Combination Chemotherapy for Breast Cancer
Trial Summary
What is the purpose of this trial?
This phase I/II trial studies the side effect and best dose of neratinib and to see how well it works with paclitaxel and with or without pertuzumab and trastuzumab before combination chemotherapy in treating patients with breast cancer that has spread to other places in the body (metastatic). Neratinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with pertuzumab and trastuzumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as paclitaxel, doxorubicin, and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving neratinib, pertuzumab, trastuzumab, paclitaxel and combination chemotherapy may work better in treating patients with breast cancer.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the drug combination used in the clinical trial for breast cancer?
Research shows that adding pertuzumab to trastuzumab-based chemotherapy improves response rates in HER2-positive breast cancer, although it may increase side effects. Additionally, neratinib has been shown to reduce the risk of cancer recurrence when used after trastuzumab in early-stage HER2-positive breast cancer.12345
Is the combination chemotherapy for breast cancer safe for humans?
How is the combination chemotherapy with Neratinib, Paclitaxel, Pertuzumab, and Trastuzumab different from other breast cancer treatments?
This treatment is unique because it combines four drugs, including Neratinib, which is used after initial treatment to reduce recurrence risk, and Paclitaxel, a chemotherapy drug, with Pertuzumab and Trastuzumab, both targeting HER2-positive breast cancer. This combination aims to enhance effectiveness by targeting cancer cells in multiple ways, but it may also increase the risk of side effects.125910
Research Team
Rachel M Layman
Principal Investigator
M.D. Anderson Cancer Center
Eligibility Criteria
This trial is for adults with confirmed breast cancer that has spread and who can take oral meds. They must have good heart function, normal blood counts, liver function within certain limits, and agree to use birth control. It's not for those breastfeeding, with a history of certain autoimmune diseases or other recent cancers, uncontrolled high blood pressure, serious infections or hepatitis B/C.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive neratinib, paclitaxel, pertuzumab, and trastuzumab, followed by doxorubicin and cyclophosphamide
Surgery
Participants undergo standard of care surgery after completion of chemotherapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Cyclophosphamide
- Doxorubicin
- Neratinib
- Paclitaxel
- Pertuzumab
- Trastuzumab
Neratinib is already approved in United States, European Union for the following indications:
- Extended adjuvant treatment of women with early-stage HER2-positive breast cancer
- Extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator