54 recruiting, 35 completed, 19 terminated, 16 active not recruiting. 78 Phase 2, 42 Phase 1, 13 Phase 3, 7 Not applicable, 3 Phase 4.
Follow HER2-Negative Breast Cancer: new trials by email Literature Review of HER2-Negative Breast Cancer trials Research Report on HER2-Negative Breast Cancer
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| SOLIS: Single-Dose Radiotherapy With Omission of Lumpectomy for Intact Small Breast Cancers Stereotactic Radiation Therapy, Endocrine Therapy - Breast Cancer, Early-Stage Breast Carcinoma | Not applicable | Not yet recruiting | Renaissance Institute of Precision Oncology and Radiosurgery | 30 | 2027-01-01 | 2026-09-28 |
| A Study to Learn How Well Participants With a Specific Type of Early Breast Cancer (ER-Positive, HER2-Negative) Tolerate and Stay on Treatment With Giredestrant and How They Feel During Treatment Giredestrant - Early Breast Cancer, Estrogen Receptor-Positive Breast Cancer | Phase 3 | Not yet recruiting | Hoffmann-La Roche | 1500 | 2026-10-30 | 2026-10-15 |
| A Study of the TheraBionic P1 Device in Breast Cancer TheraBionic P1 Device - Breast Cancer Stage I, Breast Cancer Stage II | Not applicable | Recruiting | Barbara Ann Karmanos Cancer Institute | 24 | 2026-10-01 | 2026-04-21 |
| Metronomic Oral Paclitaxel Monotherapy for Advanced HER2-Negative Breast Cancer: A Two-Stage Dose-Finding and Expansion Study Paclitaxel Oral Solution (50mg/qd), Paclitaxel Oral Solution (100mg/TIW), Paclitaxel Oral Solution (OTD) - Advanced Breast Cancer, HER2-negative Breast Cancer | Phase 2 | Recruiting | Zhejiang Cancer Hospital | 73 | 2026-08-04 | 2026-08-11 |
| Real-life Evaluation of Endopredict® in Early HR+/HER2- Breast Cancer Endopredict test - Breast Cancer (Early Breast Cancer), Breast Cancer Survivors | Recruiting | Assistance Publique - Hôpitaux de Paris | 1000 | 2026-06-28 | 2026-03-13 | |
| Real-world Study of SKB264 Monotherapy or Combination Therapy in Recurrent or Metastatic HER2-negative Breast Cancer SKB264 Monotherapy or Combination Therapy - HER2-negative Breast Cancer, Recurrence | Recruiting | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | 500 | 2026-05-28 | 2026-08-18 | |
| CDK4/6 Inhibitors Combined With Endocrine Therapy for Neoadjuvant Treatment CDK4/6 inhibitor with endocrine therapy - Hormone Receptor-Positive Breast Cancer, High-risk Breast Cancer | Phase 2 | Recruiting | Peking University People's Hospital | 158 | 2026-04-20 | 2026-07-13 |
| Study of Multi-mode Thermal Therapy Combined With Immunotherapy In Patients With HER2-negative Breast Cancer With Liver Metastases SHR-A1811, SKB264, Pembrolizumab - HER2-negative Breast Cancer | Phase 2 | Not yet recruiting | Fudan University | 30 | 2026-03-15 | 2026-03-12 |
| A Study of the Impact of Endocrine Therapy on Surgical Outcomes in People With Lobular Breast Cancer Neoadjuvant endocrine therapy - Breast Cancer, HER2-negative Breast Cancer | Phase 2 | Recruiting | Memorial Sloan Kettering Cancer Center | 176 | 2026-03-13 | 2026-06-04 |
