- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00944047
Evaluate Trastuzumab Plus Standard Chemotherapy Given Before Surgery in Breast Cancer Patients With Low HER 2 Expression
Abraxane and Trastuzumab Followed by Dose Dense Doxorubicin and Cyclophosphamide as Neoadjuvant Therapy in Invasive Breast Cancer With Low HER2 Expression (1+ or 2+ by IHC)
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Neoadjuvant (primary) chemotherapy refers to chemotherapy given before surgery. Neoadjuvant chemotherapy has a number of potential advantages including increasing the chances for breast preservation at the time of surgery as well as it may improve the local control of the cancer. Several national breast cancer studies have shown that neoadjuvant chemotherapy was equal to chemotherapy given following surgery.
A standard treatment for stage II or Stage III invasive breast cancer with low HER2 expression is combination chemotherapyAdriamycin, Cytoxan,followed by a Taxane: given either before or after surgery), followed by surgery +/- radiation therapy.
The main purpose of chemotherapy however is to reduce the risk of recurrence of cancer and also make surgery more successful. HER2 is a receptor located on the surface of some cells. This receptor plays a role in regulating the growth of the cell, in addition to the growth of tumors. High levels of the HER2 receptor may predict those women who benefit from treatment with agents such as Herceptin that target HER2. Herceptin (Trastuzumab) is a drug that is effective both alone and in combination with standard chemotherapy. There is some data to suggest that patients whose tumors have low expression of the HER2 protein and are normal by FISH may also receive benefit from Herceptin.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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Kansas
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Hays, Kansas, Estados Unidos, 67601
- Hays Medical Center
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Kansas City, Kansas, Estados Unidos, 66205
- University of Kansas Medical Center Cancer Center
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Female patient ≥ 18 years of age
- Histologically proven stage II or III adenocarcinoma of the breast
- Must be candidate for neoadjuvant treatment (Tumor size ≥ 2 cm, T2, T3, T4 and/or clinical N1 or N2).
- HER-2/neu 1+ or 2+ by immunohistochemistry
- Must have operable tumor.
- Performance status of 2 or better per SWOG criteria
- LVEF ≥ 55% by echocardiogram performed within 4 weeks prior to treatment initiation
- If patient of childbearing potential, pregnancy test is negative
- Patients with reproductive potential must use an effective method to avoid pregnancy for the duration of the trial.
- Adequate bone marrow function: ANC > 1500/mm3, platelet count > 100,000/mm3, and hemoglobin > 9 g/dL
- Adequate kidney function: serum creatinine of < 1.5mg/dl and/or creatinine clearance of > 60 mL/min
- Adequate hepatic function: transaminases < 2.5 x upper limit of normal and total bilirubin < 1.5 mg/dL
- Must be informed of the investigational nature of the study and must sign an informed consent in accordance with the institutional rules.
- Pretreatment lab values must be performed within 14 days of patient registration, and other baseline studies (with the exception of mammogram) must be performed within 30 days of patient registration.
EXCLUSION CRITERIA:
- Patient with metastatic breast cancer.
- Women with tumors that are HER-2 neu 0+ or 3+ by immunohistochemistry
- Women with HER 2 FISH amplified tumors (FISH ratio >2.2)
- Patients who have had prior endocrine therapy for > 4 weeks or chemotherapy for this breast cancer will be excluded.
- Locally advanced, inoperable tumors will be excluded.
- The presence of any other medical or psychiatric disorder that, in the opinion of the treating physician, would contraindicate the use of drugs in this protocol or place the subject at undue risk for treatment complications.
- History of significant cardiac disease, cardiac risk factors or uncontrolled arrhythmias
- Ejection fraction < 55%
- Pregnancy or lactation
- Patients with inadequate laboratory values (as defined above) are excluded from study.
- Patients with NCI common toxicity criteria (CTC) grade 2 or greater peripheral neuropathy are excluded from study.
- Patients with active infection are excluded from study.
- Patients with concomitant or previous malignancies within the last 5 years, are excluded from the study. Exceptions include: adequately treated basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, and ductal carcinoma in situ (DCIS).
- Patients with emotional limitations are excluded from study.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Intervention Arm
Nab-paclitaxel, trastuzumab, doxorubicin, cyclophosphamide, Growth Factor Support, Surgery
|
100 MG/M2 IV over 30 minutes once a week for 12 weeks
Otros nombres:
4 MG loading dose followed by 2 MG/KG every week for a total of 12 weeks
Otros nombres:
60 MG/M2 every two weeks for a total of 4 cycles
Otros nombres:
600 MG/M2 every 2 weeks for 4 cycles (administered with Doxorubicin above)
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Pathologic Complete Response
Periodo de tiempo: 22 weeks
|
22 weeks
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Qamar Khan, MD, University of Kansas Medical Center Cancer Center
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades de la piel
- Neoplasias
- Neoplasias por sitio
- Enfermedades de los senos
- Neoplasias de mama
- Efectos fisiológicos de las drogas
- Mecanismos moleculares de acción farmacológica
- Inhibidores de enzimas
- Agentes antirreumáticos
- Agentes antineoplásicos
- Agentes inmunosupresores
- Factores inmunológicos
- Moduladores de tubulina
- Agentes antimitóticos
- Moduladores de mitosis
- Agentes antineoplásicos, alquilantes
- Agentes alquilantes
- Agonistas mieloablativos
- Agentes antineoplásicos, fitogénicos
- Inhibidores de la topoisomerasa II
- Inhibidores de la topoisomerasa
- Agentes antineoplásicos inmunológicos
- Antibióticos, Antineoplásicos
- Ciclofosfamida
- Paclitaxel
- Trastuzumab
- Doxorrubicina
- Mitógenos
Otros números de identificación del estudio
- 11368
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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