AzTrials
AzTrials

Triple Negative Breast CancerPhase 3NCT03281954

Clinical Trial of Neoadjuvant Chemotherapy With Atezolizumab or Placebo in Patients With Triple-Negative Breast Cancer Followed After Surgery by Atezolizumab or Placebo

A Phase 3 study testing Atezolizumab in people with Triple Negative Breast Cancer, run by NSABP Foundation Inc at 217 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The main purpose of this study is to learn if the usual chemotherapy given before surgery (neoadjuvant therapy) for breast cancer plus the experimental drug, atezolizumab, is better than the usual chemotherapy plus a placebo. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Triple Negative Breast Cancer
What is being tested?
Atezolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,550 participants
Where
217 sitesin 2 countries
Study dates
19 Dec 2017to 30 Nov 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The patient must have consented to participate and, prior to beginning specific study procedures, must have signed and dated an appropriate IRB-approved consent form that conforms to federal and institutional guidelines for study treatment and for submission of tumor samples from a research biospy as required by NSABP B-59/GBG 96-GeparDouze for baseline correlative science studies.
  • The diagnosis of invasive adenocarcinoma of the breast must have been made by core needle biopsy.
  • Local testing on the diagnostic core must have determined the tumor to be ER-negative, PgR-negative, and HER2-negative by current ASCO/CAP guidelines. (If local testing has determined a tumor to be HER2 equivocal or to have a borderline ER/PgR status (% IHC staining < 10% for both) and other eligibility criteria are met, material may be submitted for central testing to determine eligibility.)
  • Central testing for ER, PgR, and HER2 will be performed, and the tumor must be determined to be ER-negative, PgR-negative, and HER2-negative by current ASCO/CAP Guidelines Recommendations.
  • The tumor specimen used for central ER, PgR, and HER2 testing must also be used for central testing of PD-L1 status using the Ventana PD-L1 testing result including PD-L1 indeterminate Patients will be classifies as positive, negative, or indeterminate for stratification purposes.
  • Patients must be ≥ 18 years old.
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  • Patient may be female or male.
  • The ECOG performance status must be 0-1.
  • The primary tumor can be clinical stage T2 or T3, if clinically node negative according to AJCC 7th Edition. If the regional lymph nodes are cN1 and cytologically or histologically positive or cN2-N3 with or without a biopsy, the primary breast tumor can be clinically T1c, T2, or T3.
  • Ipsilateral axillary lymph nodes must be evaluated by imaging (mammogram, ultrasound, and/or MRI) within 84 days prior to study entry. If suspicious or abnormal, FNA or core biopsy is recommended. Findings of these evaluations will be used to define the nodal status prior to study entry according to the following criteria:
  • Nodal status - negative (Imaging of the axilla is negative; Imaging is suspicious or abnormal but the FNA or core biopsy of the questionable node[s] on imaging is negative)
  • Nodal status - positive (FNA or core biopsy of the node[s] is cytologically or histologically suspicious or positive; Imaging is suspicious or abnormal but FNA or core biopsy was not performed.)
  • Patients with synchronous bilateral or multicentric HER2-negative breast cancer are eligible as long as the highest risk tumor is ER-negative and PgR-negative and meets stage eligibility criteria. All of the other invasive tumors must also be HER2-negative by ASCO/CAP Guidelines based on local testing. Central testing to confirm TNBC status is only required for the highest risk tumor.
  • Blood counts performed within 28 days prior to randomization must meet the following criteria:
  • ANC must be ≥ 1500/mm3;
  • platelet count must be ≥ 100,000/mm3; and
  • hemoglobin must be ≥10 g/dL.
  • The following criteria for evidence of adequate hepatic function performed within 28 days prior to randomization must be met:
  • total bilirubin must be ≤ ULN for the lab unless the patient has a bilirubin elevation > ULN to 1.5 x ULN due to Gilbert's disease or similar syndrome involving slow conjugation of bilirubin; and
  • alkaline phosphatase must be ≤ 2.5 x ULN for the lab; and
  • AST and ALT must be ≤ 1.5 x ULN for the lab.
  • Patients with AST or ALT or alkaline phosphatase > ULN are eligible for inclusion in the study if liver imaging (CT, MRI, abdominal ultrasound, PET-CT, or PET scan) performed within 28 days prior to randomization does not demonstrate metastatic disease and the requirements in criterion (just above) are met.
  • Patients with alkaline phosphatase that is > ULN but less than or equal to 2.5 x ULN or with unexplained bone pain are eligible for inclusion in the study if bone imaging (bone scan, PET-CT scan, or PET scan) supported by additional studies when indicated (CT, x-ray, MRI) performed within 28 days prior to randomization does not demonstrate metastatic disease.
  • Patients with N2 or N3 nodal disease or T3 primary disease must undergo liver and bone imaging (as described in 4.1.13 and 4.1.14) within 28 days prior to randomization, irrespective of baseline lab results, and studies must not demonstrate metastatic disease. Chest imaging with chest x-ray PA and Lateral, CT of the chest, or PET-CT must also be performed.
  • Creatinine clearance ≥ 50 mL/min (see Section 7.2.1 for instructions regarding calculation of creatinine clearance) performed within 28 days prior to randomization.
  • PT/INR ≤ ULN within 28 days of randomization. Patients receiving therapeutic anti-coagulants are not eligible.
  • A serum TSH and AM (morning) cortisol performed within 28 days prior to randomization to obtain a baseline value. Patients with abnormal TSH or AM cortisol baseline levels should be further evaluated and managed per institutional standards. Asymptomatic patients who require initiation or adjustment of medication or are followed without initiating treatment based on endocrinologist's recommendations are eligible.
  • LVEF assessment must be performed within 42 days prior to randomization. (LVEF assessment performed by echocardiogram is preferred; however, MUGA scan may be substituted based on institutional preferences.) The LVEF must be ≥ 55% regardless of the cardiac imaging facility's lower limit of normal.
  • For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 5 months after the last dose of atezolizumab/placebo or 12 months after the last dose of chemotherapy.
  • A woman is considered to be of childbearing potential if she is not postmenopausal, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus).
  • Examples of contraceptive methods with a failure rate of < 1% per year include: bilateral tubal ligation; male partner sterilization; hormonal contraceptives that inhibit ovulation; hormone-releasing intrauterine devices; copper intrauterine devices.
  • The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.
  • Patient must be willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.

