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Study of olaparib and chemotherapy combination in stage III breast cancer patients with HER2-negative, hormone receptor impaired or deficient disease

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 study focuses on treating patients with stage III breast cancer that shows specific genetic features related to homologous recombination deficiency. The study will test whether an intensified treatment approach using chemotherapy with stem cell support, followed by the medication olaparib, can improve survival rates compared to standard treatment.

The treatment involves several medications given in different combinations. The main study medication is Lynparza (olaparib) taken as tablets. Other medications used in the treatment include paclitaxel, carboplatin, cyclophosphamide, thiotepa, doxorubicin, and capecitabine. These medications are given either through an intravenous infusion or as tablets, depending on the specific drug.

The study will compare two different treatment approaches. One group will receive intensive chemotherapy with stem cell support, while the other group will receive standard chemotherapy. Both groups will then receive additional treatment with olaparib for one year. Some patients may also receive additional treatment with capecitabine depending on how well their cancer responds to the initial treatment.

The research process

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

  1. Step 1

    Initial Treatment Phase

    You will be assigned to one of two treatment groups. Both groups receive different combinations of cancer medications.

    The medications will be administered before surgery (this is called neoadjuvant treatment)

  2. Step 2

    Group A Treatment

    If assigned to Group A, you will receive AC-CP chemotherapy, which includes:

    Doxorubicin and cyclophosphamide given through an intravenous line (into a vein)

    Followed by paclitaxel and carboplatin, also given through an intravenous line

  3. Step 3

    Group B Treatment

    If assigned to Group B, you will receive intensified treatment that includes:

    Thiotepa and other medications given through an intravenous line

    This treatment includes a procedure called stem cell rescue, which helps your body recover from the strong chemotherapy

  4. Step 4

    Surgery

    After completing the initial treatment, you will undergo breast cancer surgery

  5. Step 5

    Additional Treatment

    If the cancer has not completely disappeared after surgery, you will receive capecitabine tablets by mouth

    Following this, you will take olaparib tablets for one year

  6. Step 6

    Follow-up Period

    Regular check-ups will continue throughout the study period

    Your overall health and response to treatment will be monitored

    The study continues until September 2034

Who can join the trial?

11 criteria

  • Age between 18 and 66 years old and being healthy enough to receive stem cell transplantation from your own cells
  • Confirmed breast cancer through tissue examination (adenocarcinoma type)
  • The breast cancer must have these specific characteristics:
    • HER2-negative (specific protein not present on cancer cells)
    • Either no hormone receptors or, for high-grade tumors, very low levels of hormone receptors (unless you have BRCA1 or BRCA2 gene mutations)
    • Must be receiving treatment before surgery (neoadjuvant treatment)
    • Must have Stage III breast cancer, which means the cancer has spread locally but not to distant parts of the body
    • Must have signs that the cancer has specific genetic features related to DNA repair (homologous recombination deficiency), shown by either:
      • Having BRCA1 or BRCA2 gene mutations
      • Having specific changes in the BRCA1 gene activity
      • Having certain patterns of DNA changes in the tumor
      • Must be able to perform daily activities with minimal or no limitations (ECOG performance status 0-1)
      • Must provide informed consent to participate in the study

Who cannot join the trial?

14 criteria

  • History of other malignancies (cancers) within 5 years before starting the study, except for adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix
  • Presence of metastatic disease (cancer that has spread to other parts of the body)
  • Known hypersensitivity (allergic reaction) to study medications or their components
  • Significant heart conditions, including:
    • Uncontrolled high blood pressure
    • Heart attack within the past 6 months
    • Unstable heart disease
    • Severe liver problems or kidney dysfunction
    • Active infections requiring systemic treatment
    • Pregnancy or breastfeeding
    • Mental condition that would interfere with understanding study requirements
    • Participation in another clinical trial within 30 days before starting this study
    • Peripheral neuropathy (nerve damage causing numbness or tingling) grade 2 or higher
    • Unable or unwilling to give informed consent
    • Medical conditions that could interfere with study participation or interpretation of results
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Investigated drugs

Based on the trial information, here are the medications involved: Capecitabine is an oral chemotherapy medication used to treat breast cancer. It works by interfering with cancer cell growth and is given as additional (adjuvant) therapy for patients who don't achieve complete response to initial treatment. Olaparib is a targeted therapy medication that works by blocking an enzyme that cancer cells need to repair their DNA. It's given as a maintenance treatment for one year after the main chemotherapy treatment. The trial also includes standard chemotherapy combination known as AC-CP, which consists of: Adriamycin (also called doxorubicin) and Cyclophosphamide followed by Paclitaxel. This is a common combination of chemotherapy drugs used to treat breast cancer. The trial compares this standard treatment to intensified alkylating chemotherapy (mCTC) with stem cell support, which is a more intensive form of treatment where high-dose chemotherapy is given followed by returning the patient's own saved stem cells to help recovery.

What is already known about the treatment

  • Capecitabine

    An oral chemotherapy medication that converts to 5-fluorouracil in the body, specifically targeting cancer cells. It belongs to the class of drugs known as antimetabolites and works by interfering with cancer cell DNA production, ultimately preventing tumor growth. This medication is commonly used in breast cancer treatment, particularly in cases where other treatments haven't been effective or as part of combination therapy.

  • Olaparib

    An oral medication that belongs to a class of drugs called PARP inhibitors, which work by blocking DNA repair in cancer cells, leading to their death. It's specifically effective in patients with BRCA mutations and is used in the treatment of various cancers, including breast cancer. This targeted therapy is typically administered as a maintenance treatment to help prevent cancer recurrence.

  • AC-CP

    A combination chemotherapy regimen consisting of Adriamycin (doxorubicin) and Cyclophosphamide followed by Paclitaxel. This standard treatment protocol is commonly used in breast cancer therapy, particularly in high-risk cases. The medications are administered intravenously and work together to stop cancer cell growth through different mechanisms, including DNA damage and disruption of cell division.

Investigated diseases

Breast Cancer Stage III - A form of cancer that develops in breast tissue and has spread beyond the initial tumor. At stage III, the cancer has extended to nearby tissues or lymph nodes but has not spread to distant parts of the body. The cancer cells have grown into larger tumors and/or have spread to lymph nodes in the armpit area, near the breastbone, or other tissues near the breast. Stage III breast cancer may involve the chest wall or the skin of the breast, creating visible changes to the breast's appearance. The disease can affect women of any age, though it becomes more common with increasing age.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516196-32-00Estimated enrolment172 patientsSponsorHet Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting

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