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Paclitaxel Albumin-Stabilized Nanoparticle Formulation, Gemcitabine, and Bevacizumab in Treating Patients With Metastatic Breast Cancer

6 марта 2017 г. обновлено: Alliance for Clinical Trials in Oncology

Phase II Trial of Albumin-Bound Paclitaxel in Combination With Gemcitabine and Bevacizumab in Patients With Metastatic Breast Cancer

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving combination chemotherapy together with bevacizumab may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving paclitaxel albumin-stabilized nanoparticle formulation and gemcitabine together with bevacizumab works in treating patients with metastatic breast cancer.

Обзор исследования

Статус

Завершенный

Условия

Вмешательство/лечение

Подробное описание

OBJECTIVES:

Primary

  • To determine the 6-month progression-free survival rate of patients with metastatic breast cancer treated with paclitaxel albumin-stabilized nanoparticle formulation, gemcitabine hydrochloride, and bevacizumab.

Secondary

  • To determine the overall survival of patients treated with this regimen.
  • To determine the progression-free survival of patients treated with this regimen.
  • To determine the confirmed response rate in patients treated with this regimen.
  • To determine the duration of response in patients treated with this regimen.
  • To determine the time to treatment failure in patients treated with this regimen.
  • To determine the quality of life of patients treated with this regimen.

OUTLINE: Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline and after every other course, and then after completion of treatment.

After completion of study treatment, patients are followed periodically for 5 years.

Тип исследования

Интервенционный

Регистрация (Действительный)

