What is the mechanism of action of this treatment?

Sacituzumab Govitecan and Atezolizumab are promising treatments for breast cancer due to their targeted mechanisms of action. Sacituzumab Govitecan is an antibody-drug conjugate that targets the Trop-2 protein on cancer cells, delivering a cytotoxic agent directly to these cells, thereby minimizing damage to healthy tissues. Atezolizumab is a PD-L1 inhibitor that enhances the immune system's ability to recognize and attack cancer cells by blocking the interaction between PD-L1 on tumor cells and PD-1 on T-cells. These targeted therapies are significant for breast cancer patients as they offer the potential for more effective treatment with fewer side effects compared to traditional chemotherapy.

What side effects are associated with this type of intervention?

Sacituzumab Govitecan, an antibody-drug conjugate targeting Trop-2, commonly causes side effects such as neutropenia, diarrhea, nausea, fatigue, and alopecia. Atezolizumab, a PD-L1 inhibitor, is associated with immune-related side effects including fatigue, rash, diarrhea, and potential inflammation of organs such as the lungs (pneumonitis) and liver (hepatitis). These side effects are typical of antibody-drug conjugates and immune checkpoint inhibitors used in breast cancer treatment.

What prior FDA approvals exist?

Sacituzumab Govitecan, an antibody-drug conjugate targeting Trop-2, has been FDA-approved for the treatment of metastatic triple-negative breast cancer (TNBC) after at least two prior therapies. Atezolizumab, a PD-L1 inhibitor, has also received FDA approval for use in combination with nab-paclitaxel for the treatment of PD-L1-positive, metastatic TNBC. These approvals highlight the advancement in targeted therapies and immunotherapies for breast cancer, providing new options for patients with specific subtypes of the disease.

What other types of research exist?

Promising novel alternatives for breast cancer treatment in 2024 include: 1) Trastuzumab Deruxtecan (an ADC targeting HER2) which has shown efficacy in HER2-positive breast cancer, and 2) Pembrolizumab (a PD-1 inhibitor) which has been effective in various cancers including triple-negative breast cancer. These treatments offer new mechanisms of action and have demonstrated positive outcomes in clinical trials.

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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.

Must not have

Clinical or radiographic evidence of metastatic disease

History of prior invasive breast cancer in either breast.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a combination of two drugs for patients with a difficult-to-treat type of breast cancer. One drug targets and delivers chemotherapy directly to cancer cells, while the other helps the immune system recognize and attack these cells.

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer has spread to other parts of my body.

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I have had breast cancer before.

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I do not have any serious ongoing illnesses like infections needing treatment, serious liver disease, uncontrolled diabetes, or high cholesterol.

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I have not received a live vaccine in the last 4 weeks and do not plan to while on the study treatment.

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My breast cancer is non-invasive or very early stage after surgery.

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I am not allergic to any study drugs or their components.

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I have a stomach or intestine problem that affects how I absorb medicine.

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I have a heart condition known as long QT syndrome or my heart's electrical recovery time is longer than normal.

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I have never been treated with sacituzumab govitecan, irinotecan, or similar drugs.

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I received chemotherapy before surgery.

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I haven't had major surgery in the last 4 weeks and don't expect to need one during the study.

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I am not pregnant and will not breastfeed during the study.

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I haven't taken strong UGT1A1 affecting drugs recently.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Rate of undetectable circulating tumor cfDNA- 6 Cycles

Secondary study objectives

Distant metastasis free survival (DMFS) Rate

Invasive disease-free survival (iDFS) Rate

Number of Participants With Treatment-Related Adverse Events

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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

2016

Completed Phase 3

~5860

Sacituzumab govitecan

2017

Completed Phase 3

~530

0 / 20Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Sacituzumab Govitecan and Atezolizumab are promising treatments for breast cancer due to their targeted mechanisms of action. Sacituzumab Govitecan is an antibody-drug conjugate that targets the Trop-2 protein on cancer cells, delivering a cytotoxic agent directly to these cells, thereby minimizing damage to healthy tissues. Atezolizumab is a PD-L1 inhibitor that enhances the immune system's ability to recognize and attack cancer cells by blocking the interaction between PD-L1 on tumor cells and PD-1 on T-cells. These targeted therapies are significant for breast cancer patients as they offer the potential for more effective treatment with fewer side effects compared to traditional chemotherapy.