Who cannot join

  • Excisional biopsy or lumpectomy performed prior to study entry.
  • FNA alone to diagnose the breast cancer.
  • Surgical axillary staging procedure prior to randomization. Exception: FNA or core biopsy of an axillary node is permitted for any patient. A pre-neoadjuvant therapy sentinel lymph node biopsy for patients with clinically negative axillary nodes is prohibited.
  • Definitive clinical or radiologic evidence of metastatic disease.
  • Previous history of contralateral invasive breast cancer. (Patients with synchronous and/or previous contralateral DCIS or LCIS are eligible.)
  • Previous history of ipsilateral invasive breast cancer or ipsilateral DCIS. (Patients with synchronous or previous ipsilateral LCIS are eligible.)
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  • History of non-breast malignancies (except for in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin) within 5 years prior to study entry.
  • Treatment including radiation therapy, chemotherapy, or targeted therapy, for the currently diagnosed breast cancer prior to randomization.
  • Previous therapy with anthracyclines or taxanes for any malignancy.
  • Cardiac disease (history of and/or active disease) that would preclude the use of the drugs included in the treatment regimens. This includes but is not confined to:
  • Active cardiac disease: angina pectoris that requires the use of anti-anginal medication; ventricular arrhythmias except for benign premature ventricular contractions; supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication; conduction abnormality requiring a pacemaker; valvular disease with documented compromise in cardiac function; or symptomatic pericarditis.
  • History of cardiac disease: myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of left ventricular function within 6 months prior to randomization; history of documented CHF; or documented cardiomyopathy.
  • Uncontrolled hypertension defined as sustained systolic BP > 150 mmHg or diastolic BP > 90 mmHg. (Patients with initial BP elevations are eligible if initiation or adjustment of BP medication lowers pressure to meet entry criteria.) Patients requiring ≥ 3 BP medications are not eligible.
  • History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins.
  • Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells.
  • Known allergy or hypersensitivity to the components of the atezolizumab formulation.
  • Known allergy or hypersensitivity to the components of the doxorubicin, epirubicin, cyclophosphamide, carboplatin, or paclitaxel formulations.
  • Known allergy or hypersensitivity to liposomal or pegylated G-CSF formulations.
  • Active or history of autoimmune disease or immune deficiency, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis for a more comprehensive list of autoimmune diseases and immune deficiencies) with the following exceptions:
  • Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone may be eligible for this study.
  • Patients with controlled Type 1 diabetes mellitus on a stable dose of insulin regimen may be eligible for this study.
  • Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are permitted provided all of following conditions are met: Rash must cover < 10% of body surface area; Disease is well controlled at baseline and requires only low-potency topical corticosteroids; No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12 months.
  • History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.
  • Patients known to be HIV positive.
  • Active hepatitis B virus (HBV) infection, defined as having a positive hepatitis B surface antigen (HBsAg) test at screening. Patients with a past or resolved HBV infection, defined as having a negative HBsAg test and a positive total hepatitis B core antibody (HBcAb) test at screening, are eligible for the study if active HBV infection is ruled out on the basis of HBV DNA viral load per local guidelines.
  • Active hepatitis C virus (HCV) infection, defined as having a positive HCV antibody test at screening confirmed by a polymerase chain reaction (PCR) positive for HCV RNA.
  • Patients with clinically active tuberculosis.
  • Severe infection within 28 days prior to randomization, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia.
  • Prior allogeneic stem cell or solid organ transplantation.
  • Administration of a live, attenuated vaccine within 28 days prior to randomization or anticipation that such vaccine will be required during the study. Patients must agree not to receive live, attenuated influenza vaccine (e.g., FluMist) within 28 days prior to randomization, during treatment or within 5 months following the last dose of atezolizumab/placebo.
  • Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications.
  • Prior treatment with CD137 agonists or immune checkpoint-blockade therapies, including anti-CD40, anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies.
  • Treatment with systemic immunosuppressive medications (including but not limited to interferons, IL-2) within 28 days or 5 half-lives of the drug, whichever is longer, prior to randomization.
  • Treatment with systemic immunosuppressive medications (including but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis [anti-TNF] factor agents) within 14 days prior to randomization or anticipation of need for systemic immunosuppressive medications during the study.
  • Nervous system disorder (paresthesias, peripheral motor neuropathy, or peripheral sensory neuropathy) ≥ Grade 2, per the CTCAE v4.0.
  • Symptomatic peripheral ischemia.
  • Pregnancy or lactation at the time of randomization or intention to become pregnant during the study. (Note: Negative serum pregnancy test must be obtained within 14 days prior to randomization).
  • Use of any investigational agent within 28 days prior to randomization.

Trial locations and contacts

217 sites in 2 countries.