50

Фаза

  • Фаза 2

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

  • Соединенные Штаты
    • Arizona
      • Scottsdale, Arizona, Соединенные Штаты, 85259-5499
        • Mayo Clinic Scottsdale
    • Connecticut
      • Hartford, Connecticut, Соединенные Штаты, 06105
        • Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
    • Florida
      • Jacksonville, Florida, Соединенные Штаты, 32224
        • Mayo Clinic - Jacksonville
    • Indiana
      • Beech Grove, Indiana, Соединенные Штаты, 46107
        • St. Francis Hospital and Health Centers - Beech Grove Campus
      • Richmond, Indiana, Соединенные Штаты, 47374
        • Reid Hospital & Health Care Services
    • Iowa
      • Cedar Rapids, Iowa, Соединенные Штаты, 52403
        • Cedar Rapids Oncology Associates
      • Cedar Rapids, Iowa, Соединенные Штаты, 52403
        • Mercy Regional Cancer Center at Mercy Medical Center
      • Clive, Iowa, Соединенные Штаты, 50325
        • Medical Oncology and Hematology Associates - West Des Moines
      • Des Moines, Iowa, Соединенные Штаты, 50309
        • CCOP - Iowa Oncology Research Association
      • Des Moines, Iowa, Соединенные Штаты, 50309
        • John Stoddard Cancer Center at Iowa Methodist Medical Center
      • Des Moines, Iowa, Соединенные Штаты, 50309
        • Medical Oncology and Hematology Associates at John Stoddard Cancer Center
      • Des Moines, Iowa, Соединенные Штаты, 50314
        • Medical Oncology and Hematology Associates at Mercy Cancer Center
      • Des Moines, Iowa, Соединенные Штаты, 50314
        • Mercy Cancer Center at Mercy Medical Center - Des Moines
      • Des Moines, Iowa, Соединенные Штаты, 50316
        • John Stoddard Cancer Center at Iowa Lutheran Hospital
      • Mason City, Iowa, Соединенные Штаты, 50401
        • Mercy Cancer Center at Mercy Medical Center - North Iowa
      • Ottumwa, Iowa, Соединенные Штаты, 52501
        • McCreery Cancer Center at Ottumwa Regional
      • Sioux City, Iowa, Соединенные Штаты, 51101
        • Siouxland Hematology-Oncology Associates, LLP
      • Sioux City, Iowa, Соединенные Штаты, 51104
        • St. Luke's Regional Medical Center
      • Sioux City, Iowa, Соединенные Штаты, 51104
        • Mercy Medical Center - Sioux City
    • Michigan
      • Ann Arbor, Michigan, Соединенные Штаты, 48106-0995
        • Saint Joseph Mercy Cancer Center
      • Ann Arbor, Michigan, Соединенные Штаты, 48106
        • CCOP - Michigan Cancer Research Consortium
      • Battle Creek, Michigan, Соединенные Штаты, 49017
        • Battle Creek Health System Cancer Care Center
      • Big Rapids, Michigan, Соединенные Штаты, 49307
        • Mecosta County Medical Center
      • Dearborn, Michigan, Соединенные Штаты, 48123-2500
        • Oakwood Cancer Center at Oakwood Hospital and Medical Center
      • Flint, Michigan, Соединенные Штаты, 48503
        • Hurley Medical Center
      • Flint, Michigan, Соединенные Штаты, 48503
        • Genesys Hurley Cancer Institute
      • Grand Rapids, Michigan, Соединенные Штаты, 49503
        • Butterworth Hospital at Spectrum Health
      • Grand Rapids, Michigan, Соединенные Штаты, 49503
        • CCOP - Grand Rapids
      • Grand Rapids, Michigan, Соединенные Штаты, 49503
        • Lacks Cancer Center at Saint Mary's Health Care
      • Grosse Pointe Woods, Michigan, Соединенные Штаты, 48236
        • Van Elslander Cancer Center at St. John Hospital and Medical Center
      • Jackson, Michigan, Соединенные Штаты, 49201
        • Foote Memorial Hospital
      • Lansing, Michigan, Соединенные Штаты, 48912-1811
        • Sparrow Regional Cancer Center
      • Livonia, Michigan, Соединенные Штаты, 48154
        • St. Mary Mercy Hospital
      • Muskegon, Michigan, Соединенные Штаты, 49443
        • Mercy General Health Partners
      • Pontiac, Michigan, Соединенные Штаты, 48341-2985
        • St. Joseph Mercy Oakland
      • Port Huron, Michigan, Соединенные Штаты, 48060
        • Mercy Regional Cancer Center at Mercy Hospital
      • Saginaw, Michigan, Соединенные Штаты, 48601
        • Seton Cancer Institute at Saint Mary's - Saginaw
      • Traverse City, Michigan, Соединенные Штаты, 49684
        • Munson Medical Center
      • Warren, Michigan, Соединенные Штаты, 48093
        • St. John Macomb Hospital
      • Wyoming, Michigan, Соединенные Штаты, 49519
        • Metro Health Hospital
    • Minnesota
      • Alexandria, Minnesota, Соединенные Штаты, 56308
      • Burnsville, Minnesota, Соединенные Штаты, 55337
        • Fairview Ridges Hospital
      • Coon Rapids, Minnesota, Соединенные Штаты, 55433
        • Mercy and Unity Cancer Center at Mercy Hospital
      • Duluth, Minnesota, Соединенные Штаты, 55805
        • CCOP - Duluth
      • Duluth, Minnesota, Соединенные Штаты, 55805-1983
        • Duluth Clinic Cancer Center - Duluth
