Skip to main content
OpenTrials
Completed

NCT Number: NCT05963984

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

The purpose of this study is to evaluate the safety and efficacy of samuraciclib in combination with fulvestrant versus fulvestrant alone in adult participants with metastatic or locally advanced Hormone Receptor (HR) positive and Human Epidermal Growth Factor Receptor (HER)2-negative breast cancer.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Metastatic Breast Cancer Breast Cancer Breast Diseases Breast Neoplasms Locally Advanced Breast Cancer Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Szent Borbala Korhaz, Tatabánya, Komárom-Esztergom, Hungary

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically confirmed diagnosis of ER-positive, HER2-negative locally advanced or metastatic breast cancer.
  • Documented objective disease progression while on or within 6 months after the end of the most recent therapy.
  • Received prior AI in combination with a CDK4/6i as the last therapy
  • Known TP53 mutation status.
  • Participants must have measurable disease or bone only disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
  • Pre/peri-menopausal participants must have commenced treatment with a luteinizing hormone-releasing hormone (LHRH) agonist at least 4 weeks prior to first dose of study intervention.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤1 with no deterioration over the past 2 weeks.
  • Expected life expectancy of >12 weeks in the judgement of the treating investigator.

Exclusion criteria

  • Inflammatory breast cancer.
  • Participants with any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix.
  • More than 1 line of endocrine treatment for locally advanced or metastatic disease treatment.
  • Inadequate hepatic, renal, and bone marrow function.
  • Clinically significant cardiovascular disease.
  • Any current or prior central nervous system metastases, carcinomatous meningitis, or leptomeningeal disease.
  • Pregnant or breastfeeding women.

Treatment and study plan

Samuraciclib

Drug

Samuraciclib tablet by mouth once a day

Fulvestrant

Drug

Injection administered monthly (i.e., every 4 weeks), plus additional dose at Cycle 1 Day 15

Other names: Faslodex

Primary outcomes

  1. Clinical Benefit Response (CBR)

    Time frame: From randomization until Week 24

    CBR is defined as the overall complete response (CR), partial response (PR), or stable disease (SD) ≥ 24 weeks according to RECIST version 1.1 recorded from randomization until disease progression, or death due to any cause.

Secondary outcomes

  1. Objective Response Rate (ORR)

    Time frame: Time from the date of first dose of study intervention until the first documentation of disease progression, death, withdrawal of consent, or start of new anticancer therapy (assessed up to week 48)

    ORR defined as the proportion of participants who achieved a best overall Response (BOR) of CR or PR per RECIST Version 1.1 from randomization until disease progression, or death due to any cause.

  2. Duration of Response (DOR)

    Time frame: Time from the date of first dose of study intervention until the first documentation of disease progression, death, withdrawal of consent, or start of new anticancer therapy (assessed up to week 48)

    DOR defined as the time from the date of first documentation of objective tumor response (CR or PR) to the earliest documented disease progression per RECIST version 1.1, or death due to any cause.

  3. Progression Free Survival (PFS)

    Time frame: Time from the date of first dose of study intervention until the first documentation of disease progression, death, withdrawal of consent, or start of new anticancer therapy (assessed up to week 48)

    PFS defined as the time from the date of randomization to the earliest documented disease progression per RECIST version 1.1, or death due to any cause.

  4. Incidence and severity of adverse events (AEs) as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0

    Time frame: From first dose of any study intervention through 28 days after the last dose of any study intervention

    Safety will be assessed by monitoring adverse events and clinically relevant changes in vital signs and clinical laboratory results.

  5. Samuraciclib plasma exposure: Cmax

    Time frame: Day 1 of Cycles 2 and 3 (each cycle is 28 days)

  6. Samuraciclib plasma exposure: Ctrough

    Time frame: Cycle 1 Days 8 and 15; Day 1 of Cycles 2, 3, 4, 5, and 6; and within 28 days of last dose (each cycle is 28 days)

  7. Fulvestrant plasma exposure: Ctrough

    Time frame: Cycle 1 Days 8 and 15; Day 1 of Cycles 2, 3, 4, 5 and 6; and within 28 days of last dose (each cycle is 28 days)

Sponsors and collaborators

Lead sponsor

Carrick Therapeutics Limited

Industry

Collaborators

  • Pfizer

Registry information

Official study title

An Open-label, Interventional, Multicenter, Randomized, Phase 2 Study of Fulvestrant With or Without Samuraciclib in Participants With Metastatic or Locally Advanced Hormone Receptor (HR) Positive and Human Epidermal Growth Factor Receptor (HER)2-Negative Breast Cancer (BC)

Acronym: SUMIT-BC

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 27, 2023
Registry last updated
Dec 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.