy Personalization (Left-Sided Breast)
    • Significance: AI triage for DIBH and streamlined gating on O‑ring linacs improve cardio-protection, broaden access, and standardize quality. (read more)
    • Mechanism insights / clinical impact: Deep‑learning models predict achievable heart‑dose reduction to select DIBH candidates; surface‑guided manual gating on Ethos/Halcyon demonstrates consistent dosimetry and responsive beam‑hold performance—together enabling individualized, efficient RT planning. (read more)
    • Patient populations affected: Left‑sided whole‑breast and post‑mastectomy RT (community and academic centers), including programs deploying Ethos/Halcyon platforms. (read more)
  • Theme 4: Imaging Triage to Reduce Invasive Procedures
    • Significance: Elastography integrated with ultrasound can refine biopsy decisions, supporting de‑escalation and resource stewardship. (read more)
    • Mechanism insights / clinical impact: Higher E‑strain ratios in malignant vs benign lesions across BI‑RADS categories suggest a reproducible adjunct to guide biopsy thresholds. (read more)
    • Patient populations affected: Diagnostic work‑up across breast clinics (global), especially where adjunct imaging can mitigate unnecessary biopsies. (read more)
  • Significance
    • Expected clinical or translational readouts: Continued maturation of DESTINY‑Breast09 and broader T‑DXd safety datasets; expansion of PAM50-guided adjuvant decision-making; prospective validation of AI DIBH-triage in multi-center workflows. (read more)
    • Regulatory or policy implications: Rapid uptake of sacituzumab govitecan+pembrolizumab in PD‑L1+ TNBC will pressure payers and PD‑L1 test logistics; RT AI tools may inform guideline updates around DIBH selection. (read more)
    • Potential shifts in standard of care: 1L PD‑L1+ TNBC anchored by ADC+IO; movement toward chemo‑sparing in genomically low‑benefit HR+/HER2− early disease; more routine AI‑guided DIBH selection. (read more)
    • Strategic implications: Align commercial strategy to ADC+IO combinations; invest in companion diagnostics and RT‑planning AI partnerships; prioritize evidence packages demonstrating toxicity, QoL, and operational advantages alongside efficacy. (read more)
Publications Related to Approved Drugs
Phase 3
pertuzumab, trastuzumab, and hyaluronidase-zzxf
Final analysis of the FeDeriCa phase III study: long-term efficacy, safety and pharmacokinetics of the fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection, plus chemotherapy, in HER2-positive early breast cancer. The final analysis of the FeDeriCa study confirms that the subcutaneous fixed-dose combination of pertuzumab and trastuzumab provides comparable long-term efficacy and safety to the standard intravenous administration in patients with HER2-positive early breast cancer. With a median follow-up of approximately 51 months, the subcutaneous formulation maintained similar event-free and overall survival rates, reinforcing its role as a faster, less invasive, and preferred treatment alternative without any new safety signals. ()
New Publications Related to Drugs in Clinical Trial Development
Phase 2
Post Hoc Analysis of the Phase II DESTINY-PanTumor02 Study: Local and Central HER2 IHC Concordance and Trastuzumab Deruxtecan Efficacy by HER2 IHC Status in HER2-Expressing Solid Tumors. This analysis of the DESTINY-PanTumor02 study revealed only moderate concordance between local and central HER2 testing in various solid tumors, underscoring the need for validated diagnostic tests and standardized algorithms to accurately identify patients who may benefit from HER2-directed therapies. ()
Phase 2
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 therapy (iSBRT) with anti-PD-L1 durvalumab and neoadjuvant chemotherapy improved pathologic complete response rates in high-risk ER+HER2- breast cancer, particularly converting immune-cold, PD-L1-negative tumors into more inflamed, responsive phenotypes. ()
Phase 3
Targeting homologous recombination deficiency with intensified chemotherapy versus standard chemotherapy followed by olaparib in stage III breast cancer (SUBITO): an open-label, randomised, controlled, phase 3 trial. The SUBITO phase 3 trial demonstrated that for patients with stage III, HER2-negative, HRD breast cancer, a state-of-the-art regimen of chemotherapy plus olaparib yields promising survival outcomes comparable to intensified chemotherapy with autologous stem cell rescue, but with a more favorable toxicity profile. ()
