Bone Marrow Micrometastases in Patients With Early Stage Breast Cancer

Breast Cancer Clinical Trial

Official title:

Bone Marrow Micrometastases in Patients With Early Stage Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02921152
• Other study ID #: ATADEK 2015/11
• Status: Recruiting
• Phase: N/A
• First received: May 17, 2016
• Last updated: September 29, 2016
• Start date: April 2016
• Est. completion date: April 2021

Study information

• Verified date: August 2016
• Source: Acibadem University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: April 2021
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

1. Patients over 18 years old and who have given informed consent to enter the study.

2. ASA I-II patients

3. Patients who have not been diagnosed as breast cancer or received any type of treatment regarding breast cancer before the time of study

4. Patients who are appropriate for bone marrow biopsy

5. Menopausal status is not relevant.

Exclusion criteria:

1. Active collagen tissue disorders

2. Patients who are diagnosed having breast cancer and received any type of treatment regarding breast cancer before the time of study

3. Pregnancy

4. Patients with bleeding disorders, who are receiving antiaggregant or anticoagulant medication.

5. Patients who refused to enter the study protocol and refused to give informed consent.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• bone marrow aspiration /trephine biopsy

Locations

Country	Name	City	State
Turkey	Acibadem University School of Medicine	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Acibadem University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Disease free survival		up to 10 years	No
Primary	Rate of bone marrow metastases in early stage breast cancer	Number of patients with bone marrow metastases/ total number of enrolled patients	up to 5 years	No
Primary	Rate of sentinel lymph node metastases in early stage breast cancer		up to 5 years	No
Primary	Rate of sentinel lymph node metastases in patients with bone marrow metastasis operated for early stage breast cancer		up to 5 years	No
Primary	Incidence of bone marrow metastasis in HER-2 positive early stage breast cancer		up to 5 years	No
Primary	Incidence of bone marrow metastases in triple negative early stage breast cancer		up to 5 years	No
Secondary	Incidence of axillary recurrence in patients with negative sentinel lymph node biopsy		Up to 10 years	No
Secondary	Overall survival		up to 10 years	No