EUCTR2018-001881-40-PL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
- 454
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 hormone receptor 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 are eligible provided at least one focus is sampled and centrally confirmed as HER2-positive
- •Patients with 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
- •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, pertuzumab, or trastuzumab emtansine, 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, pertuzumab or trastuzumab emtansine, whichever occurs last
- •For patients enrolled in the extended China enrollment phase: current resident of mainland China and of Chinese ancestry
- •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 412
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 42
排除标准
- •Prior history of invasive breast cancer •Stage IV (metastatic)breastcancer •Patients with hormone receptor-positive disease will be excluded onceapproximately 227Patients with hormone receptor-positive disease havebeen enrolled • Prior systemic therapy for treatment of breast cancer• Previous therapy with anthracyclines or taxanes for any malignancy• Ulcerating or inflammatory breast cancer•Bilateral invasive breast cancer•Undergone incisional and/or excisional biopsy of primary tumor and/orxillary lymph nodes•Sentinel lymph node procedure or axillary lymph node dissection priorto initiation of neoadjuvant therapy
- •History of other malignancy within 5 years prior to screening, with thexception of those patients who have a negligible risk of metastasis ordeath, such as adequately treated carcinoma in situ of the cervix, nonmelanomaskicarcinoma,localizedprostate cancer, ductal carcinoma insitu, or Stage I uterine cancer•Cardiopulmonary dysfunctionDyspnea at rest•Active or history of autoimmune disease or immune deficiency•History of idiopathic pulmonary fibrosis, organizing pneumonia, druginducedpneumonitis, 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 priorto 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 ofinfection, 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 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 pertuzumab
- •formulations
- •Pregnancy or breastfeeding, or intention of becoming pregnant during
- •study treatment or within 5 months after the final dose
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