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Breast cancerSeptember 2026
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Breast Cancer — Monthly Compass
Sep 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
    • FDA granted accelerated approval to AstraZeneca’s Etcamah (camizestrant) with a CDK4/6 inhibitor for adults with HR+/HER2− locally advanced or metastatic breast cancer upon ctDNA‑detected ESR1 mutation during aromatase inhibitor plus CDK4/6 therapy, enabling a first‑line treatment switch prior to radiographic progression based on an FDA‑authorized test.
    • FDA approved Eli Lilly’s Inluriyo (imlunestrant) with Verzenio (abemaciclib) for ER‑positive, HER2‑negative, ESR1‑mutated advanced or metastatic breast cancer after progression on endocrine therapy, adding an all‑oral SERD+CDK4/6 regimen contingent on detection by an FDA‑authorized test and supported by EMBER‑3 results.
  • Important Drug Publication Updates
    • The New England Journal of Medicine published phase 3 evERA results showing giredestrant plus everolimus significantly improved progression‑free survival in ER‑positive advanced breast cancer.
  • Key Clinical Development Updates
    • Genentech disclosed FDA PDUFA goal dates for giredestrant: November 30, 2026 for early‑stage indications and December 18, 2026 for advanced disease.
    • FDA approved a PMA supplement for Guardant360 CDx to detect ESR1 mutations in plasma as a companion diagnostic for selecting patients eligible for Etcamah plus a CDK4/6 inhibitor and to enable longitudinal ctDNA testing that supports early therapy switching aligned to SERENA‑6.
  • Key Conference Updates
    • At PBCC 2026 (September 18–19), sessions emphasized HR+ post‑CDK4/6 precision strategies including ESR1‑targeting oral SERDs, PI3K/AKT/PTEN‑directed therapies, and a chemo‑TKI approach with fruquintinib plus eribulin for endocrine‑refractory disease.
    • The International Invasive Lobular Carcinoma Symposium (September 23–25) highlighted non‑truncating CDH1 biology, cohorts evaluating omission of axillary surgery, and neoadjuvant therapy debates to refine ILC‑specific imaging, pathology, and operative planning.
  • Emerging Themes & Macro-Trends
    • EU approval of Enhertu plus pertuzumab in first‑line HER2‑positive metastatic breast cancer on September 1 and a September 18 CHMP positive opinion for adjuvant Enhertu in residual HER2‑positive early disease signal rapid ADC migration into frontline and early settings with imminent guideline implications.
    • Strategic priorities center on scaling DXd/TROP2 ADC manufacturing and supply, integrating companion diagnostics and ER imaging (FES‑PET) into routine workflows, and pursuing business development as China‑origin ADCs enter global breast cancer markets.
FDA Approvals/Withdrawals
FDA Approvals/Withdrawals
  • There are no press releases between 2026-09-01 and 2026-09-30 about breast cancer.
Clinical Development Regulatory Updates
Clinical Development Regulatory Updates
  • FDA granted accelerated approval to AstraZeneca’s Etcamah (camizestrant) with a CDK4/6 inhibitor for adults with HR+/HER2− locally advanced or metastatic breast cancer upon detection of an ESR1 mutation during aromatase inhibitor plus CDK4/6 therapy, based on an FDA‑authorized test. The decision enables a ctDNA‑guided treatment switch prior to radiographic progression. (fda.gov) ¹ (read more)
  • AstraZeneca filed a Form 6‑K confirming U.S. accelerated approval of Etcamah in first‑line HR+ breast cancer based on SERENA‑6 and noting concurrent authorization of a companion diagnostic. The corporate update underscores the ctDNA‑guided, first‑line treatment paradigm recognized by FDA. (sec.gov) ² (read more)
  • Guardant Health announced FDA PMA supplement approval of Guardant360 CDx as a companion diagnostic to detect ESR1 mutations in plasma for selecting patients eligible for Etcamah plus a CDK4/6 inhibitor in advanced breast cancer. The decision enables longitudinal ctDNA testing to support early therapy switching aligned to SERENA‑6. (investors.guardanthealth.com) ³ (read more)
  • FDA approved Eli Lilly’s Inluriyo (imlunestrant) in combination with Verzenio (abemaciclib) for ER‑positive, HER2‑negative, ESR1‑mutated advanced or metastatic breast cancer after progression on endocrine therapy, contingent on detection by an FDA‑authorized test. The approval reflects EMBER‑3 results and adds an all‑oral SERD+CDK4/6 option for ESR1‑mutated disease. (fda.gov) ⁴ (read more)
