EUCTR2017-000981-31-IT进行中（未招募）1 期
Atezolizumab, Pertuzumab and Trastuzumab with chemotherapy as neoadjuvant treatment of HER2 positive early high-risk and locally advanced breast cancer - APTneo
FONDAZIONE MICHELANGELO ONLUS PER L'AVANZAMENTO DELLO STUDIO E LA CURA DEI TUMORI0 个研究点目标入组 650 人开始时间: 2021年1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
- 650
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
- Female
入选标准
- •1.Female patients aged 18 years or older with early high-risk(T1cN1;T2N1;T3N0)and locally advanced and inflammatory breast cancers (stage III A-C according to AJCC) suitable for neoadjuvant treatment;2.Histologically confirmed unilateral invasive breast cancer;3.HER2 positive disease according to ASCO/CAP current guidelines;4.Known estrogen (ER) and progesterone receptor (PgR) status;5.Availability of a representative paraffin-embedded(FFPE)tumor block taken at diagnostic biopsy for central confirmation of HER2 status, assessment of ER, PgR, Ki67 and PD-L1 expression and for biomarker evaluation is mandatory. Note:the diagnostic biopsy of the breast lesion may have been taken before the screening procedures start. If diagnostic sentinel node biopsy if performed, an FFPE block should be made available, along with the tumor block of the primary tumor. An FFPE tumor block is also mandatory after the first cycle of therapy. Surgery tissue (residual tumor or tumor bed in case of pCR and axillary node material) is also mandatory;6.Consent to the collection of blood samples mandatorily before starting neoadjuvant treatment, after the first cycle of therapy, at the end of neoadjuvant treatment (before surgery), 6 months after surgery and at the end of all treatments;7.ECOG performance status 0 or 1;8.For women who are not postmenopausal (= 12 months of non-therapy-induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to remain abstinent or use single or combined contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 6 months after the last dose of study drugs. Abstinence is only acceptable if it is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar,ovulation,symptothermal,or postovulation methods) and withdrawal are not acceptable methods of contraception.Examples of contraceptive methods with a failure rate of <1% per year include tubal ligation, male sterilization, hormonal implants, established, proper use of combined oral or injected hormonal contraceptives, and certain intrauterine devices;9.Written informed consent to participate in the trial (approved by the Institutional Review Board [IRB]/ Independent Ethics Committee [IEC]) obtained prior to any study specific screening procedures;10.Willing and able to comply with the protocol
- •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 400
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 250
排除标准
- •1.Bilateral breast cancer or metastatic disease (M1);2. HER2-NEG. as 0-1+ by IHC or 2+ not amplified by ISH/other test;3.Pregnancy/breastfeeding. NEG. pregn. test for premenopausal women with intact reproductive organs or <1yr from the last menstruation;4.Potential childbearing unless surgically sterile or using contraception;5.Previous chemo,hormonal TP or investigational drug for malignancies;6.Previous investigational treatment for any condition within 4 weeks pre-random;7.Live, attenuated vaccine within 4 weeks pre-D1 or during the study;8.Previous/concomitant malignancy that could affect compliance with the protocol or interpretation of results. Pts with treated basal cell carcinoma of the skin or in situ cervix cancer are eligible;9.Pre-existing motor/sensory neuropathy of G>1;10.Severe allergic, anaphylactic, or hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins;11.Hypersensitivity/allergy to biopharmaceuticals produced in Chinese hamster ovary cells or atezolizumab formulation component;12.Pts with prior allogeneic stem cell/solid organ transplant.;13.Autoimm. disease including systemic lupus