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

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What is this study about?

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.

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

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

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

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

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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Stichting OLVG Amsterdam The Netherlands
Zuyderland Medisch Centrum Stichting Geleen The Netherlands
Frisius Heerenveen The Netherlands
University Hospital Maastricht Maastricht The Netherlands

Other Sites

Site Name City Country Status
Ziekenhuis Gelderse Vallei Stichting Ede The Netherlands
Haga Hospital Hague The Netherlands
Noordwest Ziekenhuisgroep Stichting Alkmaar The Netherlands
Groene Hart Ziekenhuis Gouda The Netherlands
Jeroen Bosch Ziekenhuis Stichting s-Hertogenbosch The Netherlands
Amphia Hospital Breda The Netherlands
Tergooiziekenhuizen Hilversum The Netherlands
Albert Schweitzer Ziekenhuis Dordrecht The Netherlands
Stichting Viecuri Medisch Centrum voor Noord-Limburg Venlo The Netherlands
Medisch Spectrum Twente Enschede The Netherlands
Diakonessenhuis Stichting Utrecht The Netherlands
Ziekenhuisgroep Twente Stichting Almelo The Netherlands
Ziekenhuis St Jansdal Harderwijk The Netherlands
Maxima Medisch Centrum Veldhoven The Netherlands
Universitair Medisch Centrum Utrecht Utrecht The Netherlands
Maasstad Ziekenhuis Stichting Rotterdam The Netherlands
Catharina Ziekenhuis Stichting Eindhoven The Netherlands
St. Antonius Ziekenhuis Nieuwegein The Netherlands
Meander Medical Center Amersfoort The Netherlands
Sint Franciscus Vlietland Groep Stichting Rotterdam The Netherlands
Deventer Ziekenhuis Deventer The Netherlands
Reinier de Graaf Groep Delft The Netherlands
Medical Center Haaglanden Leidschendam The Netherlands
Bravis Ziekenhuis Roosendaal The Netherlands
Gelre Hospitals Zutphen The Netherlands
Netherlands Cancer Institute Amsterdam The Netherlands
Spaarne Gasthuis Hoofddorp The Netherlands
Dijklander Ziekenhuis Hoorn The Netherlands
Rqyyizfqo Zqtnqucxwx Sfpqbqadt Arnhem The Netherlands
Sxyfmegek Meuxjwd Zqohkjopav Groningen The Netherlands
Aervfxei Dc Rfllmt Zaqrszyiqa Bupk Goes The Netherlands
Awekkgfmc Umk Amsterdam The Netherlands
Srn Epabddiwg Hcmdxunv Tzqtakt Tilburg The Netherlands

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

Trial status

Country Status Recruitment Start
The Netherlands The Netherlands
Not recruiting
10.10.2013

Trial locations

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.

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.

Trial ID:
2024-516202-39-00
Protocol code:
BOOG 2013-01
NCT ID:
NCT01898117
Trial Phase:
Therapeutic exploratory (Phase II)

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