Not recruiting

Study of BDC-1001 and Pertuzumab for Patients with HER2-Positive Metastatic Breast Cancer Previously Treated with Trastuzumab Deruxtecan

Verified siteRegistered drugNo placebo

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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 a type of breast cancer known as HER2-positive metastatic breast cancer. This is a form of cancer where the disease has spread to other parts of the body and involves a protein called HER2, which can promote the growth of cancer cells. The study is investigating a new treatment called BDC-1001, which is given as a solution through an infusion into the vein. The trial will explore the effects of BDC-1001 both on its own and in combination with another medication called pertuzumab, which is also administered as an infusion.

The purpose of this study is to evaluate the preliminary anti-tumor activity of BDC-1001, both alone and when combined with pertuzumab, in patients who have previously been treated with a medication called trastuzumab deruxtecan. Participants in the study will receive these treatments over a period of up to 24 months. The study will involve regular visits to the clinic for infusions and monitoring, but specific details about the schedule and procedures will be provided by the study team.

Throughout the study, participants will be closely monitored for any changes in their condition, including how well the cancer responds to the treatment and any side effects that may occur. The study aims to gather important information that could help in developing new treatment options for people with HER2-positive metastatic breast cancer.

The research process

The trial runs in 5 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, the patient will be required to sign an informed consent form, indicating understanding and agreement to participate.
A biopsy will be conducted prior to enrollment. If a biopsy is not feasible, archival tumor tissue may be submitted instead.
Step 2
Treatment initiation
The patient will receive treatment with BDC-1001 as a single agent or in combination with pertuzumab. Both medications are administered as a solution for infusion through an intravenous route.
The specific dosage and frequency of administration will be determined by the study protocol and the healthcare provider.
Step 3
Monitoring and assessments
Throughout the trial, the patient's response to treatment will be monitored using the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
Regular assessments will include monitoring vital signs, laboratory values, and electrocardiograms (ECGs).
The incidence of any treatment-emergent adverse events (AEs) and serious adverse events (SAEs) will be recorded and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.
Step 4
Evaluation of treatment response
The primary endpoint of the trial is the objective response rate, which will be evaluated according to RECIST v1.1.
Secondary endpoints include the duration of response, disease control rate, progression-free survival, and overall survival.
Step 5
Completion of the trial
The trial is estimated to end by October 20, 2027. The patient's participation will continue until the completion of the study or until the healthcare provider determines it is appropriate to discontinue treatment.

Who can join the trial?

12 criteria

Be able to understand and sign the informed consent form.
Have adequate organ function as defined by the study protocol.
Women who can have children must agree not to donate eggs and use a highly effective contraceptive method (a method with less than 1% chance of failure per year) during treatment and for 7 months after treatment ends. Non-hormonal methods are preferred.
Men who can father children and have partners who can have children must use condoms along with a second highly effective female contraceptive method during the study and agree not to donate sperm from the start of the study until 7 months after it ends. Men are considered potent unless they have been surgically sterilized.
Be 18 years or older at the time of giving consent.
Agree to have a biopsy before joining the study. If a biopsy is not safe or possible, a previously collected tumor sample must be provided.
Have a type of breast cancer called HER2-positive adenocarcinoma, confirmed by a certified laboratory.
Have received 2 or more previous treatments targeting HER2, with at least one treatment for cancer that has spread (metastatic) and one treatment being trastuzumab deruxtecan (ENHERTU®). If cancer returned within 12 months after earlier treatments, it counts as a treatment for metastatic disease.
Have experienced cancer progression or been unsuitable for the most recent therapy.
Have measurable disease according to specific criteria used to evaluate tumors.
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.
Have an expected life expectancy of more than 12 weeks according to the study doctor.

Who cannot join the trial?

8 criteria

Patients who have not been previously treated for **HER2-positive metastatic breast cancer**. This means the cancer has spread to other parts of the body and tests show it has a high level of a protein called HER2.
Patients who are not able to safely receive the study treatment due to other health conditions.
Patients who are pregnant or breastfeeding.
Patients who have another type of cancer that is not under control.
Patients who have had a severe allergic reaction to similar treatments in the past.
Patients who are participating in another clinical trial at the same time.
Patients who have an active infection that requires treatment.
Patients who have a serious heart condition that is not well managed.

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Verified sites

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

Verified
Centre De Lutte Contre Le Cancer Eugene Marquis
Rennes, France
Verified
Centre Leon Berard
Lyon, France
Verified
Fondazione I.R.C.C.S. Istituto Neurologico Besta
Milan, Italy

Trial locations

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Investigated drugs

BDC-1001
is an experimental medication being tested for its ability to fight cancer. It is being studied to see how well it works on its own in treating patients with a specific type of breast cancer that has spread to other parts of the body. This type of breast cancer is known as HER2-positive metastatic breast cancer.
Pertuzumab
is a medication used in combination with other cancer treatments. In this trial, it is combined with BDC-1001 to see if the combination is more effective in treating HER2-positive metastatic breast cancer than BDC-1001 alone. Pertuzumab works by targeting and blocking the HER2 protein, which can help slow down or stop the growth of cancer cells.

What is already known about the treatment

BDC-1001
This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating HER2-positive metastatic breast cancer. It is not yet widely used in standard medical practice, as it is still under investigation. BDC-1001 is designed to target and inhibit the HER2 receptor, which is overexpressed in certain types of breast cancer, thereby slowing down or stopping the growth of cancer cells. It belongs to the class of drugs known as monoclonal antibodies, which are engineered to specifically target cancer cells.
Pertuzumab
This medication is also administered intravenously and is used in combination with other drugs to treat HER2-positive metastatic breast cancer. It is well-established in medical literature and is approved for use in combination therapies. Pertuzumab works by binding to the HER2 receptor on cancer cells, preventing them from receiving growth signals, which helps to slow or stop tumor growth. It is classified as a monoclonal antibody, specifically targeting the HER2 protein to enhance the effectiveness of cancer treatment.

Investigated diseases

Human Epidermal Growth Factor Receptor 2–Positive Metastatic Breast Cancer – This is a type of breast cancer characterized by the overexpression of the HER2 protein, which promotes the growth of cancer cells. It is considered metastatic when the cancer has spread beyond the breast to other parts of the body. The disease often progresses by forming new tumors in distant organs, such as the liver, lungs, or brain. HER2-positive cancers tend to grow and spread more aggressively than other types of breast cancer. The progression of the disease can vary, with some patients experiencing rapid advancement while others may have a slower course. Understanding the HER2 status is crucial for determining the appropriate management and monitoring of the disease.