Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Breast Neoplasms

Triple Negative Breast Neoplasms

Recurrence

Neoplasm, Residual

Breast Diseases

Skin Diseases

Disease Attributes

Neoplastic Processes

All Drugs and Chemicals

Antineoplastic Agents

Antibodies

Sacituzumab govitecan

Atezolizumab

Immunoglobulins

Immune Checkpoint Inhibitors

Antineoplastic Agents, Immunological

Immunoconjugates

Immunologic Factors

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

Atezolizumab is a type of antibody and is administered intravenously.

Sacituzumab govitecan is an antibody drug conjugate and is administered intravenously

Elizabeth A Mittendorf, MD, PhD

The purpose of this study is to determine if a combination of two drugs ipatasertib and atezolizumab works as a treatment for residual cancer in the breast or lymph nodes and have circulating tumor DNA in the blood.

This research study involves the following investigational drugs:

* Sacituzumab govitecan
* Atezolizumab

This is an open label single-arm phase II study to evaluate the combination therapy of the antibody drug conjugate, sacituzumab govitecan, and the anti-PD-L1 antibody, atezolizumab, in patients with triple negative breast cancer.

The research study procedures include screening for eligibility and study treatment including laboratory evaluations, stool collection and follow up visits.

This research study involves the following investigational drugs:

* Sacituzumab govitecan
* Atezolizumab

Participants will receive study treatment for 18 weeks and will be followed for every 6 months for 3 years.

It is expected that about 40 people will take part in this research study.

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug or drug combination works in treating a specific disease. "Investigational" means that the drug combination is being studied.

The U.S. Food and Drug Administration (FDA) has not approved atezolizumab (Tecentriq) for residual triple negative breast cancer but it has been approved for advanced triple negative breast cancer and other cancers. Atezolizumab is a protein that affects your immune system by blocking the PD-L1 pathway. The PD-L1 pathway controls your body's natural immune response, but for some types of cancer the immune system does not work as it should and is prevented from attacking tumors. Atezolizumab works by blocking the PD-L1 pathway, which may help your immune system identify and catch tumor cells.

The U.S. Food and Drug Administration (FDA) has not approved sacituzumab govitecan (Trodelvy) for your specific disease, but it has been approved for patients with metastatic triple-negative breast cancer who have been treated with 2 or more prior treatment regimens for their cancer. Sacituzumab govitecan is composed of a chemotherapy drug, called Irinotecan, which is attached to an antibody. Antibodies are proteins normally made by the immune system that bind to substances that don't belong in the body to prevent harm. The antibody in this study binds to certain types of cancer tumors.

Atezolizumab + Sacituzumab Govitecan to Prevent Recurrence in TNBC (ASPRIA)

A Single Arm Phase 2 Trial of Atezolizumab With Sacituzumab Govitecan to Prevent Recurrence in Triple Negative Breast Cancer (ASPRIA)

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Elizabeth Mittendorf, MD, PhD. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Clearance of tumor cfDNA after 18 weeks, it will be tested using a one-sided one-sample binomial exact test (alpha 5%) against a null hypothesis value of 7% false negatives.

Proportion of patients with undetectable circulating tumor cfDNA after 1 cycle of combination therapy

Proportion of patients with undetectable circulating tumor cfDNA after 3 cycles of combination therapy

Type, incidence and severity of adverse events (AEs) as graded by NCI CTCAE v5 criteria by 12 and 24 weeks.

Estimated disease-free survival (iDFS) Rate with 90% CI

Estimated metastasis free survival (DMFS) rate with 90% CI

Estimate overall survival rate with 90% CI

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Atezolizumab + Sacituzumab Govitecan to Prevent Recurrence in TNBC (ASPRIA)	NCT04434040	Breast Cancer Triple Negative... Residual Cancer Circulating Tum...	Atezolizumab Sacituzumab gov...	18 Years -	Dana-Farber Cancer Institute
Atezolizumab + Sacituzumab Govitecan to Prevent Recurrence in TNBC (ASPRIA)	NCT04434040	Breast Cancer Triple Negative... Residual Cancer Circulating Tum...	Atezolizumab Sacituzumab gov...	18 Years -	Dana-Farber Cancer Institute
Atezolizumab + Sacituzumab Govitecan to Prevent Recurrence in TNBC (ASPRIA)	NCT04434040	Breast Cancer Triple Negative... Residual Cancer Circulating Tum...	Atezolizumab Sacituzumab gov...	18 Years -	Dana-Farber Cancer Institute

Spots Global Cancer Trial Database for residual cancer