Completed PHASE1 INTERVENTIONAL 4-arm NCT03455270

G1T48, an Oral SERD, Alone and in Combination With Palbociclib in ER-Positive, HER2-Negative Advanced Breast Cancer

A Phase 1, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of Ascending Doses of G1T48 Alone and in Combination With Palbociclib in Women With Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer

Sponsor: G1 Therapeutics, Inc.

Conditions Advanced Breast Cancer Breast Cancer Breast Cancer Female Breast Neoplasm Carcinoma, Ductal, Breast Metastatic Breast Cancer Stage IV Breast Cancer

Interventions G1T48 Palbociclib

Updated 21 times since 2018 Last updated: Dec 14, 2022 Started: May 9, 2018 Primary completion: Sep 29, 2022 Completion: Sep 29, 2022

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT03455270, this PHASE1 trial focuses on Advanced Breast Cancer and Breast Cancer and remains completed. Sponsored by G1 Therapeutics, Inc., it has been updated 21 times since 2018, reflecting substantial change activity. This study contributes to the evolving evidence base for cancer treatment protocols.

Status Flow

Change History

21 versions recorded

Sep 2025 — Present [monthly]

Completed PHASE1
Sep 2024 — Sep 2025 [monthly]

Completed PHASE1
Jul 2024 — Sep 2024 [monthly]

Completed PHASE1
Jan 2023 — Jul 2024 [monthly]

Completed PHASE1

Status: Active Not Recruiting → Completed
Sep 2022 — Jan 2023 [monthly]

Active Not Recruiting PHASE1

▶ Show 16 earlier versions

Apr 2022 — Sep 2022 [monthly]

Active Not Recruiting PHASE1
Feb 2022 — Apr 2022 [monthly]

Active Not Recruiting PHASE1
Feb 2021 — Feb 2022 [monthly]

Active Not Recruiting PHASE1

Status: Recruiting → Active Not Recruiting
Jan 2021 — Feb 2021 [monthly]

Recruiting PHASE1
Oct 2020 — Jan 2021 [monthly]

Recruiting PHASE1
Jul 2020 — Oct 2020 [monthly]

Recruiting PHASE1

Status: Active Not Recruiting → Recruiting
Mar 2020 — Jul 2020 [monthly]

Active Not Recruiting PHASE1

Status: Recruiting → Active Not Recruiting
Oct 2019 — Mar 2020 [monthly]

Recruiting PHASE1
Sep 2019 — Oct 2019 [monthly]

Recruiting PHASE1
Aug 2019 — Sep 2019 [monthly]

Recruiting PHASE1
Jun 2019 — Aug 2019 [monthly]

Recruiting PHASE1
Jan 2019 — Jun 2019 [monthly]

Recruiting PHASE1
Oct 2018 — Jan 2019 [monthly]

Recruiting PHASE1
Aug 2018 — Oct 2018 [monthly]

Recruiting PHASE1
Jun 2018 — Aug 2018 [monthly]

Recruiting PHASE1

Status: Not Yet Recruiting → Recruiting
Mar 2018 — Jun 2018 [monthly]

Not Yet Recruiting PHASE1

First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

G1 Therapeutics, Inc.

Data source: G1 Therapeutics, Inc.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Amsterdam, Netherlands , Beverly Hills, United States , Brussels, Belgium , Chapel Hill, United States , Chicago, United States , Chisinau, Moldova , Groningen, Netherlands , Kiev, Ukraine , Leuven, Belgium , Nashville, United States and 5 more locations