Chemotherapy Response Prediction for Breast Cancer
(RESPONSE Trial)
Trial Summary
What is the purpose of this trial?
The purpose of this study is to learn whether clinical response (the amount a tumor shrinks based on imaging or tumor measurements obtained by physical exam) predicts pathologic response (the amount of tumor remaining when surgery is performed) in participants with breast cancer who are receiving chemotherapy prior to surgery.
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. However, if you are on treatments for breast cancer or have a history of cardiac disease, you may need to discuss this with the trial team.
What evidence supports the effectiveness of the drugs used in the Chemotherapy Response Prediction for Breast Cancer trial?
Research shows that combinations of drugs like doxorubicin and docetaxel have higher response rates and longer time to disease progression in breast cancer treatment compared to some other drug combinations. Additionally, studies indicate that combining trastuzumab with paclitaxel or doxorubicin and cyclophosphamide can lead to better outcomes in terms of response rate and disease progression.12345
Is carboplatin generally safe for use in humans?
Carboplatin is generally considered safe for use in humans, with less kidney toxicity compared to similar drugs like cisplatin. However, it can cause side effects such as nausea, vomiting, and blood-related issues like low white blood cell counts, which can increase infection risk. Some people may also experience allergic reactions, especially after multiple treatment cycles.678910
How does this drug combination for breast cancer differ from other treatments?
This drug combination for breast cancer is unique because it includes a mix of chemotherapy agents like carboplatin, cyclophosphamide, doxorubicin, paclitaxel, pertuzumab, and trastuzumab, which are known for their effectiveness in different settings. Paclitaxel, in particular, has shown high activity in breast cancer treatment, and the combination aims to enhance response rates while potentially reducing toxicity compared to using these drugs individually.27111213
Research Team
Mothaffar Rimawi, MD
Principal Investigator
Baylor College of Medicine
Eligibility Criteria
This trial is for adults with invasive breast cancer that's at least 2 cm large, including triple negative, HER2-positive, or high-risk estrogen receptor positive types. Participants must be able to consent and use non-hormonal contraception if applicable. They should have good organ function and heart health but no severe diseases, HIV/hepatitis infections, recent other cancers, psychiatric issues preventing study compliance, prior breast cancer treatments or surgeries.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Neoadjuvant Treatment
Participants receive chemotherapy prior to surgery, including Paclitaxel and other drugs depending on the breast cancer subtype
Surgery
Surgical procedure to assess pathologic response and remove any remaining tumor
Follow-up
Participants are monitored for safety and effectiveness after surgery
Treatment Details
Interventions
- Carboplatin
- Cyclophosphamide
- Doxorubicin
- Paclitaxel
- Pembrolizumab
- Pertuzumab
- Pertuzumab/Trastuzumab/Hyaluronidase-zzxf
- Trastuzumab
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?
Baylor Breast Care Center
Lead Sponsor