PHASE1, PHASE2
PARP inhibition combined with a T-cell receptor β chain-directed antibody fusion molecule drives polyclonal antitumor immunity and tumor regression. Preclinical findings demonstrate that combining the PARP inhibitor olaparib with a selective Vβ-directed T-cell agonist (mSTAR1302) significantly enhances antitumor immunity and induces tumor regression in prostate cancer models, providing a strong rationale for clinical trials of this combination to overcome immune exclusion in solid tumors. ()
Phase 3
Lumpectomy Margins and Local Recurrence in DCIS: Results From the NRG Oncology/NSABP B-35 Randomized Clinical Trial. In postmenopausal women with HR-positive DCIS receiving radiation and endocrine therapy, this analysis of the NSABP B-35 trial found that lumpectomy margin width was not a significant predictor of ipsilateral breast tumor recurrence, suggesting that re-excision for close margins (e.g., <2 mm) can be reconsidered in this population. ()
PHASE1, PHASE2
ALFAssay: A feed‑forward neural network for quantitative fragmentomics‑based ctDNA profiling in breast cancer. This study introduces ALFAssay, a novel feed-forward neural network that accurately quantifies circulating tumor DNA (ctDNA) fraction from cfDNA fragmentation profiles, demonstrating high sensitivity and specificity and providing complementary prognostic value for liquid biopsy workflows in breast cancer. ()
Phase 3
The fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection in Chinese patients with HER2-positive early breast cancer: primary analysis of the phase III, randomized FDChina study. The phase III FDChina study confirmed that a fixed-dose subcutaneous combination of pertuzumab and trastuzumab is non-inferior to the standard intravenous infusions in Chinese patients with HER2-positive early breast cancer, offering a viable and more convenient treatment option with comparable efficacy and safety. ()
Phase 4
Secondary Analysis of the CAN-Study, a Randomised Controlled Trial - Local Anaesthesia and Overall Survival. In this non-preplanned secondary analysis of a randomized trial comparing anesthetic agents, the use of local anesthetic infiltration or regional anesthesia during breast cancer surgery was not associated with any difference in long-term overall survival. ()
Phase 4
Impact of obesity on doxorubicin pharmacokinetics in women with breast cancer. This pharmacokinetic study observed large interindividual variability in doxorubicin clearance among women with breast cancer but found no evidence to support the idea that clearance is decreased in patients with a BMI ≥35 kg/m², challenging current dosing considerations. ()
Early Phase 1
Optimized Detection of Left Ventricular Hyperpolarized [1-13C]Pyruvate Signal in Human Cardiac Metabolic Imaging. This study presents an optimized, semi-automated method for analyzing hyperpolarized [1-13C]pyruvate MRI data, which improves the reliability of quantifying the left ventricular input signal for more robust assessment of cardiac metabolism in human imaging studies. ()
PHASE1, PHASE2
Sacituzumab govitecan in Japanese participants with HR+/HER2- metastatic breast cancer: primary results from the phase II ASCENT-J02 study. This phase II study in Japanese patients with pretreated HR+/HER2- metastatic breast cancer showed that while sacituzumab govitecan did not meet the primary endpoint for objective response rate by independent review, its overall efficacy and manageable safety profile were consistent with the global TROPiCS-02 study, supporting its use in this patient population. ()
PHASE1, PHASE2
CSF1R Inhibition with Chemotherapy Relieves Systemic Immune Suppression in Patients with Metastatic Triple-Negative Breast Cancer and Boosts Anti-PD-1 Efficacy in Transgenic Mammary Tumors. This translational study found that combining the CSF1R inhibitor pexidartinib with eribulin provided clinical benefit in heavily pretreated metastatic TNBC, and preclinical data showed this strategy boosts the efficacy of anti-PD-1 therapy, providing a strong rationale for combining macrophage-targeting agents with immunotherapy. ()
Phase 3
Exploration of body mass index and circulating metabolic factors as predictors of metformin benefit in the Canadian Cancer Trials Group MA.32. This secondary analysis of the MA.32 trial found that body mass index and circulating metabolic factors like insulin and glucose did not identify any subgroups within luminal, triple-negative, or HER2-positive breast cancer that derived a survival benefit from adjuvant metformin. ()
