(Z)-4-Hydroxytamoxifen Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 370

Clinical Trials

Multiple clinical trials evaluate (Z)-4-hydroxytamoxifen across Phase 2 and Phase 3 for conditions including estrogen receptor-positive breast cancer, ductal carcinoma in situ, mammographic breast density, atypical hyperplasia, and cyclic mastalgia. Sponsored by academic and industry partners such as Northwestern University, Mayo Clinic, M.D. Anderson Cancer Center, Karolinska University Hospital, ASCEND Therapeutics, and BHR Pharma, these protocols reflect completed, terminated, and unknown recruitment statuses. Completed Phase 2 evaluations have assessed transdermal and topical formulations specifically in pre-surgical ductal carcinoma in situ and high breast density settings.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04570956	TERMINATED	Breast Atypical Hyperplasia; Breast Lobular Carcinoma in Situ; Breast Atypical Lobular Hyperplasia; Breast Carcinoma	Mayo Clinic	2021-07-26	PHASE2
NCT05133674	Unknown status	Breast Cancer\|Breast Carcinoma\|Breast Tumors\|Cancer of Breast\|Malignant Neoplasm of Breast	Karolinska University Hospital	2022-04-04	Phase 2
NCT03063619	COMPLETED	Mammographically Dense Breast	M.D. Anderson Cancer Center	2018-01-30	PHASE2
NCT02993159	COMPLETED	Ductal Breast Carcinoma In Situ; Estrogen Receptor Positive	Northwestern University	2017-05-31	PHASE2
NCT03199963	TERMINATED	Mammographic Breast Density	BHR Pharma, LLC	2017-08-21	PHASE3
NCT00952731	COMPLETED	Ductal Breast Carcinoma in Situ; Estrogen Receptor-positive Breast Cancer	Northwestern University	2009-12	PHASE2
NCT00084344	COMPLETED	Breast Cancer	Northwestern University	2003-04
NCT00272714	COMPLETED	Cyclic Breast Pain, Cyclic Mastalgia	ASCEND Therapeutics	2003-03	PHASE2

(data from https://clinicaltrials.gov, updated on 2026-09-01)

Check the (Z)-4-Hydroxytamoxifen product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

(Z)-4-Hydroxytamoxifen functions as a selective estrogen receptor modulator that binds to the estrogen receptor with an IC50 of 3.3 nM, competitively inhibiting estradiol binding and blocking downstream estrogen-dependent transcriptional activation. This inhibition of estrogenic signaling suppresses hormone-driven cell proliferation, providing the mechanistic rationale for its clinical utility in treating estrogen receptor-positive breast cancer and ductal carcinoma in situ.

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>).