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Inflammatory Breast Cancer (IBC) Registry

18 Years
Open (Enrolling)
Breast Cancer

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Trial Information

Inflammatory Breast Cancer (IBC) Registry


IBC is a rare but rapidly growing form of breast cancer. Currently, there are no known risk
factors and biological features (such as in the genes) that researchers can use to help
design better treatments for IBC.

Study Participation:

If you are diagnosed with IBC or the doctor believes that you may have IBC, you will be
asked to participate in this IBC registry study. This registry study is to collect data,
blood and tissue for future studies.

- For patients who have never received treatment for IBC or have breast condition which
the doctor believes may be IBC : You will have a core, breast tissue, and skin biopsy.
If lymph nodes are noticed during the core biopsy, lymph nodes core biopsy or final
needle aspiration will be done as well. To perform a core, breast tissue, and skin
biopsy, an affected area of skin is numbed with anesthetic, and a small amount of skin
tissue is removed with a small knife. This is a fresh sample collected for diagnosis
and for the study.

- You will have additional blood (about 4 tablespoons)drawn for this study, during a
routine blood draw. The additional blood will not be drawn if you do not have IBC.

- For patients who have received treatment for IBC: Your original biopsy specimen will be
collected for diagnosis (if needed by your doctor) and for the study.

- You will have an interview. During this interview, you will be asked questions about
your medical history as well as general background information. The interview will be
conducted by the study chair or their designee in the examination room and after the
meeting with the physician in a private setting. The interview will take about 30
minutes to complete. Language Assistance will be called if a participant is non-English
speaking. You do not have to be interviewed if you don't have IBC.

- Your clinical data will be collected from your medical record, including information
about your blood and tumor tissue samples and information from the magnetic resonance
imaging (MRI) and positron emission tomography/computed tomography (PET/CT) scans you
may have had.

- Photos of both breasts will be taken if needed.

Length of Study:

Your participation in this study will be complete after your samples and data are collected.

Research Tissue Bank:

Before your blood and tissue samples and information can be used for research, the people
doing the research must get specific approval from the Institutional Review Board (IRB) of
MD Anderson. The IRB is a committee made up of doctors, researchers, and members of the
community. The IRB is responsible for protecting the participants involved in research
studies and making sure all research is done in a safe and ethical manner. All research
done at MD Anderson, including research involving your samples and information from the IBC
tissue bank, must first be approved by the IRB.

If the doctor believes your breast condition may be IBC, but tests showed that this tissue
was not for breast cancer or IBC, the tissue samples collected will be stored in the IBC
tissue bank and used as a non-cancer or non-IBC control sample (healthy tissue used for
comparison) in future studies related to IBC.

This is an investigational study. Up to 700 patients will take part in this study. Up to
500 will be enrolled at MD Anderson.

Inclusion Criteria:

1. Patients with new clinical diagnosis of primary inflammatory breast cancer (IBC),
second primary IBC, or highly suspicious for IBC.

2. Histological diagnosis of invasive breast cancer, or highly suspicious for IBC but
pending breast cancer diagnosis.

3. Be either newly diagnosed, or highly suspicious for IBC (Cohort I) or have paraffin
blocks or up to 20 unstained slides of each representative block(s) from the time of
initial diagnosis of IBC, i.e. core biopsy, punch biopsy or lymph node biopsy (Cohort

4. Age > 18 years

5. Able to provide informed consent

Exclusion Criteria:

1) Have had mastectomy/axillary dissection for primary or secondary IBC without core
biopsy performed at initial diagnosis.

Type of Study:


Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

Number of patients with untreated newly diagnosed IBC participating in Registry

Outcome Time Frame:

6 Years

Safety Issue:


Principal Investigator

Naoto Ueno, MD, PHD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

April 2007

Completion Date:

Related Keywords:

  • Breast Cancer
  • Inflammatory Breast Cancer
  • Cancer Registry
  • Core Biopsy
  • Skin Biopsy
  • IBC
  • Breast Neoplasms
  • Inflammatory Breast Neoplasms



City of Hope Duarte, California  91010
U.T.M.D. Anderson Cancer Center Houston, Texas  77030
University of New Mexico Albuquerque, New Mexico  87131
Univeristy of New Mexico Albuquerque, New Mexico  87131
UT Health Science Center - San Antonio San Antonio, Texas  78229
Aurora HealthCare Metro Inc. St Luke's Medical Center Milwaukee, Wisconsin  53215