Early Phase 1
Evaluation of dronabinol to decrease opioid use for cancer-induced bone pain. This single-arm pilot study in breast cancer patients with bone metastases found that the addition of dronabinol helped a subset of patients decrease their opioid use and was associated with significant improvements in patient-reported pain, quality of life, and insomnia, supporting further investigation of cannabinoids for cancer-induced bone pain. ()
Phase 2
Survival Analysis of the WSG TP-II Trial: Neoadjuvant Trastuzumab and Pertuzumab Plus Endocrine Therapy Versus Chemotherapy in Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Positive Early Breast Cancer. The final 5-year survival analysis of the WSG TP-II trial demonstrates excellent outcomes for patients with HR+/HER2-positive early breast cancer, confirming the safety and efficacy of a de-escalated neoadjuvant approach using dual HER2 blockade with either endocrine therapy or chemotherapy, followed by pCR-guided adjuvant therapy. ()
Phase 3
Efficacy and safety of eribulin mesylate vs. docetaxel or paclitaxel, combined with trastuzumab and pertuzumab, as first-line treatment for HER2-positive locally advanced or metastatic breast cancer: updated subgroup analyses of JBCRG-M06/EMERALD. Updated subgroup analyses of the EMERALD study show that eribulin offers comparable efficacy to taxanes (docetaxel or paclitaxel) as a first-line treatment for HER2+ advanced breast cancer when combined with dual HER2 blockade, while demonstrating a longer time to quality of life deterioration. ()
Phase 2
Tucatinib in Combination With Trastuzumab Deruxtecan in Patients With Previously Treated HER2+ Unresectable Locally Advanced or Metastatic Breast Cancer: An Open-Label Phase 2 Study. The HER2CLIMB-04 phase 2 study showed that while adding tucatinib to trastuzumab deruxtecan (T-DXd) did not demonstrate a clear efficacy benefit over historical T-DXd monotherapy, the combination was tolerable with antidiarrheal prophylaxis and showed clinical activity in heavily pretreated patients with HER2+ metastatic breast cancer, including those with brain metastases. ()
N/A
Pharmacologic de-escalation of dexamethasone during weekly paclitaxel: a randomized phase III trial evaluating safety, endocrine effects, and quality of life. This randomized trial showed that omitting dexamethasone premedication after the second weekly paclitaxel infusion is safe and does not increase hypersensitivity reactions, while being associated with improved patient-reported outcomes such as pain, constipation, and nausea. ()
PHASE1, PHASE2
The pharmacological profile of ART6043, a first-in-class clinical DNA polymerase theta polymerase domain inhibitor potentiating PARP inhibitor efficacy. This preclinical study introduces ART6043, a first-in-class, potent, and selective inhibitor of DNA polymerase theta (Polθ) that demonstrates strong synergy with PARP inhibitors in homologous recombination deficient (HRD) tumor models, supporting its ongoing evaluation in a Phase I/IIa clinical trial. ()
Phase 3
Switching to camizestrant at ESR1 mutation emergence before disease progression during first-line treatment of hormone receptor-positive advanced breast cancer (SERENA-6): extended analysis of a double-blind, placebo-controlled, randomised, phase 3 trial. The SERENA-6 trial validates a novel strategy of using ctDNA monitoring to guide a switch to camizestrant upon detection of an ESR1 mutation, which significantly improved progression-free survival (16.8 vs 9.2 months) and second progression-free survival, supporting a proactive change in endocrine therapy to extend first-line treatment benefit. ()
Phase 3
Recurrence Score® gene group components and outcomes in the RxPONDER trial (SWOG S1007). This analysis of the RxPONDER trial reveals that despite similar overall Recurrence Score® results across ethnic groups, the underlying gene group components, such as proliferation scores, vary significantly and may contribute to outcome disparities, suggesting a need to look beyond composite scores to refine risk stratification. ()
Phase 3
Tumor infiltrating lymphocytes as a predictor of adjuvant avelumab efficacy in patients with high-risk triple negative breast cancer. Analysis of the A-BRAVE trial demonstrates that tumor-infiltrating lymphocytes (TILs) are a predictive biomarker for adjuvant avelumab, with benefit observed only in patients with high baseline TILs (≥30%), supporting TILs-guided immunotherapy strategies in high-risk early triple-negative breast cancer. ()
