Recruiting

Observational Study

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT00477100

Conditions

Inflammatory Breast Carcinoma

Invasive Breast Carcinoma

Second Primary Malignant Neoplasm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Biospecimen Collection

Interview

Medical Chart Review

Questionnaire Administration

Study Details

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.

Conditions

Inflammatory Breast Carcinoma

Invasive Breast Carcinoma

Second Primary Malignant Neoplasm

Study ID

NCT00477100

Start date

Apr 17, 2007

Status verified date

Apr, 2026

Completion date

Apr 30, 2030

Anticipated

Primary completion date

Apr 30, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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:

Study Design

Enrollment

1200 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Biospecimen Collection

Undergo collection of blood, tissue, and stool

Interview

Participate in interview

Medical Chart Review

Undergo collection of medical data

Questionnaire Administration

Ancillary Studies

Primary outcome measure

  • Data, serum, tissue, peripheral blood mononuclear cells, and plasma sample collection [ Time Frame: Up to 2 years ]

Central Contacts and Locations

Central contacts

Jie Willey

713-792-3965jwilley@mdanderson.org

Locations

Banner - MD Anderson Cancer Center

Recruiting

Gilbert, Arizona, United States, 85234

Contacts

Shakeela Bahadur, MD

480-256-6444shakeela.bahadur@bannerhealth.com

Principal Investigator:

Shakeela Bahadur, MD

Banner - MD Anderson Cancer Center - Northern Colorado

Recruiting

Greeley, Colorado, United States, 80631

Contacts

Esther Mondo, MD

970-820-5958Esther.Mondo@BannerHealth.com

Principal Investigator:

Esther Mondo, MD

Baptist - MD Anderson Cancer Center

Recruiting

Jacksonville, Florida, United States, 32207

Contacts

Cynthia Anderson, MD

904-202-7300cynthia.anderson@bmcjax.com

Principal Investigator:

Cynthia Anderson, MD

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Vicente Valero

713-563-0751vvalero@mdanderson.org

Principal Investigator:

Vicente Valero

MD Anderson in Katy

Recruiting

Houston, Texas, United States, 77094

Contacts

Vicente Valero

713-563-0751vvalero@mdanderson.org

Principal Investigator:

Vicente Valero

MD Anderson League City

Recruiting

Nassau Bay, Texas, United States, 77058

Contacts

Vicente Valero

713-563-0751vvalero@mdanderson.org

Principal Investigator:

Vicente Valero

MD Anderson in Sugar Land

Recruiting

Sugar Land, Texas, United States, 77478

Contacts

Vicente Valero

713-560-0751vvalero@mdanderson.org

Principal Investigator:

Vicente Valero

MD Anderson in The Woodlands

Recruiting

The Woodlands, Texas, United States, 77384

Contacts

Vicente Valero

713-563-0751vvalero@mdanderson.org

Principal Investigator:

Vicente Valero

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Apr 15, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-04-15.