Study on Neoadjuvant HER2-Targeted Therapy and Immunotherapy with Pembrolizumab for HER2-Positive Breast Cancer
Sponsor: University of Texas Southwestern Medical Center
ClinicalTrials ID:NCT03747120
This clinical trial is testing different combinations of HER2-targeted therapies and immunotherapy drugs given before surgery to see if they can effectively treat HER2-positive breast cancer. The study involves patients whose breast tumors are larger than 2 cm or have spread to nearby lymph nodes.
Patient Parameters
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Program Overview
The purpose of this study is to evaluate the effectiveness and safety of different treatment combinations for HER2-positive breast cancer. Patients will receive one of three treatment combinations before surgery: trastuzumab, pertuzumab, and paclitaxel (THP); trastuzumab, pertuzumab, pembrolizumab, and paclitaxel (THP-pembrolizumab); or trastuzumab, pembrolizumab, and paclitaxel (TH-pembrolizumab). After treatment, patients will undergo standard breast surgery and follow-up therapy as determined by their doctor.
Description
This study is designed to compare the effectiveness and safety of three different treatment combinations for patients with HER2-positive breast cancer. Patients will be randomly assigned to one of three groups:
- Arm A: Trastuzumab, pertuzumab, and weekly paclitaxel (THP)
- Arm B: Trastuzumab, pertuzumab, pembrolizumab, and weekly paclitaxel (THP-pembrolizumab)
- Arm C: Trastuzumab, pembrolizumab, and weekly paclitaxel (TH-pembrolizumab)
Patients will receive treatment every week for three weeks, followed by a week off, for a total of four cycles. After completing the treatment, patients will have breast surgery. The study will also look at how hormone receptor status and lymph node involvement affect treatment outcomes. Arm A will serve as the reference group for comparison.
Eligibility Criteria
Inclusion Criteria
- Men and women with confirmed HER2-positive breast cancer.
- Tumors larger than 2 cm or cancer that has spread to nearby lymph nodes.
- No previous treatment for breast cancer.
- Age 18 or older.
- Willing to use effective contraception during and after the study.
- Able to provide a tumor sample for testing.
- Good overall health with specific blood and organ function levels.
- Willing to sign informed consent and follow study procedures.
Exclusion Criteria
- Pregnant or breastfeeding women.
- Previous treatment with certain cancer drugs or therapies.
- Recent participation in another clinical trial.
- Active infections or other serious health conditions.
- History of other cancers or autoimmune diseases requiring treatment.
- Significant heart disease or other medical conditions that could interfere with the study.
- Known history of HIV, hepatitis B, hepatitis C, or tuberculosis.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Cedars Sinai Medical Center | 90048 | Los Angeles | California |
| Massachusetts General Hospital | 02114 | Boston | Massachusetts |
| New Mexico Cancer Center | 87109 | Albuquerque | New Mexico |
| Providence Cancer Institute | 97213 | Portland | Oregon |
| UT Southwestern Medical Center | 75006-7541 | Dallas | Texas |
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