Chemotherapy +/− Panitumumab for Triple Negative Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the effectiveness of adding panitumumab, an antibody that may inhibit cancer cell growth, to standard chemotherapy for patients with invasive triple-negative breast cancer. The study compares two groups: one receiving chemotherapy drugs carboplatin and paclitaxel with panitumumab, and another receiving only the chemotherapy drugs. It aims to determine if including panitumumab before surgery can shrink the tumor more effectively, potentially preserving more healthy tissue. Individuals with a confirmed diagnosis of invasive breast cancer showing rapid changes such as redness, swelling, or warmth in at least a third of the breast within the past six months may qualify. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering a chance to contribute to significant advancements in cancer therapy.
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 coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the treatments in this trial have been safe in other studies. Panitumumab has been well-tolerated with chemotherapy in some studies, but it remains experimental for treating triple-negative breast cancer. In other cancers, patients generally handle it well, though it can have side effects like any medication.
Paclitaxel, a chemotherapy drug, is commonly used for various cancers, including breast cancer. Studies indicate it is effective and usually well-tolerated. However, combining it with certain other drugs can increase side effects, so monitoring patient responses is important.
Carboplatin is another chemotherapy drug widely used and known to improve breast cancer outcomes when added to other treatments. It has a manageable safety profile, meaning doctors can monitor and manage the known side effects.
Overall, these treatments have been successful in various studies, but the combination being tested here is still under study to ensure safety for everyone. Participants will be closely monitored for any side effects.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments for triple-negative breast cancer because they explore the potential benefits of adding panitumumab to the usual chemotherapy regimen. Panitumumab is a monoclonal antibody that targets a protein called EGFR, which is often overexpressed in cancer cells. This targeted approach is different from standard chemotherapies like paclitaxel and carboplatin, which attack all rapidly dividing cells. By combining panitumumab with traditional chemotherapy, there's hope for a more effective treatment that specifically targets cancer cells, possibly leading to better outcomes for patients.
What evidence suggests that this trial's treatments could be effective for triple negative breast cancer?
Research has shown that using carboplatin and paclitaxel, with or without panitumumab, may help treat triple-negative breast cancer. In this trial, participants in Group A will receive carboplatin, paclitaxel, and panitumumab. Studies suggest that adding panitumumab, a medicine targeting cancer cells, can increase the chances of tumors completely disappearing before surgery. Specifically, one study found that 42% of patients with this type of breast cancer had a complete response when panitumumab was included. Participants in Group B will receive only carboplatin and paclitaxel, which has also proven effective in helping patients live longer. This trial studies both treatment methods for their ability to shrink tumors and improve patient outcomes.56789
Who Is on the Research Team?
Azadeh Nasrazadani
Principal Investigator
M.D. Anderson Cancer Center
Are You a Good Fit for This Trial?
This trial is for patients with invasive triple negative breast cancer who haven't had certain treatments like carboplatin or radiotherapy for their condition. They should have good organ function, no serious heart issues, and not be dealing with other major medical or psychiatric conditions that could affect the study. Women of childbearing age must test negative for pregnancy and agree to use birth control.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients receive panitumumab, paclitaxel, and carboplatin or paclitaxel, carboplatin, doxorubicin, and cyclophosphamide in cycles every 21 days for up to 8 cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Carboplatin
- Paclitaxel
- Panitumumab
Carboplatin is already approved in United States, European Union, Canada for the following indications:
- Ovarian cancer
- Testicular cancer
- Lung cancer
- Head and neck cancer
- Brain cancer
- Ovarian cancer
- Small cell lung cancer
- Ovarian cancer
- Small cell lung cancer
- Testicular cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
Amgen
Industry Sponsor
Robert A. Bradway
Amgen
Chief Executive Officer since 2012
MBA from Harvard Business School
Paul Burton
Amgen
Chief Medical Officer since 2023
MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London
National Cancer Institute (NCI)
Collaborator