| Study on the Treatment of HER2-negative Breast Cancer Brain Metastases With Radiotherapy Combined With Anlotinib Radiotherapy Combined with Anlotinib and a Microtubule Inhibitor - HER2-Negative Breast Cancer | Phase 2 | Recruiting | The First Affiliated Hospital with Nanjing Medical University | 39 | 2026-02-10 | 2026-02-09 |
| A Ph II Study of the TheraBionic P1 Device in Subjects With Hormone Positive Breast Cancer TheraBionic P1 - HER2-negative Breast Cancer, Hormone Receptor Positive Tumor | Not applicable | Recruiting | Barbara Ann Karmanos Cancer Institute | 82 | 2026-01-16 | 2026-08-26 |
| Phase III Study to Evaluate the Safety, Efficacy, and Impact on Quality of Life of Capivasertib Alongside Standard-of-care Endocrine Treatment in Patients With HR+/HER2- Advanced Breast Cancer and Progression on Prior Endocrine-based Treatment Capivasertib - Breast Cancer, HR-positive Breast Cancer | Phase 3 | Recruiting | Women's Cancer Study Group GmbH | 250 | 2025-11-27 | 2026-08-05 |
| ERADICATE: A Phase Ib/II Study of Elacestrant Plus Trastuzumab Deruxtecan in Patients With CDK4/6 Inhibitor and Endocrine-resistant HR+/HER2-low or HER2-ultralow Metastatic Breast Cancer Elacestrant, Trastuzumab Deruxtecan - Metastatic Breast Cancer, HER2 Low Breast Carcinoma | Phase 1 / Phase 2 | Recruiting | Kristina A. Fanucci | 65 | 2025-11-17 | 2026-06-10 |
| Breast Re-irradiation After Second Ipsilateral Lumpectomy Intensity modulated radiation therapy (IMRT) - Breast Cancer, Cancer | Not applicable | Recruiting | Youssef Zeidan | 114 | 2025-10-27 | 2025-11-13 |
| Prospective Registry of ADC as First- and Second-line Treatment for Breast Cancer Specimen collection, Non-Investigational Antibody-Drug Conjugates (ADC), Medical Record Review - HER2-negative Breast Cancer, HER2 Negative Breast Carcinoma | Recruiting | University of California, San Francisco | 100 | 2025-10-08 | 2026-10-16 | |
| ctDNA-Guided De-Escalation of Adjuvant Chemotherapy With Dalpiciclib in HR-Positive/HER2-Negative Breast Cancer Dalpiciclib + Aromatase Inhibitor with ctDNA-Guided Therapy, Taxane-Based Neoadjuvant Chemotherapy - Hormone Receptor-Positive Breast Cancer, High-risk Breast Cancer | Phase 2 | Recruiting | Peking University People's Hospital | 393 | 2025-08-01 | 2026-07-13 |
| A Study of DR-0202 in Patients With Locally Advanced or Metastatic, Relapsed or Refractory Carcinomas DR-0202 - Triple Negative Breast Cancer, HER2-negative Breast Cancer | Phase 1 | Recruiting | Dren Bio | 96 | 2025-06-03 | 2026-01-07 |
| NearWave Optical Molecular Monitoring NearWave monitoring - Breast Cancer, HER2-positive Breast Cancer | Not applicable | Recruiting | Indiana University | 15 | 2025-03-07 | 2026-02-17 |
| BGB-21447 (Bcl-2 Inhibitor) Combinations for Adults With Hormone-Receptor Positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Metastatic Breast Cancer BGB-21447, Fulvestrant, BGB-43395 - Hormone-receptor-positive Breast Cancer, HER2-negative Breast Cancer | Phase 1 | Recruiting | BeOne Medicines | 120 | 2025-02-04 | 2026-09-14 |
| Adherence to Aromatase Inhibitors ± Abemaciclib Treatment in Patients With Early-stage HER2-negative Breast Cancer Early Breast Cancer, Hormone Receptor Positive Tumor | Recruiting | Institute of Oncology Ljubljana | 319 | 2025-01-05 | 2026-03-06 |