  • Bayer reported FDA acceptance of its sNDA and Priority Review for Lynkuet (elinzanetant) to treat moderate‑to‑severe vasomotor symptoms in women receiving endocrine therapy for HR+ breast cancer. The filing is supported by the phase 3 OASIS‑4 trial. (bayer.com) ⁵ (read more)
  • BriaCell Therapeutics announced a seventh consecutive DSMB recommendation to continue its pivotal phase 3 Bria‑IMT plus checkpoint inhibitor study in metastatic breast cancer. The update reiterates the program’s FDA Fast Track designation. (globenewswire.com) ⁶ (read more)
  • Genentech reported NEJM publication of phase 3 evERA data showing giredestrant plus everolimus improved PFS in ER+ advanced breast cancer and disclosed FDA PDUFA goal dates for its giredestrant filings: November 30, 2026 (early‑stage) and December 18, 2026 (advanced). The corporate update highlights pending NDA decisions across two settings. (gene.com) ⁷ (read more)
Conference
Major Conference Updates
Conference Information
  • ESMO Congress 2026 (Madrid, Spain; October 23–27, 2026); Practical Breast Cancer Care Conference (PBCC 2026; Washington, DC; September 18–19, 2026); International Invasive Lobular Carcinoma (ILC) Symposium (San Francisco, CA; September 23–25, 2026). (read more)
  • Sentiment: September content signals accelerating adoption of antibody–drug conjugates (ADCs) into frontline and early settings, sharpening HR+ post‑CDK4/6 treatment segmentation, and a rising focus on histology‑tailored care for invasive lobular carcinoma.
  • Theme 1: ADCs move to the front and earlier lines
    • Significance: EU approval of Enhertu + pertuzumab in 1L HER2+ MBC (Sept 1) and a CHMP positive opinion for adjuvant Enhertu in residual HER2+ eBC (Sept 18) point to rapid standard‑of‑care evolution; ESMO-bound ADC readouts (sacituzumab tirumotecan; IBI354) extend momentum. (read more)
    • Mechanism insights / clinical impact: DXd ADCs (trastuzumab deruxtecan) deliver topoisomerase‑I payloads with high DAR and bystander effect; TROP2 ADC sacituzumab tirumotecan (belotecan‑derived payload, DAR 7.4) is set for final OS analysis in “OptiTROP‑Breast01” (Rapid Oral), while Innovent’s “IBI354 (HER2 ADC) + pertuzumab” will provide 1L activity signals—together reinforcing ADC class durability and combination potential. (read more)
    • Patient populations affected: HER2+ early (residual disease post‑neoadjuvant) and metastatic 1L; previously treated TNBC (OptiTROP‑Breast01); HER2+ 1L cohorts in Asia‑led trials. (read more)
  • Theme 2: HR+ post‑CDK4/6 precision strategies (ESR1 and PI3K/AKT/PTEN), plus VEGF–chemo combinations
    • Significance: September programs emphasized ESR1‑mutated disease management (ORSERDU [elacestrant]) and pathway‑altered tumors (PIK3CA/AKT1/PTEN), reflecting routine biomarker‑guided selection beyond first progression; parallel exploration of fruquintinib+eribulin addresses endocrine‑refractory disease with a chemo‑TKI strategy. (read more)
    • Mechanism insights / clinical impact: Oral SERDs target ligand‑binding‑domain ESR1 mutations to restore endocrine sensitivity; AKT/PI3K pathway targeting fits genomically selected 2L settings; VEGFR TKI (fruquintinib) may normalize tumor vasculature and potentiate eribulin microtubule inhibition—an all‑comers option after ET+CDK4/6. (read more)
    • Patient populations affected: HR+/HER2− mBC after CDK4/6i; PIK3CA/AKT1/PTEN‑altered tumors; broader HR+ cohorts requiring chemotherapy after endocrine resistance. (read more)
  • Theme 3: Histology‑tailored ILC care and de‑escalation debates
    • Significance: A dedicated ILC symposium underscored unmet needs in detection, surgical decision‑making, and trial design, raising the profile of lobular‑specific evidence generation. (read more)
    • Mechanism insights / clinical impact: Sessions highlighted non‑truncating CDH1 biology (“Beyond E‑cadherin”), omission of axillary surgery cohorts, and neoadjuvant therapy debates—advancing precision imaging, pathology and operative planning distinct from NST disease. (read more)
    • Patient populations affected: Early‑stage and metastatic ILC—particularly clinically node‑negative candidates for surgical de‑escalation and those needing tailored systemic strategies. (read more)
