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A Study of AC Followed by a Combination of Paclitaxel Plus Trastuzumab or Lapatinib or Both Given Before Surgery to Patients With Operable HER2 Positive Invasive Breast Cancer

2016年6月3日 更新者：NSABP Foundation Inc

A Randomized Phase III Trial of Neoadjuvant Therapy for Patients With Palpable and Operable HER2-Positive Breast Cancer Comparing the Combination of Trastuzumab Plus Lapatinib to Trastuzumab and to Lapatinib Administered With Weekly Paclitaxel Following AC Accompanied by Correlative Science Studies to Identify Predictors of Pathologic Complete Response

The primary purpose of this study is to determine whether breast cancer tumors respond (as measured by pathologic complete response: the absence of microscopic evidence of invasive tumor cells in the breast) to combined chemotherapy of AC(doxorubicin and cyclophosphamide) followed by paclitaxel plus trastuzumab or lapatinib or both given before surgery to patients with HER2-positive breast cancer. Trastuzumab will also be given to all patients after surgery. The study will also evaluate the toxic effects of the chemotherapy combination, including effects on the heart, and will determine survival and progression-free survival 5 years after treatment. Also, the study will look at whether there are gene expression profiles in the tumor tissue that can predict pathologic complete response.

調査の概要

状態

わからない

条件

介入・治療

詳細な説明

Women with breast cancers that overexpress HER2 are at greater risk for disease progression and death than women whose tumors do not overexpress HER2. Trastuzumab, a recombinant humanized monoclonal antibody against the extracellular domain of the HER2 protein blocks downstream signaling of HER2 and substantially improves the efficacy of chemotherapy in women with metastatic and early-stage HER2-positive breast cancers. Because resistance to trastuzumab eventually results in progressive disease in the metastatic setting and contributes to recurrence following adjuvant trastuzumab-based therapy, it is important to develop agents other than trastuzumab that target HER2 signaling through different mechanisms of action. Lapatinib is an oral, small molecule, dual tyrosine kinase inhibitor of HER2 and EGFR. Lapatinib has shown a lack of cross-resistance with trastuzumab in preclinical studies and activity in women with HER2-positive, metastatic breast cancer that has progressed during trastuzumab treatment. Trastuzumab blocks the downstream signaling of HER2 by binding to the extracellular domain of the receptor. Lapatinib binds to the intracellular domains of HER2 and EGFR and prevents activation of downstream signaling pathways. Because of this different mechanism of action, lapatinib may be effective in trastuzumab-resistant disease. The study will also provide important safety information on trastuzumab and lapatinib combinations immediately following anthracycline exposure, and also provide an initial direct comparison of cardiac effects of trastuzumab and lapatinib when incorporated into a standard sequential AC followed by weekly paclitaxel (neo)adjuvant regimen.

Availability of a second agent that can interrupt HER2-signaling pathways through completely different mechanisms than those of trastuzumab offers the potential for further improvement in the management of patients with HER2-overexpressing breast cancer in both the adjuvant and metastatic setting. Co-administration of both trastuzumab and lapatinib with chemotherapy may be important in improving outcomes in subsets of HER2-positive breast cancers. However, use of two inhibitors of the HER2 pathway will increase costs and may increase toxicity, so it will be important to identify the subsets of patients who would benefit from the dual therapy. Inhibition of HER2 with a single agent clearly is sufficient for many patients as evidenced by the results of the trastuzumab trials. Therefore, co-administration to unselected populations of women with HER2-positive breast cancers would not represent an optimal approach. Given the activity of lapatinib, it is likely that it will also be sufficiently active in inhibiting HER2-pathway activation in some patients to allow for its use as the sole inhibitor of the HER2 pathway. Different populations may also derive greater benefit from one of the HER2-blocking agents relative to the other. Identification of potential predictive factors for pathologic complete response to the combination or to either agent administered alone in neoadjuvant trials would provide important information for adjuvant trials designed to definitively address these important issues.

This study will compare 3 combined chemotherapy regimens: AC followed by paclitaxel plus trastuzumab and lapatinib, AC followed by paclitaxel plus lapatinib, and AC followed by paclitaxel plus trastuzumab given before surgery to patients with HER2-positive breast cancer.

