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Monoclonal Antibodies
Atezolizumab + Sacituzumab for Breast Cancer
Phase 2
Waitlist Available
Led By Elizabeth A Mittendorf, MD, PhD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Pathologically confirmed residual invasive breast cancer, in the breast and/or lymph node(s), following neoadjuvant chemotherapy. In the absence of residual invasive disease in the breast, lymph node must contain at least 2mm of invasive disease.
Patients must be within 4 months of completion of all locoregional therapy (either last surgery or last dose of radiation, whichever is later). Definitive breast surgery must have been performed and includes lumpectomy or mastectomy with pathologically clear margins (i.e. no ink on tumor). For patients undergoing lumpectomy, this must be followed by whole breast irradiation. Definitive surgery also includes axillary surgery, either sentinel lymph node biopsy or axillary lymph node dissection at the discretion of the attending surgeon.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
Study Summary
This trial will enroll participants with residual cancer in the breast or lymph nodes and have circulating tumor DNA in the blood.
Who is the study for?
This trial is for adults over 18 with HER2-negative, hormone receptor-negative breast cancer that remains after neoadjuvant chemotherapy and surgery. They must have circulating tumor DNA, be within 4 months post-treatment, and agree to use contraception. Exclusions include prior sacituzumab govitecan treatment, hypersensitivity to the drugs being tested, metastatic disease evidence, certain heart or lung conditions, active infections or other cancers within the last five years.Check my eligibility
What is being tested?
The ASPRIA trial tests whether combining Atezolizumab and Sacituzumab govitecan can prevent breast cancer recurrence in patients with residual disease post-chemotherapy who also have detectable circulating tumor DNA. It's an investigational study exploring this drug duo's effectiveness.See study design
What are the potential side effects?
Potential side effects of Atezolizumab and Sacituzumab govitecan may include allergic reactions to the medication components, organ inflammation (like pneumonitis), fatigue, digestive issues such as nausea or diarrhea, blood disorders like low white cell counts increasing infection risk.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I still have breast cancer in my breast or lymph nodes after chemotherapy.
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I finished my breast cancer surgery and any needed radiation within the last 4 months, with clear surgery margins.
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My breast cancer is not driven by estrogen or progesterone.
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My blood test shows cancer DNA after finishing all initial cancer treatments.
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My initial tumor was tested and found not to be HER2 positive.
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I am fully active or can carry out light work.
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I received chemotherapy before my breast surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of undetectable circulating tumor cfDNA- 6 Cycles
Secondary outcome measures
3-year recurrence rate
Distant metastasis free survival (DMFS) Rate
Invasive disease-free survival (iDFS) Rate
+4 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Atezolizumab and Sacituzumab govitecanExperimental Treatment2 Interventions
Patients will receive the following treatment:
Atezolizumab and Sacituzumab govitecan treatment will continue for 6 cycles (18 total weeks).
Atezolizumab intravenously (IV) at a pre-determined dose on day 1 in a 21-day cycle
Sacituzumab govitecan: intravenously (IV) at a pre-determined dose on days 1 and 8 in a 21-day cycle
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atezolizumab
2017
Completed Phase 3
~5860
Sacituzumab govitecan
2017
Completed Phase 3
~530
Find a Location
Who is running the clinical trial?
