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Study of Tuvusertib and Fulvestrant for Advanced Breast Cancer Resistant to CDK4/6 and Aromatase Inhibitors in Hormone Receptor-Positive, HER2-Negative Patients

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying advanced breast cancer, specifically in cases where the cancer is hormone receptor-positive and HER2-negative. These types of breast cancer have shown resistance to certain treatments, such as CDK4/6 inhibitors and aromatase inhibitors. The study will explore a new treatment combination using two medications: M1774, which is an ATR inhibitor, and fulvestrant, a solution for injection. The purpose of the study is to evaluate the safety and effectiveness of this combination in patients whose cancer has specific genetic changes that may affect how the cancer grows.

Participants in the study will receive the treatment over a period of up to 18 months. The study will be conducted in two phases. The first phase aims to find the best dose of M1774 when used with fulvestrant. The second phase will further assess the safety and potential benefits of this treatment combination. Some participants may receive a placebo as part of the study to help compare the effects of the new treatment.

The study will monitor participants for any side effects and measure how well the treatment works in controlling the cancer. This includes looking at how long participants live without the cancer getting worse. The study will also collect information on how the body processes the medications. The trial is expected to continue until 2028, with recruitment starting in 2024.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on specific criteria such as age, organ function, and disease characteristics.
A negative pregnancy test is required for female participants, and contraceptive use may be necessary.
Informed consent must be provided.
Step 2
Initial assessment
An initial assessment is conducted to evaluate the current state of the disease and overall health.
This includes measuring the disease using specific criteria and confirming the type of breast cancer.
Step 3
Phase I treatment
The first phase involves determining the maximum tolerated dose of the medication M1774 in combination with fulvestrant.
Fulvestrant is administered intramuscularly, while M1774 is taken orally in capsule form.
The goal is to find a safe and effective dose for further study.
Step 4
Phase II treatment
In the second phase, the focus is on evaluating the safety and effectiveness of the treatment at the recommended dose.
Participants continue to receive M1774 and fulvestrant as previously determined.
The treatment aims to assess the clinical benefit and monitor any side effects.
Step 5
Ongoing monitoring
Throughout the trial, regular monitoring is conducted to track the progression of the disease and any side effects.
This includes routine check-ups and assessments to ensure the safety and well-being of participants.
Step 6
Completion of the trial
The trial is expected to conclude by October 2028.
Upon completion, final assessments are made to evaluate the overall outcomes and effectiveness of the treatment.

Who can join the trial?

16 criteria

Must be at least 18 years old.
Must have normal organ and bone marrow function.
Must have adequate kidney function.
If female, must have a negative blood pregnancy test.
Must use birth control if applicable.
Must have a measurable disease, meaning at least one area that can be measured for changes.
Must be part of a social security system.
Must be able to give signed consent or have a trusted person do so.
Can be a man or a woman who has gone through menopause naturally, surgically, or through medication.
Must have **advanced breast cancer**.
Must have breast cancer that is **hormone receptor-positive** and **HER2-negative**.
Must have had disease progression while on a treatment combining an **aromatase inhibitor** and **CDK4/6 inhibitors**.
Must not have had more than one previous chemotherapy treatment for advanced disease.
Must not have had more than one previous hormone therapy for cancer that has spread.
If having a **gBRCA1/2** mutation, must have been treated with **PARP inhibitors** and experienced disease progression during or after this treatment.
Must have an **ECOG Performance Status** of 0 or 1, which means being fully active or having some symptoms but being able to carry out light work.

Who cannot join the trial?

8 criteria

Patients who do not have advanced breast cancer cannot participate.
Patients who are not resistant to CDK4/6 inhibitors and aromatase inhibitor-based endocrine therapy cannot participate. These are treatments used for certain types of breast cancer.
Patients whose tumors do not show specific genetic changes, like HRD (Homologous Recombination Deficiency) or mutations in genes such as BRCA1, BRCA2, or PALB2, cannot participate. These are specific genetic markers related to cancer.
Patients who have not previously been treated with PARP inhibitors cannot participate. PARP inhibitors are a type of cancer treatment.
Patients whose tumors do not have other specific molecular changes linked to cancer growth cannot participate.
Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
Both male and female patients can participate, but those who do not meet the gender criteria cannot participate.
Patients who are part of a vulnerable population, such as those unable to give consent, cannot participate.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

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Assistance Publique Hopitaux De Paris
Paris, France
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Besancon University Hospital Center
Besançon, France
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Centr Georges Francois Leclerc
Dijon, France

Trial locations

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Investigated drugs

M1774
is an experimental medication being studied as an ATR inhibitor. It is used in this trial to see if it can help treat advanced breast cancers that are hormone receptor-positive and HER2-negative. These cancers have become resistant to certain other treatments, like CDK4/6 inhibitors and aromatase inhibitors. The goal is to find out if M1774 can work in combination with another medication to improve treatment outcomes for patients with specific genetic changes in their tumors.
Fulvestrant
is a medication used in this trial to treat advanced breast cancer. It works by blocking the effects of estrogen, a hormone that can promote the growth of breast cancer cells. In this study, fulvestrant is combined with M1774 to see if the combination can be more effective in treating certain types of breast cancer that have stopped responding to other treatments.

What is already known about the treatment

M1774
This medication is administered orally and is currently being studied in clinical trials for its potential use in treating advanced breast cancer. It is an ATR inhibitor, which means it works by blocking a protein involved in DNA repair, thereby increasing the vulnerability of cancer cells to damage. The main therapeutic indication for M1774 is hormone receptor-positive, HER2-negative advanced breast cancer that is resistant to certain other treatments. As an investigational drug, it is still under evaluation to determine its safety and effectiveness in combination with other therapies.
Fulvestrant
This medication is given as an injection and is already approved for use in treating certain types of breast cancer. It is a selective estrogen receptor degrader, which means it works by binding to estrogen receptors and promoting their degradation, thereby reducing the growth of cancer cells that rely on estrogen. Fulvestrant is used primarily for hormone receptor-positive, HER2-negative advanced breast cancer, especially in cases where the cancer has become resistant to other hormone therapies. It is well-established in medical literature and is often used in combination with other treatments to enhance its effectiveness.

Investigated diseases

Advanced Breast Cancer – Advanced breast cancer refers to cancer that has spread beyond the breast and nearby lymph nodes to other parts of the body. It is often characterized by the presence of tumors in distant organs such as the bones, liver, lungs, or brain. The progression of the disease can vary, with some patients experiencing rapid growth and spread of cancer cells, while others may have a slower progression. Symptoms may include persistent pain, fatigue, and changes in the breast or other affected areas. The disease is typically classified based on hormone receptor status, such as ER-positive or HER2-negative, which can influence its behavior and response to therapies.