  • Significance
    • Expected clinical or translational readouts: ESMO (Oct 23–27) OS results for OptiTROP‑Breast01 (sacituzumab tirumotecan), Phase 2 “IBI354 + pertuzumab” in 1L HER2+, and updated “fruquintinib + eribulin” HR+ e‑poster. (read more)
    • Regulatory or policy implications: EU 1L HER2+ ADC combination already approved; adjuvant Enhertu CHMP opinion foreshadows near‑term EC decision and guideline updates. (read more)
    • Potential shifts in standard of care: ADCs anchoring 1L HER2+ and high‑risk adjuvant; biomarker‑directed SERD/PI3K‑AKT pathways as default HR+ after CDK4/6. (read more)
    • Strategic implications: Capacity and supply for DXd/TROP2 ADCs; companion diagnostics (ESR1 testing; ER imaging with FES‑PET) integration; BD opportunities as China‑origin ADCs enter global breast cancer markets. (read more)
Publications Related to Approved Drugs
Phase 3
sacituzumab govitecan
Quantitative Systems Pharmacology Model for Trop-2 Targeting Antibody-Drug Conjugate in Triple-Negative Breast Cancer. A quantitative systems pharmacology (QSP) model developed for the TROP2-targeted antibody-drug conjugate, sacituzumab govitecan, in triple-negative breast cancer (TNBC) suggests that tumor exposure to the systemically released SN-38 payload is a primary driver of cytotoxicity, contributing significantly to its efficacy beyond direct TROP2-mediated delivery. The model's predicted objective response rate was consistent with the pivotal ASCENT study, highlighting that tumor heterogeneity is a key determinant of response and providing a framework for developing rational combination strategies. ()
New Publications Related to Drugs in Clinical Trial Development
Phase 3
Neoadjuvant Anbenitamab and HB1801 in ERBB2-Positive Breast Cancer: A Phase 3 Randomized Clinical Trial. A phase 3 trial in early ERBB2-positive breast cancer demonstrated that neoadjuvant anbenitamab plus HB1801 significantly improved total pathological complete response rates compared to standard therapy (trastuzumab, pertuzumab, docetaxel), suggesting a potential new treatment option pending long-term survival data. ()
Phase 1
Safety and efficacy of ceralasertib, an ATR kinase inhibitor, combined with olaparib: dose escalation in advanced solid tumours and dose expansion in advanced breast cancer. In a Phase 1 study, the combination of the ATR inhibitor ceralasertib with the PARP inhibitor olaparib demonstrated manageable safety and promising preliminary antitumor activity in PARP inhibitor-naïve patients with BRCA1/2-mutated, HER2-negative advanced breast cancer, achieving a 37.8% objective response rate. ()
Phase 2
Separating Ranking Signal, Incremental Feature Value, and Evaluation-Induced Optimism in Breast MRI Treatment-Effect Analysis: Foundation Model and Radiomic Representations. A reanalysis of the I-SPY2 trial's pretreatment breast MRI data found that advanced imaging representations, including radiomics and foundation models, did not demonstrate a statistically significant incremental value over clinical variables alone for predicting treatment response, highlighting the need for independent evaluation. ()
Phase 2
Cemiplimab and Fianlimab With Neoadjuvant Chemotherapy in Early-Stage High-Risk ERBB2-Negative Breast Cancer: The I-SPY2 Randomized Clinical Trial. The I-SPY2 trial demonstrated that adding dual checkpoint inhibition (anti-PD-1 cemiplimab and anti-LAG-3 fianlimab) to neoadjuvant chemotherapy significantly increased pathologic complete response rates in high-risk, ERBB2-negative early-stage breast cancer, especially in patients with an immune-positive signature. ()
PHASE1, PHASE2
A multi-omics analysis of advanced triple-negative breast cancer identifies predictors to chemo-immunotherapy and on-treatment dynamics. A multi-omics analysis of the SYNERGY trial identified that an immune-enriched tumor microenvironment predicts favorable outcomes to chemo-immunotherapy in advanced TNBC, whereas treatment resistance is associated with the development of a fibrotic, angiogenic, and myeloid-reprogrammed microenvironment. ()
Phase 3
Sacituzumab tirumotecan in previously treated metastatic triple-negative breast cancer: a detailed safety analysis of the randomized OptiTROP-Breast01 study. A detailed safety analysis of the OptiTROP-Breast01 study confirms that the TROP2-directed antibody-drug conjugate sacituzumab tirumotecan has a manageable safety profile in metastatic TNBC, with key adverse events being effectively managed through dose modifications without impacting efficacy. ()