Phase 2
Dalpiciclib plus endocrine therapy in women with HR+/HER2- advanced breast cancer and visceral crisis: a multicenter, nonrandomized, phase 2 DARVIN trial. The phase 2 DARVIN trial demonstrated that dalpiciclib plus endocrine therapy is an effective and safe option for women with HR+/HER2- advanced breast cancer in visceral crisis, achieving a 6-month survival rate of 92.5% and a median progression-free survival of 11.2 months. ()
PHASE1, PHASE2
Multikinase Inhibition with Tinengotinib in Advanced Solid Tumors: Results from a Multicenter Phase Ib/II Trial. The multikinase inhibitor tinengotinib demonstrated a manageable toxicity profile and promising antitumor activity across several advanced solid tumors, including breast cancer and cholangiocarcinoma, with genomic analyses identifying potential biomarkers to guide its continued clinical development. ()
N/A
Prospective comparison of [68Ga]Ga-FAPI-04 PET/MRI, [18F]FDG PET/CT, and contrast-enhanced MRI for predicting pathologic complete response after neoadjuvant chemotherapy in breast cancer. This prospective study demonstrated that post-neoadjuvant [68Ga]Ga-FAPI-04 PET imaging outperformed [18F]FDG PET/CT and MRI in predicting pathologic complete response in breast cancer, showing particular strength in assessing axillary nodal status and supporting its potential role in preoperative planning. ()
Phase 2
A phase II clinical trial of neoadjuvant chemotherapy combined with immunotherapy and different radiotherapy fractionation regimens in HR+/HER2- breast cancer. This publication outlines the design of a phase II trial to evaluate the feasibility and efficacy of combining neoadjuvant Toripalimab and chemotherapy with three different radiotherapy fractionation schedules, aiming to identify an optimal regimen to enhance immune-mediated responses in early-stage HR+/HER2- breast cancer. ()
Phase 3
Datopotamab deruxtecan versus chemotherapy in previously treated inoperable/metastatic hormone receptor-positive HER2-negative breast cancer: safety and patient-reported outcomes from the phase III TROPION-Breast01 study. Final analysis of the TROPION-Breast01 study confirms that datopotamab deruxtecan (Dato-DXd) has a manageable safety profile and leads to delayed deterioration in global health status and quality of life compared to chemotherapy in patients with previously treated HR+/HER2- metastatic breast cancer, supporting its use as a new treatment option. ()
Phase 2
A phase II basket trial of DART SWOG S1609: the salivary gland tumor cohort. In the DART SWOG S1609 trial, the combination of ipilimumab and nivolumab demonstrated limited objective response rates in salivary gland tumors; however, 35% of patients with non-adenoid cystic histologies experienced clinical benefit, suggesting a potential role for dual checkpoint inhibition in a subset of these rare cancers. ()
Phase 2
Patient-reported outcomes from the TBCRC 022 study of neratinib and ado-trastuzumab emtansine for HER2-positive breast cancer brain metastases. This analysis from the TBCRC 022 trial demonstrates that patient-reported outcomes captured a significant gastrointestinal toxicity burden from the neratinib and T-DM1 combination that was underestimated by standard clinician reporting, highlighting the value of PROs for informing supportive care strategies. ()
Phase 3
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 treated with the KEYNOTE-522 regimen, patients with germline BRCA mutations had numerically higher pathologic complete response rates and improved recurrence-free survival, while recurrence events were predominantly seen in BRCA-negative patients who did not achieve pCR, highlighting this subgroup for potential treatment escalation. ()
Phase 3
Low-fat dietary pattern and dietary advanced glycation end-products intake: a secondary analysis of the Women's Health Initiative randomized trial. This secondary analysis of the Women's Health Initiative trial found that the low-fat dietary intervention, which previously reduced breast cancer mortality, also significantly and persistently lowered the intake of dietary advanced glycation end-products (dAGEs), suggesting a potential mechanism for the diet's protective effect. ()
N/A