      • Duluth, Minnesota, Соединенные Штаты, 55805
        • Miller - Dwan Medical Center
      • Edina, Minnesota, Соединенные Штаты, 55435
        • Fairview Southdale Hospital
      • Fridley, Minnesota, Соединенные Штаты, 55432
        • Mercy and Unity Cancer Center at Unity Hospital
      • Hutchinson, Minnesota, Соединенные Штаты, 55350
        • Hutchinson Area Health Care
      • Maplewood, Minnesota, Соединенные Штаты, 55109
        • Minnesota Oncology Hematology, PA - Maplewood
      • Maplewood, Minnesota, Соединенные Штаты, 55109
        • HealthEast Cancer Care at St. John's Hospital
      • Minneapolis, Minnesota, Соединенные Штаты, 55407
        • Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
      • Minneapolis, Minnesota, Соединенные Штаты, 55415
        • Hennepin County Medical Center - Minneapolis
      • Robbinsdale, Minnesota, Соединенные Штаты, 55422-2900
        • Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
      • Rochester, Minnesota, Соединенные Штаты, 55905
        • Mayo Clinic Cancer Center
      • Saint Cloud, Minnesota, Соединенные Штаты, 56303
        • CentraCare Clinic - River Campus
      • Saint Cloud, Minnesota, Соединенные Штаты, 56303
        • Coborn Cancer Center
      • Saint Louis Park, Minnesota, Соединенные Штаты, 55416
        • CCOP - Metro-Minnesota
      • Saint Louis Park, Minnesota, Соединенные Штаты, 55416
        • Park Nicollet Cancer Center
      • Saint Paul, Minnesota, Соединенные Штаты, 55102
        • United Hospital
      • Shakopee, Minnesota, Соединенные Штаты, 55379
        • St. Francis Cancer Center at St. Francis Medical Center
      • St. Paul, Minnesota, Соединенные Штаты, 55101
        • Regions Hospital Cancer Care Center
      • Waconia, Minnesota, Соединенные Штаты, 55387
        • Ridgeview Medical Center
      • Willmar, Minnesota, Соединенные Штаты, 56201
        • Willmar Cancer Center at Rice Memorial Hospital
      • Woodbury, Minnesota, Соединенные Штаты, 55125
        • Minnesota Oncology Hematology, PA - Woodbury
    • Montana
      • Great Falls, Montana, Соединенные Штаты, 59405-5309
        • Big Sky Oncology
      • Great Falls, Montana, Соединенные Штаты, 59405
        • Sletten Cancer Institute at Benefis Healthcare
    • Nebraska
      • Lincoln, Nebraska, Соединенные Штаты, 68510
        • Cancer Resource Center - Lincoln
      • Omaha, Nebraska, Соединенные Штаты, 68106
        • CCOP - Missouri Valley Cancer Consortium
      • Omaha, Nebraska, Соединенные Штаты, 68122
        • Immanuel Medical Center
      • Omaha, Nebraska, Соединенные Штаты, 68124
        • Alegant Health Cancer Center at Bergan Mercy Medical Center
      • Omaha, Nebraska, Соединенные Штаты, 68131-2197
        • Creighton University Medical Center
    • North Dakota
      • Bismarck, North Dakota, Соединенные Штаты, 58501
        • Bismarck Cancer Center
      • Bismarck, North Dakota, Соединенные Штаты, 58501
        • Medcenter One Hospital Cancer Care Center
      • Bismarck, North Dakota, Соединенные Штаты, 58501
        • Mid Dakota Clinic, PC
      • Bismarck, North Dakota, Соединенные Штаты, 58502
        • St. Alexius Medical Center Cancer Center
    • Ohio
      • Dayton, Ohio, Соединенные Штаты, 45405
        • Grandview Hospital
      • Dayton, Ohio, Соединенные Штаты, 45406
        • Good Samaritan Hospital
      • Dayton, Ohio, Соединенные Штаты, 45409
        • David L. Rike Cancer Center at Miami Valley Hospital
      • Dayton, Ohio, Соединенные Штаты, 45415
        • Samaritan North Cancer Care Center
      • Dayton, Ohio, Соединенные Штаты, 45420
        • CCOP - Dayton
      • Findlay, Ohio, Соединенные Штаты, 45840
        • Blanchard Valley Medical Associates
      • Franklin, Ohio, Соединенные Штаты, 45005-1066
        • Middletown Regional Hospital
      • Greenville, Ohio, Соединенные Штаты, 45331
        • Wayne Hospital
      • Kettering, Ohio, Соединенные Штаты, 45429
        • Charles F. Kettering Memorial Hospital
      • Troy, Ohio, Соединенные Штаты, 45373-1300
        • UVMC Cancer Care Center at Upper Valley Medical Center
      • Wilmington, Ohio, Соединенные Штаты, 45177
        • Clinton Memorial Hospital
      • Xenia, Ohio, Соединенные Штаты, 45385
        • Ruth G. McMillan Cancer Center at Greene Memorial Hospital
    • Oklahoma
      • Tulsa, Oklahoma, Соединенные Штаты, 74136
        • Natalie Warren Bryant Cancer Center at St. Francis Hospital
    • Pennsylvania
      • Allentown, Pennsylvania, Соединенные Штаты, 18105
        • Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
    • South Dakota
      • Sioux Falls, South Dakota, Соединенные Штаты, 57105
        • Medical X-Ray Center, PC
      • Sioux Falls, South Dakota, Соединенные Штаты, 57117-5039
        • Sanford Cancer Center at Sanford USD Medical Center