Phase 3
Atezolizumab in early triple-negative breast cancer: the randomized phase 3 NSABP B-59/GeparDouze trial. The phase 3 NSABP B-59/GeparDouze trial found that adding atezolizumab to neoadjuvant chemotherapy did not significantly improve event-free survival in early-stage TNBC, although exploratory analyses suggest a potential benefit for specific subgroups like node-positive patients or those with basal-like immune-activated tumors. ()
Phase 2
Targeting the NO-sGC-cGMP Pathway in Cancer Therapy-Related Cardiac Dysfunction: The Emerging Role of Vericiguat. This review highlights the biological rationale for using vericiguat to manage cancer therapy-related cardiac dysfunction (CTRCD), noting that while preclinical data are promising, the phase II ELEVATE trial in breast cancer-associated CTRCD has not yet reported efficacy results. ()
Phase 2
Safety and Efficacy of Ceralasertib plus Olaparib for Advanced/Metastatic Triple-Negative Breast Cancer in Three Molecular Strata: The Phase II VIOLETTE Study. The phase II VIOLETTE study showed that combining the ATR inhibitor ceralasertib with olaparib did not improve progression-free survival but did significantly increase the objective response rate in patients with advanced, non-HRR mutated triple-negative breast cancer. ()
Phase 3
Trastuzumab Botidotin Versus Trastuzumab Emtansine in Human Epidermal Growth Factor Receptor 2-Positive Advanced Breast Cancer: A Phase III, Open-Label, Randomized Controlled Trial. In a phase III trial for previously treated HER2-positive advanced breast cancer, the novel antibody-drug conjugate trastuzumab botidotin demonstrated a significant improvement in progression-free survival over trastuzumab emtansine (11.1 vs. 4.4 months), establishing a new potential standard of care. ()
Phase 3
Summary of Research: 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 HER2CLIMB-05 phase III trial established a new first-line maintenance option for HER2-positive metastatic breast cancer, showing that adding tucatinib to trastuzumab and pertuzumab significantly extended progression-free survival to 24.9 months from 16.3 months. ()
Phase 1
First-line fecal microbiota transplantation for the management of immune checkpoint inhibitor-mediated diarrhea and colitis. A preliminary analysis suggests that first-line fecal microbiota transplantation (FMT) is an effective strategy for managing immune checkpoint inhibitor-mediated diarrhea and colitis, with over 76% of patients achieving a clinical response and rapid time to improvement. ()
Phase 2
First-line PD-1/VEGF bispecific antibody plus chemotherapy in triple-negative breast cancer: a phase 2 trial. In a phase 2 trial for advanced triple-negative breast cancer, the first-line combination of the PD-1/VEGF bispecific antibody ivonescimab with chemotherapy showed a highly encouraging 80% objective response rate, warranting further investigation. ()
Phase 3
Association of cancer antigen 15-3 with distant recurrence in immunohistochemically defined breast cancer subtypes in Canadian Cancer Trials Group MA.32. An analysis from the MA.32 trial indicates that a rising CA 15-3 level at 6 months post-diagnosis is a prognostic marker for distant recurrence in patients with luminal and triple-negative breast cancer, but not in the HER2-positive subtype. ()
Phase 2
Endocrine Biomarker Changes in a Randomised Low-Dose Tamoxifen Trial for Breast Cancer Prevention. The KARISMA trial demonstrated that low-dose tamoxifen for breast cancer prevention induces measurable endocrine changes, particularly in SHBG levels, supporting the biological activity of lower doses which may inform future individualized prevention strategies. ()
Phase 2
Efficacy, safety and circulating tumor cell dynamics in patients treated with Eribulin for HER2-negative advanced breast cancer - results from the phase II DETECT IVb trial. The phase II DETECT IVb trial confirmed the efficacy of eribulin in HER2-negative metastatic breast cancer and established that early clearance of circulating tumor cells is a strong predictor of improved progression-free survival. ()
Phase 3
