Bone Marrow Micrometastases in Patients With Early Stage Breast Cancer

Not Applicable

• Conditions: Breast Cancer
• Interventions: Procedure: bone marrow aspiration /trephine biopsy

• Registration Number: NCT02921152
• Lead Sponsor: Acibadem University

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 Description

Not available

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-05-17
• Status Verified: 2016-08
• Study First Submitted QC: 2016-09-29
• Last Update Submitted: 2016-09-29
• Study First Posted: 2016-10-03
• Last Update Posted: 2016-10-03
• Primary Completion: 2018-04
• Study Completion: 2021-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 1000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
all	bone marrow aspiration /trephine biopsy	All patients with early breast cancer

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Incidence of axillary recurrence in patients with negative sentinel lymph node biopsy	Up to 10 years
Overall survival	up to 10 years

Trial Locations

Locations (1)

Acibadem University School of Medicine; 🇹🇷 Istanbul, Turkey