Numerous clinical trials evaluate the efficacy and safety of elacestrant both as monotherapy and in combination regimens with CDK4/6 inhibitors across Early Phase 1 through Phase 3 studies. Sponsored by various academic and research institutions, these investigations target oncology indications including estrogen receptor-positive, HER2-negative, and HER2-positive breast carcinomas, as well as advanced uterine sarcomas. Across this clinical portfolio, recruitment statuses range from actively recruiting and active not recruiting to completed, terminated, and withdrawn.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07242352 | RECRUITING | Breast Cancer; HR+/HER2- Breast Cancer |
Women's Cancer Study Group GmbH |
2026-04-29 | PHASE3 |
| NCT05512364 | RECRUITING | ER-positive Breast Cancer; HER2-negative Breast Cancer; Stage IIB Breast Cancer; Stage III Breast Cancer |
European Organisation for Research and Treatment of Cancer - EORTC |
2023-12-15 | PHASE3 |
| NCT07753954 | NOT_YET_RECRUITING | ER+ / HER2- Advanced Breast Cancer |
Jules Bordet Institute |
2026-09-13 | PHASE2 |
| NCT07222215 | RECRUITING | Estrogen-receptor-positive Breast Cancer; Metastatic Breast Cancer; Breast Cancer; Hormone Receptor Positive Breast Cancer; Human Epidermal Growth Factor 2 Negative Carcinoma of Breast; HER2- Breast Cancer; ESR1 Gene Mutation; ER Wildtype; Breast Neoplasms |
Kristina A. Fanucci |
2026-01-16 | PHASE2 |
| NCT06120283 | RECRUITING | Advanced Solid Tumor; Advanced Breast Cancer; Metastatic Breast Cancer; Hormone-receptor-positive Breast Cancer; Hormone Receptor Positive Breast Carcinoma; Hormone Receptor Positive Malignant Neoplasm of Breast; HER2-negative Breast Cancer; Hormone Receptor Positive HER-2 Negative Breast Cancer |
BeOne Medicines |
2023-12-01 | PHASE1 |
| NCT06492616 | RECRUITING | Breast Cancer |
Stemline Therapeutics, Inc. |
2024-09-27 | PHASE3 |
| NCT07612215 | RECRUITING | ER Positive, HER2 Positive Breast Cancer |
NYU Langone Health |
2026-05-13 | PHASE1; PHASE2 |
| NCT06201234 | RECRUITING | Hormone Receptor Positive HER-2 Negative Breast Cancer; Advanced or Metastatic Breast Cancer; BRCA1 Mutation; BRCA2 Mutation |
GBG Forschungs GmbH |
2024-12-13 | PHASE2 |
| NCT07634601 | NOT_YET_RECRUITING | Advanced Endometrial Carcinoma; Metastatic Endometrial Carcinoma; Recurrent Endometrial Carcinoma; Stage III Endometrial Cancer; Stage IV Endometrial Cancer |
Jonsson Comprehensive Cancer Center |
2026-12-18 | PHASE2 |
| NCT07395336 | RECRUITING | Breast Cancer |
European Institute of Oncology |
2026-05-11 | PHASE2 |
| NCT06075953 | RECRUITING | Ductal Carcinoma in Situ |
QuantumLeap Healthcare Collaborative |
2024-02-17 | PHASE2 |
| NCT07209449 | RECRUITING | Endometrial Cancer |
Memorial Sloan Kettering Cancer Center |
2025-10-01 | PHASE2 |
| NCT07766018 | RECRUITING | Breast Cancer |
Stemline Therapeutics, Inc. |
2026-08 | PHASE2 |
| NCT06062498 | RECRUITING | Estrogen-receptor-positive Breast Cancer; HER2/Neu-Negative Breast Cancer; Advanced Breast Cancerv; Metastatic Breast Cancer |
Northwestern University |
2023-09-29 | PHASE2 |
| NCT07198724 | RECRUITING | Metastatic Breast Cancer; HER2 Low Breast Carcinoma; HER2-negative Breast Cancer; Breast Cancer; Breast Cancer Female |
Kristina A. Fanucci |
2025-11-17 | PHASE1; PHASE2 |
| NCT05573126 | RECRUITING | Hormone Receptor-positive Breast Cancer; Hormone Receptor Positive HER-2 Negative Breast Cancer; Metastatic Breast Cancer |
Ellipses Pharma |
2023-01-11 | PHASE1; PHASE2 |
| NCT06638307 | RECRUITING | Advanced Breast Cancer |
Stemline Therapeutics, Inc. |
2024-10-25 | PHASE1 |
| NCT06382948 | RECRUITING | Advanced Breast Cancer; ER-positive Breast Cancer; HER2-negative Breast Cancer; ESR1 Gene Mutation |
