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

NCT04434040 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 20-028
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 7

Brief Summary

The purpose of this study is to determine if a combination of two drugs sacituzumab govitecan 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

Conditions

Breast Cancer; Triple Negative Breast Cancer; Residual Cancer; Circulating Tumor DNA

Keywords

Breast Cancer; Triple Negative Breast Cancer; Residual Cancer; Circulating Tumor DNA

Outcome Measures

Primary Outcomes (1)

• Rate of undetectable circulating tumor cfDNA- 6 Cycles

  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.

  18 Weeks

Secondary Outcomes (7)

• Rate of undetectable circulating tumor cfDNA - 1 Cycle

  3 weeks

• Rate of undetectable circulating tumor cfDNA - 3 Cycles

  9 weeks

• Number of Participants With Treatment-Related Adverse Events

  18 Weeks

• Invasive disease-free survival (iDFS) Rate

  3 years

• Distant metastasis free survival (DMFS) Rate

  3 years

Study Arms (1)

Atezolizumab and Sacituzumab govitecan

EXPERIMENTAL

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

Drug: Atezolizumab; Drug: Sacituzumab govitecan

Interventions

Atezolizumab DRUG

Atezolizumab is a type of antibody and is administered intravenously.

Also known as: Tecentriq

Atezolizumab and Sacituzumab govitecan

Sacituzumab govitecan DRUG

Sacituzumab govitecan is an antibody drug conjugate and is administered intravenously

Also known as: Trodelvy, IMMU-132

Atezolizumab and Sacituzumab govitecan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• HER2 negative in primary tumor pre-treatment by local pathology assessed according to current ASCO/CAP guidelines:
• In situ hybridization non-amplified (ratio of HER2 to CEP17 \< 2.0 or single probe average HER2 gene copy number \< 4 signals/cell), OR
• Immunohistochemistry (IHC) 0 or IHC 1+.
• ER and PR negative in primary tumor pre-treatment defined as \< 10% of cells expressing hormonal receptors via IHC analysis by local laboratory assessment.
• Patients must have received neoadjuvant chemotherapy prior to breast surgery.
• 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.
• Evidence of ctDNA in blood sample collected after completion of all local and systemic neoadjuvant therapy (preoperative chemotherapy, surgery and radiation), confirmed by central testing. Detection of any tumor specific mutations (TSMs) within the sample will be considered positive for purposes of study eligibility.
• Concurrent receipt of bone modifying agents (bisphosphonates or rank-ligand inhibitors)is allowed.
• Prior treatment with an immune checkpoint inhibitor in the neoadjuvant setting is permitted.
• ECOG Performance Status of 0 or 1
• Men and women, age ≥ 18 years
• Adequate hematologic and organ function defined by the following:
• ANC ≥ 1.5 × 109/L (1500/μL) without granulocyte colony-stimulating factor support
• WBC count ≥ 2.5 × 109/L (2500/μL)

You may not qualify if:

• Prior therapy with sacituzumab govitecan, irinotecan, or any topoisomerase I-containing antibody-drug conjugates at any time for early stage disease.
• Receipt of adjuvant chemotherapy (all chemotherapy prior to registration must have occurred in the preoperative setting)
• Prior hypersensitivity to atezolizumab or the excipients of atezolizumab or sacituzumab govitecan
• Clinical or radiographic evidence of metastatic disease
• Residual DCIS or LCIS alone without invasive cancer OR pT0N0i and pT0N1mic residual disease
• Concurrent enrollment on another investigational therapy trial
• Prior treatment-related toxicity must be resolved to ≤ Grade 1 prior to study enrollment with the exception of alopecia and peripheral neuropathy, prior to study enrollment.
• Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study
• Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment Patients receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible for the study.
• Intercurrent illness including, but not limited to: ongoing or active infection requiring systemic therapy, active tuberculosis, serious liver disease such as cirrhosis, active bleeding diathesis, uncontrolled Type I or Type II diabetes mellitus, Grade ≥ 2 uncontrolled or untreated hypercholesterolemia, Hypertriglyceridemia or hypercalcemia
• Cardiovascular disease including: congestive heart failure of New York Heart Association Class III or IV, myocardial infarction (\<6 months prior to enrollment) unstable angina pectoris, serious uncontrolled cardiac arrhythmia or any other clinically significant cardiac disease, in the opinion of the investigator
• History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
• Active (acute or chronic) autoimmune disease of any type except hypothyroidism on a thyroid-replacement hormone, celiac disease, or well-controlled psoriasis, eczema, lichen simplex chronicus or vitiligo.
• Impairment of gastrointestinal function or active gastrointestinal disease that may significantly alter the absorption of the study agents (e.g., ulcerative disease, uncontrolled nausea(\> grade 2), vomiting (\> grade 2), diarrhea (\> grade 2), malabsorption syndrome or small bowel resection).
• Congenital long QT syndrome or screening QT interval corrected through use of Fridericia's formula \>480 ms.

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• Genentech, Inc.: collaborator
• Stand Up To Cancer: collaborator

Study Sites (7)

University of California San Francisco

San Francisco, California, 94115, United States

RECRUITING

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

WITHDRAWN

University of Chicago Comprehensive Cancer Center at Silver Cross Hospital

New Lenox, Illinois, 60451, United States

WITHDRAWN

University of Chicago Medical Center for Advanced Care Orland Park

Orland Park, Illinois, 60462, United States

WITHDRAWN

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

University of Pennsylvania-Abramson Cancer Center

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Triple Negative Breast Neoplasms; Neoplasm, Residual

Interventions

atezolizumab; sacituzumab govitecan

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Elizabeth A Mittendorf, MD, PhD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizabeth A Mittendorf, MD, PhD

CONTACT

617-713-2294; emittendorf@bwh.harvard.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 14, 2020
• First Posted: June 16, 2020
• Study Start: July 2, 2020
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

Locations

US (7)