研究の種類

介入

入学 (実際)

529

段階

  • フェーズ 3

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • アメリカ
    • Alabama
      • Mobile、Alabama、アメリカ、36608
        • MBCCOP, Gulf Coast
    • California
      • La Jolla、California、アメリカ、92037
        • Scripps Cancer Center-San Diego
      • Long Beach、California、アメリカ、90813
        • Pacific Shores Medical Group
      • Long Beach、California、アメリカ、90801
        • University of California, Irvine Medical Center
      • Orange、California、アメリカ、92868
        • St. Joseph Hospital
      • Palm Springs、California、アメリカ、92262
        • Desert Regional Medical Center Comprehensive Cancer Center
      • Palo Alto、California、アメリカ、94304
        • Stanford University Medical Center
      • Sacramento、California、アメリカ、95816
        • Sutter Medical Center
      • San Diego、California、アメリカ、92120
        • Kaiser Permanente-San Diego
      • Santa Rosa、California、アメリカ、95403
        • Santa Rosa Memorial Hospital
      • Vallejo、California、アメリカ、94589
        • Kaiser Permanente-Vallejo
    • Colorado
      • Aurora、Colorado、アメリカ、80045
        • University of Colorado Cancer Center
      • Colorado Springs、Colorado、アメリカ、80909
        • Memorial Hospital
      • Denver、Colorado、アメリカ、80205
        • Kaiser Permanente-Franklin
      • Denver、Colorado、アメリカ、80224
        • CCOP-Colorado Cancer Research Prog. Inc.(Administrative Only)
      • Lafayette、Colorado、アメリカ、80026
        • Kaiser Permanente Rock Creek
    • Connecticut
      • Hartford、Connecticut、アメリカ、06102
        • Hartford Hospital
      • Norwich、Connecticut、アメリカ、06360
        • Eastern Connecticut Hematology & Oncology Associates
    • District of Columbia
      • Washington、District of Columbia、アメリカ、20016
        • Sibley Memorial Hospital
    • Florida
      • Orlando、Florida、アメリカ、32806
        • MD Anderson Cancer Center
    • Georgia
      • Albany、Georgia、アメリカ、31701
        • Phoebe Putney Memorial Hospital
      • Augusta、Georgia、アメリカ、30912
        • MBCCOP, Medical College of Georgia Research Institute
    • Hawaii
      • Honolulu、Hawaii、アメリカ、96813
        • University of Hawaii
      • Honolulu、Hawaii、アメリカ、96819
        • Kaiser Permanente Hawaii - Moanalua Med Center
    • Idaho
      • Coeur D'Alene、Idaho、アメリカ、83814
        • Kootenai Cancer Center
    • Illinois
      • Chicago、Illinois、アメリカ、60612
        • Rush University Medical Center
      • Decatur、Illinois、アメリカ、62526
        • Decatur Memorial Hospital
      • Elk Grove、Illinois、アメリカ、60007
        • Cancer Institute at Alexian Brothers Hospital Network
      • Naperville、Illinois、アメリカ、60566
        • Edward Hospital
      • Plainfield、Illinois、アメリカ、60585
        • Edward Cancer Center Plainfield
      • Springfield、Illinois、アメリカ、62526
        • CCOP, Central Illinois
      • Urbana、Illinois、アメリカ、61801
        • CCOP, Carle Cancer Center
    • Indiana
      • Indianapolis、Indiana、アメリカ、46260
        • St. Vincent Hospital and Health Care Center
      • South Bend、Indiana、アメリカ、46601
        • CCOP, Northern Indiana Cancer Research Consortium
    • Iowa
      • Des Moines、Iowa、アメリカ、52501
        • CCOP, Des Moines, IA
      • Iowa City、Iowa、アメリカ、52242
        • University of Iowa
      • Sioux City、Iowa、アメリカ、51101
        • CCOP, Sioux Community Cancer consortium
    • Kansas
      • Wichita、Kansas、アメリカ、67214
        • CCOP, Wichita KS
    • Kentucky
      • Lexington、Kentucky、アメリカ、40536
        • University of Kentucky Medical Center
      • Louisville、Kentucky、アメリカ、40202
        • NortonHealtcare Inc.
    • Louisiana
      • New Orleans、Louisiana、アメリカ、70121
        • CCOP, Ochsner Clinic Foundation
    • Maryland
      • Baltimore、Maryland、アメリカ、21204
        • Greater Baltimore Medical Center
      • Baltimore、Maryland、アメリカ、21237
        • Franklin Square Hospital Center
    • Massachusetts
      • Boston、Massachusetts、アメリカ、02118
        • Boston Medical Center
    • Michigan
      • Ann Arbor、Michigan、アメリカ、48106
        • CCOP, Michigan Cancer Research Consortium
      • Detroit、Michigan、アメリカ、48202
        • Henry Ford Hospital
      • Detroit、Michigan、アメリカ、48202
        • Henry Ford Health System
      • Grand Rapids、Michigan、アメリカ、49503
        • CCOP, Grand Rapids Clnical Oncology Program
      • Kalamazoo、Michigan、アメリカ、49007
        • CCOP, Kalamazoo, MI
      • Lansing、Michigan、アメリカ、48910
        • Michigan State University - Breslin Cancer Center
      • Royal Oak、Michigan、アメリカ、48073
        • CCOP, William Beaumont Hospital
      • Southfield、Michigan、アメリカ、48075-9975
        • Providence Hospital - Southfield
    • Minnesota
      • Minneapolis、Minnesota、アメリカ、55415
        • Hennepin County Medical Center
      • Minneapolis、Minnesota、アメリカ、55416
        • CCOP, Metro-Minnesota
    • Missouri
      • Columbia、Missouri、アメリカ、65203
        • University of Missouri-Ellis Fischel
