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Combination Chemotherapy in Treating Women With Breast Cancer

Overview

Información sobre este estudio

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective for breast cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens in treating women with breast cancer who have undergone surgery to remove the tumor.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

DISEASE CHARACTERISTICS:

  • Histologically confirmed resectable adenocarcinoma of the breast
  • Histologically positive lymph nodes (1 to 3) OR Lymph node negative and high risk disease Tumor greater than 1.0 cm diameter
  • May have undergone an axillary dissection with at least 6 nodes removed and examined or a sentinel node biopsy
  • Patients who are positive by sentinel node biopsy will receive an axillary dissection
  • No locally advanced or inflammatory or metastatic breast cancer
  • Hormone receptor status: Not specified

PATIENT CHARACTERISTICS:

  • Age: 18 and over
  • Sex: Female
  • Menopausal status: Not specified
  • Performance status: Not specified
  • Life expectancy: Not specified
  • Hematopoietic:
    • Neutrophil count at least 1,500/mm3
    • Platelet count at least 100,000/mm3
  • Hepatic:
    • Adequate hepatic function
    • Bilirubin no greater than upper limit of normal
  • Renal: Adequate renal function
  • Cardiovascular:
    • Adequate cardiac function
    • Normal MUGA or echocardiogram
  • Other:
    • Not pregnant or nursing
    • Fertile patients must use effective barrier method contraception
    • At least 5 years since prior invasive malignancies, except basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

  • Biologic therapy: Not specified
  • Chemotherapy: No prior chemotherapy for this malignancy
  • Endocrine therapy:
    • No concurrent tamoxifen
    • Up to 4 weeks of tamoxifen treatment for this malignancy allowed
  • Radiotherapy:
    • No prior radiotherapy for this malignancy
    • Prior radiotherapy to the breast for ductal carcinoma in situ allowed
  • Surgery:
    • Tumor should be removed by either a modified radical mastectomy and/or a segmental mastectomy plus axillary lymph node dissection or sentinel node biopsy before beginning treatment on protocol
    • No greater than 84 days since last surgical procedure that constitutes or completes definitive surgical therapy (mastectomy; axillary dissection/sentinel node biopsy; or resection of primary site to obtain a negative margin)

More information

Publicaciones

Publications are currently not available

Otros temas en investigación

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CLS-20154132

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