A Study of Trastuzumab Emtansine in Combination With Atezolizumab or Placebo as a Treatment for Participants With Human Epidermal Growth Factor 2 (HER2)-Positive and Programmed Death-ligand 1 (PD-L1)-Positive Locally Advanced (LABC) or Metastatic Breast Cancer (MBC)
Megadott ok: Due to low enrollment, the Sponsor decided to prematurely terminate the study
Key facts
- Where
- Beijing, Changchun, Guangzhou, Hangzhou, Harbin, Nanjing, Tianjing, Wuhan és Zhengzhou, KínaSee the 10 sites
- Phase
- 3. fázis
Where in Kína
- Beijing Cancer HospitalBeijing, KínaNo longer taking part
- Peking University People's HospitalBeijing, KínaNo longer taking part
- The First Hospital of Jilin UniversityChangchun, KínaNo longer taking part
- Sun Yat-sen Memorial Hospital, Sun Yat-sen UniversityGuangzhou, KínaNo longer taking part
- Zhejiang Provincial People's HospitalHangzhou, KínaNo longer taking part
- Harbin Medical University Cancer HospitalHarbin, KínaNo longer taking part
- Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)Nanjing, KínaNo longer taking part
- Tianjin Medical University Cancer Institute & HospitalTianjing, KínaNo longer taking part
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyWuhan, KínaNo longer taking part
- Henan Cancer HospitalZhengzhou, KínaNo longer taking part
Trial details
- Who runs it
- Hoffmann-La Roche
- Trial code
- NCT04740918
- Record updated
- 2025. augusztus 8.
- Original description
This study will evaluate the efficacy, safety and patient-reported outcomes of trastuzumab emtansine plus atezolizumab compared with trastuzumab emtansine plus placebo in participants with HER2-positive and PD-L1-positive LABC or MBC.Participants must have progressed either during or after prior trastuzumab- (+/- pertuzumab) and taxane-based therapy for LABC/MBC; or during (or within 6 months after completing) trastuzumab- (+/-pertuzumab) and taxane-based therapy in the neoadjuvant and/or adjuvant setting.Read full original descriptionShow less
A Randomized, Multicenter, Double-Blind, Placebo-Controlled Phase III Study of the Efficacy and Safety of Trastuzumab Emtansine in Combination With Atezolizumab or Placebo in Patients With HER2-Positive and PD-L1-Positive Locally Advanced or Metastatic Breast Cancer Who Have Received Prior Trastuzumab- (+/- Pertuzumab) and Taxane-Based Therapy (KATE3)
This study will evaluate the efficacy, safety and patient-reported outcomes of trastuzumab emtansine plus atezolizumab compared with trastuzumab emtansine plus placebo in participants with HER2-positive and PD-L1-positive LABC or MBC.Participants must have progressed either during or after prior trastuzumab- (+/- pertuzumab) and taxane-based therapy for LABC/MBC; or during (or within 6 months after completing) trastuzumab- (+/-pertuzumab) and taxane-based therapy in the neoadjuvant and/or adjuvant setting.
Inclusion: HER2+ and PD-L1+ locally advanced (LABC) or metastatic breast cancer (MBC); Progression must have occurred during most recent treatment for LABC/MBC or during, or within 6 months after completing, neoadjuvant and/or adjuvant therapy; Prior treatment with trastuzumab (+/- pertuzumab) and taxane in the neoadjuvant and/or adjuvant, locally advanced, or metastatic setting; No more than two prior lines of therapy in the metastatic setting; Measurable disease per RESIST version 1.1; Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1; Life expectancy >= 6 months; Adequate hematologic and end-organ function; For women of childbearing potential: agreement to remain abstinent or use contraception, and agreement to refrain from donating eggs; For men: agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating sperm.
Exclusion: Prior treatment with trastuzumab emtansine in metastatic setting; Prior allogeneic stem cell or solid organ transplantation; Receipt of a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, during treatment, or within 5 months following the last dose of study treatment; History of exposure to cumulative doses of anthracyclines; History of malignancy within 5 years prior to initiation of study treatment, with the exception of the cancer under investigation and malignancies with a negligible risk of metastasis or death; History of leptomeningeal disease; Active or history of autoimmune disease or immune deficiency; Active hepatitis B, hepatitis C and/or tuberculosis; Symptomatic or actively progressing central nervous system (CNS) metastases; asymptomatic CNS lesions ≤ 2cm without clinical requirement for local intervention or asymptomatic patients with treated CNS lesions are eligible; Current Grade >= 3 peripheral neuropathy; Cardiopulmonary dysfunction; Pregnancy or lactation.