Study on Pertuzumab and Trastuzumab as Pre-Surgery Treatment for HER2-Positive Breast Cancer
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials ID:NCT01937117
This clinical trial is exploring whether early changes seen in PET scans can help predict which patients with HER2-positive breast cancer will respond well to a combination of trastuzumab and pertuzumab before surgery.
Patient Parameters
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Program Overview
The aim of this study is to find out if early changes in PET scan results can indicate how well patients with HER2-positive breast cancer will respond to treatment with trastuzumab and pertuzumab before surgery. This approach is new and could change how doctors treat this type of breast cancer by potentially reducing the need for additional chemotherapy. The study will help identify patients who might benefit from a more personalized treatment plan, minimizing side effects and costs without losing effectiveness.
Description
This study is the first to look at the relationship between early changes in PET scan results and the complete disappearance of cancer in patients with HER2-positive breast cancer who are receiving trastuzumab and pertuzumab before surgery. The results could lead to a new way of treating this type of breast cancer, focusing on using these drugs without the need for additional chemotherapy. This approach could be very important for both doctors and patients, as it aims to provide a more personalized treatment plan that reduces side effects and costs while still being effective. The findings from this study will be used to plan future research to further refine this treatment strategy.
Eligibility Criteria
Inclusion Criteria
- Men and women aged 18 or older.
- Diagnosed with HER2-positive breast cancer that has not been treated or removed, and meets specific medical criteria.
- Cancer must be at a certain stage and not inflammatory breast cancer.
- Good overall health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Adequate organ function, including specific blood counts and kidney and liver function.
- Heart function must be sufficient, with a heart's pumping ability at or above 50%.
- Able to undergo PET/CT imaging and biopsy procedures required by the study.
- Women of childbearing potential must agree to use effective non-hormonal birth control during treatment and for six months after.
- Understands the study and agrees to sign an informed consent form.
Exclusion Criteria
- Have received any prior treatment for the current breast cancer, except for certain preventive treatments stopped at least one month before the study.
- Have had systemic treatment for another cancer within the last five years, except for certain skin cancers or cervical cancer treated with specific procedures.
- Are pregnant or breastfeeding.
- Are currently using any investigational drugs.
- Have known allergies to trastuzumab or pertuzumab.
- Have medical conditions that could lead to serious complications during the study, such as uncontrolled high blood pressure, unstable heart conditions, or recent heart attack.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Alabama Comprehensive Cancer Center | 35294 | Birmingham | Alabama |
| Johns Hopkins Kimmel Cancer Center at Sibley Memorial Hospital | 20016 | Washington D.C. | District of Columbia |
| Indiana University Simon Cancer Center | 46202 | Indianapolis | Indiana |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | 21287-0013 | Baltimore | Maryland |
| Mayo Clinic | 55905 | Rochester | Minnesota |
| Lineberger Comprehensive Cancer Center | 27599 | Chapel Hill | North Carolina |
| Vanderbilt University | 37232 | Nashville | Tennessee |
| Baylor College of Medicine | 77030 | Houston | Texas |
| The University of Texas MD Anderson Cancer Center | 77030 | Houston | Texas |
| Fred Hutchinson Cancer Research Center - University of Washington | 98109 | Seattle | Washington |
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