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Sacituzumab Govitecan +/- Pembrolizumab for Breast Cancer
Study Summary
This trial is studying two different interventions to see how well they work in treating patients with HR+/HER2- 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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- I am on long-term steroids or other drugs that weaken my immune system.You had an allergic reaction to the ingredients in pembrolizumab or sacituzumab govitecan therapy before.I have had lung inflammation that needed steroids or have it now.I have brain metastases that are either untreated, causing symptoms, or need treatment for symptom control.My cancer worsened during or after hormone therapy, and I am now considered suitable for chemotherapy.I have not had major surgery in the last 2 weeks.My breast cancer is advanced and cannot be removed by surgery.I agree to have two biopsies: one now and another 3-6 weeks after starting treatment.I have had at most one chemotherapy for my metastatic breast cancer and have not been on chemotherapy for the last 14 days.I have not received a live vaccine in the last 28 days.I am a woman who can have children, tested negative for pregnancy, and agree to use birth control.I don't have any health issues that could affect the study's results.I am currently on steroids or immunosuppressants for an autoimmune disease.I understand the study requirements and agree to participate.My organs and bone marrow are functioning normally.I agree to use birth control during and for 3 months after my treatment.I have previously been treated with specific immunotherapy drugs.I do not have any severe illnesses that are not under control.My breast cancer is HR-positive and HER2-negative.I have a specific genetic condition related to the UGT1A1*28 allele.I have had cancer before, but it fits the exceptions for this trial.Your disease must be able to be measured according to specific guidelines.I have a history of HIV, Hepatitis B, or active Hepatitis C.
- Group 1: Retreatment
- Group 2: Sacituzumab Govitecan + Pembrolizumab
- Group 3: 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 indications has Sacituzumab Govitecan been approved to treat?
"Sacituzumab Govitecan is a common choice of treatment for malignant neoplasms as well as unresectable melanoma, microsatellite instability high and conditions that have progressed after chemotherapy."
Could you elucidate the previous experiments involving Sacituzumab Govitecan?
"Sacituzumab Govitecan was first investigated at City of Hope a decade ago, and since then it has been subject to 253 clinical trials. This number is expected to rise with 990 active studies currently taking place around South Weymouth, Illinois."
Are there opportunities for people to enroll in this experiment currently?
"Affirmative, data hosted on clinicaltrials.gov confirm that this medical study is actively seeking participants. The trial was initially posted on September 23rd 2020 and has been recently revised as of November 14th 2022. 110 individuals need to be recruited from 8 distinct clinics."
How many facilities are currently conducting this trial?
"This clinical trial is being conducted across a network of medical centres including DF/BWCC in affiliation with South Shore Hospital located in South Weymouth, Illinois; Dana Farber Cancer Institute situated in Boston, Pennsylvania; and University of Chicago Medical Center based out of Chicago, Georgia. There are 8 other sites involved as well."
Is there any potential for harm associated with taking Sacituzumab Govitecan?
"As this is a phase 2 clinical trial, our team assigned Sacituzumab Govitecan with an estimation of safety at a level 2 due to the limited data available on efficacy."
Approximately how many individuals are engaged in this research?
"Affirmative. The clinical trial, initially posted on September 23rd 2020, is actively recruiting participants according to the information displayed on clinicaltrials.gov. A total of 110 patients are required across 8 different medical sites for this study."
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