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MCLA-128 + Standard Therapies for Breast Cancer
Study Summary
This trial is designed to find the best combination of drugs to treat metastatic breast cancer. MCLA-128 will be given in combination with other drugs, either doublet or triplet, in two different groups of patients. There will be a safety run-in for each combination followed by an efficacy expansion. In total, up to 80 patients will be enrolled in the trial.
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.Side effects data
From 2023 Phase 2 trial • 105 Patients • NCT03321981Trial Design
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- I am fully active or restricted in physically strenuous activity but can do light work.I have received a certain amount of anthracycline drugs.I have lasting side effects from cancer treatment, but no severe nerve pain.I have previously been treated with vinorelbine.I have a known infection of HIV, HBV, or HCV.My cancer can be measured by scans, or I have bone cancer with specific types of lesions.I am fully active or restricted in physically strenuous activity but can do light work.I have serious heart issues, but not atrial fibrillation or sudden fast heartbeats.I haven't had major surgery or extensive radiotherapy in the last 3 weeks.I haven't had cancer treatment in the last 3 weeks, or 6 weeks for certain drugs.My breast cancer has spread and cannot be cured with surgery or radiation.My cancer has spread to the lining of my brain and spinal cord.I have brain metastases that are untreated, symptomatic, or need ongoing treatment.My cancer has spread to other organs and is causing symptoms that could be life-threatening soon.I am not pregnant or breastfeeding and will use birth control during and 6 months after the study.I had a heart attack less than 6 months ago.I need oxygen therapy all the time or have trouble breathing even when resting.I have not had any cancer other than non-melanoma skin cancer or cervical carcinoma in situ in the past 3 years.Your doctor believes you will live for at least 12 more weeks.My blood pressure is not well-managed or I have unpredictable chest pain.I regularly take high doses of oral steroids.I do not have any serious illness like uncontrolled infections or significant lung, metabolic, or mental health issues.Your heart's pumping ability is normal based on specific heart tests.My cancer can be measured by scans, or I have bone cancer with specific types of lesions.My organs are working well.I have had a severe allergic reaction to trastuzumab or mouse proteins.
- Group 1: Cohort 1 doublet
- Group 2: Cohort 1 triplet
- Group 3: Cohort 2
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- 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 illnesses does Endocrine therapy usually target?
"In cases of disease progression, endocrine therapy is often prescribed to treat malignant neoplasms and tamoxifen. This form of treatment also increases the chance of remission if there is a high risk for recurrence."
In how many different venues is this research endeavor being conducted?
"Patients can be enrolled in this medical study at 5 different locations, such as Sarah Cannon Research Institute located in Nashville, HCA Midwest Health situated in Kansas City and Tennessee Oncology Chattanooga based in Chattanooga."
To what extent have Endocrine therapies been explored in other research projects?
"Research into endocrine therapy began in 1995 at the NIH Clinical Center. To date, 810 trials have run their course and 485 separate studies are currently recruiting patients; many of these can be found in Nashville, Tennessee."
How many individuals are currently receiving treatment in this clinical trial?
"At present, the project has ceased to recruit participants. It was first posted on January 15th 2018 and last updated August 10th 2022. For those interested in similar studies, there are currently 2285 clinical trials recruiting patients with breast cancer as well as 485 endocrine therapy-related studies actively seeking volunteers."
What perils might be associated with Endocrine therapy?
"Endocrine therapy's safety has been moderately confirmed as it is currently in its second stage of clinical trials. It scored a 2 on our scale because there are some data that confirm the drug's security, yet no documents proving efficacy have surfaced."
Are there still slots available for individuals to join this experiment?
"Currently, this trial is not recruiting. It was first posted on January 15th 2018 and the last update was August 10th 2022. Those seeking out alternative trials might be interested to know that there are 2285 studies related to breast cancer actively enrolling patients, as well as 485 medical experiments involving endocrine therapy searching for participants."
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