217 sites in 2 countries

United States212 sites

  • New York Oncology Hematology PC

    Albany, New York, 12206

  • Aultman Alliance Cancer Center

    Alliance, Ohio, 44601

  • Kaiser Permanente-Anaheim

    Anaheim, California, 92806

  • Katmai Oncology Group

    Anchorage, Alaska, 99508

  • MRCC Auburn

    Auburn, Washington, 98001

  • Dell Seton Medical Center at the University of Texas-Seton Infusion Center

    Austin, Texas, 72701

  • Mount Sinai Comprehensive Cancer Center Aventura

    Aventura, Florida, 33180

  • Kaiser Permanente-Baldwin Park

    Baldwin Park, California, 91706

  • Greater Baltimore Medical Center

    Baltimore, Maryland, 21204

  • Medstar Union Memorial Hospital

    Baltimore, Maryland, 21218

  • Harry and Jeanette Weinberg Cancer Center at Franklin Square

    Baltimore, Maryland, 21237

  • UPMC Hillman Cancer Center-Beaver

    Beaver, Pennsylvania, 15009

  • Texas Oncology Bedford

    Bedford, Texas, 76022

  • Kaiser Permanente-Bellflower

    Bellflower, California, 90706

  • Maryland Oncology Hematology

    Bethesda, Maryland, 20817

  • Broome Oncolgy

    Binghamton, New York, 13905

  • Illinois Cancer Care-Bloomington

    Bloomington, Illinois, 61704

  • Maryland Oncology - Hematology Brandywine

    Brandywine, Maryland, 20613

  • Wellmont Medical Associates-Oncology and Hematology

    Bristol, Virginia, 24201

  • Henry Ford Cancer Institute Brownstown

    Brownstown, Michigan, 48183

  • Aurora Cancer Care-Southern Lakes

    Burlington, Wisconsin, 53105

  • Aultman Hospital

    Canton, Ohio, 44710

  • Aultman Medical Group Hematology and Oncology

    Canton, Ohio, 44710

  • Texas Oncology Carrollton

    Carrollton, Texas, 75010

  • RHOA of Cary

    Cary, North Carolina, 27518

  • Waverly Hematology Oncology

    Cary, North Carolina, 27518

  • Mercy Medical Center Hall-Perrine Cancer Center

    Cedar Rapids, Iowa, 52403

  • Cancer Center of Kansas - Chanute

    Chanute, Kansas, 66720

  • CAMC Health Education and Research Institute

    Charleston, West Virginia, 25304

  • Carolinas Medical Center-Levine Cancer Insitute

    Charlotte, North Carolina, 28204

  • Levine Cancer Center Institute Pineville

    Charlotte, North Carolina, 28210

  • John H. Stroger, Jr. Hospital of Cook County

    Chicago, Illinois, 60612

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Affiliated Oncologists

    Chicago Ridge, Illinois, 60415

  • Henry Ford Cancer Institute Macomb Hospital

    Clinton Township, Michigan, 48038

  • Arrowhead Regional Medical Center

    Colton, California, 92324

  • Maryland Oncology - Hematology PA

    Columbia, Maryland, 21044

  • University of Missouri-Ellis Fischel Cancer Center

    Columbia, Missouri, 65212

  • The Ohio State University Wexner Medical Center-Investigational Drug Service Oncology

    Columbus, Ohio, 43210

  • The Stephanie Speilman Comprehensive Breast Center

    Columbus, Ohio, 43212

  • UPMC Hillman Cancer Center - Passavant North

    Cranberry Township, Pennsylvania, 16066

  • Texas Oncology - Methodist Dallas Cancer Center

    Dallas, Texas, 75203

  • Texas Oncology - Medical City Dallas

    Dallas, Texas, 75230

  • Texas Oncology Dallas Presbyterian Hospital

    Dallas, Texas, 75231

  • Henry Ford Medical Center Fairlane

    Dearborn, Michigan, 48126

  • Cancer Care Specialists of Central Illinois

    Decatur, Illinois, 62526

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • Texas Oncology Denton

    Denton, Texas, 76201

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Cancer Center of Kansas - Dodge City

    Dodge City, Kansas, 67801

  • City of Hope

    Duarte, California, 91010

  • Gwinnett Hospital System Center for Cancer Care

    Duluth, Georgia, 30096

  • Michigan State University

    East Lansing, Michigan, 48823

  • Crossroads Cancer Center

    Effingham, Illinois, 62401

  • Susan B. Allen Memorial Hosptial

    El Dorado, Kansas, 67042

  • Emhurst Memorial Nancy W. Knowles Cancer Center

    Elmhurst, Illinois, 60126

  • Ephrata Cancer Center

    Ephrata, Pennsylvania, 17522

  • Allegheny Cancer Institute St. Vincent

    Erie, Pennsylvania, 16505

  • St. Vincent Hospital

    Erie, Pennsylvania, 16544

  • Willamette Valley Cancer Institute and Research Center

    Eugene, Oregon, 97401

  • Sanford Roger Maris Cancer Center

    Fargo, North Dakota, 58122

  • UPMC Cancer Center Horizon

    Farrell, Pennsylvania, 16121

  • Texas Oncology Flower Mound

    Flower Mound, Texas, 75028

  • Aurora Health Center Fond du Lac

    Fond du Lac, Wisconsin, 54937

  • Kaiser Permanente-Fontana

    Fontana, California, 92335

  • Fort Wayne Medical Oncology and Hematology Inc (W. Jefferson Blvd)

    Fort Wayne, Indiana, 46804

  • Fort Wayne Medical Oncology and Hematology Inc (Parkview Plaza)

