Last updated on April 2019

ASCENT-Study of Sacituzumab Govitecan in Refractory/Relapsed Triple-Negative Breast Cancer


Brief description of study

This is an international, multi-center, open-label, randomized, Phase III study in patients with metastatic TNBC refractory or relapsing after at least 2 prior chemotherapies (including a taxane) for their metastatic disease. Patients meeting eligibility will be randomized 1:1 to receive either sacituzumab govitecan or treatment of physician choice (TPC) Patients will be treated until progression, unacceptable toxicity, study withdrawal, or death, whichever comes first. Tumor progression leading to treatment withdrawal will be assessed by the investigator. Starting with the initial dose of sacituzumab govitecan or TPC, Imaging assessments will be obtained at least every 8 weeks until the occurrence of progression of disease requiring discontinuation of further treatment. All patients, will be followed every 4 weeks during the first year and every 8 weeks thereafter for survival follow-up.

Detailed Study Description

This is an international, multi-center, open-label, randomized, Phase III study in patients with metastatic TNBC refractory or relapsing after at least 2 prior chemotherapies (including a taxane) for their metastatic disease.

The primary objective of this study is to compare the efficacy of sacituzumab govitecan to the treatment of physician's choice (TPC) as measured by progression-free survival (PFS) in patients with metastatic TNBC previously treated with at least two systemic chemotherapy regimens.

The secondary objectives of the study are to compare between the two treatment groups for:

  • Overall Survival (OS)
  • Independently-determined Objective Response Rate (ORR), duration of response and time to onset of response per RECIST 1.1 criteria
  • Quality of life
  • Safety (adverse events, safety laboratories, incidence of dose delays and dose reductions, treatment discontinuations due to adverse events) Exploratory objectives include exposure-response analysis for the efficacy (PFS and OS) and safety (incidence of Grade 3-5 adverse events, related to UGT1A1 endpoints).

Four-Hundred and eighty-eight patients are anticipated to be enrolled. Approximately 150 institutions will participate in this study, including sites in North America and Europe.

Clinical sites will use standard ASCO/CAP criteria for the pathological diagnosis of TNBC, defined as negative for estrogen receptor (ER), progesterone receptor (PR) and human epidermal growth factor receptor 2 (HER2). Receptor results will be based on local assessment. TNBC status will be reviewed centrally but these results are not required prior to determining eligibility.

BRCA 1&2 mutational status will be collected, if known. Baseline serum biomarkers (CA15-3, CA27-29, and CEA) will be measured. A single whole-blood sample will be also collected from all patients for determination of UGT1A1 genotype for retrospective assessment predicting of toxicity.

The Sponsor will request slides from prior (archived) biopsy or surgical specimens, particularly for immunohistology documentation of tumor Trop-2 expression and other appropriate tumor markers, including topoisomerase 1.

Patients meeting eligibility will be randomized 1:1 to receive either sacituzumab govitecan or treatment of physician choice (TPC), which needs to be selected prior to randomization from one of the 4 allowed regimens. Randomization will be stratified by number of prior chemotherapies for advanced disease (2-3 vs > 3) and geographical location (North America vs Europe).

Patients will be treated until progression, unacceptable toxicity, study withdrawal, or death, whichever comes first. Tumor progression leading to treatment withdrawal will be assessed by the investigator.

No crossover to sacituzumab govitecan treatment will be allowed after discontinuing treatment in the TPC arm, but otherwise there is no restriction on subsequent therapies that a patient may receive after discontinuing the study.

All patients, including those prematurely terminating study participation, will be followed every 4 weeks for survival follow-up.

Clinical Study Identifier: NCT02574455

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UZ Leuven

Leuven, Belgium
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Texas Oncology

Denton, TX United States
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Florence Lerebours

Saint-Cloud, France
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Research Medical Center

Kansas City, MO United States
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Florida Cancer Specialist

Bonita Springs, FL United States
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Gustave Roussy

Villejuif, France
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Tennessee Oncology, LLC

Dickson, TN United States
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Tennesee Oncology - PLLC

Chattanooga, TN United States
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Mayo, 200 First Street SW

Rochester, MN United States
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Maryland Oncology Hematology

Rockville, MD United States
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Tenesse Oncology - PLLC

Cleveland, TN United States
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Illinois Cancer Specialists

Arlington Heights, IL United States
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Yale School Of Medicine

New Haven, CT United States
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Miami Cancer Institute

Miami, FL United States
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Northside Hospital

Atlanta, GA United States
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Mayo Clinic

Rochester, MN United States
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Providence Medical Group

Portland, OR United States
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Hillman Cancer Center

Pittsburgh, PA United States
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Methodist Hospital

Houston, TX United States
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Texas Oncology

Plano, TX United States
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US Oncology

Tyler, TX United States
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Swedish Cancer Institute

Issaquah, WA United States
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Tennessee Ocology, LLC

Franklin, TN United States
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Tennessee Oncology, LLC

Gallatin, TN United States
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Tennessee Oncology, LLC

Hermitage, TN United States
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Tennessee Oncology, LLC

Lebanon, TN United States
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Tennessee Oncology, LLC

Murfreesboro, TN United States
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Tennessee Oncology, LLC

Nashville, TN United States
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Tennessee Ocology, LLC

Nashville, TN United States
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Tennessee Oncology, LLC

Shelbyville, TN United States
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Virginia Cancer Specialists, PC

Alexandria, VA United States
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Virginia Oncology Associates

Chesapeake, VA United States
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Virginia Cancer Specialists, PC

Gainesville, VA United States
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Virginia Oncology Associates

Newport News, VA United States
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Virginia Oncology Associates

Virginia Beach, VA United States
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Virginia Cancer Specialists, PC

Woodbridge, VA United States
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Florida Cancer Specialists

Bradenton, FL United States
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Florida Cancer Specialists

Cape Coral, FL United States
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Florida Cancer Specialists

Fort Myers, FL United States
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Florida Cancer Specialists

Port Charlotte, FL United States
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Florida Cancer Specialists

Sarasota, FL United States
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GCS/Annex

Atlanta, GA United States
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GCS/Canton

Canton, GA United States
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GCS/Stemmer

Decatur, GA United States
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GCS/Macon

Macon, GA United States
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GCS/Kennestone

Marietta, GA United States
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GCS/Northside

Sandy Springs, GA United States
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Maryland Oncology Hematology

Bethesda, MD United States
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Maryland Oncology Hematology

Brandywine, MD United States
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Maryland Oncology Hematology

Columbia, MD United States
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Maryland Oncology Hematology

Silver Spring, MD United States
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Mercy Hospital

Coon Rapids, MN United States
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Suburban Imaging Northwest

Coon Rapids, MN United States
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Suburban Imaging

Coon Rapids, MN United States
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Abbot Northwestern Hospital

Minneapolis, MN United States
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New York Oncology Hematology, P.C.

Clifton Park, NY United States
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Tenessee Oncology

Nashville, TN United States
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Swedish Cancer Institute

Edmonds, WA United States
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Swedish Cancer Institute

Seattle, WA United States
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Mayo Clinic Hospital

Phoenix, AZ United States
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Mayo Clinic Hospital

Scottsdale, AZ United States
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Sylvester Comprehensive Cancer Center

Deerfield Beach, FL United States
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UNC Health Care System

Chapel Hill, NC United States
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Recruitment Status: Open


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