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The Comparison of Lymph Fluid and Blood From Metastatic and Non-metastatic Invasive Breast Cancer Patients for Identification of Novel Biomarkers


N/A
18 Years
80 Years
Not Enrolling
Female
Adenocarcinoma of the Breast

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Trial Information

The Comparison of Lymph Fluid and Blood From Metastatic and Non-metastatic Invasive Breast Cancer Patients for Identification of Novel Biomarkers


The goal of the study is to identify node-negative breast cancer patients who are unlikely
to benefit from adjuvant chemotherapy, thus saving them from the adverse effects of
unnecessary treatment. We propose to identify and validate protein markers that can
determine breast cancer recurrence and metastasis, based on an approach our group has
recently found highly promising for biomarker discovery.

The objective of our research is to identify and validate metastasis protein markers in
lymph collected from vessels exiting from the primary tumor and prior to their entry into
sentinel lymph node in women with metastatic breast cancer. Realizing that this novel
procedure cannot be adopted for routine clinical use, we will examine the peripheral blood
for the presence of these identified markers in order to develop a user friendly clinical
test to detect metastasis and to evaluate response to therapy.


Inclusion Criteria:



- Women, age greater than or equal to 18, with histologically and/or cytologically
confirmed diagnosis of adenocarcinoma of the breast with metastatic (node positive)
and/or non-metastatic (node negative) breast cancer.

- No prior chemotherapy treatment.

- Women, age greater than or equal to 18, with carcinoma in situ that opted for
mastectomy.

- Able to provide informed consent and HIPAA authorization.

Exclusion Criteria:

- Hormone therapy in the past six months. Birth control pill use is allowed.

- History of radiation therapy to the chest.

- Previous or current use of aromatase inhibitor (AI) or Selective Estrogen Receptor
Modulator (SERM) medication.

- History of chemotherapy for breast or other cancers.

- Pregnant or breast-feeding.

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Identification and Validation of Metastasis Protein Markers

Outcome Description:

Lymph fluid collected at surgery; blood collected at surgery and then every 6 months for 5 years.

Outcome Time Frame:

Every 6 mo. for 5 years

Safety Issue:

No

Principal Investigator

Monet Bowling, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Indiana University

Authority:

United States: Institutional Review Board

Study ID:

0911-04

NCT ID:

NCT01075607

Start Date:

April 2010

Completion Date:

April 2022

Related Keywords:

  • Adenocarcinoma of the Breast
  • Lymph fluid collection
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Breast Neoplasms

Name

Location

Indiana University HospitalIndianapolis, Indiana  46202