Biospecimen and Medical Data Collection and Tumor Biopsy in Creating Research Tissue Registry in Patients with Inflammatory or Invasive Breast Cancer

Recruiting

Conditions: Inflammatory Breast Carcinoma
Second Primary Malignant Neoplasm
Invasive Breast Carcinoma

Interventions: Procedure: Biospecimen Collection
Other: Interview
Other: Medical Chart Review
Other: Questionnaire Administration

Brief Summary: This trial studies the biospecimen and medical data collection in creating a research tissue registry in patients with inflammatory or invasive breast cancer. Collecting medical data and storing samples of blood, tissue, and stool from patients with inflammatory breast cancer to study in the laboratory may help doctors find better ways to treat and study inflammatory breast cancer in the future.

Detailed Description: PRIMARY OBJECTIVES:

I. To prospectively collect tissue (including primary inflammatory breast cancer \[IBC\], ipsilateral nodal metastasis and/or distant metastasis \[if applicable\] obtained prior to primary systemic therapy and mastectomy/axillary dissection), serum, plasma, whole blood, clinical, and imaging data from patients with recently diagnosed inflammatory breast cancer (IBC), or highly suspicious for IBC, who have not received systemic therapy.

II. To collect paraffin tissue blocks or unstained slides (including primary, ipsilateral nodal metastasis and/or distant metastasis \[if applicable\] obtained prior to primary systemic therapy), mastectomy/axillary dissection tissue, serum, plasma, whole blood, clinical, and imaging data (if available) from patients with previously diagnosed inflammatory breast cancer (IBC), who have been treated or partially treated, but have not had mastectomy and are seeking further treatment in the IBC clinic at M. D. Anderson or participating cancer network sites.

III. To collect oral swab, skin and stool bacterial culture swab for microbiome analysis to compare patients with specific breast cancer subtype to report changes in flora during the course of treatment and correlated to toxicity.

OUTLINE:

Patients complete questionnaires and participate in interview over 30 minutes. Patients also undergo collection of medical data and blood, tissue, and stool samples.

Recruitment & Eligibility

Inclusion Criteria

Patients with clinical diagnosis of primary inflammatory breast cancer (IBC), second primary IBC, or highly suspicious for IBC (MD Anderson patients only).
Histological diagnosis of invasive breast cancer, or highly suspicious for IBC (MD Anderson patients only) but pending breast cancer diagnosis.
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)
Age > 18 years
Able to provide informed consent

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Observational (biospecimen and medical data collection)	Medical Chart Review	Patients complete questionnaires and participate in interview over 30 minutes. Patients also undergo collection of medical data and blood, tissue, and stool samples.
Observational (biospecimen and medical data collection)	Biospecimen Collection	Patients complete questionnaires and participate in interview over 30 minutes. Patients also undergo collection of medical data and blood, tissue, and stool samples.
Observational (biospecimen and medical data collection)	Questionnaire Administration	Patients complete questionnaires and participate in interview over 30 minutes. Patients also undergo collection of medical data and blood, tissue, and stool samples.
Observational (biospecimen and medical data collection)	Interview	Patients complete questionnaires and participate in interview over 30 minutes. Patients also undergo collection of medical data and blood, tissue, and stool samples.

Primary Outcome Measures

Name	Time	Method
Data, serum, tissue, peripheral blood mononuclear cells, and plasma sample collection	Up to 2 years	No statistical considerations are provided. For each clinical question that will use the data collected in this registry, a separate protocol will be submitted to the Institutional Review Board (IRB) that will include a sample size justification and an analysis plan.

Secondary Outcome Measures

Name	Time	Method

Locations (10): Banner - MD Anderson Cancer Center
🇺🇸
Gilbert, Arizona, United States
Scripps - MD Anderson Cancer Center
🇺🇸
La Jolla, California, United States
Banner - MD Anderson Cancer Center - Northern Colorado
🇺🇸
Greeley, Colorado, United States
Baptist - MD Anderson Cancer Center
🇺🇸
Jacksonville, Florida, United States
Covenant Medical Center
🇺🇸
Saginaw, Michigan, United States
M D Anderson Cancer Center
🇺🇸
Houston, Texas, United States
MD Anderson in Katy
🇺🇸
Houston, Texas, United States
MD Anderson League City
🇺🇸
Nassau Bay, Texas, United States
MD Anderson in Sugar Land
🇺🇸
Sugar Land, Texas, United States
MD Anderson in The Woodlands
🇺🇸
The Woodlands, Texas, United States