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Breast Neoplasms (105) · Triple Negative Breast Neoplasms (33) · Neoplasm Metastasis (9) · Breast Neoplasms, Male (7) · Endometrial Neoplasms (6) · Ovarian Neoplasms (6) · Stomach Neoplasms (6) · Colonic Neoplasms (5) · Pancreatic Neoplasms (5) · Prostatic Neoplasms (5) · Rectal Neoplasms (5) · Carcinoma, Lobular (4) · Gallbladder Neoplasms (4) · Small Cell Lung Carcinoma (4) · Squamous Cell Carcinoma of Head and Neck (4)
Neoplasms (116) · Neoplasms by Site (116) · Breast Diseases (113) · Skin Diseases (113) · Skin and Connective Tissue Diseases (113) · Neoplasms by Histologic Type (19) · Digestive System Diseases (16) · Digestive System Neoplasms (16) · Endocrine Gland Neoplasms (16) · Endocrine System Diseases (16) · Carcinoma (15) · Neoplasms, Glandular and Epithelial (15) · Pathological Conditions, Signs and Symptoms (14) · Gastrointestinal Diseases (13) · Adenocarcinoma (12)
Fulvestrant (21) · Letrozole (17) · Paclitaxel (15) · Carboplatin (11) · Anastrozole (10) · Taxes (9) · ribociclib (9) · Tamoxifen (8) · eribulin (8) · Capecitabine (7) · Cyclophosphamide (7) · Doxorubicin (7) · abemaciclib (7) · elacestrant (7) · palbociclib (7)
Fudan University (7) · National Cancer Institute (NCI) (5) · BeOne Medicines (3) · Dana-Farber Cancer Institute (3) · Memorial Sloan Kettering Cancer Center (3) · The First Affiliated Hospital with Nanjing Medical University (3) · University of Washington (3) · Abramson Cancer Center at Penn Medicine (2) · Ana C Garrido-Castro, MD (2) · Barbara Ann Karmanos Cancer Institute (2) · Cancer Institute and Hospital, Chinese Academy of Medical Sciences (2) · Eisai Co., Ltd. (2) · Emory University (2) · European Organisation for Research and Treatment of Cancer - EORTC (2) · H. Lee Moffitt Cancer Center and Research Institute (2)
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Ana Garrido-Castro, MD (2) · Filipa Lynce, MD (2) · Jennifer Specht (2) · Norman Wolmark, MD (2) · Adam Cohen, MD (1) · Aditya Bardia, MD,MPH (1) · Adlinda Alip, FRCR (1) · Aixa Soyano Muller, MD (1) · Amy Fowler, MD, PhD (1) · Andreas Schneeweiss, MD, Prof. (1) · Andrew Seidman (1) · Antonio C Giordano, MD, PhD (1)
PMID 21796368, PMID 22198468, PMID 22623692, PMID 22649152, PMID 26006067, PMID 26059540, PMID 26126970, PMID 27406346, PMID 27406347, PMID 28045625, PMID 28851423, PMID 30928806, PMID 32031889, PMID 32053137, PMID 32450725, PMID 32641862, PMID 32692450, PMID 32701140, PMID 33710812, PMID 34398557, PMID 34529000, PMID 34741021, PMID 35119530, PMID 35623341, PMID 35695563, PMID 35993306, PMID 36069821, PMID 36383907, PMID 36410913, PMID 36456573, PMID 36457575, PMID 37029329, PMID 37325931, PMID 37505107, PMID 37796398, PMID 38086377, PMID 38092228, PMID 38180338, PMID 38236590, PMID 38362377, PMID 38729567, PMID 38745646, PMID 38969879, PMID 39073142, PMID 39158353, PMID 39277671, PMID 39277672, PMID 39613746, PMID 39625569, PMID 40404608
P30CA015704 (2), U10CA031946 (2), 2023 (1), K08CA252457 (1), K08CA267189 (1), N01CM00032 (1), P30CA014520 (1), P30CA036727 (1), P30CA044579 (1), P30CA072720 (1), R01CA127927 (1), U01CA062491 (1), U01CA099168 (1), U01CA132123 (1)