A Randomized Phase II Pilot Trial of Carboplatin Compared to Docetaxel for Patients With Metastatic Genetic Breast Cancer [BRCA Trial]
Colección de datos
Enfermedades Urogenitales+16
+ Enfermedades de la Mama
+ Neoplasias de la Mama
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de septiembre de 2005
Fecha en la que se inscribió al primer participante.OBJECTIVES: Primary * Compare the safety and effectiveness of carboplatin vs docetaxel in women with metastatic breast cancer and the BRCA1 or BRCA2 gene mutation. Secondary * Compare time to disease progression in patients treated with these regimens. * Compare progression-free survival of patients treated with carboplatin vs docetaxel. OUTLINE: This is a randomized, open-label, multicenter, pilot study. Patients are stratified according to gene mutation (BRCA1 vs BRCA2), prior adjuvant taxane chemotherapy (yes vs no), liver or lung metastasis affecting the parenchyma (yes vs no), Jewish ancestry by parent or grandparent (yes vs no), and first-line treatment vs second-line treatment. Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive carboplatin IV over 1 hour on day 1. * Arm 2: Patients receive docetaxel IV over 1 hour on day 1. In both arms, treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with disease progression after 3 or 6 courses of treatment may crossover to the alternative treatment arm. If progression is present after 3 courses in the crossover arm, patients may receive further treatment at the discretion of their oncologist. Patients responding to and tolerating treatment well, may be given 2 further courses in accordance with local center policy, although this is not encouraged. Patients with HER2-positive disease may receive trastuzumab (Herceptin®) IV once every 7 or 21 days. After completion of study treatment, patients are followed periodically for survival. Peer Reviewed and Funded or Endorsed by Cancer Research UK PROJECTED ACCRUAL: A total of 148 patients will be accrued for this study.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 148 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Mujer
Sexo biológico de los participantes elegibles para inscribirse.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
DISEASE CHARACTERISTICS: * Histologically confirmed breast cancer * BRCA1 or BRCA2 mutation carrier * Metastatic disease * Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan * Stable, treated brain metastases allowed provided other sites of measurable disease are present * Patients with bone metastases who are currently receiving bisphosphonates for palliation are eligible provided other sites of measurable disease are present * Patients who have not received anthracycline-based chemotherapy in the adjuvant setting may receive a non-taxane, anthracycline regimen as the first-line metastatic treatment and enter the trial at confirmed progression (second-line) * No bone-limited disease * No disease suitable for endocrine therapy alone * Hormone receptor status not specified PATIENT CHARACTERISTICS: * Menopausal status not specified * Sex: female * WHO performance status 0-2 * Life expectancy ≥ 3 months * AST and/or ALT ≤ 5 times upper limit of normal (ULN) (≤ 3 if alkaline phosphatase \> 5 times ULN) * Glomerular filtration rate ≥ 30 mL/min * Normal urea and creatinine * Normal hematological and biochemical studies * Normal bilirubin * Not pregnant or nursing * Fertile patients must use effective contraception during and for 6 months after completion of study treatment * Negative pregnancy test * No known allergy to platinum compounds or mannitol * No known sensitivity to taxanes * No other malignancy within the past 10 years except adequately treated in situ carcinoma of the cervix or basal cell or squamous cell carcinoma of the skin * No sensory or motor neuropathy \> grade 1 * No other serious uncontrolled medical conditions or concurrent medical illness that would preclude study compliance * No contraindication to chemotherapy PRIOR CONCURRENT THERAPY: * See Disease Characteristics * At least 12 months since prior taxane therapy * No prior chemotherapy with a platinum drug, unless treatment was for a non-breast cancer-related disease more than 10 years ago
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.Objetivos del Estudio
Objetivos Primarios
Objetivos Secundarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene 25 ubicaciones
Soroka University Medical Center
Beersheba, IsraelNaharia Hospital
Nahariya, IsraelChaim Sheba Medical Center
Tel Litwinsky, Israel