Endocrine + Chemotherapy for Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether adding endocrine therapy (hormone treatment) to the usual chemotherapy and HER2-targeted therapy can enhance treatment effectiveness for hormone receptor-positive, HER2-positive breast cancer. The researchers aim to determine if this combination leads to a better response by the time patients undergo surgery. The trial seeks adults with newly diagnosed, untreated breast cancer that is hormone receptor-positive and HER2-positive, who plan to undergo at least four cycles of specific chemotherapy. Participants should not have had breast cancer in the past five years or other cancers in the past two years. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Is there any evidence suggesting that concurrent endocrine therapy with chemotherapy and HER2 directed therapy is likely to be safe for humans?
Research has shown that using hormone therapy alongside chemotherapy is generally safe for patients with hormone receptor-positive breast cancer. Studies have found that most patients tolerate this combination well. A review of multiple studies supports the safety of using these treatments together.
However, combining these treatments can sometimes lead to more side effects. Some patients might experience more severe side effects, especially when additional targeted therapies are included. It's important to weigh these potential risks against the benefits when considering participation in such a trial. Consulting healthcare professionals is crucial to understand what this means personally.12345Why do researchers think this study treatment might be promising?
Unlike the standard of care for breast cancer, which typically involves sequential treatment with chemotherapy and endocrine therapy, the concurrent endocrine therapy being studied is administered simultaneously with chemotherapy and HER2-directed therapy. This approach has the potential to enhance the effectiveness of treatment by targeting cancer cells from multiple angles at once, potentially leading to better outcomes. Researchers are excited because this simultaneous delivery could improve the response rate and reduce the time it takes to see treatment benefits, offering a more aggressive and hopefully more effective strategy against breast cancer.
What evidence suggests that concurrent endocrine therapy might be an effective treatment for breast cancer?
Research has shown that combining hormone treatment with chemotherapy effectively treats breast cancer. In this trial, participants will receive concurrent endocrine therapy with chemotherapy and HER2-directed therapy. A review of multiple studies found that this combination improved patient outcomes. Specifically, studies indicate that patients with advanced breast cancer lived longer when chemotherapy was paired with hormone treatment. This suggests that using both treatments together might enhance the response to treatment before surgery. While more research is needed, these findings are promising for this combined approach.12356
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive concurrent neoadjuvant chemotherapy, HER2 directed therapy, and endocrine therapy
Surgery
Participants undergo surgery to assess response to therapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Concurrent endocrine therapy
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
Legacy Health System
Lead Sponsor
Citations
breast cancer: a systematic review and meta-analysis - PMC
Our findings provide evidence for the efficacy and safety of concurrent neoadjuvant endocrine therapy (AIs) with chemotherapy as an available option.
Sequential versus concurrent adjuvant chemo-endocrine ...
Current researches found significant improvement in the survival of advanced breast cancer patients treated with chemotherapy alongside with AI or fulvestrant ...
A Randomized Trial Comparing Concurrent versus ...
Data showed that for patients commencing endocrine therapy concurrently with, or sequential to, radiotherapy, there was no difference in ...
Concurrent Neoadjuvant Chemo/Endocrine Therapy in ...
The usual approach to care for hormone receptor positive, HER2 positive breast cancer is chemotherapy and HER2 targeted therapy followed by ...
Sequential versus concurrent use of chemotherapy and ...
However, no direct evidence so far demonstrated better efficacy of sequential use of chemotherapy and endocrine therapy over concurrent.
Concurrent versus sequential adjuvant chemo-endocrine ...
The administration of both treatment results in the improvement of overall survival (OS) and disease-free survival (DFS) [3] as compared to no adjuvant ...
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