Paclitaxel + Trastuzumab + Pertuzumab for Breast Cancer
Trial Summary
Do I need to stop my current medications for this trial?
The trial information does not specify if you need to stop taking your current medications. However, it does mention that you cannot have received any prior treatment for the current breast cancer, including chemotherapy, hormonal therapy, radiation, or experimental therapy.
What data supports the effectiveness of the drug combination Paclitaxel, Trastuzumab, and Pertuzumab for breast cancer?
Is the combination of Paclitaxel, Trastuzumab, and Pertuzumab generally safe for humans?
The combination of Trastuzumab and Pertuzumab with chemotherapy has been studied for safety, showing that while it can increase survival in breast cancer patients, it may also lead to side effects like diarrhea, skin issues, and low white blood cell counts. Cardiac safety is generally maintained, but monitoring is important, especially for those with existing heart conditions.15678
What makes the Paclitaxel + Trastuzumab + Pertuzumab drug combination unique for breast cancer?
This drug combination is unique because it targets HER2-positive breast cancer by using two different antibodies, trastuzumab and pertuzumab, which bind to different sites on the HER2 protein, enhancing the treatment's effectiveness. Paclitaxel, a chemotherapy drug, is added to further attack cancer cells, making this combination a standard first-line treatment for this type of breast cancer.12459
What is the purpose of this trial?
This trial tests a combination of three drugs to treat breast cancer. It aims to see if patients' responses can help decide their future treatment. The drugs work by stopping cancer growth and boosting the immune system to fight the cancer.
Research Team
Adrienne Waks, MD
Principal Investigator
Dana-Farber Cancer Institute
Eligibility Criteria
This trial is for adults with Stage II or III HER2-positive invasive breast cancer, who can provide consent and tissue samples. They must have a tumor size of at least 1.5 cm, no serious heart conditions, an ECOG performance status of 0 or 1 (fully active or restricted in physically strenuous activity but ambulatory), and acceptable blood test results. Pregnant/nursing individuals, those with unresolved infections or significant cardiovascular disease are excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Neoadjuvant Treatment
Participants receive Paclitaxel, Trastuzumab, and Pertuzumab intravenously in 21-day cycles before surgery
Surgery and Evaluation
Participants undergo surgery and evaluation of pathologic complete response (pCR)
Adjuvant Treatment
Participants receive antibody doublet therapy in the adjuvant setting based on response to neoadjuvant treatment
Follow-up
Participants are monitored for recurrence-free interval (RFI), event-free survival (EFS), and overall survival (OS)
Treatment Details
Interventions
- Paclitaxel
- Pertuzumab
- Trastuzumab
Paclitaxel is already approved in United States, European Union, Canada for the following indications:
- Ovarian cancer
- Breast cancer
- Non-small cell lung cancer
- Kaposi's sarcoma
- Ovarian cancer
- Breast cancer
- Non-small cell lung cancer
- Kaposi's sarcoma
- Ovarian cancer
- Breast cancer
- Non-small cell lung cancer
- Kaposi's sarcoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
Dana-Farber Cancer Institute
Lead Sponsor
Terri Brodeur Breast Cancer Foundation
Collaborator
Susan G. Komen Breast Cancer Foundation
Collaborator
Breast Cancer Research Foundation
Collaborator