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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
Basisinformationen
Sponsor
Hoffmann-La Roche
Phase
Phase 2
Studien-ID
NCT02924883, WO30085, 2015-004189-27
Condition
Metastatic Breast Cancer
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
≥18 Years
No
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
Diese Seite fasst Informationen von öffentlichen Studienregister-Websites wie ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com usw. zusammen. Weitere Informationen zu dieser Studie finden Sie auf der Registerkarte „Für medizinische Fachkräfte" oder auf einer der Studienregister-Websites.
Die Informationen stammen direkt von Websites öffentlicher Register wie ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com usw. und wurden nicht modifiziert.
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