      • Kansas City、Missouri、アメリカ、64131
        • CCOP, Kansas City (Administrative Only)
      • Springfield、Missouri、アメリカ、65804
        • CCOP, Ozark Health Ventures LLC
      • St. Louis、Missouri、アメリカ、63110
        • Saint Louis UniversityHealth Sciences Center
      • St. Louis、Missouri、アメリカ、63131
        • CCOP, Heartland Cancer Research
    • Montana
      • Billings、Montana、アメリカ、59101
        • CCOP, Montana Cancer Consortium
    • Nebraska
      • Omaha、Nebraska、アメリカ、74136
        • CCOP, Missouri Valley Consortium
    • New Jersey
      • New Brunswick、New Jersey、アメリカ、08901
        • Cancer Institute of New Jersey
      • Newark、New Jersey、アメリカ、07112
        • Newark Beth Israel Medical Center
    • New York
      • Albany、New York、アメリカ、12206
        • New York Oncology Hematology PC-Albany
      • Glens Falls、New York、アメリカ、12801
        • Cancer Center at Glens Falls Hospital
      • Syracuse、New York、アメリカ、13057
        • CCOP, Hematology-Oncology Associates of CNY
    • North Carolina
      • Burlington、North Carolina、アメリカ、27215
        • Alamance Regional Medical Center
      • Chapel Hill、North Carolina、アメリカ、28302
        • University of North Carolina at Chapel Hill
      • Charlotte、North Carolina、アメリカ、28203
        • CCOP, Southeast Cancer Control Consortium
      • Mebane、North Carolina、アメリカ、27302
        • Alamance Regional Medical Center - Off site Clinic
      • Winston-Salem、North Carolina、アメリカ、27157
        • Wake Forest University School of Medicine
    • Ohio
      • Akron、Ohio、アメリカ、44304
        • Akron City Hospital
      • Canton、Ohio、アメリカ、44710
        • Aultman Hospital
      • Cleveland、Ohio、アメリカ、44106
        • Case Western Reserve/University Hospitals-Ireland Cancer Cntr.
      • Columbus、Ohio、アメリカ、43017
        • Ohio State University
      • Columbus、Ohio、アメリカ、43215
        • CCOP, Columbus, OH
      • Dayton、Ohio、アメリカ、45429
        • CCOP, Dayton, OH
    • Oklahoma
      • Tulsa、Oklahoma、アメリカ、74136
        • CCOP, Oklahoma
    • Pennsylvania
      • Allentown、Pennsylvania、アメリカ、18105
        • LeHigh Valley Hospital
      • Danville、Pennsylvania、アメリカ、17882-2170
        • Geisinger Clinic
      • Hershey、Pennsylvania、アメリカ、17033
        • Hershey Medical Center
      • Philadelphia、Pennsylvania、アメリカ、19141-3098
        • Albert Einstein Healthcare Network
      • Pittsburgh、Pennsylvania、アメリカ、15213
        • University of Pittsburgh
      • Pittsburgh、Pennsylvania、アメリカ、15224
        • Western Pennsylvania Hospital
      • Pittsburgh、Pennsylvania、アメリカ、15212
        • Allegheny General Hospital/Allegheny-Singer Research Institute
      • Pittsburgh、Pennsylvania、アメリカ、15212
        • NSABP Foundation, Inc.
      • Scranton、Pennsylvania、アメリカ、18501
        • Mercy Hospital
      • West Reading、Pennsylvania、アメリカ、19612
        • Reading Hospital & Medical Center
      • Wynnewood、Pennsylvania、アメリカ、19096
        • CCOP, Main Line Health
    • South Carolina
      • Spartanburg、South Carolina、アメリカ、29303
        • CCOP, Upstate Carolina
    • South Dakota
      • Souix Falls、South Dakota、アメリカ、57104
        • Sanford Cancer Center
    • Tennessee
      • Knoxville、Tennessee、アメリカ、37909
        • Thompson Cancer Survival Center-Dowell Springs
    • Texas
      • Lubbock、Texas、アメリカ、79410
        • Joe Arrington Cancer Research & Treatment Center
      • San Antonio、Texas、アメリカ、78229
        • University of Texas Health Science Center at San Antonio
    • Virginia
      • Richmond、Virginia、アメリカ、23298
        • MBCCOP, Virginia Commonwealth University
    • Washington
      • Seattle、Washington、アメリカ、98109
        • Puget Sound Oncology Consortium
      • Seattle、Washington、アメリカ、99519
        • CCOP, Virginia Mason
      • Tacoma、Washington、アメリカ、83706
        • CCOP, Northwest
    • West Virginia
      • Morgantown、West Virginia、アメリカ、26506-9162
        • West Virginia University Hospitals Inc.
      • Parkersburg、West Virginia、アメリカ、26101
        • Camden-Clark Memorial Hospital
      • Wheeling、West Virginia、アメリカ、26003
        • Wheeling Hospital
    • Wisconsin
      • Marshfield、Wisconsin、アメリカ、54449
        • CCOP, Marshfield Clinic
      • Milwaukee、Wisconsin、アメリカ、53226
        • Medical College of Wisconsin
  • カナダ
    • Ontario
      • Toronto、Ontario、カナダ、M4N 3M5
        • Odette Cancer Centre
    • Quebec
      • Montreal、Quebec、カナダ、H3T 1E2
        • Jewish General Hospital
      • Montreal、Quebec、カナダ、H3A 1A1
        • Royal Victoria Hospital
      • Montreal、Quebec、カナダ、H3T 1M5
        • St. Mary's Hospital Center
      • Montreal、Quebec、カナダ
        • University of Montreal Hospital Group
      • Quebec City、Quebec、カナダ、G1S 4L8
        • Centre Hospitalier Affilie Universitaire De Quebec, Hospital du St-Sacrement
  • プエルトリコ
      • San Juan、プエルトリコ、00936
        • MBCCOP, San Juan, Puerto Rico

