EUCTR2016-004734-22-ES进行中（未招募）1 期
A PHASE III RANDOMIZED STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF ATEZOLIZUMAB (ANTI-PD-L1 ANTIBODY) IN COMBINATION WITH NEOADJUVANT ANTHRACYCLINE/TAXANE-BASED CHEMOTHERAPY COMPARED WITH PLACEBO AND CHEMOTHERAPY IN PATIENTS WITH PRIMARY INVASIVE TRIPLE-NEGATIVE BREAST CANCER
Roche Farma S.A.(Soc. Unipersonal)que realiza el ensayo en España y que actúa como representante F.Hoffmann-La Roche LTD0 个研究点目标入组 324 人开始时间: 2019年7月5日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 324
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
- •- Women or men aged >= 18 years
- •- Eastern Cooperative Oncology Group performance status of 0 or 1
- •- Histologically documented triple-negative breast cancer (TNBC) (negative human epidermal growth factor receptor 2 [HER2], estrogen receptor [ER], and progesterone receptor [PgR]). HER2 negativity will be defined by central laboratory assessment using in situ hybridization or immunohistochemistry (IHC) assays per American Society of Clinical Oncology (ASCO)/ College of American Pathologists (CAP) criteria and ER/PgR negativity will be defined by central laboratory assessment using IHC per ASCO/CAP criteria. Central laboratory assessment will occur prior to randomization.
- •- Patients with multifocal tumors (more than one tumor confined to the same quadrant as the primary tumor) are eligible provided all discrete lesions are sampled and centrally confirmed as TNBC.
- •- Confirmed tumor programmed death-ligand 1 (PD-L1) evaluation as documented through central testing of a representative tumor tissue specimen
- •- Primary breast tumor size of > 2 cm by at least one radiographic or clinical measurement
- •- Stage at presentation: cT2 cT4, cN0 cN3, cM0
- •- Patient agreement to undergo appropriate surgical management including axillary lymph node surgery and partial or total mastectomy after completion of neoadjuvant treatment
- •- Baseline left ventricular ejection fraction >= 53% measured by echocardiogram or multiple-gated acquisition scans
- •- Adequate hematologic and end-organ function
- •- Representative formalin-fixed, paraffin-embedded tumor specimen in paraffin blocks (preferred) or at least 20 unstained slides, with an associated pathology report documenting ER, PgR, and HER2 negativity
- •- Women who are not postmenopausal (>=12 months of non-therapy-induced amenorrhea) or have undergone a sterilization procedure must have a negative serum pregnancy test result within 14 days prior to initiation of study drug
- •- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating eggs.
- •-For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from donating sperm,
- •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 292
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 32
排除标准
- •- Prior history of invasive breast cancer
- •- Stage IV (metastatic) breast cancer
- •- Prior systemic therapy for treatment and prevention of breast cancer
- •- Previous therapy with anthracyclines or taxanes for any malignancy
- •- History of ductal carcinoma in situ (DCIS), except for patients treated exclusively with mastectomy >5 years prior to diagnosis of current breast cancer
- •- History of pleomorphic lobular carcinoma in situ (LCIS), except for patients surgically managed >5 years prior to diagnosis of current breast cancer (note that patients with nonpleomorphic LCIS [either untreated or treated with surgery] are allowed)
- •- Bilateral breast cancer
- •- Undergone incisional and/or excisional biopsy of primary tumor and/or axillary lymph nodes
- •- 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 with a negligible risk of metastasis or death (e.g., 5-year OS of >90%), such as adequately treated carcinoma in situ of the cervix, non melanoma skin carcinoma, localized prostate cancer, DCIS, or Stage I uterine cancer
- •- Cardiopulmonary dysfunction
- •- History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
- •- Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells
- •- Known allergy or hypersensitivity to the components of the formulations of atezolizumab, nab-paclitaxel, cyclophosphamide, or doxorubicin, filgrastim or pegfilgrastim
- •- Active or history of autoimmune disease or immune deficiency diseases except history of autoimmune-related hypothyroidism, controlled Type I diabetes mellitus, and only dermatologic manifestations of eczema, psoriasis, lichen simplex chronicus, or vitiligo (e.g., patients with psoriatic arthritis are excluded)
- •- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
- •- Positive HIV test at screening
- •- Active hepatitis B and hepatitis C virus infection
- •- Active tuberculosis
- •- Severe infections 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 oral or IV antibiotics within 2 weeks prior to initiation of study treatment, except prophylactic antibiotics
- •- Major surgical procedure within 4 weeks prior to initiation of study treatment or anticipation of need for a major surgical procedure during the course of the study
- •- Prior allogeneic stem cell or solid organ transplantation
- •- Administration of a live attenuated vaccine within 4 weeks prior to initiation of study treatment or anticipation of need for such a vaccine during the study
- •- Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications
- •- Prior treatment with CD137 agonists or immune checkpoint-blockade therapies, including anti-CD40, anti-CTLA-4, anti-PD-1, an
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