Inflammatory Breast Cancer (IBC) Registry

IBC:

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.

All participants will have the following performed:

- You will have additional blood (about 3-4 tablespoons each time) drawn for this study
during a routine blood draw before chemotherapy or the beginning of this study, at the
end of your first round of chemotherapy, before and after surgery and/or radiation
therapy, and then about every 6 months for 2 years.

- 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.

- If you have standard of care surgery, part of the tissue that is removed during surgery
will be collected, unless it is already known that you do not have IBC.

Participants who have been treated for IBC will have the following performed:

°Your original biopsy sample and/or breast surgery tissue sample will be collected for
diagnosis (if needed by your doctor) and for the study.

Participants who have never been treated for IBC will also have the following performed:

- If you have never received treatment for IBC or you have a breast condition which the
doctor believes may be IBC, you will have a tumor 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.

- When you join the study, and then before radiation therapy begins, you will have a cheek
(buccal cell) swab, a skin swab, and a stool swab sample collected either in the clinic
or at home. For the cheek swab, a small sample of cells from the inside of your mouth
will be collected by scraping a special brush against the inside of your cheek a few
times, until enough cells are collected. For the skin swab, the same procedure will be
done on the skin on your chest. For the stool swab sample, you will collect a swab of
your stool when you go to the bathroom. If you need to collect the samples at home, you
will be given supplies and instructions on how to do this. You will then mail the
samples back to the clinic.

Length of Study:

Your participation in this study will be complete after your samples and data are collected
(about 2 years after your active participation on this study).

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.

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 (MD Anderson patients only)
[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 and punch biopsy)
and/or from mastectomy (Cohort II-MD Anderson patients only)

4. Age > 18 years

5. Able to provide informed consent

Exclusion Criteria: