Metastatic Breast CancerPhase 2SUMIT-BCNCT05963984
A Study of Samuraciclib in Combination With Fulvestrant in Metastatic or Locally Advanced Breast Cancer in Adult Participants
A Phase 2 study testing Samuraciclib and Fulvestrant in people with Metastatic Breast Cancer and Locally Advanced Breast Cancer, run by Carrick Therapeutics Limited at 32 sites in 5 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer, Locally Advanced Breast Cancer, Breast Cancer
- What is being tested?
- Samuraciclib and Fulvestrant
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 32 sitesin 5 countries
- Study dates
- 16 Nov 2023to 28 Aug 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
32 sites in 5 countries.
32 sites in 5 countries
Spain10 sites
Hospital Infanta Cristina
Badajoz, 06080
Parc de Salut Mar - Hospital del Mar
Barcelona, 08003
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Institut Català d'Oncologia - L'Hospitalet
L'Hospitalet de Llobregat, Barcelona, 08908
Hospital Clinico San Carlos
Madrid, Madrid, Comunidad de, 28040
MD Anderson Cancer Center
Madrid, 28015
Hospital Vithas Málaga
Málaga, 29016
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
Salamanca, 37007
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria Comunidad de, 39002
Hospital Clinico de Valencia
Valencia, 46010
Turkey (Türkiye)8 sites
Gulhane Egitim ve Arastirma Hastanesi
Ankara, 06010
Gazi University
Ankara, 06120
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi
Ankara, 06200
Hacettepe Universite Hastaneleri
Ankara, 06230
Trakya University
Edirne, 22030
Istanbul Universitesi Istanbul Tıp Fakultesi Hastanesi
Istanbul, 34093
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi
Istanbul, 34722
I.E.U. Medical Point Hastanesi
Izmir, 35575
Mexico6 sites
Cryptex Investigación Clínica S.A. de C.V.
Cuauhtémoc, 06100
Actualidad Basada en la Investigación del Cáncer
Guadalajara, Jalisco, 44280
Renati Innovation S.A.P.I de C.V
Guadalajara, Jalisco, 44680
Soltmed SMO
Mexico City, Mexico City, 03650
Oaxaca Site Management Organization S.C.
Oaxaca City, 68000
Centro de Investigacion Clinica de Oaxaca
Oaxaca City, 68020
United States5 sites
Mfsmc-Hjwci
Baltimore, Maryland, 21237
The Center for Cancer and Blood Disorders
Fort Worth, Texas, 76104
Saint Luke's Cancer Institute
Kansas City, Missouri, 64111
Ocala Oncology Center PL DBA Florida Cancer Affiliates
Ocala, Florida, 34474
Sidney Kimmel Cancer Center - Jefferson Health
Philadelphia, Pennsylvania, 19107
Hungary3 sites
Semmelweis Egyetem
Budapest, 1082
Nograd Varmegyei Szent Lazar Korhaz
Salgótarján, Nógrád megye, 3100
Szent Borbala Korhaz
Tatabánya, Komárom-Esztergom, 2800
About this study
Official 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)
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.
- Being tested
- Samuraciclib, Fulvestrant
- Keywords
- Metastatic Breast Cancer, Advanced Breast Cancer, Breast Cancer, HR Positive, HER2-Negative
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SamuraciclibDrug
Samuraciclib tablet by mouth once a day
FulvestrantDrug
Also called Faslodex
Injection administered monthly (i.e., every 4 weeks), plus additional dose at Cycle 1 Day 15
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Participants will receive 360 mg of samuraciclib on cycles of 28 days (Cycle 1 to 6), 56 days (Cycle 7 to 9) and up to 84 days (Cycles 10 onwards in combination with fulvestrant administered monthly, plus an additional dose at Cycle 1 Day 15. Receives: Drug: Samuraciclib; Drug: Fulvestrant |
| Arm B | Experimental | Participants will receive 240 mg of samuraciclib on cycles of 28 days (Cycle 1 to 6), 56 days (Cycle 7 to 9) and up to 84 days (Cycles 10 onwards in combination with fulvestrant administered monthly, plus an additional dose at Cycle 1 Day 15. Receives: Drug: Samuraciclib; Drug: Fulvestrant |
| Arm C | Experimental | Participants will receive fulvestrant administered monthly, plus additional dose at Cycle 1 Day 15. Receives: Drug: Fulvestrant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Benefit Response (CBR)
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.
Measured: From randomization until Week 24
Secondary outcomes (7)
Objective Response Rate (ORR)
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.
Measured: 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)
Duration of Response (DOR)
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.
Measured: 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)
Progression Free Survival (PFS)
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.
Measured: 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)
Incidence and severity of adverse events (AEs) as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0
Safety will be assessed by monitoring adverse events and clinically relevant changes in vital signs and clinical laboratory results.
Measured: From first dose of any study intervention through 28 days after the last dose of any study intervention
Samuraciclib plasma exposure: Cmax
Measured: Day 1 of Cycles 2 and 3 (each cycle is 28 days)
Samuraciclib plasma exposure: Ctrough
Measured: 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)
Fulvestrant plasma exposure: Ctrough
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start16 Nov 2023
- Primary completion20 Mar 2025
- Study completion28 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carrick Therapeutics Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05963984
- Sponsor's protocol ID
- CT7001_002
- Other IDs
- 2023-503903-27-00, Z0041001, 2023
- Acronym
- SUMIT-BC
- Status last verified
- Dec 2025
- First submitted
- 30 Jun 2023
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT05963984
- Acronym / sponsor ID
- SUMIT-BC / CT7001_002
- Keywords
- Metastatic Breast Cancer, Advanced Breast Cancer, Breast Cancer, HR Positive, HER2-Negative
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Carrick Therapeutics LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Study start
- 16 Nov 2023 (actual)
- Primary completion
- 20 Mar 2025 (actual)
- Study completion
- 28 Aug 2025 (actual)
- First posted
- 27 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: Samuraciclib, Drug: FulvestrantParticipants will receive 360 mg of samuraciclib on cycles of 28 days (Cycle 1 to 6), 56 days (Cycle 7 to 9) and up to 84 days (Cycles 10 onwards in combination with fulvestrant administered monthly, plus an additional dose at Cycle 1 Day 15. |
| Arm B | Experimental | Drug: Samuraciclib, Drug: FulvestrantParticipants will receive 240 mg of samuraciclib on cycles of 28 days (Cycle 1 to 6), 56 days (Cycle 7 to 9) and up to 84 days (Cycles 10 onwards in combination with fulvestrant administered monthly, plus an additional dose at Cycle 1 Day 15. |
| Arm C | Experimental | Drug: FulvestrantParticipants will receive fulvestrant administered monthly, plus additional dose at Cycle 1 Day 15. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SamuraciclibSamuraciclib tablet by mouth once a day | Drug | Arm A, Arm B |
| FulvestrantAlso: FaslodexInjection administered monthly (i.e., every 4 weeks), plus additional dose at Cycle 1 Day 15 | Drug | Arm A, Arm B, Arm C |
Primary outcome
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.
7 secondary outcomes
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)
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)
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)
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
Samuraciclib plasma exposure: Cmax
Time frame: Day 1 of Cycles 2 and 3 (each cycle is 28 days)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
32 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Samuraciclib and Fulvestrant in people with Metastatic Breast Cancer and Locally Advanced Breast Cancer, run by Carrick Therapeutics Limited at 32 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in Spain, Turkey (Türkiye), Mexico, United States, Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Benefit Response (CBR) (time frame: From randomization until Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2025.