Clinical Trial: Bone Marrow Micrometastases in Patients With Early Stage Breast Cancer

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Bone Marrow Micrometastases in Patients With Early Stage Breast Cancer

Brief Summary: Operable early stage breast cancer patients staged according to NCCN guidelines are subjected to bone marrow aspiration/trephine biopsy at the time of the definitive operation under general anesthesia. The specimen will be fixated in neutral tamponaded formalin and the sections will be examined by H&E and cytokeratin immunohistochemically. If disseminated tumor cells are identified ER (estrogen receptor), PR (progesterone receptor), HER2/neu will be studied. Disseminated tumor cells will be recorded quantitively and semiquantitatively. Results of the pilot study will be evaluated as observational study.

Detailed Summary:
Sponsor: Acibadem University

Current Primary Outcome:

  • Rate of bone marrow metastases in early stage breast cancer [ Time Frame: up to 5 years ]
    Number of patients with bone marrow metastases/ total number of enrolled patients
  • Rate of sentinel lymph node metastases in early stage breast cancer [ Time Frame: up to 5 years ]
  • Rate of sentinel lymph node metastases in patients with bone marrow metastasis operated for early stage breast cancer [ Time Frame: up to 5 years ]
  • Incidence of bone marrow metastasis in HER-2 positive early stage breast cancer [ Time Frame: up to 5 years ]
  • Incidence of bone marrow metastases in triple negative early stage breast cancer [ Time Frame: up to 5 years ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Incidence of axillary recurrence in patients with negative sentinel lymph node biopsy [ Time Frame: Up to 10 years ]
  • Overall survival [ Time Frame: up to 10 years ]


Original Secondary Outcome: Same as current

Information By: Acibadem University

Dates:
Date Received: May 17, 2016
Date Started: April 2016
Date Completion: April 2021
Last Updated: September 29, 2016
Last Verified: August 2016