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DZD1516 Combinations for HER2 Positive Breast Cancer
Study Summary
This trial is testing a new drug, DZD1516, for safety and effectiveness in treating metastatic HER2 positive breast cancer. This is the first time this drug has been tested in patients, so researchers are looking at what side effects may occur and how well the drug works by itself and in combination with other treatments.
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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- I do not have any severe or uncontrolled illnesses.You are expected to live for at least 12 more weeks.I haven't had major surgery or significant injury in the last 4 weeks and don't expect to need major surgery during the study.I have a tumor that can be measured and I don't have brain metastases.I have not received any live vaccines in the last 4 weeks.I cannot control my nausea or vomiting with medication, have chronic stomach issues, trouble swallowing pills, or had a major gut surgery affecting medicine absorption.I haven't had cancer drugs for my metastatic breast cancer in the last 4 weeks.I haven't had cancer in the last 5 years, except for certain skin cancers or treated in-situ cervical or uterine cancer.I have a measurable brain tumor according to specific criteria.I do not have active infections like TB, hepatitis B, hepatitis C, or HIV.My advanced breast cancer is HER2 positive and did not respond to previous treatments.My blood counts and organ functions are within normal ranges.You are expected to live for at least 12 more weeks.I can care for myself and perform daily activities, regardless of having LM.I haven't had extensive radiotherapy in the last 4 weeks or targeted radiotherapy for symptom relief in the last week.I haven't had chemotherapy injected into my spine in the last 2 weeks.I am 18 years old or older.I haven't taken any experimental drugs in the last 4 weeks.I need urgent brain surgery due to complications.
- Group 1: daily dose of DZD1516
- 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
What is the upper limit for participants in this scientific experiment?
"At present, this medical trial has ceased patient recruitment. It was first announced on September 21st 2020 and the last update was made May 29th 2022. For individuals looking for other studies, there are 2290 clinical trials presently searching for breast cancer patients, as well as 521 seeking participants to test DZD1516 mono therapy in Part A; a combination of DZD1516 with trastuzumab or capecitabine in Part B; and finally a pairing of DZD1516 with T-DM1 in Part C."
For what therapeutic purposes are the components of DZD1516 mono therapy in Part A, DZD1516 in combination with trastuzumab and/or capecitabine in Part B, and DZD1516 in combination with T-DM1 in Part C typically prescribed?
"As an intervention, DZD1516 mono therapy in Part A, combined with trastuzumab and/or capecitabine in Part B or T-DM1 in Part C is often recommended for refractory fallopian tube carcinoma. This therapeutic approach may also be employed to treat other maladies such as breast cancer, high risk of recurrence metastatic colorectal carcinoma."
What is the ultimate aim of this clinical trial?
"According to the sponsor, Dizal Pharmaceuticals, this trial will measure its success by gauging the Recommended Phase II Combination Dose (RP2CD) of DZD1516 in combination with trastuzumab and capecitabine over 21 days. Additionally, secondary objectives include assessing Plasma AUC of capecitabine and 5-FU (Part B only), Disease Control Rate (DCR) as a means to evaluate preliminary anti-tumor efficacy of DZD1516 both alone or combined with other treatments, and overall survival for those patients suffering from leptomeningeal metastasis receiving"
Are researchers currently seeking participants for this experiment?
"According to clinicaltrials.gov, the search for participants of this medical trial has concluded; it was posted on September 21st 2020 and last updated May 29th 2022. Despite that, there are currently 2,811 other trials actively recruiting patients at present."
What potential hazards have been identified for patients undergoing DZD1516 mono therapy in Part A, DZD1516 combination with trastuzumab and/or capecitabine in Part B, or DZD1516 combined with T-DM1 in Part C?
"Limited efficacy and safety data is available for DZD1516 mono therapy in Part A, DZD1516 combined with trastuzumab/capecitabine in Part B, and DZD1516 paired with T-DM1 in Part C; thus this received a score of 1."
What other analyses have been conducted concerning DZD1516 mono therapy, as well as its combination with trastuzumab and/or capecitabine in Part A, and its merger with T-DM1 in Part C?
"As of now, 521 ongoing trials related to DZD1516 mono therapy in Part A, DZD1516 in combination with trastuzumab and/or capecitabine in Part B, and DZD1516 combined with T-DM1 as part of Phase 3 have been identified. Of those experiments the majority are concentrated around Seattle, Washington; however there are still 27860 sites across the US running similar studies involving this medicine."
Who else is applying?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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