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Lapatinib + Trastuzumab for Breast Cancer (HELEX Trial)
HELEX Trial Summary
This trial demonstrates that targeted therapies can be very successful in reducing tumor recurrences and mortality in early breast cancer. However, there is still a need for new strategies to overcome resistance to these treatments.
HELEX Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.HELEX Trial Design
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Who is running the clinical trial?
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- You have a serious, long-term health condition.You are in good enough health and expected to live for at least 6 more months.You have a condition that affects how your body absorbs nutrients, or a significant disease that affects your stomach or intestines. If you have ulcerative colitis, you will also be excluded.You have not had any other cancers, except for certain types of skin and cervical cancers that were treated and are not a current concern.You have active, infectious Hepatitis B, Hepatitis C, or HIV.If you could become pregnant, you must have a negative pregnancy test within 7 days before starting the study drug.You have cancer in both breasts.You have severe or uncontrolled high blood pressure, or a history of serious heart problems.You have a heart condition called cardiomyopathy or your heart's pumping function is less than 50%.You have had a previous invasive breast cancer on the same side, or a non-invasive breast cancer, and now have a new cancer.You have been treated for breast cancer in the past five years, including surgery, chemotherapy, hormone therapy, or targeted therapy.You have breast cancer that is larger than 3 cm, or larger than 2 cm with signs of spread to the nearby lymph nodes. If the tumor is smaller than 3 cm, the size will be checked using imaging to see if it meets the size criteria.You must have a specific type of breast cancer with high levels of a protein called HER2, as confirmed by a lab test.Your kidney and liver function tests should be close to the normal range, not more than 1.5 times higher than the usual limit.You should not have cancer that has spread to the brain or the tissues surrounding the brain, or any other advanced stage of cancer.
- Group 1: 24-week arm
- Group 2: 12-week arm
- 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
Can Lapatinib be administered without fear of adverse consequences?
"Lapatinib has been assigned a safety evaluation of 2, as its efficacy is yet to be confirmed but the available data does suggest it carries some level of security."
How has Lapatinib been employed to treat certain medical conditions?
"Lapatinib is a drug that has seen much success against the BRCA1 gene-related illnesses, such as breast cancer and inflammatory breast cancer (IBC). It can also be employed in tamoxifen treatment."
Are there any opportunities to participate in this clinical experiment currently?
"According to clinicaltrials.gov, this research trial is not currently recruiting patients. The study began on October 1st 2011 and was last edited on May 15th 2022. There are numerous other medical trials actively looking for volunteers at the present time: a total of 2940 in fact."
Could you provide information on other research initiatives regarding Lapatinib?
"Currently, there are 340 active trials investigating the usage of Lapatinib. Out of those studies, 91 have reached Phase 3. Notably, though Seattle is a major centre for this drug's research, over 25 thousand medical centres across the world are administering clinical tests for Lapatinib."
How many sites are facilitating this experiment?
"This research trial is taking place at Duke University in Durham, North carolina and Indiana University in Indianapolis, Indiana. Other locations include Vanderbilt University Medical Center in Nashville, Tennessee as well as 8 other sites."
How many individuals have been accepted to partake in this medical trial?
"Unfortunately, this clinical trial has already closed its recruitment period. Initially posted on October 1st 2011 and last updated on May 15th 2022, it is no longer enrolling patients. Nevertheless, 2600 trials related to breast cancer are still recruiting participants and 340 studies involving Lapatinib remain open for enrolment."
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