Sensitivity to Endocrine Therapy Index Predicts Benefit from Weekly Adjuvant Paclitaxel for Hormone Receptor-Positive Breast Cancer in the GEICAM/9906 Trial. This analysis of the GEICAM/9906 trial validates the SETER/PR index as a predictive biomarker, demonstrating that patients with HR-positive/HER2-negative breast cancer and low endocrine sensitivity derive significant benefit from the addition of weekly paclitaxel to adjuvant chemotherapy. ()
Phase 3
Menopausal hormone therapy and primary liver cancer: long-term follow-up of the women's health initiative randomized trials. Long-term follow-up from the Women's Health Initiative trials showed no overall association between menopausal hormone therapy and liver cancer risk, though subgroup analysis suggested a potential increased risk with combined estrogen-progestin therapy in women aged 50-59 and prior oral contraceptive users. ()
Phase 3
Serum-based biomarker development for dietary macronutrient densities and their association with breast and colorectal cancer risk in a cohort of postmenopausal females. A study within the Women's Health Initiative developed serum-based biomarkers for dietary intake and found that a higher density of monounsaturated fatty acids was associated with an increased risk of colorectal cancer in postmenopausal women, while associations with breast cancer were inconclusive. ()
Phase 3
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. A quality-of-life analysis from the JBCRG-M06/EMERALD trial showed that eribulin, combined with dual HER2 blockade, maintained patient quality of life for longer and avoided the early deterioration seen with taxane-based therapy in HER2-positive advanced breast cancer. ()
Phase 3
Efficacy and Safety of EG12014 (Biosimilar Trastuzumab) Compared to Reference Trastuzumab in HER2-Positive Early Breast Cancer: A Phase III Randomized Study. A phase III trial confirmed that the biosimilar EG12014 has equivalent efficacy to reference trastuzumab for treating HER2-positive early breast cancer, meeting the primary endpoint for pathological complete response and showing comparable safety and pharmacokinetic profiles. ()
Phase 3
Lumpectomy Margins and Local Recurrence in DCIS: Results From the NRG Oncology/NSABP B-35 Randomized Clinical Trial. An analysis of the NSABP B-35 trial found that for postmenopausal women with HR-positive DCIS treated with lumpectomy, radiation, and endocrine therapy, the absolute risk of local recurrence was low even with close margins (<1 mm or <2 mm), questioning the necessity of routine re-excision. ()
Phase 3
Clinical Relevance of Post-Treatment Circulating Tumor DNA Detection in Early Breast Cancer Using a Tissue-Free Epigenomic Assay: A 2-Year Landmark Analysis. A landmark analysis from the SUCCESS-A trial demonstrated that post-treatment circulating tumor DNA, detected via a tissue-free epigenomic assay, is a powerful prognostic marker for identifying early breast cancer patients at high risk for distant recurrence, often months before clinical detection. ()
Phase 2
Molecular evaluation of residual disease following neoadjuvant chemotherapy in triple-negative breast cancer CALGB 40603 (Alliance). Molecular analysis of the CALGB 40603 trial revealed that basal-like residual disease in TNBC after neoadjuvant chemotherapy is immune-cold and predicts poor survival, but preclinical models suggest this high-risk group may benefit from adjuvant antibody-drug conjugate therapy. ()
Phase 3
Atezolizumab plus pertuzumab, trastuzumab, and chemotherapy in HER2-positive early breast cancer: final results of the phase III IMpassion050 trial. The final analysis of the phase III IMpassion050 trial confirmed that adding atezolizumab to a standard neoadjuvant and adjuvant regimen for high-risk, HER2-positive early breast cancer did not significantly improve event-free or disease-free survival outcomes. ()
PHASE1, PHASE2
Steroidogenesis inhibitor ODM-209 for metastatic castration-resistant prostate cancer and advanced breast cancer: Results from the first-in-human STESIDES study. The first-in-human STESIDES study of the steroidogenesis inhibitor ODM-209 showed clinical activity in heavily pretreated metastatic castration-resistant prostate cancer but did not demonstrate responses in the small cohort of patients with advanced breast cancer. ()
N/A
