Not recruiting

Study comparing carboplatin-cyclophosphamide versus paclitaxel with atezolizumab as first treatment for advanced triple negative breast cancer

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 focuses on triple negative breast cancer that has spread to other parts of the body (metastatic breast cancer). The study compares different treatment combinations to find the most effective approach for patients. The treatments being tested include chemotherapy drugs (carboplatin, cyclophosphamide, and paclitaxel) along with newer medicines called atezolizumab and bevacizumab, which help the immune system fight cancer cells.

The main purpose of the study is to determine which combination of treatments works best for different groups of patients based on specific characteristics of their cancer, particularly something called the BRCA1-like status. The study will also look at how well the treatments work when combined with atezolizumab, a type of immunotherapy that helps the body's immune system attack cancer cells.

During the study, patients will receive their assigned treatment through an intravenous infusion. The medications will be given in different combinations, and doctors will monitor how well the treatments work in stopping or slowing down the growth of cancer. They will also track how long patients live without their cancer getting worse and examine various biological markers that might help predict which patients will respond best to specific treatments.

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
Initial treatment assignment
You will be randomly assigned to one of two treatment groups: either carboplatin-cyclophosphamide or paclitaxel
Each group may receive additional treatment with atezolizumab
Step 2
Treatment administration
All medications will be given through intravenous infusion
Treatment will continue until disease progression or other stopping criteria are met
Regular visits will be scheduled for treatment administration and monitoring
Step 3
Disease monitoring
Your disease status will be evaluated regularly using imaging tests
The effectiveness of treatment will be measured by tracking changes in tumor size and other disease indicators
Side effects will be monitored and documented according to standardized criteria
Step 4
Treatment continuation or modification
If the initial treatment is not effective, you may be eligible to switch to the other treatment group
Treatment modifications may be made based on your response and tolerance to the medications
Step 5
Long-term follow-up
Your health status will be monitored throughout the study period until 2028
Regular assessments will continue to evaluate the long-term effects of treatment

Who can join the trial?

11 criteria

Must have confirmed triple negative breast cancer that has spread to other parts of the body (metastatic) or is locally advanced and cannot be cured
Must have a WHO performance status of 0 or 1 (able to perform daily activities with minimal limitations)
A tissue sample from where cancer has spread should be tested to confirm triple negative status
Additional confirmation of spread is needed if blood marker CA 15.3 levels are normal
Must provide tumor tissue sample for BRCA1-like testing (a genetic test)
Must provide a tissue sample from where cancer has spread for research (except from bone)
Must not have received any chemotherapy for cancer that has spread
If previously treated with paclitaxel or platinum drugs, must have been cancer-free for at least 12 months after completing that treatment
If previously treated with docetaxel, must have been cancer-free for at least 6 months after completing that treatment
Must have cancer that can be measured or evaluated according to standard criteria (RECIST V1.1)
Open to adults of any gender

Who cannot join the trial?

14 criteria

Age below 18 years or above 65 years
Previous treatment with chemotherapy for metastatic breast cancer (cancer that has spread to other parts of the body)
Known allergic reactions to the study medications
Presence of active brain metastases (cancer spread to the brain) that are not stable or require treatment
Severe heart conditions, including:
- Uncontrolled high blood pressure
- Heart attack within the last 6 months
- Unstable heart rhythm problems
- Serious liver problems (liver function tests more than 3 times the normal upper limit)
- Serious kidney problems (creatinine clearance less than 50 mL/min)
- Active infections requiring treatment
- Other active cancers (except for adequately treated non-melanoma skin cancer or cervical cancer in situ)
- Pregnancy or breastfeeding
- Unable to follow study procedures or attend scheduled visits
- Participation in another clinical trial within 30 days before starting this study

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Verified sites

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

Amsterdam UMC
Responsive
Amsterdam, The Netherlands
Sint Franciscus Vlietland Groep Stichting
Responsive
Rotterdam, The Netherlands
Universitair Medisch Centrum Utrecht
Responsive
Utrecht, The Netherlands

Trial locations

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Investigated drugs

Carboplatin
A chemotherapy medication used to treat various types of cancer. It belongs to a group of drugs called platinum-based drugs. It works by interfering with cancer cell DNA, which helps stop cancer cells from growing.
Cyclophosphamide
A chemotherapy medication that belongs to a class of drugs called alkylating agents. It works by damaging the DNA of cancer cells, which prevents them from multiplying. It is commonly used to treat various types of cancer, including breast cancer.
Paclitaxel
A chemotherapy medication that belongs to a class of drugs called taxanes. It works by stopping cancer cells from dividing and growing. It is commonly used in the treatment of breast cancer and other types of cancer.
Atezolizumab
An immunotherapy medication that helps the body's immune system fight cancer cells. It works by blocking a protein called PD-L1, which cancer cells use to hide from the immune system. This allows the immune system to better recognize and attack cancer cells.

What is already known about the treatment

Carboplatin
An intravenously administered platinum-based chemotherapy drug that works by binding to DNA and preventing cancer cell division. It belongs to the alkylating agents class of medications and is commonly used in treating various types of cancer, including metastatic breast cancer. The medication interferes with cancer cell growth by forming crosslinks in DNA strands, ultimately leading to cell death.
Cyclophosphamide
An oral or intravenous chemotherapy medication belonging to the alkylating agent class that works by damaging the DNA of rapidly dividing cells. It is widely used in treating breast cancer and other malignancies, with its mechanism of action involving the formation of DNA crosslinks that prevent cancer cell replication. The drug becomes active after being processed by the liver enzymes.
Paclitaxel
An intravenously administered chemotherapy medication derived from the Pacific yew tree that belongs to the taxane class of drugs. It works by stabilizing microtubules during cell division, preventing cancer cells from completing their growth cycle and ultimately causing cell death. This medication is a standard treatment option for various cancers, including metastatic breast cancer.
Atezolizumab
An immunotherapy medication administered intravenously that belongs to the class of PD-L1 inhibitors. It works by blocking the interaction between PD-L1 and PD-1 proteins, which helps activate the body's immune system to recognize and attack cancer cells. This targeted therapy is used in various cancers, including triple-negative breast cancer, and represents a modern approach to cancer treatment.

Investigated diseases

Metastatic Breast Cancer - A form of breast cancer that has spread beyond the breast and nearby lymph nodes to other parts of the body. The cancer cells from the original tumor break away and travel through the bloodstream or lymphatic system to form new tumors in other organs such as bones, liver, lungs, or brain. This stage of breast cancer occurs when the original cancer grows and spreads to other areas of the body. Metastatic breast cancer can develop months or years after a person has completed treatment for early or locally advanced breast cancer. In some cases, metastatic breast cancer is discovered when the initial breast cancer diagnosis is made.