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T-DM1 vs TH for Breast Cancer
Study Summary
This trial is studying two different combination of HER2-directed therapies to see how well they work in treating patients with newly diagnosed breast cancer.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I have been on tamoxifen or another hormone therapy for up to 4 weeks.My liver and bone marrow are functioning well.I have had breast cancer before.I have a small, ER+ (>10%), HER2-negative cancer besides my main HER2-positive tumor.I have an active liver condition.My tumor was completely removed with surgery and the edges were cancer-free.My cancer has spread to nearby lymph nodes, as found by a sentinel node test.My cancer is confirmed HER2 positive by a central lab.My cancer's hormone receptor status was tested.I am fully active or restricted in physically strenuous activity but can do light work.I am premenopausal and have a negative pregnancy test.I have tumor tissue samples available for research.I can safely receive radiation therapy for breast conservation.My breast cancer is HER2-positive, early stage, and has not spread to lymph nodes or only has tiny cancer cells in them.I have had chemotherapy or paclitaxel therapy in the last 5 years.My cancer was advanced but localized when diagnosed.
- Group 1: Arm A. T-DM1 followed by Trastuzumab SC
- Group 2: Arm B: Paclitaxel with Trastuzumab SC, followed by Trastuzumab SC alone
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Does this research endeavor seek to bring on new participants?
"Confirmed, clinicaltrials.gov states that this trial is presently enrolling patients. The original advertisement was posted on June 16th 2021 and has been revised as recently as October 19th 2022. 500 individuals are sought from 28 distinct treatment sites."
Could you provide an assessment of the risks associated with trastuzumab-emtansine use?
"Trastuzumab-emtansine was given a safety score of 2, as clinical trials have not yet provided evidence for efficacy but earlier rounds have established its security."
How many individuals are eligible to partake in this scientific endeavor?
"The sponsor, Genentech Inc., aims to recruit 500 eligible patients from two spots: Dana-Farber Brigham Cancer Center - Foxborough in Foxboro, Massachusetts and NH Oncology - Hematology in Concord, New hampshire."
How extensively is this exploratory trial being conducted across the medical community?
"28 clinics across the United States are currently recruiting participants for this trial. This includes locations in Foxboro, Concord and Manchester as well as 25 other sites, so finding a clinic in your vicinity should not be difficult."
What objectives is this investigation trying to accomplish?
"This research aims to assess the occurrence of clinically relevant toxicities (CRT). Additionally, investigators will assess the effect of therapy on work productivity utilizing the Work Productivity and Activity Impairment Questionnaire (WPAI-SHP), measure grade 3-4 cardiac left ventricular dysfunction in patients treated with adjuvant trastuzumab emtansine followed by trastuzumab SC compared to those receiving paclitaxel with trastuzumab SC, and analyze genomic profiling via a large panel of cancer gene mutations and gene expression in Stage I HER2-positive breast cancer sufferers over a 72 month"
What has trastuzumab-emtansine been primarily utilized to treat?
"trastuzumab-emtansine is conventionally used to alleviate symptoms of cyclophosphamide, but also holds potential for rehydration, advanced non-small cell lung cancer and metastatic bladder cancer."
Could you elaborate on the additional investigations concerning trastuzumab-emtansine?
"Since 1997, trastuzumab-emtansine has been investigated through 1470 trials, many of which are currently taking place in Foxboro, Massachusetts. In total there have been 1024 live studies conducted on the drug since its conception."
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