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

18 лет и старше (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Описание

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed infiltrating breast cancer

    • Clinical evidence of metastatic disease

  • Measurable disease, defined as at least one measurable lesion per RECIST criteria

    • No non-measurable disease only, defined as all other lesions, including small lesions (longest diameter < 2 cm) and truly non-measurable lesions, including any of the following:

      • Bone lesions
      • Leptomeningeal disease
      • Ascites
      • Pleural/pericardial effusion
      • Inflammatory breast disease
      • Lymphangitis cutis/pulmonis
      • Abdominal masses that are not confirmed and followed by imaging techniques
      • Cystic lesions
  • Patients with HER-2/neu positive tumors, must have received prior treatment with trastuzumab (Herceptin®) or have a contraindication for trastuzumab

  • No evidence of active brain metastasis, including leptomeningeal involvement, on MRI or CT scan

    • CNS metastasis controlled by prior surgery and/or radiotherapy allowed

      • Must be asymptomatic for ≥ 2 months with no evidence of progression prior to study entry
  • Hormone receptor status not specified

PATIENT CHARACTERISTICS:

  • Menopausal status not specified
  • Life expectancy ≥ 12 weeks
  • ECOG performance status 0-1
  • ANC ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 9.0 g/dL
  • AST and ALT ≤ 2.5 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 2.5 times ULN
  • Total bilirubin ≤ 1.5 times ULN
  • Creatinine ≤ 1.5 mg/dL

  • Urine protein:creatinine ratio < 1 or urinalysis < 1+ protein

    • Patients discovered to have ≥ 1+ proteinuria at baseline must demonstrate 24-hour urine protein < 1 g
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 30 days after completion of study therapy
  • Able to complete questionnaires alone or with assistance
  • No peripheral neuropathy > grade 1
  • No history of allergy or hypersensitivity to albumin-bound paclitaxel, paclitaxel, gemcitabine hydrochloride, bevacizumab, albumin, drug product excipients, or chemically similar agents
  • No stage III or IV invasive, non-breast malignancy within the past 5 years

  • No other active malignancy, except nonmelanoma skin cancer or carcinoma in situ of the cervix

    • Patient must not be receiving other specific treatment for a prior malignancy

  • No uncontrolled hypertension (i.e., blood pressure [BP] > 160/90 mm Hg on ≥ 2 occasions at least 5 minutes apart)

    • Patients who have recently started or adjusted antihypertensive medications are eligible providing that BP is < 140/90 mm Hg on any new regimen for ≥ 3 different observations in ≥ 14 days
  • No bleeding diathesis or uncontrolled coagulopathy
  • No hemoptysis within the past 6 months
  • No prior arterial or venous thrombosis within the past 12 months
  • No history of cerebrovascular accident
  • No history of hypertensive crisis or hypertensive encephalopathy
  • No abdominal fistula or gastrointestinal perforation within the past 6 months
  • No serious non-healing wound, ulcer, or fracture

  • No clinically significant cardiac disease, defined as any of the following:

    • Congestive heart failure
    • Symptomatic coronary artery disease
    • Unstable angina
    • Cardiac arrhythmias not well controlled with medication
    • Myocardial infarction within the past 12 months
  • No comorbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for study entry or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics

  • No prior chemotherapy for metastatic disease

    • May have received one prior adjuvant chemotherapy regimen

  • Prior neoadjuvant chemotherapy allowed

    • More than 6 months since prior adjuvant or neoadjuvant taxane (i.e., docetaxel or paclitaxel) therapy
  • Prior hormonal therapy in either adjuvant or metastatic setting allowed

  • More than 4 weeks since prior radiotherapy (except if to a non-target lesion only, or single dose radiation for palliation)

    • Prior radiotherapy to a target lesion is allowed provided there has been clear progression of the lesion since radiotherapy was completed
  • More than 4 weeks since prior cytotoxic chemotherapeutic agent or investigational drug
  • More than 2 weeks since prior and no concurrent acetylsalicylic acid, anticoagulants, or thrombolytic agents (except for once-daily 81 mg acetylsalicylic acid)
  • More than 6 weeks since prior major surgery, chemotherapy, or immunologic therapy

  • More than 1 week since prior minor surgery (e.g., core biopsy)

    • Placement of a vascular access device within 7 days is allowed
  • More than 3 months since prior neurosurgery

  • No concurrent treatment in a different clinical study in which investigational procedures are performed or investigational therapies are administered

    • Trials related to symptom management (Cancer Control) which do not employ hormonal treatments or treatments that may block the path of the targeted agents used in this study may be allowed

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Н/Д
  • Интервенционная модель: Одногрупповое задание
  • Маскировка: Нет (открытая этикетка)

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: paclitaxel + gemcitabine + bevacizumab

Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline and after every other course, and then after completion of treatment.

After completion of study treatment, patients are followed periodically for 5 years.
Лекарство: гемцитабина гидрохлорид
Биологический: бевацизумаб
Лекарство: состав наночастиц паклитаксела, стабилизированный альбумином

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
6-month Progression-free Survival (PFS) Rate
Временное ограничение: at 6 months
The primary endpoint of this trial is the 6-month progression-free survival rate. A patient is considered to be a 6-month progression-free survivor if the patient is 6 months from registration without a documentation of disease progression (note, the patient need not be on study treatment at 6 months to be considered a success). The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated using the properties of the binomial distribution. Progression is defined using the RECIST Criteria, as at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, appearance of one or more new lesions, or unequivocal progression of existing non-target lesions.
at 6 months

