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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

3 de junio de 2016 actualizado por: 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.

Descripción general del estudio

Estado

Desconocido

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Actual)

529

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Femenino

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Group 1: AC then paclitaxel + trastuzumab
AC followed by paclitaxel plus trastuzumab
Droga: doxorubicin
60 mg/m2 IV every 21 days for cycles 1-4
Droga: cyclophosphamide
600 mg/m2 IV every 21 days for cycles 1-4
Droga: paclitaxel
80 mg/m2 IV on days 1, 8, and 15 every 28 days for cycles 5-8
Droga: 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
Experimental: Group 2: AC then paclitaxel + lapatinib
AC followed by paclitaxel plus lapatinib
Droga: doxorubicin
60 mg/m2 IV every 21 days for cycles 1-4
Droga: cyclophosphamide
600 mg/m2 IV every 21 days for cycles 1-4
Droga: paclitaxel
80 mg/m2 IV on days 1, 8, and 15 every 28 days for cycles 5-8
Droga: 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.
Experimental: Group 3: AC then paclitaxel + trastuzumab + lapatinib
AC followed by paclitaxel plus trastuzumab plus lapatinib
Droga: doxorubicin
60 mg/m2 IV every 21 days for cycles 1-4
Droga: cyclophosphamide
600 mg/m2 IV every 21 days for cycles 1-4
Droga: paclitaxel
80 mg/m2 IV on days 1, 8, and 15 every 28 days for cycles 5-8
Droga: 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
Droga: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
Determination of pathologic complete response (pCR), defined by the absence of microscopic evidence of invasive tumor cells in the post chemotherapy surgical breast specimen.
Periodo de tiempo: surgery following chemotherapy
surgery following chemotherapy

Medidas de resultado secundarias

Medida de resultado
Periodo de tiempo
The determination of pCR in the surgical breast and lymph node specimens following chemotherapy.
Periodo de tiempo: surgery following chemotherapy
surgery following chemotherapy
Clinical tumor measurement as assessed by physical exam of the breast and lymph nodes
Periodo de tiempo: 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
Periodo de tiempo: 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.
Periodo de tiempo: through 5 years after entry
through 5 years after entry
Overall survival as measured by time from randomization until death from any cause.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: Tissue sample collected at surgery following chemotherapy
Tissue sample collected at surgery following chemotherapy

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

NSABP Foundation Inc

Colaboradores

GlaxoSmithKline

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de julio de 2007

Finalización primaria (Actual)

1 de junio de 2012

Finalización del estudio (Anticipado)

1 de marzo de 2017

Fechas de registro del estudio

Enviado por primera vez

13 de junio de 2007

Primero enviado que cumplió con los criterios de control de calidad

13 de junio de 2007

Publicado por primera vez (Estimar)

15 de junio de 2007

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

6 de junio de 2016

Última actualización enviada que cumplió con los criterios de control de calidad

3 de junio de 2016

Última verificación

1 de junio de 2016

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • NSABP B-41

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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