EUCTR2018-001881-40-ES进行中（未招募）1 期
A phase III, randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of Atezolizumab or placebo in combination with neoadjuvant doxorubicin + cyclophosphamide followed by paclitaxel + trastuzumab + pertuzumab in early HER2-positive breast cancer - IMpassion050
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 224
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Age >= 18 years
- •Ability to comply with the study protocol, in the investigator's judgment
- •Confirmed diagnosis of HER2-positive breast cancer, and hormonal and programmed death-ligand 1 (PD-L1) status, as documented through central testing of a representative tumor tissue specimen, is required
- •Primary breast tumor size of > 2 cm by radiographic measurement
- •Stage at presentation: T2-T4, N1-N3, M0 as determined by American Joint Committee on Cancer staging system, 8th edition
- •Pathologic confirmation of nodal involvement with malignancy must be determined by fine-needle aspiration or core-needle biopsy. Surgical excision of lymph nodes is not permitted
- •Patients with multifocal tumors or multicentric tumors are eligible provided all discrete lesions are sampled and centrally confirmed as HER2-positive
- •In patients with multifocal or multicentric breast cancer, the largest lesion should be measured to determine T stage
- •Patients with synchronous bilateral invasive disease are eligible so long as both lesions are HER2-positive
- •In case of bilateral cancer, the investigator has to decide prospectively which side will be evaluated for the primary endpoint
- •Patient agreement to undergo appropriate surgical management, including axillary lymph node surgery and partial or total mastectomy, after completion of neoadjuvant treatment
- •Eastern Cooperative Oncology Group Performance Status of 0 or 1
- •Baseline left ventricular ejection fraction >= 55% measured by echocardiogram or multiple-gated acquisition scans
- •Adequate hematologic and end-organ function
- •Negative HIV test at screening
- •Negative hepatitis B surface antigen (HBsAg) and negative total hepatitis B core antibody (HBcAb) test at screening, or positive total HBcAb test followed by a negative hepatitis B virus (HBV) DNA test at screening
- •Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening
- •For women of childbearing potential: agreement to remain abstinent or use contraceptive methods, and agreement to refrain from donating eggs, Women must remain abstinent or use contraceptive methods with a failure rate of < 1% per year during the treatment period and for 5 months after the final dose of atezolizumab/placebo, 6 months after the final dose of doxorubicin, 12 months after the final dose of cyclophosphamide, 6 months after the final dose of paclitaxel, and 7 months after the final dose of trastuzumab and/or pertuzumab, whichever occurs last
- •For men: agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating sperm, men who are not surgically sterile must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of < 1% per year during the treatment period and for 6 months after the final dose of doxorubicin and/or cyclophosphamide, 6 months after the final dose of paclitaxel, and 7 months after the final dose of trastuzumab and/or pertuzumab, whichever occurs last
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 202
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 22
排除标准
- •Prior history of invasive breast cancer
- •Stage IV (metastatic) breast cancer
- •Prior systemic therapy for treatment of breast cancer
- •Previous therapy with anthracyclines or taxanes for any malignancy
- •Ulcerating breast cancer
- •Undergone incisional and/or excisional biopsy of primary tumor and/or axillary lymph nodes
- •Sentinel lymph node procedure or axillary lymph node dissection prior to initiation of neoadjuvant therapy
- •History of other malignancy within 5 years prior to screening, with the exception of those who patients have a negligible risk of metastasis or death, such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer
- •Cardiopulmonary dysfunction
- •Dyspnea at rest
- •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 antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis
- •History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography scan
- •Active tuberculosis
- •Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment or anticipation of need for a major surgical procedure during the study
- •Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia
- •Treatment with therapeutic antibiotics within 2 weeks (IV antibiotics) or 5 days (oral antibiotics) prior to initiation of study treatment
- •Prior allogeneic stem cell or solid organ transplantation
- •Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug and may affect the interpretation of the results, or may render the patient at high risk from treatment complications
- •Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during atezolizumab/placebo treatment or within 5 months after the final dose of atezolizumab/placebo
- •Treatment with investigational therapy within 28 days prior to initiation of study treatment
- •Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-cytotoxic T lymphocyte-associated protein-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies
- •Treatment with systemic immunostimulatory agents within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment
- •Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment
- •History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins
- •Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab formulation
- •Known allergy or hypersensitivity to the components of the paclitaxel, cyclophosphamide, or doxorubicin formulations
- •Known allergy or hypersensitivity to trastuzumab or pert
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