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Overall Survival Time
Временное ограничение: Up to 5 years
Overall Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier (1958).
Up to 5 years
PFS Time
Временное ограничение: Up to 5 years
Progression-free survival time is defined as the time from registration to the earliest date of documentation of disease progression. If a patient dies without a documentation of disease progression the patient will be considered to have had disease progression at the time of their death. The distribution of time to progression will be estimated using the method of Kaplan-Meier (1958). Progression is defined using the RECIST Criteria, as at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, appearance of one or more new lesions, or unequivocal progression of existing non-target lesions.
Up to 5 years
Confirmed Response (Complete or Partial Response) Rate
Временное ограничение: Up to 5 years
A confirmed response is defined to be either a complete response (CR) or partial response (PR) noted as the objective status on 2 consecutive evaluations at least 8 weeks apart. The confirmed response rate (percentage) will be estimated by the number of confirmed responses in evaluable patients divided by the total number of evaluable patients multiplied by 100. The appropriate confidence interval will be calculated based on the binomial distribution.
Up to 5 years
Duration of Response
Временное ограничение: Up to 5 years
Duration of response is defined for all evaluable patients who have achieved a confirmed response as the date at which the patient's earliest best objective status is first noted to be either a CR or PR to the earliest date progression is documented. If a patient dies subsequent to the confirmed response without a documentation of disease progression, the patient will be considered to have had disease progression at the time of their death. In the case of a patient failing to return for evaluations before a documentation of disease progression, the patient will be censored for progression on the date of last evaluation. The distribution of duration of response will be estimated using the method of Kaplan-Meier (1958).
Up to 5 years
Time to Treatment Failure
Временное ограничение: Up to 5 years
Time to treatment failure is defined to be the time from the date of registration to the date at which the patient is removed from treatment due to progression, adverse events, or refusal. If the patient is considered to be a major treatment violation or is taken off study as a non-protocol failure, the patient will be censored on the date they were removed from treatment. The distribution of time to treatment failure will be estimated using the method of Kaplan-Meier (1958). Progression is defined using the RECIST Criteria, as at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, appearance of one or more new lesions, or unequivocal progression of existing non-target lesions.
Up to 5 years
Quality of Life, as Measure by the Mean Change in FACT-B TOI Score at Cycle 8
Временное ограничение: From baseline to end of Cycle 8; Up to 24 weeks

Quality of life (QOL) as measured by the mean change (from baseline) in FACT-B (TOI) Trial Outcome Index at Cycle 8 (24 weeks). FACT-B was scored according to the published scoring (*) criteria with higher scores representing better QOL. The FACT-B TOI was the sum of the following FACT-B subscale/scale scores: physical (score range 0-28), functional (score range 0-28), and Breast Cancer Subscale (score range 0-40); range of the FACT-B TOI is 0-96 (the change scores have a possible range of -96 to 96). The mean change and 95% confidence interval are reported below. A one-sample t-test is used to compare the change from baseline to a value of 0.

(*)= Brady MJ, Cella DF, Mo F, Bonomi AE, Tulsky DS, Lloyd SR, Deasy S, Cobleigh M, Shiomoto G. Reliability and validity of the Functional Assessment of Cancer Therapy-Breast (FACT-B) quality of life instrument. J Clin Oncol 1997;15:974-986.
From baseline to end of Cycle 8; Up to 24 weeks

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Alliance for Clinical Trials in Oncology

Соавторы

National Cancer Institute (NCI)

Следователи

  • Учебный стул: Donald W. Northfelt, MD, FACP, Mayo Clinic

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Общие публикации

  • Northfelt DW, Dueck AC, Flynn TP, et al.: Phase II trial combining nab-paclitaxel (NP), gemcitabine (G), and bevacizumab (B) in patients (pts) with metastatic breast cancer (MBC): NCCTG N0735. [Abstract] J Clin Oncol 29 (Suppl 15): A-1126, 2011.

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования

1 ноября 2008 г.

Первичное завершение (Действительный)

1 августа 2010 г.

Завершение исследования (Действительный)

1 августа 2013 г.

Даты регистрации исследования

Первый отправленный

18 апреля 2008 г.

Впервые представлено, что соответствует критериям контроля качества

18 апреля 2008 г.

Первый опубликованный (Оценивать)

21 апреля 2008 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

17 апреля 2017 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

6 марта 2017 г.

Последняя проверка

1 марта 2017 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • NCCTG-N0735
  • NCI-2009-00666 (Идентификатор реестра: CTRP (Clinical Trials Reporting System))
  • CDR0000593581 (Идентификатор реестра: PDQ (Physician Data Query))

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

Клинические исследования гемцитабина гидрохлорид

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