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Combination Therapies for Breast Cancer (Morpheus-panBC Trial)
Morpheus-panBC Trial Summary
This trial is testing multiple immunotherapy-based treatment combinations to see if they are effective and safe in patients with metastatic or inoperable TNBC. The study will be performed in two stages, with different cohorts of patients in each stage.
Morpheus-panBC Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowMorpheus-panBC Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Morpheus-panBC Trial Design
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Who is running the clinical trial?
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- I do not meet the exclusion criteria for Stage 1.You have or had a condition where your immune system attacks your own body, or your immune system doesn't work properly.I haven't had any systemic treatment for my advanced triple-negative breast cancer.My cancer is HER2 positive or low, and my blood sugar levels are within normal limits.I have had cancer spread to the lining of my brain and spinal cord.Your blood sugar levels are within a certain range when fasting and your HbA1c level is not too high.The requirements for joining Cohort 4.You have had serious and unexpected reactions to fluoropyrimidine therapy in the past.I have not had a severe infection in the last 4 weeks.I have a serious heart condition.You have a measurable disease with at least one specific area that can be monitored according to RECIST v1.1 guidelines.Inclusion criteria for Cohort 3: The requirements that participants must meet to be included in the third group of the study.Your heart's pumping ability, measured by special tests, is more than 50%.My breast cancer cannot be removed by surgery and has spread, and I've had treatments for it before.My doctor recommends hormone therapy instead of chemotherapy for my condition.I am postmenopausal or willing to undergo hormone therapy if not.My cancer has a PIK3CA mutation.My side effects from previous cancer treatments are mild, except for hair loss or mild nerve pain.I do not have congenital long QT syndrome.I have not taken sorivudine or similar drugs.My body lacks the enzyme dihydropyrimidine dehydrogenase.I couldn't tolerate atezolizumab in the first stage of treatment.I am 18 years old or older.I am fully active or can carry out light work.I haven't taken any immune-weakening medication in the last 2 weeks.My breast cancer cannot be removed by surgery and may have spread.My tumor can be easily reached for a biopsy.I agree to either not have sex or use birth control, and not donate sperm while on treatment.My breast cancer has spread and cannot be removed by surgery.My recent blood and organ function tests are within normal ranges.I am not eligible for Stage 2 of the trial.My tumor shows PD-L1 expression of 1% or more.I have not had cancer, other than breast cancer, in the last 2 years.Inclusion Criteria for Group 1I meet all the requirements for Stage 1 and Stage 2 of the trial.I have had a previous transplant of stem cells or an organ.I can provide a sample of my tumor for testing.I haven't had any biological treatment or other systemic treatments for TNBC in the last 2 weeks or longer.I have previously received treatments that boost the immune system to fight cancer.I am not eligible for the 2L CIT-naive cohort, Stage 1.I am eligible for treatment with capecitabine alone.I am not eligible for Stage 1 or Stage 2 of the trial.I frequently need procedures to remove excess fluid from my body.I understand specific drug exclusions may apply to me.I have not taken any strong antibiotics in the last 2 weeks.I have brain metastases that are untreated or getting worse.I have pain from my cancer that isn't managed well.I have had lung conditions like pulmonary fibrosis, but not due to radiation.My cancer has a PIK3CA mutation.My breast cancer has spread and cannot be removed by surgery.I have active tuberculosis.My breast cancer has worsened after one round of chemotherapy.I have been treated with capecitabine before.
- Group 1: Inavolisib (9 mg) + Trastuzumab Deruxtecan
- Group 2: Inavolisib + Ribociclib + Fulvestrant
- Group 3: Inavolisib (6 mg) + Trastuzumab Deruxtecan
- Group 4: Atezolizumab + Chemo (Gemcitabine + Carboplatin or Eribulin)
- Group 5: Inavolisib + Abemaciclib + Fulvestrant
- Group 6: Atezolizumab + SGN-LIV1A
- Group 7: Atezolizumab + Selicrelumab + Bevacizumab
- Group 8: Atezolizumab + Nab-Paclitaxel + Tocilizumab
- Group 9: Capecitabine
- Group 10: Atezolizumab + Ipatasertib
- Group 11: Atezolizumab + Nab-Paclitaxel
- Group 12: Atezolizumab + Sacituzumab Govitecan
- 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 standard purpose of Gemcitabine + Carboplatin or Eribulin chemotherapy?
"Chemotherapy, specifically Gemcitabine in conjunction with Carboplatin or Eribulin, is regularly used to treat neoplasm metastasis. It is also an effective treatment for a variety of other conditions like metastatic ureter urothelial carcinoma, lymphoma, non-hodgkin's recurrent cervical cancer."
How many people are helping to test this new medication?
"Currently, this study is not recruiting patients. However, it was last edited on November 10th, 2022. Additionally, there are 2439 studies actively searching for patients with breast cancer and 2333 trials for Chemotherapy (Gemcitabine + Carboplatin or Eribulin) enrolling participants."
Are new participants still being accepted into this clinical research project?
"This trial has completed recruitment for its study. However, there are 2439 other trials related to breast cancer and 2333 chemotherapy trials that patients may be eligible for. These studies were active as of the 11th of October, 2022."
Do we have any precedence for using Gemcitabine + Carboplatin or Eribulin in cancer patients?
"Chemotherapy was first trialed in 1997 at City of Hope Comprehensive Cancer Center. Since then, there have been a total of 3695 completed clinical trials worldwide. Out of these 2333 are presently active, with many taking place in Howell, New jersey."
In how many hospitals is this trial being conducted?
"Presently, there are 6 sites where recruitment is underway for this trial. They are in Howell, Stanford and Nashville as well as other locations. If you decide to participate in the trial, it would be advantageous to select the site closest to your home to reduce travel burdens."
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