Study Comparing 6 Months vs. 12 Months of HER2-Targeted Treatment for HER2+ Breast Cancer After Complete Response to Chemotherapy
Sponsor: Alliance for Clinical Trials in Oncology
ClinicalTrials ID:NCT06876714
This clinical trial is exploring whether 6 months of HER2-targeted therapy is as effective as 12 months for patients with HER2-positive breast cancer who showed no signs of cancer after initial chemotherapy with trastuzumab.
Patient Parameters
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Program Overview
The study aims to find out if 6 months of HER2-targeted therapy is just as good as 12 months for treating HER2-positive breast cancer in patients who had a complete response to chemotherapy before surgery. HER2-targeted therapies like trastuzumab and pertuzumab work by attaching to the HER2 protein on cancer cells, blocking signals that make the cells grow, and helping the immune system destroy them. Researchers want to see if a shorter treatment duration can be as effective, with fewer side effects, and improve patients' quality of life.
Description
The study has two main goals: to see if 6 months of HER2-targeted therapy is as effective as 12 months in preventing cancer from coming back, and to compare the quality of life between the two groups. Researchers will also look at side effects, overall survival, and how long patients stay cancer-free.
Participants will be randomly assigned to one of two groups. In the first group, patients will receive trastuzumab (and possibly pertuzumab) for up to 17 cycles, which is about 12 months. In the second group, patients will receive the same treatment for up to 9 cycles, or about 6 months. Both groups will have regular heart and imaging tests to monitor their health and the treatment's effects.
After finishing the treatment, patients will have follow-up visits every 6 months for 5 years, and then annually for a total of 10 years, to check for any signs of cancer returning.
Eligibility Criteria
Inclusion Criteria
- Adults aged 18 and older with early-stage HER2-positive breast cancer.
- Must have no remaining invasive cancer in the breast or lymph nodes after initial chemotherapy, although non-invasive cancer (DCIS) is allowed.
- Must have received at least 12 weeks of chemotherapy with trastuzumab before surgery.
- Must have had surgery to remove all visible cancer.
- Must have adequate heart, liver, kidney, and bone marrow function.
- Women of childbearing potential must not be pregnant or nursing and must use effective contraception.
- No history of stage IV breast cancer or other invasive breast cancer.
- Patients with HIV, Hepatitis B, or Hepatitis C can participate if they are healthy and meet other criteria.
- No severe heart problems or history of severe side effects from trastuzumab or pertuzumab.
- Must be able to start the study within 14 weeks after surgery.
Exclusion Criteria
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Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Cancer Center at Saint Joseph's | 85004 | Phoenix | Arizona |
| Mercy Hospital Fort Smith | 72903 | Fort Smith | Arkansas |
| CARTI Cancer Center | 72205 | Little Rock | Arkansas |
| Mission Hope Medical Oncology - Arroyo Grande | 93420 | Arroyo Grande | California |
| Mercy Cancer Center - Carmichael | 95608 | Carmichael | California |
| Mercy San Juan Medical Center | 95608 | Carmichael | California |
| Enloe Medical Center | 95926 | Chico | California |
| Kaiser Permanente Dublin | 94568 | Dublin | California |
| Mercy Cancer Center - Elk Grove | 95758 | Elk Grove | California |
| Kaiser Permanente-Fremont | 94538 | Fremont | California |
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