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

女性

説明

Inclusion criteria:

  • Female
  • 18 years or older
  • ECOG performance status of 0 or 1
  • Primary breast tumor palpable and measures greater than or equal to 2.0 cm by physical exam
  • Diagnosis of invasive adenocarcinoma made by core needle biopsy
  • Breast cancer determined to be HER2-positive
  • LVEF assessment by MUGA scan or ECG within 3 months prior to randomization

  • Blood counts must meet the following criteria:

    • ANC greater than or equal to 1200/mm3
    • Platelet count greater than or equal to 100,000/mm3
    • Hemoglobin greater than or equal to 10 g/dL
  • Serum creatinine less than or equal to ULN for the lab

  • Adequate hepatic function by these criteria:

    • Total bilirubin less than or equal to the ULN for the lab unless the patient has a bilirubin elevation greater than ULN to 1.5 x ULN resulting from Gilbert's disease or similar syndrome due to slow conjugation of bilirubin; and
    • Alkaline phosphatase less than or equal to 2.5 x ULN; and
    • AST less than or equal to 1.5 x ULN for the lab.
  • If skeletal pain present or alkaline phosphatase greater than ULN (but less than or equal to 2.5 x ULN), bone scan or PET scan must not demonstrate metastatic disease
  • If AST or alkaline phosphatase greater than ULN , liver imaging (CT, MRI or PET scan) must not demonstrate definitive metastatic disease and the requirements in criterion for hepatic function must be met
  • Able to swallow oral medications

Exclusion criteria:

