Surgery and Radiotherapy for Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if combining surgery, radiation therapy, and specific medications (including Paclitaxel, Pertuzumab, and Trastuzumab) is more effective for treating HER2-positive oligometastatic breast cancer than the usual treatment. Researchers will also observe any side effects from this new combination. Participants must have this specific type of breast cancer with five or fewer metastatic sites and no cancer in the brain or spinal cord. Those who began first-line treatment 3 to 12 months ago and have not experienced cancer progression may qualify for this trial. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop your current medications. It seems you must have started first-line systemic therapy and shown no disease progression, but it's unclear if you need to stop any medications. Please consult with the trial coordinators for specific guidance.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that Paclitaxel, a drug used to treat breast cancer, is generally well-tolerated. One study found that only about 4% of patients experienced serious side effects like fever and infection, indicating that most people handle the drug well.
Pertuzumab, another drug used in this trial, has proven effective and safe for many patients. Studies have shown that long-term use can significantly improve survival, with manageable side effects.
For radiotherapy, research indicates it enhances breast cancer treatment outcomes. Most patients do not experience severe side effects, making it a safe option for many.
Lastly, Trastuzumab has a strong safety record. It has been shown to significantly reduce the chance of cancer recurrence. Serious side effects are rare, and most people tolerate it well.
Overall, studies have demonstrated that the treatments in this trial are safe for most people.12345Why are researchers excited about this trial's treatments?
Researchers are excited about this trial because it combines surgery and locoregional radiation therapy with promising drug treatments like Paclitaxel, Pertuzumab, and Trastuzumab, which are already used in breast cancer treatment but now being explored in a new combination. Unlike the standard of care that typically involves ongoing systemic drug therapy, this approach integrates SBRT (Stereotactic Body Radiotherapy), which allows for precise targeting of cancer cells with minimal damage to surrounding tissue. By exploring this integrated method, researchers hope to improve outcomes and potentially reduce long-term treatment burdens for patients.
What evidence suggests that this trial's treatments could be effective for oligometastatic HER2-positive breast cancer?
This trial will compare a consolidation arm with a standard of care arm for breast cancer treatment. Studies have shown that combining trastuzumab and pertuzumab with chemotherapy drugs like paclitaxel can significantly improve survival rates for patients with HER2-positive breast cancer. Specifically, adding pertuzumab has been linked to a median survival time of over 57 months, which is very encouraging. Trastuzumab has improved outcomes for patients with advanced breast cancer, demonstrating its effectiveness. Research also indicates that this combination can delay cancer progression, preventing it from worsening for a longer period. These treatments show strong potential for better long-term outcomes for those battling this type of breast cancer.678910
Who Is on the Research Team?
Lior Braunstein, MD
Principal Investigator
Memorial Sloan Kettering Cancer Center
Are You a Good Fit for This Trial?
This trial is for individuals with HER2-positive breast cancer that has spread to a limited number of other places in the body. Participants should be suitable for surgery like lumpectomy or mastectomy and must not have received certain treatments before.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-randomization Treatment
Participants receive standard of care first-line systemic therapy (paclitaxel, trastuzumab, and pertuzumab) for 3-12 months without evidence of progression
Randomization and Treatment
Participants are randomly assigned to either the consolidation arm (surgery, locoregional radiation therapy, SBRT, and usual approach) or the standard of care arm (continuation of first-line systemic therapy)
Follow-up
Participants are monitored for progression-free survival until disease progression or 3 years after randomization
What Are the Treatments Tested in This Trial?
Interventions
- Paclitaxel
- Pertuzumab
- Radiotherapy
- Trastuzumab
Find a Clinic Near You
Who Is Running the Clinical Trial?
Memorial Sloan Kettering Cancer Center
Lead Sponsor
Gateway for Cancer Research
Collaborator