    Fort Wayne, Indiana, 46845

  • Maryland Oncology - Hematology Frederick

    Frederick, Maryland, 21702

  • Illinois Cancer Care-Galesburg

    Galesburg, Illinois, 61401

  • RHOA of Garner

    Garner, North Carolina, 27529

  • Aurora Cancer Care-Germantown Health Center

    Germantown, Wisconsin, 53022

  • Wellspan Medical Oncology

    Gettysburg, Pennsylvania, 17325

  • MRCC Gig Harbor

    Gig Harbor, Washington, 98335

  • Aurora Cancer Care-Grafton

    Grafton, Wisconsin, 53024

  • Aurora BayCare Medical Center

    Green Bay, Wisconsin, 54311

  • UPMC Hillman Cancer Center- Mountain View

    Greensburg, Pennsylvania, 15601

  • UPMC Cancer Center Greenville

    Greenville, Pennsylvania, 16125

  • Gibbs Cancer Center and Research Institute - Pelham

    Greer, South Carolina, 29651

  • Meritus Center for Clinical Research

    Hagerstown, Maryland, 21742

  • Kaiser Permanente-Harbor City

    Harbor City, California, 90710

  • UNC Regional Physicians Hematology and Oncolgoy

    High Point, North Carolina, 27262

  • Memorial Healthcare System Office of Human Research

    Hollywood, Florida, 33021

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Houston Methodist Cancer Center

    Houston, Texas, 77030

  • Harris Health System-Smith Clinic

    Houston, Texas, 77054

  • Cancer Center at Mercy - W. Laurel

    Independence, Kansas, 67301

  • Kaiser Permanente-Irvine

    Irvine, California, 92618

  • Henry Ford Allegiance Health

    Jackson, Michigan, 49201

  • AHN Cancer Institute at Jefferson

    Jefferson Hills, Pennsylvania, 15025

  • Broome Oncology

    Johnson City, New York, 13790

  • Wellmont Cancer Institute

    Johnson City, Tennessee, 37601

  • St. Bernard's Medical Center

    Jonesboro, Arkansas, 72401

  • Ochsner Medical Center-Kenner

    Kenner, Louisiana, 70065

  • Aurora Cancer Care-Kenosha South

    Kenosha, Wisconsin, 53142

  • Kingman Community Hospital

    Kingman, Kansas, 67068

  • Wellmont Cancer Institute

    Kingsport, Tennessee, 37660

  • Maryland Oncology - Hematology PA

    Lanham, Maryland, 20706

  • Michigan State University-Breslin Cancer Center

    Lansing, Michigan, 48910

  • Gwinnett Hospital System Center for Cancer Care

    Lawrenceville, Georgia, 30046

  • Seechler Family Cancer Center

    Lebanon, Pennsylvania, 17042

  • Virginia Cancer Care Specialist

    Leesburg, Virginia, 20176

  • Southwest Medical Center

    Liberal, Kansas, 67901

  • Cancer and Blood Specialty Clinic

    Los Alamitos, California, 90720

  • Kaiser Permanente-Sunset

    Los Angeles, California, 90027

  • Kaiser Permanente-West Los Angeles

    Los Angeles, California, 90034

  • Norton Cancer Institute-Downtown

    Louisville, Kentucky, 40202

  • Norton Cancer Institute-Norton Healthcare Pavilion

    Louisville, Kentucky, 40202

  • University of Louisville-James Graham Brown Cancer Center

    Louisville, Kentucky, 40202

  • Baptist Health Louisville; Consultants in Blood Disorders and Cancer

    Louisville, Kentucky, 40207

  • Norton Cancer Institute-St Matthews

    Louisville, Kentucky, 40207

  • Norton Cancer Institute-Brownsboro

    Louisville, Kentucky, 40241

  • Centra Lynchburg Hematology Oncology

    Lynchburg, Virginia, 24501

  • West Jefferson Medical Center Cancer Center

    Marrero, Louisiana, 70072

  • Texas Oncology - McAllen South Second

    McAllen, Texas, 78503

  • McPherson Center for Health

    McPherson, Kansas, 67460

  • Bon Secours Richmond Community Hospital Medical Oncology Associates at Memorial Regional Medical Center

