Numerous clinical trials evaluate giredestrant across Phase 1, Phase 2, and Phase 3 development alongside expanded access programs, predominantly focusing on estrogen receptor-positive, HER2-negative early, locally advanced, or metastatic breast cancer, as well as ovarian and endometrial cancers. Supported by major pharmaceutical sponsors such as Hoffmann-La Roche and Genentech in collaboration with academic cooperative groups like the ETOP IBCSG Partners Foundation and Alliance Foundation Trials, these studies evaluate various therapeutic regimens and combination therapies. Across these investigations, recruitment statuses encompass actively recruiting, active not recruiting, completed, available, and terminated.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07541079 | RECRUITING | Early Breast Cancer |
Genentech, Inc. |
2026-08-25 | PHASE3 |
| NCT03424005 | RECRUITING | Metastatic Breast Cancer |
Hoffmann-La Roche |
2018-03-30 | PHASE1; PHASE2 |
| NCT04802759 | RECRUITING | Inoperable, Locally Advanced or Metastatic, ER-positive Breast Cancer |
Hoffmann-La Roche |
2021-06-22 | PHASE1; PHASE2 |
| NCT07100106 | RECRUITING | Breast Cancer |
Genentech, Inc. |
2025-10-07 | PHASE1; PHASE2 |
| NCT05708235 | RECRUITING | Breast Cancer |
MedSIR |
2024-04-01 | PHASE2 |
| NCT04931342 | ACTIVE_NOT_RECRUITING | Ovarian Cancer |
Hoffmann-La Roche |
2021-10-07 | PHASE2 |
| NCT05296798 | ACTIVE_NOT_RECRUITING | Locally Advanced or Metastatic Breast Cancer |
Hoffmann-La Roche |
2022-07-18 | PHASE3 |
| NCT07054190 | RECRUITING | Breast Cancer |
Hoffmann-La Roche |
2025-09-09 | PHASE2 |
| NCT06065748 | RECRUITING | Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer |
Hoffmann-La Roche |
2023-12-11 | PHASE3 |
| NCT04486352 | RECRUITING | Endometrial Cancer |
Alliance Foundation Trials, LLC. |
2021-10-20 | PHASE1; PHASE2 |
| NCT05634499 | ACTIVE_NOT_RECRUITING | Endometrial Cancer |
Hoffmann-La Roche |
2023-06-27 | PHASE2 |
| NCT07214662 | TERMINATED | Breast Cancer |
Genentech, Inc. |
2026-01-13 | PHASE1 |
| NCT06259929 | RECRUITING | Breast Cancer |
Fondazione Oncotech |
2025-01-27 | PHASE2 |
| NCT04546009 | ACTIVE_NOT_RECRUITING | Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer |
Hoffmann-La Roche |
2020-10-09 | PHASE3 |
| NCT05896566 | COMPLETED | Breast Cancer |
ETOP IBCSG Partners Foundation |
2024-01-23 | PHASE2 |
| NCT04961996 | ACTIVE_NOT_RECRUITING | Early Breast Cancer |
Hoffmann-La Roche |
2021-08-27 | PHASE3 |
| NCT05306340 | ACTIVE_NOT_RECRUITING | Estrogen Receptor (ER)-Positive, HER2-negative, Locally Advanced or Metastatic Breast Cancer |
Genentech, Inc. |
2022-08-03 | PHASE3 |
| NCT05659563 | COMPLETED | Breast Cancer; Breast Cancer, Early-Onset |
MedSIR |
2023-07-20 | PHASE2 |
| NCT04576455 | ACTIVE_NOT_RECRUITING | Estrogen Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer |
Hoffmann-La Roche |
2020-11-27 | PHASE2 |
| NCT04436744 | COMPLETED | Early Breast Cancer |
Hoffmann-La Roche |
2020-09-04 | PHASE2 |
| NCT03916744 | COMPLETED | Breast Cancer |
Genentech, Inc. |
2019-07-26 | PHASE1 |
(data from https://clinicaltrials.gov, updated on 2026-09-01)
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>).