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Monoclonal Antibodies
Sacituzumab Govitecan + Pembrolizumab for Breast Cancer (NeoSTAR Trial)
Phase 2
Recruiting
Led By Laura Spring, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Regional lymph node AJCC (v7) TNM stages N0-N2
Participants must have biopsy proven ER negative (ER-), PR negative (PR-), HER2 negative (HER2-), invasive breast cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time from the first dose of study treatment to disease recurrence/progression by recist v1.1 or death due to any cause, up to 36 months
Awards & highlights
NeoSTAR Trial Summary
This trial is studying sacituzumab govitecan to see how well it works in combination with pembrolizumab in treating patients with localized triple-negative breast cancer.
Who is the study for?
This trial is for adults with a specific breast cancer type called triple negative (no ER, PR, HER2 receptors), who haven't been treated yet. They must have a tumor of at least 1 cm without spread to distant parts of the body and be in good health overall. Pregnant or breastfeeding individuals, those with other cancers within 3 years, uncontrolled illnesses, HIV on antiretrovirals or certain heart conditions can't join.Check my eligibility
What is being tested?
The study is testing Sacituzumab Govitecan alone and in combination with Pembrolizumab for treating localized triple negative breast cancer. It aims to see how well these drugs work before any standard treatments like surgery or radiation are given.See study design
What are the potential side effects?
Sacituzumab Govitecan may cause nausea, diarrhea, hair loss, fatigue and low blood cell counts which could lead to increased infection risk. Pembrolizumab might cause immune system-related side effects affecting various organs.
NeoSTAR Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer has spread to nearby lymph nodes but not beyond.
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My breast cancer is not driven by estrogen, progesterone, or HER2.
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My blood tests show my organs and bone marrow are working well.
Select...
I am fully active or can carry out light work.
Select...
I have signed the consent form and can follow the study's requirements.
Select...
My cancer has not spread to distant parts of my body.
Select...
My breast cancer diagnosis is confirmed and I haven't received any treatment yet.
Select...
I am a woman, regardless of my menopausal status.
NeoSTAR Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ time from the first dose of study treatment to disease recurrence/progression by recist v1.1 or death due to any cause, up to 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time from the first dose of study treatment to disease recurrence/progression by recist v1.1 or death due to any cause, up to 36 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pathological complete response(pCR) rate with sacituzumab govitecan
Secondary outcome measures
Assessment of Quality of life (QOL)
Change in Breast Conserving Surgery Rate (BCS) rate
Disease-Free Survival
+2 moreNeoSTAR Trial Design
2Treatment groups
Experimental Treatment
Group I: Sacituzumab Govitecan and Pembrolizumab (combination cohort)Experimental Treatment2 Interventions
- The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.
Sacituzumab govitecan via iv, predetermined dosage per protocol, IV, 2 days per each 21-day cycle, for 4 cycles.
Pembrolizumab via iv, predetermined dosage per protocol, IV, 1 day per each 21-day cycle, for 4 cycles.
This can be followed by standard chemotherapy at the discretion of treating physician.
Group II: Sacituzumab Govitecan (monotherapy cohort)Experimental Treatment1 Intervention
- The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.
Sacituzumab govitecan via iv, predetermined dosage per protocol, IV, 2 days per each 21-day cycle, for 4 cycles.
This can be followed by standard chemotherapy at the discretion of treating physician.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
2,933 Previous Clinical Trials
13,198,241 Total Patients Enrolled
81 Trials studying Breast Cancer
132,912 Patients Enrolled for Breast Cancer
Aditya BardiaLead Sponsor
Gilead SciencesIndustry Sponsor
1,084 Previous Clinical Trials
848,219 Total Patients Enrolled
17 Trials studying Breast Cancer
6,454 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have uncontrolled heart disease or abnormal heart rhythms.I am 18 years old or older.My cancer has spread to nearby lymph nodes but not beyond.My breast cancer is not driven by estrogen, progesterone, or HER2.My blood tests show my organs and bone marrow are working well.I am fully active or can carry out light work.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.I have signed the consent form and can follow the study's requirements.My cancer has not spread to distant parts of my body.My breast cancer diagnosis is confirmed and I haven't received any treatment yet.I am not on systemic therapy for another cancer nor have I been in the last 3 years.The main tumor is at least 1 centimeter in size as seen on imaging scans.I am a woman, regardless of my menopausal status.I am HIV-positive and on antiretroviral therapy.My breast cancer is either inflammatory or has come back in the same area.
Research Study Groups:
This trial has the following groups:- Group 1: Sacituzumab Govitecan (monotherapy cohort)
- Group 2: Sacituzumab Govitecan and Pembrolizumab (combination cohort)
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What diseases is Sacituzumab Govitecan most regularly utilized for?
"Sacituzumab Govitecan is a powerful therapeutic tool for treating malignant neoplasms, along with unresectable melanoma, microsatellite instability high conditions and chemotherapy-resistant progression."
Answered by AI
Are there any additional investigations covering Sacituzumab Govitecan?
"Presently, 990 Sacituzumab Govitecan trials are in progress with 127 of them having reached Phase 3. Most clinical experiments are being conducted at the Houston research hub; however, there are 37,062 other locations hosting this medication trial."
Answered by AI
Are there still opportunities to enroll in this medical experiment?
"According to clinicaltrials.gov, this particular medical experiment is no longer recruiting patients due to its last update on October 25th 2021. Although it has finished taking applications, over 3300 other trials are open and actively accepting participants at the moment."
Answered by AI
How many participants have registered for this medical experiment?
"At present, this medical trial is not actively seeking out participants. It was initially made available on the 7th of July 2020 and last modified on the 25th of October 2021; if you're interested in alternative studies there are 2354 trials recruiting patients with malignant neoplasms & 990 looking for individuals to take part in Sacituzumab Govitecan research."
Answered by AI
Has Sacituzumab Govitecan been accepted as a viable medical treatment by the FDA?
"There is evidence of Sacituzumab Govitecan's safety, however no data supports its efficacy, thus it has been given a score of 2."
Answered by AI
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