  • FNA alone to diagnose the primary tumor
  • Excisional biopsy or lumpectomy was performed prior to randomization
  • Surgical axillary staging procedure prior to randomization. Exceptions: 1) FNA or core biopsy of an axillary node for any patient, and 2) although not recommended, a pre-neoadjuvant therapy SN biopsy for patients with clinically negative axillary nodes.
  • Tumors clinically staged as T4
  • Ipsilateral cN2b or cN3 disease (Patients with cN1 or cN2a disease are eligible)
  • Definitive clinical or radiologic evidence of metastatic disease
  • Synchronous bilateral invasive breast cancer
  • Requirement for chronic use of any of the medications or substances specified in the protocol
  • Treatment including RT, chemotherapy, and/or targeted therapy for the currently diagnosed breast cancer prior to randomization
  • Any sex hormonal therapy, e.g., birth control pills, ovarian hormone replacement therapy, etc. (These patients are eligible if therapy is discontinued prior to randomization)
  • Continued therapy with any hormonal agent such as raloxifene, tamoxifen, or other SERM. (Patients are eligible only if these medications are discontinued prior to randomization)
  • Prior history of breast cancer, including DCIS (Patients with a history of LCIS are eligible)
  • Prior therapy with anthracyclines, taxanes, trastuzumab, or lapatinib for any malignancy
  • Other malignancies unless the patient is considered to be disease-free for 5 or more years prior to randomization and is deemed by her physician to be at low risk for recurrence. Patients with the following cancers are eligible if diagnosed and treated within the past 5 years: carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinoma of the skin.

  • Cardiac disease that would preclude the use of the drugs included in the B-41 treatment regimens. This includes but is not confined to:

    • Active cardiac disease:

      • angina pectoris requiring the use of anti-anginal medication;
      • ventricular arrhythmias except for benign premature ventricular contractions controlled by medication;
      • conduction abnormality requiring a pacemaker;
      • supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication; and
      • clinically significant valvular disease.

    • History of cardiac disease:

      • myocardial infarction;
      • congestive heart failure; or
      • cardiomyopathy.
  • Uncontrolled hypertension, defined as blood pressure greater than 150/90 mm/Hg on antihypertensive therapy
  • History of or current symptomatic interstitial pneumonitis or pulmonary fibrosis or definitive evidence of interstitial pneumonitis or pulmonary fibrosis described on CT or chest x-ray in asymptomatic patients
  • Sensory/motor neuropathy greater than or equal to grade 2, as defined by the NCI's CTCAE v3.0
  • Malabsorption syndrome, ulcerative colitis, resection of the stomach or small bowel, or other disease significantly affecting gastrointestinal function
  • Other non-malignant systemic disease that would preclude treatment with any of the treatment regimens or would prevent required follow-up
  • Conditions that would prohibit administration of corticosteroids
  • Administration of any investigational agents within 30 days before randomization
  • Pregnancy or lactation

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
アクティブコンパレータ：Group 1: AC then paclitaxel + trastuzumab
AC followed by paclitaxel plus trastuzumab
薬：doxorubicin
60 mg/m2 IV every 21 days for cycles 1-4
薬：cyclophosphamide
600 mg/m2 IV every 21 days for cycles 1-4
薬：paclitaxel
80 mg/m2 IV on days 1, 8, and 15 every 28 days for cycles 5-8
薬：trastuzumab
First dose: 4 mg/kg IV, subsequent doses: 2 mg/kg IV weekly beginning on day 1 of the first paclitaxel cycle until 1-7 days before surgery
実験的：Group 2: AC then paclitaxel + lapatinib
AC followed by paclitaxel plus lapatinib
薬：doxorubicin
60 mg/m2 IV every 21 days for cycles 1-4
薬：cyclophosphamide
600 mg/m2 IV every 21 days for cycles 1-4
薬：paclitaxel
80 mg/m2 IV on days 1, 8, and 15 every 28 days for cycles 5-8
薬：lapatinib
Group 2: 1250 mg PO daily beginning on day 1 of the first paclitaxel cycle until 1 day before surgery. Group 3: 750 mg PO daily beginning on day 1 of the first paclitaxel cycle until 1 day before surgery.
実験的：Group 3: AC then paclitaxel + trastuzumab + lapatinib
AC followed by paclitaxel plus trastuzumab plus lapatinib
薬：doxorubicin
60 mg/m2 IV every 21 days for cycles 1-4
薬：cyclophosphamide
600 mg/m2 IV every 21 days for cycles 1-4
薬：paclitaxel
80 mg/m2 IV on days 1, 8, and 15 every 28 days for cycles 5-8
薬：trastuzumab
First dose: 4 mg/kg IV, subsequent doses: 2 mg/kg IV weekly beginning on day 1 of the first paclitaxel cycle until 1-7 days before surgery
薬：lapatinib
Group 2: 1250 mg PO daily beginning on day 1 of the first paclitaxel cycle until 1 day before surgery. Group 3: 750 mg PO daily beginning on day 1 of the first paclitaxel cycle until 1 day before surgery.

