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A Study of Samuraciclib in Combination With Fulvestrant in Metastatic or Locally Advanced HR Positive and HER2-Negative BC
EU CTIS ID: 2023-503903-27-00
What this study is testing
To evaluate the efficacy of two doses of samuraciclib in combination with fulvestrant.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Histologically confirmed diagnosis of BC. Evidence of metastatic or locally advanced disease, not amenable to resection or radiation therapy with curative intent and having the following specifics: estrogen receptor positive with or without progesterone receptor positive tumor; HER2-negative.
- 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 in the following settings: locally advanced or metastatic, or adjuvant.
- Known TP53 mutation status.
- Participants must have measurable disease or bone only disease (which can be measurable or non-measurable) 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.
You likely can't join if
- Inflammatory BC.
- 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.
- Prior treatment with: a selective estrogen receptor degrader (SERD) or similar agents in the advanced/metastatic setting; 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.
See the full eligibility criteria
- Histologically confirmed diagnosis of BC. Evidence of metastatic or locally advanced disease, not amenable to resection or radiation therapy with curative intent and having the following specifics: estrogen receptor positive with or without progesterone receptor positive tumor; HER2-negative.
- 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 in the following settings: locally advanced or metastatic, or adjuvant.
- Known TP53 mutation status.
- Participants must have measurable disease or bone only disease (which can be measurable or non-measurable) 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.
- Inflammatory BC.
- 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.
- Prior treatment with: a selective estrogen receptor degrader (SERD) or similar agents in the advanced/metastatic setting; 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.
The study team makes the final eligibility decision.
Where it's taking place
- Turkey
- Mexico
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Turkey; Mexico; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.