Serum lipidomic profiles associated with Mediterranean diet in overweight and obese breast cancer survivors: an exploratory study. An exploratory study in overweight breast cancer survivors demonstrated that an 8-week Mediterranean diet intervention improved body composition and was associated with favorable changes in the serum lipidomic profile, particularly a reduction in saturated triacylglycerols. ()
Clinical Trials
Clinical Trials Summary
Number of Clinical Trials in breast cancer updated from 2026-09-01 to 2026-09-30:
Phase 1Phase 1/2Phase 2Phase 2/3Phase 3Phase 4Total
Enrolling by Invitation----1-1
Not Yet Recruiting3316-6129
Recruiting4225512331154
Available-------
Approved for Marketing-------
Active, Not Recruiting211427219184
Completed--4--15
Total6642984594273
Phase 1 Clinical Trials within 3 Months of Primary Completion Date:
DRUGNCTIDStatusClinical Trial NameCompletion Date
MNPR-101-DFO*-89Zr NCT06337084 ACTIVE_NOT_RECRUITING Open Label Pilot Study Evaluating Diagnostic Efficacy and Dosimetry of MNPR-101-DFO*-89Zr in Patients With Solid Tumors 2026-12
LOXO-783, Fulvestrant, Abemaciclib, Imlunestrant, Paclitaxel, Anastrozole, Exemestane, or Letrozole NCT05307705 RECRUITING A Study of LOXO-783 Administered as Monotherapy and in Combination With Anticancer Therapies for Patients With Advanced Breast Cancer and Other Solid Tumors With a PIK3CA H1047R Mutation 2026-12
Phase 2 Clinical Trials within 3 Months of Primary Completion Date:
DRUGNCTIDStatusClinical Trial NameCompletion Date
Tamoxifen 10 mg Tablet NCT06033092 COMPLETED Low Dose TamOxifen and LifestylE Changes for bReast cANcer prevenTion: a Randomized Phase II Biomarker Trial in Subjects at Increased Risk 2026-07-31
Carboplatin, Nivolumab NCT03414684 COMPLETED A Randomized Phase II Trial of Carboplatin With or Without Nivolumab in First-line Metastatic Triple-negative Breast Cancer 2026-08-05
18F-DCFPyL NCT04573231 COMPLETED Evaluation of Prostate Specific Membrane Antigen (PSMA) in HER2-negative, Androgen Receptor (AR)-Positive Metastatic Breast Cancer With 18F-DCFPyL PSMA-based PET/CT 2026-08-31
Pentoxifylline 400mg plus chemotherapy NCT07137793 COMPLETED Clinical Study to Evaluate The Cardioprotective Effect of Pentoxifylline Against Doxorubicin Induced Cardiotoxicity in Breast Cancer Patients 2026-09-23
Pembrolizumab, Tobemstomig, Nab-Paclitaxel NCT05852691 ACTIVE_NOT_RECRUITING A Phase II, Multicenter, Randomized, Double-Blind Study of Tobemstomig/RO7247669 Combined With Nab-Paclitaxel Compared With Pembrolizumab Combined With Nab-Paclitaxel in Participants With Previously Untreated, PD-L1-Positive, Locally-Advanced Unresectable or Metastatic Triple-Negative Breast Cancer 2026-10-19
Simvastatin 40mg NCT05550415 RECRUITING Vimentin Expression-based Therapeutic Response in Triple Negative Breast Cancer Receiving Combination of Simvastatin and NAC: A Randomized, Double-Blind, Placebo-Controlled Trial 2026-12
Halneuron, Halneuron (Open Label Extension) NCT06848348 ACTIVE_NOT_RECRUITING A Randomized, Double-Blind, Placebo Controlled, Multicenter Study With Optional Open-Label Extension to Evaluate the Efficacy and Safety Study of Halneuron in the Treatment of Chemotherapy-Induced Neuropathic Pain 2026-12
Phase 3 Clinical Trials within 3 Months of Primary Completion Date:
DRUGNCTIDStatusClinical Trial NameCompletion Date
Letrozole Tablets, Tamoxifen, Exemestane Tablets, Anastrozole Tablets, TOL2506 NCT04906395 ACTIVE_NOT_RECRUITING Phase 3,Single Arm,Open-Label Study Evaluating Ovarian Suppression Following 3 Month Leuprolide Acetate For Injectable Suspension (TOL2506) in Combination With Endocrine Therapy in Premenopausal Subjects With Hormone-Receptor-Positive (HR+),Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer 2026-11-30
Phase 4 Clinical Trials within 3 Months of Primary Completion Date:
DRUGNCTIDStatusClinical Trial NameCompletion Date
Iodinated Contrast Media (ICM) NCT05206331 COMPLETED Contrast Enhanced Mammography (CEM) to Reduce Biopsy Rates for Less Than Highly Suspicious Breast Abnormalities: a Prospective Study 2026-08-21
Trastuzumab deruxtecan NCT06429761 ACTIVE_NOT_RECRUITING Aprospective, Multi Center Phase 4 Study to Assess the Safety of Trastuzumab Deruxtecan, an Anti-her2-antibody Drug Conjugate in Indian Patients With Unresectable or Metastatic her2-positive Breast Cancer Who Have Received a Prior Anti-her2-based Regimen 2026-10-31
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