Genentech, Inc.Industry Sponsor
1,539 Previous Clinical Trials
567,649 Total Patients Enrolled
96 Trials studying Breast Cancer
23,178 Patients Enrolled for Breast Cancer
Stand Up To CancerOTHER
51 Previous Clinical Trials
40,254 Total Patients Enrolled
3 Trials studying Breast Cancer
106 Patients Enrolled for Breast Cancer
Dana-Farber Cancer InstituteLead Sponsor
1,079 Previous Clinical Trials
340,908 Total Patients Enrolled
141 Trials studying Breast Cancer
22,577 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have an active autoimmune disease, except for controlled thyroid issues, celiac, psoriasis, eczema, lichen simplex chronicus, or vitiligo.My blood and organs are functioning well.My cancer has spread to other parts of my body.I have had breast cancer before.I have had lung conditions like pulmonary fibrosis but not due to radiation.I do not have any serious ongoing illnesses like infections needing treatment, serious liver disease, uncontrolled diabetes, or high cholesterol.I have not received a live vaccine in the last 4 weeks and do not plan to while on the study treatment.My breast cancer is non-invasive or very early stage after surgery.You have HIV, Hepatitis B, or Hepatitis C.I agree to use non-hormonal birth control during and for 6 months after my treatment.All my previous treatment side effects are mild, except for hair loss and nerve issues.I've been cancer-free for 5 years, except for treated thyroid cancer without lymph node spread.I still have breast cancer in my breast or lymph nodes after chemotherapy.I finished my breast cancer surgery and any needed radiation within the last 4 months, with clear surgery margins.I do not have serious heart conditions such as recent heart attacks or uncontrolled heart rhythm problems.I haven't taken any immune-weakening drugs in the last 2 weeks and don't expect to need any during the study.My breast cancer is not driven by estrogen or progesterone.I am not allergic to any study drugs or their components.I have a stomach or intestine problem that affects how I absorb medicine.My blood test shows cancer DNA after finishing all initial cancer treatments.I have a heart condition known as long QT syndrome or my heart's electrical recovery time is longer than normal.My initial tumor was tested and found not to be HER2 positive.I have never been treated with sacituzumab govitecan, irinotecan, or similar drugs.I received chemotherapy before surgery.You have had a bad reaction to atezolizumab or its ingredients before.I haven't taken antibiotics for treatment in the last 2 weeks, but I may be on preventive antibiotics.I haven't had major surgery in the last 4 weeks and don't expect to need one during the study.I am not pregnant and will not breastfeed during the study.I am fully active or can carry out light work.I haven't taken strong UGT1A1 affecting drugs recently.I am 18 years old or older.I received chemotherapy before my breast surgery.I am currently taking medication for bone health.I have previously received immune therapy before surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Atezolizumab and Sacituzumab govitecan
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
How many participants is this research endeavor accommodating?
"This trial requires 40 individuals to meet the prerequisites and enroll. Potential participants can sign up from University of Pennsylvania-Abramson Cancer Center in Philadelphia, as well as University of Chicago Medical Center for Advanced Care Orland Park in Illinois."
Answered by AI
To what extent could Sacituzumab govitecan pose a hazard to individuals?
"The safety profile of Sacituzumab govitecan was assigned a score of 2, as this is only phase two trial. There are preliminary data demonstrating its safety but no evidence to attest to the drug's efficacy at this time."
Answered by AI
What medical condition is typically addressed by Sacituzumab govitecan?
"Sacituzumab govitecan may be employed as a therapeutic strategy, through pharmacological means, to combat small cell lung cancer."
Answered by AI
Has there ever been a similar research endeavor conducted before?
"Since 2008, the development of Sacituzumab govitecan has been advancing rapidly. Initially sponsored by Hoffmann-La Roche, a trial involving 720 participants was completed in 2008 leading to Phase 2 drug approval. Currently there are 380 ongoing studies encompassing 1717 cities and 74 countries across the world."
Answered by AI
Are there any locales in North America where this clinical investigation is being conducted?
"Currently, this medical trial is being conducted in 9 cities, including Philadelphia and New Lenox. To reduce the burden of having to travel far distances, it's best if you select a site that is nearby your home."
Answered by AI
Has Sacituzumab govitecan been the subject of any prior investigations?
"Sacituzumab govitecan was first trialed in 2008 at SCRI Tennessee Oncology Chattanooga, and there are now a total of 90 completed studies. Currently, 380 active trials are running across the United States with a large concentration based out of Philadelphia, Pennsylvania."
Answered by AI
Are there any vacancies for participation in this research endeavor?
"The details hosted on clinicaltrials.gov suggest that this medical study is still actively recruiting patients. It was posted online on July 2nd 2020 and the information has been updated as of May 25th 2022."
Answered by AI
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