EUCTR2016-004734-22-IT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 COMBINATIONWITH NEOADJUVANT ANTHRACYCLINE/TAXANE-BASED CHEMOTHERAPY COMPARED WITH PLACEBO AND CHEMOTHERAPY IN PATIENTS WITHPRIMARY INVASIVE TRIPLE-NEGATIVE BREAST CANCER - IMpassion031
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
- 333
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-therapyinduced 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, druginduced 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, and anti-PD-L1 therapeutic antibodies
- •- Treatment with systemic immunostimulato
研究者
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