Chemotherapy + Trastuzumab for Early-Stage HER2 Positive Breast Cancer
Trial Summary
What is the purpose of this trial?
This phase II trial studies the side effects and how well cyclophosphamide, paclitaxel, and trastuzumab work when given after surgery in treating patients with stage I-II human epidermal growth factor receptor (HER2/neu) positive breast cancer (confined to the breast or the breast and lymph nodes under the arm). Drugs used in chemotherapy, such as cyclophosphamide and paclitaxel, 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. Monoclonal antibodies, such as trastuzumab, may interfere with the ability of tumor cells to grow and spread. Giving cyclophosphamide, paclitaxel, and trastuzumab after surgery may help prevent the cancer from coming back.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor to get a clear answer.
What data supports the effectiveness of the drug combination of chemotherapy and trastuzumab for early-stage HER2-positive breast cancer?
Is the combination of chemotherapy and trastuzumab safe for early-stage HER2-positive breast cancer?
How is the drug combination of chemotherapy and trastuzumab unique for early-stage HER2-positive breast cancer?
The combination of chemotherapy and trastuzumab is unique because it targets HER2-positive breast cancer by using trastuzumab, a drug that specifically binds to the HER2 protein on cancer cells, along with chemotherapy to enhance the treatment's effectiveness. This approach is different from using chemotherapy alone, as trastuzumab helps improve survival rates and quality of life by specifically targeting cancer cells with minimal additional toxicity.12346
Research Team
Amulya Yellala, MD
Principal Investigator
University of Nebraska
Eligibility Criteria
This trial is for women with stage I-II HER2/neu positive breast cancer post-surgery. Participants must have normal organ function, not be pregnant or nursing, agree to use birth control, and have no history of severe illnesses or conditions that could interfere with the study.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Systemic Therapy
Patients receive cyclophosphamide, paclitaxel, and trastuzumab intravenously on day 1, repeated every 14 days for 6 courses
Maintenance Trastuzumab Therapy
Patients receive trastuzumab intravenously every 21 days for up to 52 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Cyclophosphamide
- Paclitaxel
- Trastuzumab
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Nebraska
Lead Sponsor
National Cancer Institute (NCI)
Collaborator