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Study on the Effects of Samuraciclib and Elacestrant for Patients with Hormone Receptor-Positive, HER2-Negative Breast Cancer

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What is this study about?

This clinical trial is focused on studying a type of breast cancer known as Hormone Receptor-positive (HR+) and Human Epidermal Growth Factor Receptor 2-negative (HER2-) breast cancer. The study is testing a combination of two treatments: Samuraciclib, which is taken as a capsule, and Elacestrant, available in film-coated tablets. The purpose of the study is to find the best dose of these medications when used together and to see how effective they are in treating this type of breast cancer.

The study is divided into two phases. In the first phase, researchers will determine the most suitable dose of the combination treatment. In the second phase, they will assess how well the treatment works in terms of delaying the progression of the disease. Participants will take the medications orally, and their health will be monitored throughout the study to observe any changes in their condition and to check for any side effects.

Participants in this study have breast cancer that has either spread to other parts of the body or is locally advanced, meaning it cannot be removed or treated with radiation to cure it. The study aims to provide valuable information on the effectiveness of the combination of Samuraciclib and Elacestrant in managing this specific type of breast cancer.

1 joining the study

Upon joining the study, the participant will be informed about the trial’s purpose and procedures. The study involves testing the combination of two medications: samuraciclib and elacestrant.

The participant will be required to provide consent to participate in the study, acknowledging understanding of the trial’s objectives and potential risks.

2 phase 1b: dose finding

This phase aims to determine the recommended dose for the next phase. Participants will receive samuraciclib and elacestrant orally.

The dosage will be adjusted to identify the optimal dose that balances effectiveness and safety. Participants will be monitored for any side effects or adverse reactions.

3 phase 2: expansion

In this phase, the effectiveness of the medication combination will be assessed. The focus will be on progression-free survival, which measures the time during and after treatment that the participant lives with the disease without it getting worse.

Participants will continue to take samuraciclib and elacestrant orally at the dose determined in Phase 1b.

4 medication details

Samuraciclib is administered in capsule form, while elacestrant is available as film-coated tablets in two dosages: 86 mg and 345 mg.

Both medications are taken orally, and the specific dosage and frequency will be determined by the study team based on the participant’s response and tolerance.

5 monitoring and assessments

Throughout the trial, participants will undergo regular assessments to monitor their health and the effectiveness of the treatment.

These assessments may include blood tests, imaging studies, and other evaluations to track the progression of the disease and any side effects.

6 end of trial

The trial is expected to conclude by June 2025. Participants will be informed about the results and any further steps if necessary.

Upon completion, participants may receive follow-up care as determined by the study team.

Who Can Join the Study?

  • Must have a confirmed diagnosis of breast cancer that has spread or is advanced, and cannot be treated with surgery or radiation to cure it.
  • The cancer must be ER-positive, meaning the tumor has at least 10% of cells that react to estrogen, with or without being PgR-positive (reacting to progesterone).
  • The cancer must be HER2-negative, which means it does not have high levels of a protein called HER2.
  • Must have either measurable disease or bone-only disease with lesions that can be evaluated. If radiation was done on the bone, there must be at least one lesion in an area that wasn’t treated with radiation.
  • Must show that the disease has gotten worse while on or within 6 months after the last treatment.
  • Must have taken an aromatase inhibitor (a type of hormone therapy) with a CDK4/6 inhibitor (a type of cancer treatment) and benefited from it for at least 6 months. If the CDK4/6 inhibitor was stopped early due to side effects, the aromatase inhibitor must have been taken for at least 6 months.
  • Must have a life expectancy of more than 12 weeks.
  • Both males and females can participate.

Who Cannot Join the Study?

  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients with a history of severe allergic reactions to the study drugs cannot participate.
  • Patients with uncontrolled medical conditions, such as high blood pressure or diabetes, cannot participate.
  • Patients who have received another investigational drug within the last 4 weeks cannot participate.
  • Patients with active infections, such as a cold or flu, cannot participate.
  • Patients with a history of other cancers, except for certain skin cancers, cannot participate.
  • Patients with significant heart problems, such as heart failure, cannot participate.
  • Patients with liver disease, such as hepatitis, cannot participate.
  • Patients with kidney disease, such as chronic kidney disease, cannot participate.
  • Patients who are unable to swallow pills cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hospital Clinico San Carlos Madrid Spain
Hospital Universitario Hm Sanchinarro Madrid Spain
Hospital Universitario De Navarra Pamplona Spain

Other Sites

Site Name City Country Status
Hospital Universitario Quironsalud Madrid Pozuelo De Alarcon Spain
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer Barcelona Spain
Clinique Victor Hugo Le Mans France
Institut de Cancérologie de l’Ouest Saint-Herblain France
Clytbl Lhbh Blxkao Lyon France
Ihggizvq Cppiek Dvqawjglvfybsqryc L'hospitalet De Llobregat Spain
Hssrtatl Viym dbwtmjzv Barcelona Spain
Iwimvbsz Pnvslpqrgbvywoe Chwqsi Cndvua Marseille France
Hjzqjfor Usqbxuubvjnhe dp A Cparhv A Coruna Galicia Spain
Illftksw Cuarg Paris France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not recruiting
01.11.2023
Spain Spain
Not recruiting
01.11.2023

Trial locations

Investigated drugs:

Samuraciclib is a medication being studied for its potential to treat certain types of breast cancer. It is being tested in combination with another drug to see if it can help stop or slow down the growth of cancer cells in patients with hormone-receptor-positive and HER2-negative breast cancer.

Elacestrant is another medication involved in this study. It is used to target and block the effects of hormones that can promote the growth of breast cancer cells. In this trial, it is combined with samuraciclib to evaluate if the combination is more effective in treating breast cancer compared to using each drug alone.

Investigated diseases:

Breast Cancer – Breast cancer is a disease where cells in the breast grow uncontrollably, forming a tumor that can often be felt as a lump or seen on an X-ray. It typically begins in the ducts or lobules of the breast and can spread to other parts of the body if not managed. The progression of breast cancer can vary, with some tumors growing slowly and others more rapidly. Hormone receptor status, such as estrogen receptor-positive or negative, can influence the growth and spread of the cancer. The disease can cause changes in breast shape, size, or appearance, and may lead to symptoms like skin dimpling or nipple discharge. Early detection and understanding of the cancer’s characteristics are crucial for managing its progression.

Trial ID:
2023-503846-30-00
Protocol code:
CT7001_003
Trial Phase:
Human Pharmacology (Phase I) – Other

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