CT7001_002 (SUMIT-BC) - An open-label Interventional, Multicenter, Randomized, Phase 2 Study of Fulvestrant with or without Samuraciclib in Participants with Metastatic or Locally Advanced Hormone Receptor Positive and Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-503903-27-00

Enrollment

Registered

2023-09-25

Start date

2023-10-11

Completion date

2025-09-02

Last updated

2025-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

metastatic or locally advanced Hormone Receptor positive and Human Epidermal Growth Factor Receptor 2 negative breast cancer

Brief summary

Clinical benefit response (CBR) (complete response [CR], partial response [PR], or stable disease [SD] (≥ 24 weeks after randomization)).

Detailed description

Adverse events (AEs) and laboratory abnormalities as graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0, Progression free survival (PFS); Objective response rate (ORR); Duration of response (DOR)., Samuraciclib: Cmax and Ctrough; Fulvestrant: Ctrough.

Interventions

DRUGFaslodex 250 mg solution for injection.

DRUGCT7001 Tablet

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Clinical benefit response (CBR) (complete response [CR], partial response [PR], or stable disease [SD] (≥ 24 weeks after randomization)).	—

Secondary

Measure	Time frame
Adverse events (AEs) and laboratory abnormalities as graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0, Progression free survival (PFS); Objective response rate (ORR); Duration of response (DOR)., Samuraciclib: Cmax and Ctrough; Fulvestrant: Ctrough.	—

Countries

Hungary, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026