    Mechanicsville, Virginia, 23116

  • Mount Sinai Comprehensive Cancer Center

    Miami Beach, Florida, 33140

  • Texas Oncology Midland Allison Cancer Center

    Midland, Texas, 79701

  • Bon Secours St Francis Medical Center

    Midlothian, Virginia, 23114

  • Aurora Cancer Care

    Milwaukee, Wisconsin, 53209

  • Aurora Cancer Care-Milwaukee South

    Milwaukee, Wisconsin, 53215

  • Aurora St. Lukes Medical Center-Pharmacy Only

    Milwaukee, Wisconsin, 53215

  • Aurora West Allis Medical Center

    Milwaukee, Wisconsin, 53227

  • Aurora Sinai Medical Center

    Milwaukee, Wisconsin, 53233

  • University of South Alabama Mitchell Cancer Institute

    Mobile, Alabama, 36604

  • Forbes Regional Hospital

    Monroeville, Pennsylvania, 15146

  • UPMC Hillman Cancer Center UPMC East-Monroeville

    Monroeville, Pennsylvania, 15146

  • West Virginia University

    Morgantown, West Virginia, 26506

  • UPMC Hillman Cancer Center Norwin

    N. Huntingdon, Pennsylvania, 15642

  • Edward Cancer Center

    Naperville, Illinois, 60540

  • UPMC Hillman Cancer Center New Castle

    New Castle, Pennsylvania, 16105

  • University Medical Center New Orleans

    New Orleans, Louisiana, 70112

  • Ochsner Medical Center

    New Orleans, Louisiana, 70121

  • Newark Beth Israel Medical Center

    Newark, New Jersey, 07112

  • Newton Medical Center

    Newton, Kansas, 67114

  • Southwest Virginia Regional Cancer Center

    Norton, Virginia, 24273

  • Henry Ford Medical Center Columbus

    Novi, Michigan, 48377

  • UF Health Cancer Center at Orlando Health

    Orlando, Florida, 32806

  • Vince Lombardi Cancer Clinic Oshkosh

    Oshkosh, Wisconsin, 54904

  • Illinois Cancer Care-Ottawa

    Ottawa, Illinois, 61350

  • Kaiser Permanente-Panorama City

    Panorama City, California, 91402

  • St. Bernard's Medical Center

    Paragould, Arkansas, 72450

  • Labette Health

    Parsons, Kansas, 67357

  • Illinois Cancer Care PC

    Peoria, Illinois, 61615

  • Illinois Cancer Care-Peru

    Peru, Illinois, 61354

  • FirstHealth of the Carolinas FirstHealth Outpatient Cancer Center

    Pinehurst, North Carolina, 28374

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • WPAON at AGH

    Pittsburgh, Pennsylvania, 15212

  • WPAON at WPH

    Pittsburgh, Pennsylvania, 15212

  • Magee-Women's Hospital of Pittsburgh

    Pittsburgh, Pennsylvania, 15213

  • Western Pennsylvania Hospital

    Pittsburgh, Pennsylvania, 15224

  • UPCI Investigational Drug Services

    Pittsburgh, Pennsylvania, 15232

  • UPMC Hillman Cancer Center @ Passavant - HOA

    Pittsburgh, Pennsylvania, 15237

  • UPMC Hillman Cancer Center @ Passavant - OHA

    Pittsburgh, Pennsylvania, 15237

  • UPMC Hillman Cancer Center-Upper Saint Clair

    Pittsburgh, Pennsylvania, 15243

  • Berkshire Hematology Oncology Services at Berkshire Medical Center Cancer and Infusion Center

    Pittsfield, Massachusetts, 01201

  • Edward Cancer Center Plainfield

    Plainfield, Illinois, 60585

  • Texas Oncology Plano

    Plano, Texas, 75075

  • Kaiser Permanente Northwest-Oncology/Hematology

    Portland, Oregon, 97227

  • Health Quest Medical Practice

    Poughkeepsie, New York, 12601

  • Vassar Brothers Medical Center

    Poughkeepsie, New York, 12601

  • Pratt Regional Medical Center

    Pratt, Kansas, 67124

  • Women's and Infants Hospital

    Providence, Rhode Island, 02905

  • MRCC Puyallup

    Puyallup, Washington, 98372

  • Aurora Cancer Care-Racine

    Racine, Wisconsin, 53406

  • Rex Cancer Center

    Raleigh, North Carolina, 27607

  • RHOA of Blue Ridge

    Raleigh, North Carolina, 27607

  • RCC of Wakefield

    Raleigh, North Carolina, 27614

  • Bon Secours Richmond Community Hospital Oncology Associates at St. Mary's Hospital

