Personalized Anti-HER2 Therapies for Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine whether a personalized treatment approach can effectively manage and potentially cure HER2+ metastatic breast cancer. By combining blood tests, imaging scans, and local treatments, the trial seeks to tailor therapy to each participant's needs and prevent the cancer from spreading to the brain or spine. This trial suits individuals with HER2+ breast cancer that has advanced to stage IV, especially if it presents significant daily challenges. The treatment under study includes Trastuzumab deruxtecan-nxki, a targeted therapy for HER2+ breast cancer. 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 this treatment is likely to be safe for humans?
Research has shown that trastuzumab deruxtecan-nxki is generally well-tolerated by patients with HER2-positive metastatic breast cancer. A safety update found no new concerns about this treatment. In a study with 257 patients, common side effects included nausea and tiredness, which were often manageable. Serious side effects occurred less frequently. The FDA has approved this treatment for certain breast cancer cases, indicating a strong safety record. Overall, evidence suggests that while some side effects may occur, the treatment is considered safe for patients.12345
Why do researchers think this study treatment might be promising for breast cancer?
Trastuzumab deruxtecan-nxki is unique because it combines targeted therapy with a chemotherapy payload. Unlike standard treatments like trastuzumab or pertuzumab, which focus solely on blocking the HER2 receptor, this drug carries a chemotherapy agent directly into the cancer cell. Researchers are excited about its potential for greater precision in attacking cancer cells while sparing healthy ones, which could lead to better outcomes and fewer side effects for patients with advanced breast cancer.
What evidence suggests that this treatment might be an effective treatment for HER2+ metastatic breast cancer?
Research has shown that trastuzumab deruxtecan-nxki, the treatment under study in this trial, is a promising option for HER2-positive metastatic breast cancer. One study found that it significantly improved progression-free survival, allowing patients to live longer without their cancer worsening. Another study demonstrated a 53% reduction in the risk of cancer recurrence or death compared to another treatment. In tests, 87% of patients responded well, and 15% experienced complete cancer disappearance. These results suggest that trastuzumab deruxtecan-nxki could be highly effective in managing HER2-positive breast cancer.46789
Who Is on the Research Team?
Pedram Razavi, MD, PhD
Principal Investigator
Memorial Sloan Kettering Cancer Center
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive personalized treatment using ctDNA tests and standard imaging to guide sequential anti-HER2 therapies and CNS prophylaxis
Maintenance/Surveillance
Participants are monitored to maintain Complete Response (CR) and Molecular Complete Response (mCR)
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Trastuzumab deruxtecan-nxki
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Male or female participants who are ≥18 years old with histologically confirmed diagnosis of unresectable locally advanced or metastatic breast cancer/MBC
Find a Clinic Near You
Who Is Running the Clinical Trial?
Memorial Sloan Kettering Cancer Center
Lead Sponsor
Citations
Trastuzumab Deruxtecan plus Pertuzumab for HER2- ...
In this trial, trastuzumab deruxtecan plus pertuzumab showed a significant benefit in progression-free survival as compared with THP in advanced ...
Efficacy of Trastuzumab Deruxtecan in HER2-Positive ... - PMC
In conclusion, T-DXd demonstrated robust efficacy in both HER2-positive and HER2-low metastatic breast cancer patients, with an excellent safety ...
3.
enhertuhcp.com
enhertuhcp.com/en/her2-positive-metastatic-breast-cancer/efficacy/destiny-breast-09-efficacy-dataEfficacy Data | ENHERTU® (fam-trastuzumab deruxtecan- ...
ENHERTU + pertuzumab demonstrated a confirmed ORR of 87%, with CR achieved in 15% of patients · Consistent PFS results observed with ENHERTU + pertuzumab across ...
ENHERTU® (fam-trastuzumab deruxtecan-nxki) reduced ...
ENHERTU® (fam-trastuzumab deruxtecan-nxki) reduced the risk of disease recurrence or death by 53% vs. T-DM1 in patients with high-risk HER2- ...
Results in adults receiving their first treatment for mBC
At the time of data analysis (May 2021), median progression-free survival was not yet reached for people receiving ENHERTU. This means that more than half of ...
Safety profile of trastuzumab deruxtecan in advanced breast ...
T-DXd represents a highly efficacious treatment option for pretreated patients with HER2-positive and HER2-low advanced or metastatic breast cancer. Results ...
Safety Data | ENHERTU® (fam-trastuzumab deruxtecan-nxki)
The safety of ENHERTU was evaluated in 257 patients with unresectable or metastatic HER2-positive breast cancer who received at least 1 dose of ENHERTU 5.4 mg/ ...
8.
oncologynewscentral.com
oncologynewscentral.com/article/trastuzumab-deruxtecan-continues-to-demonstrate-solid-safety-profile-in-her2-metastatic-breast-cancerUpdated Safety Data for Trastuzumab Deruxtecan (Enhertu ...
“No new safety signals were observed for T-DXd in patients with HER2+ metastatic breast cancer in this safety update,” said Erika Hamilton, MD, ...
Real-world efficacy and safety of trastuzumab deruxtecan in ...
There are limited clinical data to compare the efficacy of trastuzumab deruxtecan (T-DXd) between the immunohistochemistry (IHC) 1+ and 2+ ...
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