Antacid co-treatment and pregnane X receptor genetic polymorphisms are survival determinants in patients treated with palbociclib. This real-life study on first-line palbociclib for metastatic breast cancer identified that concomitant antacid use and specific NR1I2 single nucleotide polymorphisms (SNPs) were associated with reduced progression-free survival, highlighting key factors that negatively influence treatment outcomes. ()
Phase 2
Cemiplimab and Fianlimab With Neoadjuvant Chemotherapy in Early-Stage High-Risk ERBB2-Negative Breast Cancer: The I-SPY2 Randomized Clinical Trial. In the I-SPY2 trial, adding the dual checkpoint inhibitor combination of cemiplimab (anti-PD-1) and fianlimab (anti-LAG-3) to standard neoadjuvant chemotherapy significantly improved pathologic complete response rates across all ERBB2-negative subtypes, particularly in patients with an immune-positive signature. ()
Phase 2
Efficacy and safety of trastuzumab deruxtecan in patients with HER2-expressing biliary tract or pancreatic tumors: a subgroup analysis of DESTINY-PanTumor02. This subgroup analysis of the DESTINY-PanTumor02 trial demonstrated that trastuzumab deruxtecan (T-DXd) provides a clinically meaningful benefit in pretreated HER2-expressing biliary tract cancer, particularly in IHC 3+ tumors, while its efficacy in pancreatic cancer was limited in this small cohort. ()
Phase 3
TroFuse-011 study design: sacituzumab tirumotecan with or without pembrolizumab for advanced triple-negative breast cancer with PD-L1 CPS <10. This publication details the design of the TroFuse-011 phase 3 trial, which will evaluate the novel TROP2-directed antibody-drug conjugate sacituzumab tirumotecan, with or without pembrolizumab, against standard chemotherapy in patients with advanced triple-negative breast cancer and low PD-L1 expression, a population with poor outcomes. ()
Early Phase 1
CT-guided intratumoral immunotherapy for advanced solid tumors: a prospective clinical study of safety and systemic antitumor effects. This prospective pooled study of 169 patients with advanced solid tumors demonstrates that CT-guided intratumoral injection of various immunotherapies is safe, with a low rate of grade 3-4 adverse events (8.88%), and shows preliminary efficacy, suggesting this approach may be a promising strategy to mitigate systemic toxicity. ()
Phase 2
Circulating tumor DNA concentration at diagnosis is a modifiable prognostic factor for distant metastatic recurrence in patients with high-risk breast cancer receiving neoadjuvant therapy. Analysis from the I-SPY2 trial shows that while high ctDNA concentration at diagnosis is a poor prognostic factor, early clearance of ctDNA during neoadjuvant therapy is associated with improved distant recurrence-free survival, suggesting ctDNA dynamics can further stratify risk beyond residual cancer burden. ()
Phase 2
Single-fraction or multi-fraction stereotactic ablative body radiotherapy followed by atezolizumab in advanced triple-negative breast cancer: a randomized phase II trial. The AZTEC phase II trial showed that combining stereotactic ablative body radiotherapy (SABR) with atezolizumab was safe but did not improve progression-free survival in a broad population of advanced triple-negative breast cancer patients, though clinical benefit was observed in a subset of patients with oligometastatic disease. ()
Phase 2
Coenzyme Q10 as an adjunctive strategy to reduce paclitaxel-induced toxicities in breast cancer: a randomized controlled trial. This randomized trial demonstrated that Coenzyme Q10 supplementation significantly reduced the incidence and severity of paclitaxel-induced peripheral neuropathy and other toxicities in breast cancer patients, suggesting its potential as a supportive care strategy to improve treatment tolerability. ()
PHASE1, PHASE2
A first-in-human phase 1a study of LP-184, a tumor-site activated novel alkylating agent, in patients with advanced solid tumors. The first-in-human dose-escalation trial of LP-184, a novel alkylating agent activated by PTGR1, established a maximum tolerated dose of 0.49 mg/kg and demonstrated a favorable safety profile in patients with advanced refractory solid tumors, with stable disease achieved in 40% of evaluable patients. ()
Phase 3