MedSIR |
2024-12-05 | PHASE3 |
| NCT06923527 | RECRUITING | ER+ Breast Cancer |
Yale University |
2025-09-30 | PHASE2 |
| NCT07467772 | RECRUITING | Uterine Sarcoma; Uterine Leiomyosarcoma; Endometrial Stromal Sarcoma; ESS; Perivascular Epithelioid Cell Tumors; Uterine Adenosarcoma; Uterine PEComa; Estrogen Receptor Positive Tumor; uLMS |
Dana-Farber Cancer Institute |
2026-03-25 | PHASE2 |
| NCT04757688 | WITHDRAWN | Ventricular Tachycardia |
John Stahl |
2022-11 | |
| NCT07005882 | NOT_YET_RECRUITING | Breast Cancer Patients; Breast Cancer Early Stage Breast Cancer (Stage 1-3); HR+/HER2- Breast Cancer; Radiation Therapy |
Azienda Ospedaliero-Universitaria Careggi |
2025-09-01 | PHASE2 |
| NCT07159451 | RECRUITING | Breast Cancer |
Gustave Roussy, Cancer Campus, Grand Paris |
2025-10-06 | PHASE2 |
| NCT05563220 | ACTIVE_NOT_RECRUITING | Breast Cancer; Metastatic Breast Cancer |
Stemline Therapeutics, Inc. |
2023-01-24 | PHASE1; PHASE2 |
| NCT05982093 | RECRUITING | Breast Cancer; HER2-negative Breast Cancer; Hormone Receptor Positive Tumor; Premenopausal Breast Cancer |
SOLTI Breast Cancer Research Group |
2023-02-03 | PHASE2 |
| NCT05386108 | RECRUITING | Breast Neoplasms; Brain Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Central Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases |
Stemline Therapeutics, Inc. |
2022-08-31 | PHASE1; PHASE2 |
| NCT05596409 | ACTIVE_NOT_RECRUITING | Metastatic Breast Cancer |
Stemline Therapeutics, Inc. |
2023-05-19 | PHASE2 |
| NCT06691035 | ACTIVE_NOT_RECRUITING | Breast Cancer Metastatic Breast Cancer; HER2-negative Breast Cancer |
H. Lee Moffitt Cancer Center and Research Institute |
2024-11-04 | PHASE1 |
| NCT05963997 | COMPLETED | Metastatic Breast Cancer; Locally Advanced Breast Cancer; Breast Cancer |
Carrick Therapeutics Limited |
2023-10-09 | PHASE1; PHASE2 |
| NCT06126575 | COMPLETED | Hepatic Impairment |
Stemline Therapeutics, Inc. |
2023-03-13 | PHASE1 |
| NCT04791384 | TERMINATED | Breast Cancer |
Criterium, Inc. |
2022-04-21 | PHASE1; PHASE2 |
| NCT06938711 | WITHDRAWN | Breast Cancer |
Context Therapeutics Inc. |
2023-06 | PHASE1; PHASE2 |
| NCT05618613 | TERMINATED | Breast Cancer |
Context Therapeutics Inc. |
2022-12-02 | PHASE1; PHASE2 |
| NCT04797728 | COMPLETED | Breast Cancer; Hormone Receptor Positive Breast Carcinoma |
SOLTI Breast Cancer Research Group |
2021-02-09 | EARLY_PHASE1 |
| NCT03778931 | COMPLETED | Breast Cancer |
Stemline Therapeutics, Inc. |
2019-05-10 | PHASE3 |
| NCT02338349 | COMPLETED | Advanced ER+, HER2-Negative Breast Cancer |
Stemline Therapeutics, Inc. |
2015-01 | PHASE1 |
| NCT02650817 | COMPLETED | Metastatic Breast Cancer |
Stemline Therapeutics, Inc. |
2016-04-01 | PHASE1 |
| NCT02653417 | TERMINATED | Vasomotor Symptoms; Hot Flashes |
Radius Pharmaceuticals, Inc. |
2015-12 | PHASE2 |
| NCT00875420 | COMPLETED | Hot Flashes |
Radius Pharmaceuticals, Inc. |
2009-03 | PHASE2 |
(data from https://clinicaltrials.gov, updated on 2026-08-07)
Check the
Elacestrant (RAD1901) Dihydrochloride
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).
- Elacestrant (RAD1901) Dihydrochloride Solubility in DMSO
- Elacestrant (RAD1901) Dihydrochloride Stock Solution
- Elacestrant (RAD1901) Dihydrochloride Storage
- Elacestrant (RAD1901) Dihydrochloride Stability
- Elacestrant (RAD1901) Dihydrochloride Molecular Weight
- Elacestrant (RAD1901) Dihydrochloride SMILES
- Elacestrant (RAD1901) Dihydrochloride CAS Number
- Elacestrant (RAD1901) Dihydrochloride Chemical Structure (2D and 3D)
- Elacestrant (RAD1901) Dihydrochloride SDS｜MSDS
Note: Technical data last updated: Sep 1, 2026.