Phase II Study on Optimizing Additional Therapy for HER2+ Breast Cancer Patients, MolecularPCR Trial
Sponsor: M.D. Anderson Cancer Center
ClinicalTrials ID:NCT07407920
This clinical trial is exploring a reduced treatment approach after surgery for patients with early-stage breast cancer who have shown a complete response to initial therapy and have no cancer genetic material in their blood. The study aims to see if less treatment can maintain good outcomes while reducing side effects.
Patient Parameters
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Program Overview
This phase II study is investigating whether reducing the amount of treatment after surgery can still effectively control early-stage breast cancer in patients who have responded well to initial therapy. The focus is on patients whose cancer has completely responded to pre-surgery treatment and who have no detectable cancer genetic material in their blood. The standard treatment after surgery usually involves a year of medications like pembrolizumab for triple-negative breast cancer or trastuzumab with or without pertuzumab for HER2+ breast cancer. These medications help the immune system attack cancer cells and block signals that help cancer grow. By lowering the amount of treatment after surgery, the study hopes to maintain the positive response to treatment while reducing side effects.
Description
The main goals of this study are to see if patients with early-stage triple-negative breast cancer (TNBC) or HER2+ breast cancer can maintain a good outcome three years after surgery if they stop additional treatment early. This is for patients who have shown a complete response to initial therapy and have no cancer genetic material in their blood.
For patients with TNBC, the study will look at those who have responded completely to initial treatment with pembrolizumab and chemotherapy and have no detectable cancer genetic material. These patients may stop additional pembrolizumab treatment and will be monitored regularly.
For patients with HER2+ breast cancer, the study will focus on those who have responded completely to initial treatment with trastuzumab, pertuzumab, and chemotherapy, and have no detectable cancer genetic material. These patients may stop additional trastuzumab and pertuzumab treatment and will also be monitored regularly.
The study will also explore how often cancer genetic material reappears in the blood and how long it takes for this to happen in patients who reduce their treatment. It will also look at how many patients have detectable cancer genetic material after initial therapy and how this affects their outcomes.
Eligibility Criteria
Inclusion Criteria
- For HER2+ Breast Cancer: Must be diagnosed with HER2+ invasive breast cancer, either hormone-receptor positive or negative, based on local guidelines.
- For TNBC: Must be diagnosed with triple-negative breast cancer (TNBC), with low hormone receptor levels, based on local guidelines.
- For Both Groups: Must have invasive breast cancer of any grade or subtype, including ductal, lobular, mucinous, papillary, tubular, metaplastic, or mixed types.
- Must have a clinical tumor stage of T1-4, N0-2a, M0, and no evidence of metastatic breast cancer.
- For HER2+ Breast Cancer: Must have completed initial therapy with trastuzumab, pertuzumab, and chemotherapy, followed by surgery showing complete response, and be willing to stop additional trastuzumab and pertuzumab.
- For TNBC: Must have completed initial therapy with pembrolizumab and chemotherapy, followed by surgery showing complete response, and be willing to stop additional pembrolizumab.
- Must have a complete response to surgery and be willing to stop standard additional therapy.
- Must provide adequate tumor tissue samples from initial diagnosis.
- Must be 18 years or older.
- Must have a performance status score of 2 or less, indicating good overall health.
- Must have adequate blood cell counts and organ function based on specific tests.
- Must have controlled hepatitis B or C if applicable, and be HIV-negative or have controlled HIV.
- Must be able to understand and sign a consent form.
Exclusion Criteria
- Cannot have a tumor stage of cN2b or cN3.
- Cannot have had other cancers in the past 5 years, except for certain skin cancers or cervical cancer in situ.
- Cannot be receiving other experimental cancer treatments.
- Cannot have known cancer spread from other sites.
- Cannot have uncontrolled illnesses like active infections or severe heart conditions.
- Cannot have psychiatric or social issues that would prevent following the study.
- Cannot have had a blood transfusion within 2 weeks before blood testing for the study.
- Cannot have received 4 or more cycles of additional trastuzumab/pertuzumab (HER2+) or pembrolizumab (TNBC).
- Pregnant women cannot participate.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| M D Anderson Cancer Center | 77030 | Houston | Texas |
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