この研究は何を測定していますか？

主要な結果の測定

結果測定
時間枠
Determination of pathologic complete response (pCR), defined by the absence of microscopic evidence of invasive tumor cells in the post chemotherapy surgical breast specimen.
時間枠：surgery following chemotherapy
surgery following chemotherapy

二次結果の測定

結果測定
時間枠
The determination of pCR in the surgical breast and lymph node specimens following chemotherapy.
時間枠：surgery following chemotherapy
surgery following chemotherapy
Clinical tumor measurement as assessed by physical exam of the breast and lymph nodes
時間枠：baseline (prior to starting protocol therapy), at the completion of AC (before starting paclitaxel and trastuzumab and/or lapatinib), and at the conclusion of the sequential regimens (prior to surgery).
baseline (prior to starting protocol therapy), at the completion of AC (before starting paclitaxel and trastuzumab and/or lapatinib), and at the conclusion of the sequential regimens (prior to surgery).
Determination of cardiac toxicity as measured by the incidence of cardiac events defined as definite or probable cardiac death
時間枠：two year cumulative incidence
two year cumulative incidence
Determination of non-cardiac toxicities as measured by frequencies of adverse events categorized using CTCAE v3.0.
時間枠：through 5 years after entry
through 5 years after entry
Overall survival as measured by time from randomization until death from any cause.
時間枠：through 5 years after entry
through 5 years after entry
Recurrence-free interval as measured by occurrence of inoperable progressive disease, or from time of surgery to occurrence of local, regional, or distant recurrence in patients with operable disease.
時間枠：through 5 years after entry
through 5 years after entry
In tumor tissue, a comparison of array comparative genomic hybridization (CGH) data with gene expression profile data to examine coordinated overexpression of amplified genes, especially in HER2 and cMYC loci.
時間枠：Tissue sample collected at surgery following chemotherapy
Tissue sample collected at surgery following chemotherapy

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

NSABP Foundation Inc

協力者

GlaxoSmithKline

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2007年7月1日

一次修了 (実際)

2012年6月1日

研究の完了 (予想される)

2017年3月1日

試験登録日

最初に提出

2007年6月13日

QC基準を満たした最初の提出物

2007年6月13日

最初の投稿 (見積もり)

2007年6月15日

学習記録の更新

投稿された最後の更新 (見積もり)

2016年6月6日

QC基準を満たした最後の更新が送信されました

2016年6月3日

最終確認日

2016年6月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • NSABP B-41

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

浸潤性乳がんの臨床試験

  • Tianjin Medical University Cancer Institute and...
    Guangxi Medical University; Sun Yat-sen University; Chinese PLA General Hospital; The First Affiliated... と他の協力者
    完了
    乳がんの診断プロセスにおける CBBCT の技術操作と標準的な臨床応用プロトコル (CBBCT)
    Conebeam Breast CT の臨床応用ガイド
    中国
  • Jonsson Comprehensive Cancer Center
    National Cancer Institute (NCI); Highlight Therapeutics
    積極的、募集していない
    切除可能な軟部肉腫の治療のための手術前のニボルマブと BO-112
    平滑筋肉腫 | 悪性末梢神経鞘腫瘍 | 滑膜肉腫 | 未分化多形肉腫 | 骨の未分化高悪性度多形肉腫 | 粘液線維肉腫 | II期の体幹および四肢の軟部肉腫 AJCC v8 | III期の体幹および四肢の軟部肉腫 AJCC v8 | IIIA 期の体幹および四肢の軟部肉腫 AJCC v8 | IIIB 期の体幹および四肢の軟部肉腫 AJCC v8 | 切除可能な軟部肉腫 | 多形性横紋筋肉腫 | 切除可能な脱分化型脂肪肉腫 | 切除可能な未分化多形肉腫 | 軟部組織線維肉腫 | 紡錘細胞肉腫 | ステージ I 後腹膜肉腫 AJCC (American Joint Committee on Cancer) v8 | 体幹および四肢の I 期軟部肉腫 AJCC v8 | ステージ... およびその他の条件
    アメリカ

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