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RecruitingNCT00477100Updated Apr 15, 2026

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

An observational study in Inflammatory Breast Carcinoma, Invasive Breast Carcinoma and Second Primary Malignant Neoplasm, sponsored by M.D. Anderson Cancer Center. Recruiting at 10 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-15.

Sponsored by M.D. Anderson Cancer Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,200
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Inflammatory Breast Carcinoma
  • Invasive Breast Carcinoma
  • Second Primary Malignant Neoplasm
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Participants with inflammatory or invasive breast cancer

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

Exclusion Criteria:

04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,200 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Observational (biospecimen and medical data collection)

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

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

Interventions

  • ProcedureBiospecimen Collection

    Undergo collection of blood, tissue, and stool

  • OtherInterview

    Participate in interview

  • OtherMedical Chart Review

    Undergo collection of medical data

    Also known as: Chart Review

  • OtherQuestionnaire Administration

    Ancillary Studies

05

What researchers measure

Primary outcomes

  1. Data, serum, tissue, peripheral blood mononuclear cells, and plasma sample collection

    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.

    Time frame: Up to 2 years

06

Study locations

8 of 10 sites recruiting
  • Banner - MD Anderson Cancer Center
    Gilbert, Arizona 85234, United States
    Recruiting
  • Scripps - MD Anderson Cancer Center
    La Jolla, California 92037, United States
    Active, not recruiting
  • Banner - MD Anderson Cancer Center - Northern Colorado
    Greeley, Colorado 80631, United States
    Recruiting
  • Baptist - MD Anderson Cancer Center
    Jacksonville, Florida 32207, United States
    Recruiting
  • Covenant Medical Center
    Saginaw, Michigan 48604, United States
    Active, not recruiting
  • M D Anderson Cancer Center
    Houston, Texas 77030, United States
    Recruiting
  • MD Anderson in Katy
    Houston, Texas 77094, United States
    Recruiting
  • MD Anderson League City
    Nassau Bay, Texas 77058, United States
    Recruiting
  • MD Anderson in Sugar Land
    Sugar Land, Texas 77478, United States
    Recruiting
  • MD Anderson in The Woodlands
    The Woodlands, Texas 77384, United States
    Recruiting
07

References and documents

08

Registry details

Key details

Study ID
NCT00477100
Lead sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI), Texas Appropriation for Rare and Aggressive diseases
Responsible party
Sponsor
First posted
May 22, 2007
Start date
Apr 17, 2007
Primary completion
Apr 30, 2030 (estimated)
Completion
Apr 30, 2030 (estimated)
Last update
Apr 15, 2026

Study contacts

Jie Willey
Contact
jwilley@mdanderson.org
713-792-3965
VIcente Valero, MD
principal investigator · M.D. Anderson Cancer Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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