    Richmond, Virginia, 23226

  • Kaiser Permanente-Riverside

    Riverside, California, 92505

  • Maryland Oncology Hematology

    Rockville, Maryland, 20850

  • Nash UNC Health Care - Danny Talbott Cancer Center

    Rocky Mount, North Carolina, 28704

  • Cancer Center of Kansas - Salina

    Salina, Kansas, 67401

  • Kaiser Permanente Medical Group

    San Diego, California, 92108

  • Kaiser Permanente-Zion

    San Diego, California, 92120

  • Kaiser Permanente - Otay

    San Diego, California, 92153

  • Kaiser Permanente- San Marcos

    San Marcos, California, 92078

  • UPMC Cancer Center Northwest

    Seneca, Pennsylvania, 16346

  • Vince Lombardi Cancer Clinic Sheboygan

    Sheboygan, Wisconsin, 53081

  • Capital Hematology Oncology Associates

    Silver Spring, Maryland, 20904

  • Holy Cross Hospital

    Silver Spring, Maryland, 20910

  • Sanford Cancer Center Oncology Clinic

    Sioux Falls, South Dakota, 57104

  • Avera Cancer Institute-Sioux Falls

    Sioux Falls, South Dakota, 57105

  • Avera Cancer Institute

    Sioux Falls, South Dakota, 57105

  • Gwinnett Hospital System Center for Cancer Care

    Snellville, Georgia, 30078

  • City of Hope - South Pasadena

    South Pasadena, California, 91030

  • Spartanburg Medical Center

    Spartanburg, South Carolina, 29303

  • Aurora Medical Center in Summit

    Summit, Wisconsin, 53066

  • Cancer Care Specialists of Central Illinois-Swansea

    Swansea, Illinois, 62226

  • MultiCare Health System

    Tacoma, Washington, 98405

  • MultiCare Institute for Research & Innovation

    Tacoma, Washington, 98405

  • Texas Oncology - The Woodlands

    The Woodlands, Texas, 77380

  • Northwest Cancer Specialists

    Tigard, Oregon, 97223

  • Torrance Memorial Physician Network

    Torrance, California, 90505

  • University of Maryland, St. Joseph Medical Center

    Towson, Maryland, 21204

  • Vince Lombardi Cancer Clinic-Two Rivers

    Two Rivers, Wisconsin, 54241

  • UPMC Hillman Cancer Center - Uniontown

    Uniontown, Pennsylvania, 15401

  • City of Hope - Upland

    Upland, California, 91786

  • MD Anderson Cancer Center at Cooper

    Voorhees Township, New Jersey, 08043

  • UPMC Hillman Cancer Center-Washington

    Washington, Pennsylvania, 15301

  • Aurora Cancer Care

    Wauwatosa, Wisconsin, 53226

  • Henry Ford Hospital W Bloomfield

    West Bloomfield, Michigan, 48322

  • Wexford Health & Wellness Pavilion

    Wexford, Pennsylvania, 15090

  • Maryland Oncology Hematology

    Wheaton, Maryland, 20902

  • PIH Health

    Whittier, California, 90602

  • Cancer Center of Kansas - Wichita

    Wichita, Kansas, 67214

  • Cancer Center of Kansas

    Wichita, Kansas, 67214

  • Winfield Healthcare Center

    Winfield, Kansas, 67156

  • Kaiser Permanente-Woodland Hills

    Woodland Hills, California, 91367

  • Henry Ford Cancer Institute Wyandotte Hospital

    Wyandotte, Michigan, 48192

  • Cancer Care Associates of York

    York, Pennsylvania, 17403

  • Wellspan Health-York Cancer Center Oncology Research

    York, Pennsylvania, 17403

Other trials in United States

Canada5 sites

  • CIUSSS de l'Est-de-l'Ile-de-Montreal-Hopital-Maisonneuve-Rosemont

    Montreal, Quebec, H1T2M4

  • Centre Hospitalier d'Universite de Montreal CHUM-Hotel Dieu

    Montreal, Quebec, H2XOA9

  • SMBD-Jewish General Hospital (MPSG)

    Montreal, Quebec, H3T 1E2

  • McGill University Health Centre-Cedars Cancer Centre

    Montreal, Quebec, H4A3J1

  • CHU de Quebec-Hospital du Saint-Sacrement

    Québec, Quebec, G1S4L8

Other trials in Canada

About this study

Official title: A Randomized, Double-Blind, Phase III Clinical Trial of Neoadjuvant Chemotherapy With Atezolizumab or Placebo in Patients With Triple-Negative Breast Cancer Followed by Adjuvant Continuation of Atezolizumab or Placebo

The main purpose of this study is to learn if the usual chemotherapy given before surgery (neoadjuvant therapy) for breast cancer plus the experimental drug, atezolizumab, is better than the usual chemotherapy plus a placebo. (A placebo is a drug that looks like the study drug but contains no medication.) The usual chemotherapy in this study is paclitaxel (WP) and carboplatin followed by doxorubicin and cyclophosphamide (AC) or epirubicin and cyclophosphamide (EC). Usually, after neoadjuvant therapy and surgery for triple negative breast cancer, no additional treatment is given unless the cancer returns. This study will also look at continuing treatment after surgery with atezolizumab or the placebo. To be better, atezolizumab given with the neoadjuvant therapy should be better at: 1) decreasing the amount of tumor in the breast than the placebo given with the usual chemotherapy and 2) decreasing the chance of the cancer from returning after surgery.

Another purpose of this study is to test the good and bad effects of atezolizumab when added to the usual chemotherapy. Atezolizumab may keep your cancer from growing but it can also cause side effects.

Read the detailed description

NSABP B-59/GBG 96-GeparDouze is a prospective, randomized, double-blind, Phase III clinical trial. This is a collaborative study being conducted by NSABP Foundation, Inc. in partnership with the German Breast Group (GBG), and supported by funding by Genentech, a Member of the Roche Group, and F. Hoffmann-La Roche, Ltd.

In this clinical trial of neoadjuvant and adjuvant administration of atezolizumab/placebo in patients with high risk triple-negative breast cancer, the potential incremental efficacy and safety of neoadjuvant administration of atezolizumab/placebo with a sequential regimen of weekly paclitaxel with every-3-week carboplatin followed immediately by neoadjuvant administration of atezolizumab/placebo with AC/EC will be evaluated. Patients will then undergo surgery. Following recovery from surgery, patients will initiate approximately 6 months of adjuvant therapy with atezolizumab/placebo and receive the same investigational agent they received pre-operatively. Administration of radiation therapy will be based on local standards at the discretion of patients and investigators, but if administered, atezolizumab/placebo will be administered concurrently. Adjuvant atezolizumab/placebo may be delayed until after completion of radiation therapy per investigator discretion. Patients with residual invasive cancer at the time of surgery may receive capecitabine concurrently with atezolizumab/placebo in the adjuvant setting per investigator discretion and local guidelines. Patients with germline BRCA1 or BRCA2 mutations with residual invasive cancer at the time of surgery may receive olaparib in the adjuvant setting per investigator discretion and local guidelines. Patients receiving olaparib must discontinue atezolizumab/placebo.

The primary aims of the study are 1) to determine value of atezolizumab in improving pathologic complete response in the breast and post-therapy lymph nodes evaluated histologically (pCR breast and nodes [(ypT0/Tis ypN0)]), and 2) to determine the value of atezolizumab in improving event-free survival (EFS). Secondary aims include: pathologic complete response in the breast (ypT0/Tis); pathologic complete response in the breast and lymph nodes (ypT0 ypN0); positive nodal status conversion rate; overall survival; recurrence-free interval: distant disease-free survival; brain metastases free survival; and toxicity. The stratification factors for the study are: 1) clinical size of the primary tumor (1.1-3.0 cm; > 3.0 cm); 2) nodal status as determined by protocol-specified criteria (negative, positive); 3) AC/EC (every 2 weeks; every 3 weeks); and 4) Region (North America; Europe).

For patient eligibility, local testing on the diagnostic core must have determined the patient's tumor to be ER-negative, PgR-negative, and HER2-negative by current ASCO/CAP guidelines. Material from either the diagnostic core biopsy or the research biopsy must be sent for central testing for confirmation of ER, PgR, and HER2 to confirm eligibility. If local testing has determined a tumor to be HER2 equivocal or to have a borderline ER/PgR status (% IHC staining < 10% for both), material may be submitted for central testing to determine eligibility.

