A Study of the Efficacy and Safety of Atezolizumab Plus Chemotherapy for Patients With Early Relapsing Recurrent Triple-Negative Breast Cancer (IMpassion132)

  • End date
    Sep 30, 2024
  • participants needed
  • sponsor
    Hoffmann-La Roche
Updated on 9 April 2023
measurable disease
breast cancer
programmed cell death 1 ligand 1
triple negative breast cancer
triple-negative breast cancer
formalin-fixed paraffin-embedded


This study will evaluate the efficacy and safety of atezolizumab plus chemotherapy compared with placebo plus chemotherapy in patients with inoperable recurrent triple-negative breast cancer (TNBC).

Condition Triple Negative Breast Neoplasms
Treatment Capecitabine, carboplatin, Placebo, Gemcitabine, Atezolizumab
Clinical Study IdentifierNCT03371017
SponsorHoffmann-La Roche
Last Modified on9 April 2023


Yes No Not Sure

Inclusion Criteria

Histologically confirmed triple negative breast cancer (TNBC) that is either locally recurrent, inoperable and cannot be treated with curative intent or is metastatic
Documented disease progression occurring within 12 months from the last treatment with curative intent
Prior treatment (of early breast cancer) with an anthracycline and taxane
Have not received prior chemotherapy or targeted systemic therapy for their locally advanced inoperable or metastatic recurrence. Prior radiation therapy for recurrent disease is permitted
Measurable or non-measurable disease, as defined by RECIST 1.1
Availability of a representative formalin-fixed, paraffin-embedded (FFPE) tumour block (preferred) or at least 17 unstained slides obtained from relapsed metastatic or locally advanced diseases may be submitted, if clinically feasible, with an associated pathology report, if available. If a fresh tumour sample is not clinically feasible, either the diagnosis sample, the primary surgical resection sample, or the most recent FFPE tumour biopsy sample should be used
Eastern Cooperative Oncology Group performance status 0-1
Life expectancy ≥ 12 weeks
Adequate haematologic and end-organ function
Negative human immunodeficiency virus (HIV) test ---Negative hepatitis B surface antigen (HBsAg) test at screening
Negative total hepatitis B core antibody (HBcAb) test at screening, or positive HBcAb test followed by a negative hepatitis B virus (HBV) DNA test at screening
The HBV DNA test will be performed only for patients who have a negative HBsAg and a positive HBcAb test
Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening
Women of childbearing potential must agree to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with a failure rate of ≤1% per year during the treatment period and for at least 5 months after the last dose of atezolizumab or 6 months after the last dose of capecitabine, whichever is later. In addition, women must refrain from donating eggs during the same time period
Men must agree to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agree to refrain from donating sperm
Inclusion criteria for patients enrolled after the recruitment of all-comers
is complete
PD-L1-positive tumour status (assessed centrally prior to randomisation), defined as PD-L1
expression on tumour-infiltrating immune cells (IC) of 1% or greater

Exclusion Criteria

Spinal cord compression not definitively treated with surgery and/or radiation, or
Symptomatic or rapid visceral progression
previously diagnosed and treated spinal cord compression without evidence that disease
No prior treatment with an anthracycline and taxane
has been clinically stable for > 2 weeks prior to randomisation
History of leptomeningeal disease
Symptomatic, untreated, or actively progressing central nervous system (CNS)
Uncontrolled tumour-related pain
Uncontrolled or symptomatic hypercalcemia
Malignancies other than TNBC within 5 years prior to randomisation)
Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent
Presence of an abnormal ECG
drainage procedures (once monthly or more frequently) (patients with indwelling
catheters such as PleurX® are allowed)
Current treatment with anti-viral therapy for HBV
Treatment with investigational therapy within 28 days prior to randomisation
Significant cardiovascular disease, within 3 months prior to randomisation, unstable
Exclusion Criteria Related to Atezolizumab
arrhythmias, or unstable angina
Severe infection requiring oral or IV antibiotics within 4 weeks prior to
History of autoimmune disease
randomisation, including but not limited to hospitalization for complications of
Prior allogeneic stem cell or solid organ transplantation
infection, bacteraemia, or severe pneumonia
Active tuberculosis
Major surgical procedure within 4 weeks prior to randomisation or anticipation of the
need for a major surgical procedure during the course of the study other than for
Pregnant or lactating, or intending to become pregnant during or within 5 months after
Exclusion Criteria Related to Capecitabine
the last dose of atezolizumab, or within 6 months after the last dose of capecitabine
Inability to swallow pills
whichever is later
History of severe allergic, anaphylactic, or other hypersensitivity reactions to
Exclusion Criteria Related to Carboplatin/Gemcitabine
chimeric or humanised antibodies or fusion proteins
Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster
ovary cells or to any component of the atezolizumab formulation
History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced
pneumonitis, organizing pneumonia (i.e. bronchiolitis obliterans, cryptogenic
organizing pneumonia), or evidence of active pneumonitis on screening chest
computerised tomography (CT) scan History of radiation pneumonitis in the radiation
field (fibrosis) is permitted
Receipt of a live, attenuated vaccine within 4 weeks prior to randomisation or
anticipation that a live, attenuated vaccine will be required during
atezolizumab/placebo treatment or within 5 months after the last dose of
Prior treatment with CD137 agonists, anti-PD-1, or anti-PD-L1 therapeutic antibody or
pathway targeting agents
Treatment with systemic immunostimulatory agents (including but not limited to
interferons or interleukin [IL]-2) within 4 weeks or five half-lives of the drug
(whichever is longer) prior to randomisation
Treatment with systemic corticosteroids or other systemic immunosuppressive
medications within 2 weeks prior to start of study treatment, or anticipated
requirement for systemic immunosuppressive medications during the trial
Malabsorption syndrome, disease significantly affecting gastrointestinal function
resection of the stomach or small bowel, or ulcerative colitis
Known dihydropyrimidine dehydrogenase (DPD) deficiency or history of severe and
unexpected reactions to fluoropyrimidine therapy in patients selected to receive
Hypersensitivity to platinum containing compounds or any component of carboplatin or
gemcitabine drug formulations in patients selected to receive carboplatin and Gemcitabine
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