A Phase 1b/2 Open-label Study of Samuraciclib in Combination With Elacestrant in Participants With Metastatic or Locally Advanced Hormone Receptor-positive and Human Epidermal Growth Factor Receptor 2-negative Breast Cancer

Plain English Summary

A Study of Samuraciclib and Elacestrant in Participants With Metastatic or Locally Advanced HR+/HER2-negative Breast Cancer is a Phase 2 clinical trial sponsored by Carrick Therapeutics Limited studying Metastatic Breast Cancer, Locally Advanced Breast Cancer, Breast Cancer. This trial tests a combination of two drugs, samuraciclib and elacestrant, to see if they are safe and effective for treating advanced breast cancer. It is for adults with hormone-receptor-positive (HR+), HER2-negative, metastatic or locally advanced breast cancer that has progressed after prior treatments. Participants will take both study drugs by mouth daily. The study is open-label, meaning both patients and doctors will know which treatments are being given. Alternative treatments may include other hormone therapies, targeted therapies, or chemotherapy, depending on the patient's specific situation and prior treatments. The trial aims to enroll 49 participants.

Official Summary

This is an international, multisite, open-label, Phase 1b/2 study, to confirm safety and efficacy of samuraciclib in combination with elacestrant in adult participants with metastatic or locally advanced Hormone Receptor (HR) positive and Human Epidermal Growth Factor Receptor (HER)2-negative breast cancer.

Who Can Participate

Here is what you need to know about eligibility for this trial. Adults with HR+, HER2-negative locally advanced or metastatic breast cancer. Patients whose cancer has progressed on or within 6 months of their last therapy, which must have included a CDK4/6 inhibitor and an aromatase inhibitor. Must have measurable disease or bone-only disease and adequate organ function. Not eligible if you have inflammatory breast cancer, other active cancers within the last 3 years (except certain skin cancers), or current/prior brain metastases. This trial is studying Metastatic Breast Cancer, Locally Advanced Breast Cancer, Breast Cancer, so participants generally need a confirmed diagnosis.

What They're Measuring

The primary outcomes measure how well the combination therapy works in shrinking tumors and controlling the cancer's growth over a specific period, indicating its potential effectiveness. The specific primary outcome measures are: Phase 1b (Dose-finding) (From the date of first dose of any study intervention (Day 1 Cycle 1) and through 28 days after the last dose of any study intervention); Phase 2 (Expansion) (From the date of first dose of any study intervention (Cycle 1 Day 1) until the first documentation of disease progression, death, withdrawal of consent, or start of new anticancer therapy (assessed up to week 48)). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 2, which tests whether the treatment actually works against the target condition. Phase 2 trials involve 100-300 patients and continue to monitor safety while evaluating effectiveness. This phase often tests different dosages to find the optimal amount. About 33% of Phase 2 drugs advance to Phase 3. If successful, the treatment will move to large-scale Phase 3 trials needed for FDA approval.

Why This Trial Matters

This trial addresses a need for new treatment options for patients with advanced HR+/HER2- breast cancer that has stopped responding to standard therapies. Phase 2 success would typically lead to larger Phase 3 trials needed for regulatory approval. This research targets Metastatic Breast Cancer, Locally Advanced Breast Cancer, Breast Cancer, where improved treatment options are needed.

Investor Insight

This trial targets a significant market for advanced breast cancer treatments, with the combination of novel agents potentially offering a competitive advantage if proven effective and safe. Phase 2 trials have approximately a 15-20% chance of eventually gaining FDA approval.

Is This Trial Right for Me?

Ask your doctor about the specific risks and benefits of samuraciclib and elacestrant, and how this combination might fit your treatment history. Be prepared for regular clinic visits for drug administration, blood tests, and imaging scans to monitor your response and side effects. Understand that this is an open-label study, meaning you and your doctor will know you are receiving the study drugs. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: NON_RANDOMIZED
• Model: SEQUENTIAL
• Masking: NONE
• Enrollment: 49 participants

Interventions

• DRUG: Samuraciclib — Samuraciclib capsules by mouth once a day
• DRUG: Elacestrant Dihydrochloride — Elacestrant tablets by mouth once a day

Primary Outcomes

• Phase 1b (Dose-finding) (From the date of first dose of any study intervention (Day 1 Cycle 1) and through 28 days after the last dose of any study intervention)
• Phase 2 (Expansion) (From the date of first dose of any study intervention (Cycle 1 Day 1) until the first documentation of disease progression, death, withdrawal of consent, or start of new anticancer therapy (assessed up to week 48))

Secondary Outcomes

• Treatment-Emergent Adverse Events and Laboratory Abnormalities (Safety and Tolerability) (From the date of first dose of any study intervention through 28 days after the last dose of any study intervention)
• Clinical Benefit Response (CBR) (From the date of first dose of any study intervention (Cycle 1 Day 1) to ≥ 24 weeks or until disease progression or death to any cause (assessed up to week 24))
• Overall response rate (ORR) (the date of first dose of study intervention (Cycle 1 Day 1) 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) (From the date of first dose of study intervention (Cycle 1 Day 1) until the first documentation of disease progression, death, withdrawal of consent, or start of new anticancer therapy (assessed up to week 48))
• Best percent change in tumor size. (From the date of first dose of study intervention (Cycle 1 Day 1) until the first documentation of disease progression, death, withdrawal of consent, or start of new anticancer therapy (assessed up to week 48))

Full Eligibility Criteria

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 and ESR1 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.

Trial Locations

• Site 38 - Northwestern University, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, United States
• Site 42 - Dana-Farber Cancer Institute, EDDC, Boston, Massachusetts, United States
• Site 35 - Cleveland Clinic, Taussig Cancer Institute, Cleveland, Ohio, United States
• Site 41 - The START Center for Cancer Care, South Texas Oncology and Hematology, San Antonio, Texas, United States
• Site 32 - Swedish Medical Center, Swedish Cancer Institute (SCI),Cherry Hill Campus, Seattle, Washington, United States
• Site 81 - Bergonie unicancer, Nouvelle-Aquitaine, L'Institut Bergonie, Bordeaux, France
• Site 80 - Centre Jean Bernard, Clinique Victor Hugo, Le Mans, France
• Site 83 - Institut Paoli Calmettes (IPC), Marseille, France
• Site 85 - Institut Curie, Paris, France
• Site 82 - Institut de Cancerologie de Ouest (ICO), Saint-Herblain, France
• ...and 10 more locations

Frequently Asked Questions

Related Conditions

• Metastatic Breast Cancer
• Locally Advanced Breast Cancer
• Hormone Receptor-Positive Breast Cancer
• HER2-Negative Breast Cancer
• Endocrine-Resistant Breast Cancer
• ER-Positive Breast Cancer
• Advanced Solid Tumors
• Oncology
• Breast Neoplasms
• Neoplasm Metastasis

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