In order to proactively identify and further assess any cardiac toxicity that may occur with the combination of anthracyclines and atezolizumab, this study includes a cardiac safety lead-in for the first 60 patients who initiate AC/EC. The safety lead-in will consist of assessment of ECG and serum troponin-T obtained just prior to administration of the first dose of AC/EC, following completion of the administration of the 1st and 3rd cycle of AC/EC prior to initiation of the atezolizumab/placebo. An additional assessment of LVEF with echocardiogram or MUGA scan will also be obtained prior to the 3rd dose of AC/EC. In order to provide an early assessment of cardiac safety, results of the troponin-T assessments, ECGs, LVEF assessment, and cardiac safety data will be evaluated by the Data Safety Monitoring Board (DSMB) when the last of the initial 20 patients who initiate AC/EC undergo their scheduled post-surgery LVEF assessment. When the last of the first 60 patients to initiate AC/EC undergo their scheduled post-surgery LVEF assessment, results of the troponin assessments, ECGs, LVEF assessments, and cardiac safety data from all 60 patients will be evaluated by the DSMB.

Research core biopsies of breast primary at baseline and 1-4 days prior to the second dose of atezolizumab/placebo are a study requirement for all patients. One to three representative blocks of residual primary tumor containing the maximum amount of tumor and node with the largest focus of metastasis is required from the definitive breast surgery if gross residual disease is greater than or equal to 1.0 cm. If gross residual disease is less than 1.0 cm, tissue should be submitted, if possible. Blood specimens will be collected on all patients at baseline for exploratory biomarker analysis and to support future correlative studies.

Accrual to NSABP B-59/GBG 96-GeparDouze began in December 2017 and was completed in May 2021 with a total of 1550 patients randomized. Based on actual accrual and the decision to eliminate pCR as a co-primary endpoint, we recalculated the power to detect a hazard ratio of 0.70 attributed to the addition of atezolizumab, assuming a lost-to-follow-up rate of 0.00083 per month, using the actual accrual pattern for the power calculation. With 1550 patients accrued in 42 months, an additional 22 months follow up will allow us to obtain 252 events under the assumptions stated above, which will provide 80% power to detect a HR of 0.7 between the atezolizumab and the placebo arm at an overall 2-sided alpha level of 0.05.

Being tested
Placebo, Atezolizumab
Keywords
anti-PD-L1 antibody, TNBC
Medical subject headings
Triple Negative Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    Following randomization, patients will receive Paclitaxel 80 mg/m2 IV weekly x 12 doses + Carboplatin AUC of 5 IV Day 1 every 3 weeks for 4 cycles + placebo IV Day 1 every 3 weeks for 4 doses.

    Followed 2-3 weeks later by Doxorubicin (A) 60 mg/m2 IV + cyclophosphamide (C) 600 mg/m2 IV Day 1 every 2 or 3 weeks for 4 cycles OR Epirubicin (E) 90 mg/m2 IV + cyclophosphamide (C) 600 mg/m2 IV Day 1 every 2 or 3 weeks for 4 cycles.

    + placebo IV Day 1 every 3 weeks for 3 to 4 doses depending on AC/EC schedule used.

    Approximately 3-4 weeks later: Surgery (Lumpectomy or mastectomy and axillary staging), followed by placebo IV Day 1 every 3 weeks after surgery until 1 year after the first dose.

  • AtezolizumabDrug

    Following randomization, patients will receive Paclitaxel 80 mg/m2 IV weekly x 12 doses + Carboplatin AUC of 5 IV Day 1 every 3 weeks for 4 cycles + Atezolizumab 1200 mg Day 1 every 3 weeks for 4 doses.

    Followed 2-3 weeks later by Doxorubicin (A) 60 mg/m2 IV + cyclophosphamide (C) 600 mg/m2 IV Day 1 every 2 or 3 weeks for 4 cycles OR Epirubicin (E) 90 mg/m2 IV + cyclophosphamide (C) 600 mg/m2 IV Day 1 every 2 or 3 weeks for 4 cycles.

    + Atezolizumab 1200 mg Day 1 every 3 weeks for 3 to 4 doses depending on AC/EC schedule used.

    Approximately 3-4 weeks later: Surgery (Lumpectomy or mastectomy and axillary staging), followed by Atezolizumab 1200 mg Day 1 every 3 weeks after surgery until 1 year after the first dose.

Study groups in NCT03281954
Study groupRoleWhat they receive
PlaceboPlacebo comparatorIV infusion once every 3 weeks for 4 doses (Cycle 1), once every 3 weeks for 4 doses (Cycle 2) and once every 3 weeks after surgery for 1 year after first dose
Receives: Drug: Placebo
AtezolizumabExperimentalIV infusion, 1200mg, once every 3 weeks for 4 doses (Cycle 1), once every 3 weeks for 4 doses (Cycle 2) and once every 3 weeks after surgery for 1 year after first dose
Receives: Drug: Atezolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Event-free survival (EFS)

    Time from randomization until event

    Measured: From randomization until event, through study follow up to the time target number of events is obtained, up to 5 years

Secondary outcomes (12)

  1. Overall survival (OS)

    Time from randomization until death from any cause

    Measured: From date of randomization through study follow-up, to the time the target number of events is obtained, up to 5 years

  2. Pathologic complete response in the breast and lymph nodes (ypT0/Tis ypN0)

    Absence of any invasive component in the resected breast specimen and all resected lymph nodes

    Measured: Following completion of neoadjuvant therapy (ypT0/Tis ypN0)

  3. Distant disease-free survival (DDFS)

    Time from randomization until distant recurrence, death from breast cancer, death from other causes, and second primary invasive cancer (non-breast)

    Measured: From date of randomization through study follow-up, to the time the target number of events is obtained, up to 5 years

  4. Disease-free survival (DFS)

    Ipsilateral invasive breast tumor recurrence, ipsilateral local-regional invasive breast cancer recurrence, distant recurrence, contralateral invasive breast cancer, ipsilateral or contralateral DCIS, second primary non-breast invasive cancer and death attributable to any cause including breast cancer, non-breast cancer, or unknown cause.