Trastuzumab rezetecan versus pyrotinib plus capecitabine for patients with HER2-positive metastatic breast cancer (HORIZON-Breast01): interim analysis of a multicentre, open-label, randomised, controlled, phase 3 trial. Interim analysis of the HORIZON-Breast01 phase 3 trial shows that trastuzumab rezetecan significantly prolonged progression-free survival compared to pyrotinib plus capecitabine (30.6 vs 8.3 months) in patients with previously treated HER2-positive metastatic breast cancer, establishing it as a potential new treatment option with a manageable safety profile. ()
Clinical Trials
Clinical Trials Summary
Number of Clinical Trials in breast cancer updated from 2026-07-01 to 2026-07-31:
Phase 1Phase 1/2Phase 2Phase 2/3Phase 3Phase 4Total
Enrolling by Invitation-------
Not Yet Recruiting1611-4123
Recruiting241542-9898
Available-------
Approved for Marketing-------
Active, Not Recruiting161030123282
Completed2-2---4
Total43318513611207
Phase 1 Clinical Trials within 3 Months of Primary Completion Date:
DRUGNCTIDStatusClinical Trial NameCompletion Date
68Ga-R10602 injection NCT06745804 COMPLETED Phase 1 Imaging Study of 68Ga-R10602-101 in Hormone Receptor-Positive Breast Cancer 2026-05-04
Fulvestrant, E7090, Exemestane NCT04572295 COMPLETED An Open-label Phase 1b Study of E7090 Monotherapy and in Combination With Other Anticancer Agents in Subjects With ER+, HER2- Recurrent/Metastatic Breast Cancer 2026-06-18
: Atezolizumab, Cabozantinib S-malate, Nab-paclitaxel NCT05092373 RECRUITING Phase I Study of Tumor Treating Fields (TTF) in Combination With Cabozantinib or With Pembrolizumab and Nab-Paclitaxel in Patients With Advanced Solid Tumors Involving the Abdomen or Thorax 2026-09-01
Immunotherapy NCT06130826 RECRUITING A Phase I Study of M5A-IL2 Immunocytokine Combined With Stereotactic Body Radiation Therapy (SBRT) in Patients With Metastatic Colorectal Cancer or CEA-Positive Metastatic Breast Cancer 2026-09-05
: Nivolumab, : Ipilimumab, Entinostat NCT02453620 ACTIVE_NOT_RECRUITING A Phase 1 Study Evaluating Safety, Tolerability, and Preliminary Antitumor Activity of Entinostat and Nivolumab With or Without Ipilimumab in Advanced Solid Tumors 2026-09-17
Phase 2 Clinical Trials within 3 Months of Primary Completion Date:
DRUGNCTIDStatusClinical Trial NameCompletion Date
CDK4/6 inhibitor (Qilu),Trastuzumab (Hanquyou) NCT05969184 COMPLETED Palbociclib Combine With Endocrine Therapy and Anti-HER2 Therapy in HR Positive and HER2 Positive Advanced Breast Cancer 2026-06-25
Carboplatin, Pembrolizumab, Paclitaxel NCT06604858 COMPLETED Neoadjuvant Phase II Study of Pembrolizumab and Carboplatin Plus Paclitaxel for Stage I Triple-negative Breast Cancer (The TELESCOPE Study) 2026-07-07
[No Drug Info] NCT05534438 RECRUITING Stereotactic Body Radiation Therapy (SBRT) to Extend the Benefit of Systemic Therapy in Patients With Solitary Disease Progression 2026-09-06
Carboplatin, Paclitaxel, Atezolizumab NCT02883062 ACTIVE_NOT_RECRUITING Randomized Phase 2 Study of Neoadjuvant Chemotherapy, Carboplatin and Paclitaxel, With or Without Atezolizumab in Triple Negative Breast Cancer (TNBC) 2026-09-11
Adavosertib 150 mg BD + olaparib 200 mg BD (21-day cycle)., Olaparib Continuous (28-Day cycle) 300 mg BD., Ceralasertib 160 mg OD + olaparib continuous 300 mg BD (28-day cycle). NCT03330847 ACTIVE_NOT_RECRUITING A Phase II, Open Label, Randomised, Multi-centre Study to Assess the Safety and Efficacy of Agents Targeting DNA Damage Repair in Combination With Olaparib Versus Olaparib Monotherapy in the Treatment of Metastatic Triple Negative Breast Cancer Patients Stratified by Alterations in Homologous Recombinant Repair (HRR)-Related Genes (Including BRCA1/2) (VIOLETTE). 2026-10-09
Phase 3 Clinical Trials within 3 Months of Primary Completion Date:
No phase 3 trials completing within the next three months.
Phase 4 Clinical Trials within 3 Months of Primary Completion Date:
DRUGNCTIDStatusClinical Trial NameCompletion Date
Bone modifying agent NCT04549207 ACTIVE_NOT_RECRUITING A Randomised Trial Comparing Continuation or De-escalation of Bone Modifying Agents (BMA) in Patients Treated for Over 2 Years for Bone Metastases From Either Breast or Castration-resistant Prostate Cancer (REaCT-Hold BMA) 2026-09
Granulocyte Colony-Stimulating Factor (G-CSF), Omission of Granulocyte Colony-Stimulating Factor (G-CSF) NCT05753618 RECRUITING A Randomized Pragmatic Trial Evaluating Omission of Granulocyte Colony-stimulating Factors in Breast Cancer Patients Receiving Paclitaxel Portion of Dose-dense Adriamycin-cyclophosphamide and Paclitaxel Chemotherapy (REaCT-OGF) 2026-10
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