Eine Studie zur Beurteilung der Wirksamkeit und Sicherheit von Trastuzumab-Emtansin in Kombination mit Atezolizumab oder Atezolizumab-Placebo bei Patientinnen mit HER2-positivem (HER2: humaner epidermaler Wachstumsfaktor-Rezeptor 2), lokal fortgeschrittenem oder metastasierendem Brustkrebs (BC), die zuvor eine Trastuzumab- und Taxan-basierte Therapie erhalten haben

A Study to Evaluate the Efficacy and Safety of Trastuzumab Emtansine in Combination With Atezolizumab or Atezolizumab-Placebo in Participants With Human Epidermal Growth Factor-2 (HER2) Positive Locally Advanced or Metastatic Breast Cancer (BC) Who Received Prior Trastuzumab and Taxane Based Therapy (KATE2)

  • Krebs
  • Brustkrebs
  • Metastatic Breast Cancer
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Status der Studie:

Abgeschlossen

Diese Studie läuft in
Städte
  • Berlin
  • Essen
  • Freiburg im Breisgau
  • Heidelberg
  • Koblenz
Studien-ID:

NCT02924883 2015-004189-27 WO30085

      Studienzentren finden

      Die folgenden Informationen stammen aus der öffentlich zugänglichen Website ClinicalTrials.gov und werden für Laien bearbeitet.

      Die folgenden Informationen stammen aus der öffentlich zugänglichen Website ClinicalTrials.gov und werden nicht geändert.

      Results Disclaimer

      Studienzusammenfassung

      This Phase II, double-blind, randomized, placebo-controlled multicenter study will investigate the efficacy and safety of trastuzumab emtansine in combination with atezolizumab or atezolizumab-placebo in participants with HER2-positive locally advanced or metastatic BC who have received prior trastuzumab and taxane based therapy, either alone or in combination, and/or who have progressed within 6 months after completing adjuvant therapy.

      Hoffmann-La Roche Sponsor
      Phase 2 Phase
      NCT02924883, WO30085, 2015-004189-27 Studien-ID
      Atezolizumab, Trastuzumab emtansine, Placebo Treatments
      Metastatic Breast Cancer Condition
      Official Title

      A Randomized, Multicenter, Double-Blind, Placebo-Controlled Phase II Study of the Efficacy and Safety of Trastuzumab Emtansine in Combination With Atezolizumab or Atezolizumab-Placebo in Patients With HER2-Positive Locally Advanced or Metastatic Breast Cancer Who Have Received Prior Trastuzumab and Taxane Based Therapy

      Einschlusskriterien

      All Gender
      ≥18 Years Age
      No Healthy Volunteers
      Inclusion Criteria
      • Archival tumor samples must be obtained from primary and/or metastatic sites
      • Able to submit tumor tissue that is evaluable for programmed death- ligand 1 (PD-L1) expression
      • HER-2 positive BC as defined by an immunohistochemistry score of 3 or gene amplified by in-situ hybridization as defined by a ratio of greater than or equal to (>=) 2.0 for the number of HER2 gene copies to the number of chromosome 17 copies
      • Histologically or cytologically confirmed invasive BC: incurable, unresectable, locally advanced BC previously treated with multimodality therapy or metastatic BC
      • Prior treatment for BC in the: adjuvant; unresectable locally advanced; or metastatic settings; which must include both, a taxane and trastuzumab (alone or in combination with another agent)
      • Progression must have occurred during or after most recent treatment for locally advanced/metastatic BC or within 6 months after completing adjuvant therapy
      • Participants must have measurable disease that is evaluable as per RECIST v1.1
      • Eastern Cooperative Oncology Group Performance Status of 0 or 1
      • Negative serum pregnancy test within 7 days of enrollment for pre-menopausal women and for women less than 12 months after the onset of menopause
      • Use of highly effective method of contraception as defined by the protocol
      Exclusion Criteria
      • Prior treatment with trastuzumab emtansine, cluster of differentiation 137 agonists, anti-programmed death-1, or anti-PD-L1 therapeutic antibody or pathway-targeting agents
      • Receipt of any anti-cancer drug/biologic or investigational treatment within 21 days prior to Cycle 1 Day 1 except hormone therapy, which can be given up to 7 days prior to Cycle 1 Day 1; recovery of treatment related toxicity consistent with other eligibility criteria
      • Radiation therapy within 2 weeks prior to Cycle 1, Day 1
      • History of exposure to the cumulative doses of anthracyclines
      • History of other malignancy within the previous 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or participants who have undergone potentially curative therapy with no evidence of disease and are deemed by the treating physician to be at low risk for recurrence
      • Cardiopulmonary dysfunction, symptomatic pleural effusion, pericardial effusion, or ascites
      • Participants with severe infection within 4 weeks prior to randomization, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
      • Current severe, uncontrolled systemic disease
      • Major surgical procedure or significant traumatic injury within 28 days prior to randomization or anticipation of the need for major surgery during the course of study treatment
      • Clinically significant history of liver disease, including cirrhosis, current alcohol abuse, autoimmune hepatic disorders, sclerosis cholangitis or active infection with human immunodeficiency virus, hepatitis B virus, or hepatitis C virus
      • Need for current chronic corticosteroid therapy (>=10 mg of prednisone per day or an equivalent dose of other anti-inflammatory corticosteroids)
      • Spinal cord compression not definitively treated with surgery and/or radiation, or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for greater than (>) 2 weeks prior to randomization
      • Participants with known central nervous system disease
      • Leptomeningeal disease
      • History of autoimmune disease
      • Prior allogeneic stem cell or solid organ transplantation
      • Active tuberculosis
      • Receipt of a live, attenuated vaccine within 4 weeks prior to randomization or anticipation that such a live, attenuated vaccine will be required during the study
      • Treatment with systemic immunostimulatory agents within 4 weeks or five half-lives of the drug (whichever is shorter) prior to randomization
      • Treatment with systemic corticosteroids or other systemic immunosuppressive medications within 2 weeks prior to randomization, or anticipated requirement for systemic immunosuppressive medications during the trial
      • Participants who are breastfeeding, or intending to become pregnant during the study

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