Samuraciclib

DRUG4 trials

Sponsors

Hoffmann-La Roche, Carrick Therapeutics Limited, Pfizer

Conditions

Breast CancerInoperable, Locally Advanced or Metastatic, ER-positive Breast CancerLocally Advanced Breast CancerMetastatic Breast Cancer

Phase 1

A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Participants With Breast Cancer

RecruitingNCT04802759

Hoffmann-La RocheInoperable, Locally Advanced or Metastatic, ER-positive Breast Cancer

Start: 2021-06-22End: 2029-05-30Target: 316Updated: 2026-05-11

A Study of Samuraciclib and Elacestrant in Participants With Metastatic or Locally Advanced HR+/HER2-negative Breast Cancer

CompletedNCT05963997

Carrick Therapeutics LimitedBreast Cancer, Locally Advanced Breast Cancer, Metastatic Breast Cancer

Start: 2023-10-09End: 2026-03-06Updated: 2026-03-23

TACTIVE-U: A Study to Learn About the Study Medicine (Vepdegestrant) When Given With Other Medicines in People With Advanced or Metastatic Breast Cancer. (Sub-Study C)

Active, not recruitingNCT06125522

PfizerBreast Cancer

Start: 2024-01-10End: 2026-12-31Updated: 2026-05-06

Phase 2

A Study of Samuraciclib in Combination With Fulvestrant in Metastatic or Locally Advanced Breast Cancer in Adult Participants

CompletedNCT05963984

Carrick Therapeutics LimitedBreast Cancer, Locally Advanced Breast Cancer, Metastatic Breast Cancer

Start: 2023-11-16End: 2025-08-28Updated: 2025-12-26

Related Papers

Abstract PS1-08-06: Results of the phase 2 SUMIT-BC study, a randomized controlled trial of the cyclin-dependent kinase 7 inhibitor (CDK7i) samuraciclib with fulvestrant in advanced hormone receptor positive (HR+) breast cancer after a CDK4/6 inhibitor (CDK4/6i)

Clinical Cancer Research2026-02-17

Abstract P4-12-03: Vepdegestrant, a PROteolysis TArgeting Chimera (PROTAC) Estrogen Receptor (ER) Degrader, Plus Abemaciclib in ER-Pos/Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Advanced or Metastatic Breast Cancer: TACTIVE-U Prelim Phase 1b Results

Clinical Cancer Research2025-06-134 citations

Abstract P2-07-22: Cyclin-dependent kinase 7 (CDK7) inhibitor samuraciclib combined with selective estrogen receptor degrader (SERD) elacestrant in advanced HR+ breast cancer after CDK4/6i: dose escalation data from the Phase 1b/2 SUMIT-ELA study

Clinical Cancer Research2025-06-13

Giredestrant (G) with atezolizumab (ATEZO), and/or abemaciclib (ABEMA) in patients (pts) with ER+/HER2– locally advanced/metastatic breast cancer (LA/mBC): Interim analysis (IA) from the phase I/II MORPHEUS Breast Cancer study.

Journal of Clinical Oncology2025-05-281 citations

VERITAC-2: a Phase III study of vepdegestrant, a PROTAC ER degrader, versus fulvestrant in ER+/HER2- advanced breast cancer

Future Oncology2024-07-2965 citations

Fulvestrant with or without the cyclin-dependent kinase 7 (CDK7) inhibitor samuraciclib in advanced hormone receptor positive (HR+) breast cancer after CDK4/6 inhibition: Phase II SUMIT-BC study.

Journal of Clinical Oncology2024-06-013 citations

Interim analysis (IA) of the giredestrant (G) + everolimus (EVERO) arm in MORPHEUS Breast Cancer (BC): A phase I/II study of G treatment (tx) combinations in patients (pts) with estrogen receptor-positive (ER+), HER2-negative, locally advanced/metastatic BC (LA/mBC).

Journal of Clinical Oncology2024-06-011 citations

heredERA Breast Cancer: a phase III, randomized, open-label study evaluating the efficacy and safety of giredestrant plus the fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection in patients with previously untreated HER2-positive, estrogen receptor-positive locally advanced or metastatic breast cancer

BMC Cancer2024-05-246 citations

Abstract PS17-07: Interim analysis of giredestrant + inavolisib in MORPHEUS Breast Cancer: a Phase Ib/II study of giredestrant treatment combinations in estrogen receptor-positive, HER2-negative, locally advanced/metastatic breast cancer

Cancer Research2024-05-022 citations

Phase Ia/b Study of Giredestrant ± Palbociclib and ± Luteinizing Hormone-Releasing Hormone Agonists in Estrogen Receptor–Positive, HER2-Negative, Locally Advanced/Metastatic Breast Cancer

Clinical Cancer Research2023-11-0318 citations

Interim analyses (IA) of the giredestrant (G), G + abemaciclib (A), and G + ribociclib (R) arms in MORPHEUS Breast Cancer (BC): A phase I/II study of G treatment (tx) combinations in patients (pts) with estrogen receptor-positive, HER2-negative locally advanced/metastatic BC (ER+, HER2– LA/mBC).

Journal of Clinical Oncology2023-06-0110 citations