    Measured: From the first breast surgical procedure to the first disease recurrence or death from any cause

  5. Frequency of Adverse Events

    Frequency of adverse events graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0)

    Measured: From beginning of study therapy to 90 days after last dose of study therapy

  6. Frequency of immune Adverse Events of Special Interest

    Frequency of immune adverse events of special interest according to the NCI Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0)

    Measured: From beginning of study therapy to 90 days after last dose of study therapy

  7. Cardiac safety lead-in (Troponin-T)

    Troponin-T levels in blood prior to initial dose of AC/EC following completion of carboplatin/paclitaxel co-administered with atezolizumab/placebo

    Measured: prior to initial dose of AC/EC following completion of carboplatin/paclitaxel co-administered with atezolizumab/placebo, approximately 12 weeks

  8. Cardiac safety lead-in (Troponin-T)

    Troponin-T levels in blood after administration of the 1st cycle of AC/EC prior to administration of atezolizumab/placebo

    Measured: After administration of the 1st dose of AC/EC prior to administration of atezolizumab/placebo, approximately 1 hour after beginning the 1st dose of AC/EC

  9. Cardiac safety lead-in (Troponin-T)

    Troponin-T levels in blood after administration of the 3rd cycle of AC/EC prior to administration of atezolizumab/placebo

    Measured: After administration of the 3rd dose (Cycle 3; each cycle is 21 days) of AC/EC prior to administration of atezolizumab/placebo, approximately 1 hour after beginning the 3rd dose of AC/EC

  10. Cardiac safety lead-in (Left ventricular ejection fraction; LVEF)

    LVEF levels measured at baseline prior to initiation of carboplatin/paclitaxel and atezolizumab/placebo

    Measured: Prior to initiation of carboplatin/paclitaxel and atezolizumab/placebo, at baseline

  11. Cardiac safety lead-in (Left ventricular ejection fraction; LVEF)

    LVEF levels measured before 3rd cycle of AC/EC

    Measured: Prior to the 3rd cycle (each cycle is every 21 days) of AC/EC, approximately 6 weeks after initiation of AC/EC

  12. Cardiac safety lead-in (Left ventricular ejection fraction; LVEF)

    LVEF levels measured after surgery

    Measured: Four to 6 weeks after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2017
  2. Study start19 Dec 2017
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion30 Nov 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
1,550 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03281954
Sponsor's protocol ID
NSABP B-59/GBG 96-GeparDouze
Other IDs
2017-002771-25, MO39875, 2017
Status last verified
Apr 2024
First submitted
8 Sep 2017
Last updated
8 Apr 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Balic M, Tang G, Rastogi P, Young G, Wallace M, Acosta J, Schneeweiss A, Hilton CJ, Freeman TJ, Li J, Denkert C, Reinisch M, Palomares MR, Arrick BA, Petitt M, Maley SK, Hassan S, Murali S, Boileau JF, Boudreau D, Polewski PJ, Mashru S, Hargis JB, Mortimer J, Thirlwell M, Sikov W, Tan AR, Garces J, Costa G, LoBello J, Mouta J, Darbonne WC, Baehner FL, Mamounas EP, Wolmark N, Loibl S, Geyer CE Jr. Evaluation of a Tumor-Informed Molecular Residual Disease Assay in Early Triple-Negative Breast Cancer Treated With Neoadjuvant Chemotherapy, With or Without Atezolizumab. JCO Precis Oncol. 2026 Sep;10(9):e2600114. doi: 10.1200/PO-26-00114. Epub 2026 Sep 11.

    PubMed 42727049

  • Loibl S, Tang G, Nekljudova V, Rastogi P, Rachakonda S, Reinisch M, Acosta J, Schneeweiss A, Hilton C, Seiler S, Bhargava R, Karn T, Cortazar P, Moreno F, Andersen J, Christensen S, Klare P, Murali S, Morales S, Huober J, Boileau JF, Rodriguez-Lescure A, Boudreau D, Polewski PJ, Teply-Szymanski J, Mouta J, Mamounas EP, Denkert C, Wolmark N, Geyer CE Jr. Atezolizumab in early triple-negative breast cancer: the randomized phase 3 NSABP B-59/GeparDouze trial. Nat Med. 2026 Sep 1. doi: 10.1038/s41591-026-04565-6. Online ahead of print.

    PubMed 42680950

  • Perez-Garcia J, Soberino J, Racca F, Gion M, Stradella A, Cortes J. Atezolizumab in the treatment of metastatic triple-negative breast cancer. Expert Opin Biol Ther. 2020 Sep;20(9):981-989. doi: 10.1080/14712598.2020.1769063. Epub 2020 May 25.

    PubMed 32450725

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Atezolizumab in people with Triple Negative Breast Cancer, run by NSABP Foundation Inc at 217 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 33 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 8 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 217 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Event-free survival (EFS) (time frame: From randomization until event, through study follow up to the time target number of events is obtained, up to 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03281954, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2024.

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