erythematosus, rheum.arthritis, inflamm. bowel disease, vascular thrombosis associated with antiphospholipid syndr., Wegener’s granulomatosis, Sjögren’s syndr., Bell’s palsy, Guillain-Barré syndr., multiple sclerosis, vasculitis, glomerulonephritis;14.IPF (including bronchiolitis obliterans with organizing pneumonia) or active pneumonitis on screening chest CTscan;15.Liver disease, including active viral, alcoholic or other hepatitis, cirrhosis, fatty liver, and inherited liver disease;16. HIV, active hepatitis B or C. Pts with past/resolved hepatitis B infection (NEG. HBsAg and positive hepatitis B core antigen) are eligible.Pts positive for hepatitis C (HCV) antibody are eligible if polymerase chain reaction assay (PCR) is NEG for HCV RNA;17.Active TBC;18.Severe infections within 4 weeks pre-D1, including hospitaliz. for infections complications, bacteremia or severe pneumonia. Significant infection within 2weeks pre-D1;19. Oral/IV antibiotics within 2weeks pre-D1;20.Other serious illness/condition including: congestive cardiac failure; NYHA >=2CHF; angina pectoris requiring anti-anginal medication or unstable angina within 6months pre-D1; transmural infarction on ECG; myocardial infarction stroke/TIA within 6 months pre-D1; poorly controlled hypertension (e.g. systolic>180 mmHg or diastolic>100 mmHg;but pts with well controlled hypertension are eligible); significant valvular heart disease;high-risk uncontrolled arrhythmias, severe dyspnea at rest with O2; uncontrolled pleural effusion, pericardial effusion or ascites requiring recurrent drainage; Uncontrolled or symptomatic hypercalcemia (ionized calcium>1.5 mmol/L, calcium>12 mg/dL or corrected calcium>ULN);21. history of uncontrolled seizures, CNS disorders or significant psychiatric disability precluding I.C. or affecting compliance with study drug;22.Serious uncontrolled infections/poorly controlled diabetes mellitus;23.Abnormal baseline hematological values:WBC;Lymphocyte;Platelet count;Hb;24.Abnormal baseline lab tests:Serum total bilirubin (except for Gilbert’s syndr.);ALT or AST;Alkaline phosphatase;Serum creatinine;INR and aPTT within 2weeks pre-enroll. This applies to Pts who are not receiving therapeutic anticoagulation;Pts receiving therapeutic anticoagulation should be on a stable dose;25.LVEF< 55% by echocardiography/MUGA;26.Major surgical p
研究者
相似试验
进行中（未招募）
1 期
Atezolizumab, Pertuzumab and Trastuzumab with chemotherapy as neoadjuvant (before surgery) treatment of HER2 positive early high-risk and locally advanced breast cancer.Women with a diagnosis of non-metastatic high-risk invasive unilateral, HER2-positive breast cancer.MedDRA version: 20.0Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2017-000981-31-BEFONDAZIONE MICHELANGELO ONLUS PER L'AVANZAMENTO DELLO STUDIO E LA CURA DEI TUMORI650
进行中（未招募）
1 期
Atezolizumab, Pertuzumab and Trastuzumab with chemotherapy as neoadjuvant (before surgery) treatment of HER2 positive early high-risk and locally advanced breast cancer.EUCTR2017-000981-31-ATFONDAZIONE MICHELANGELO ONLUS PER L'AVANZAMENTO DELLO STUDIO E LA CURA DEI TUMORI650
进行中（未招募）
1 期
Atezolizumab, Pertuzumab and Trastuzumab with chemotherapy as neoadjuvant (before surgery) treatment of HER2 positive early high-risk and locally advanced breast cancer.Women with a diagnosis of non-metastatic high-risk invasive unilateral, HER2-positive breast cancer.MedDRA version: 20.0Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2017-000981-31-ROFONDAZIONE MICHELANGELO ONLUS PER L'AVANZAMENTO DELLO STUDIO E LA CURA DEI TUMORI650
招募中
3 期
Atezolizumab, Pertuzumab and Trastuzumab with chemotherapy as neoadjuvant treatment of HER2 positive early high-risk and locally advanced breast cancer (APTneo)Invasive Breast Cancer2024-518026-32-00Fondazione Michelangelo646
尚未招募
不适用
eoadjuvant trastuzumab, pertuzumab and tucatinib without chemotherapy in HER2-positive breast cancer: the TRAIN-4 studyBreast cancerNL-OMON53609Antoni van Leeuwenhoek Ziekenhuis30