Inflammatory Breast CarcinomaNCT00477100
Biospecimen and Medical Data Collection and Tumor Biopsy in Creating Research Tissue Registry in Patients With Inflammatory or Invasive Breast Cancer
An observational study of Inflammatory Breast Carcinoma and Invasive Breast Carcinoma, run by M.D. Anderson Cancer Center at 10 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Breast Carcinoma, Invasive Breast Carcinoma, Second Primary Malignant Neoplasm
- What is being tested?
- Biospecimen Collection, Interview and Medical Chart Review
- Type of treatment
- Surgery or procedure
- How many people
- 1,200 participants
- Where
- 10 sitesUnited States
- Study dates
- 17 Apr 2007to 30 Apr 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with inflammatory or invasive breast cancer
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
United States10 sites, 8 recruiting
- Recruiting
Banner - MD Anderson Cancer Center
Gilbert, Arizona, 85234
Shakeela Bahadur, MD, 480-256-6444, shakeela.bahadur@bannerhealth.com
Shakeela Bahadur, MD
- Recruiting
Banner - MD Anderson Cancer Center - Northern Colorado
Greeley, Colorado, 80631
Esther Mondo, MD, 970-820-5958, Esther.Mondo@BannerHealth.com
Esther Mondo, MD
- Recruiting
M D Anderson Cancer Center
Houston, Texas, 77030
Vicente Valero, 713-563-0751, vvalero@mdanderson.org
Vicente Valero
- Recruiting
MD Anderson in Katy
Houston, Texas, 77094
Vicente Valero, 713-563-0751, vvalero@mdanderson.org
Vicente Valero
- Recruiting
Baptist - MD Anderson Cancer Center
Jacksonville, Florida, 32207
Cynthia Anderson, MD, 904-202-7300, cynthia.anderson@bmcjax.com
Cynthia Anderson, MD
- Active, not recruiting
Scripps - MD Anderson Cancer Center
La Jolla, California, 92037
- Recruiting
MD Anderson League City
Nassau Bay, Texas, 77058
Vicente Valero, 713-563-0751, vvalero@mdanderson.org
Vicente Valero
- Active, not recruiting
Covenant Medical Center
Saginaw, Michigan, 48604
- Recruiting
MD Anderson in Sugar Land
Sugar Land, Texas, 77478
Vicente Valero, 713-560-0751, vvalero@mdanderson.org
Vicente Valero
- Recruiting
MD Anderson in The Woodlands
The Woodlands, Texas, 77384
Vicente Valero, 713-563-0751, vvalero@mdanderson.org
Vicente Valero
About this study
Official title: Inflammatory Breast Cancer (IBC) Registry
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:
- 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.
- Conditions
- Inflammatory Breast Carcinoma, Invasive Breast Carcinoma, Second Primary Malignant Neoplasm
- Being tested
- Biospecimen Collection, Interview, Medical Chart Review, Questionnaire Administration
- Medical subject headings
- Inflammatory Breast Neoplasms, Neoplasms, Second Primary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Undergo collection of blood, tissue, and stool
InterviewOther
Participate in interview
Medical Chart ReviewOther
Also called Chart Review
Undergo collection of medical data
Questionnaire AdministrationOther
Ancillary Studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Biospecimen Collection; Other: Interview; Other: Medical Chart Review; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2007 (estimated)
- Study start17 Apr 2007
- Primary completion30 Apr 2030 (estimated)
- Study completion30 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Breast CarcinomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Texas Appropriation for Rare and Aggressive diseases
- Responsible party
- Sponsor
- Investigators
- VIcente Valero, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00477100
- Sponsor's protocol ID
- 2006-1072
- Other IDs
- NCI-2018-01784, 2006-1072
- Status last verified
- Oct 2026
- First submitted
- 18 May 2007
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammatory Breast Cancer (IBC) Registry
- ClinicalTrials.gov ID
- NCT00477100
- Acronym / sponsor ID
- 2006-1072
- Conditions
- Inflammatory Breast Carcinoma, Invasive Breast Carcinoma, Second Primary Malignant Neoplasm
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Texas Appropriation for Rare and Aggressive diseases
- Study start
- 17 Apr 2007 (actual)
- Primary completion
- 30 Apr 2030 (estimated)
- Study completion
- 30 Apr 2030 (estimated)
- First posted
- 22 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (biospecimen and medical data collection) | – | Procedure: Biospecimen Collection, Other: Interview, Other: Medical Chart Review, Other: Questionnaire AdministrationPatients complete questionnaires and participate in interview over 30 minutes. Patients also undergo collection of medical data and blood, tissue, and stool samples. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with inflammatory or invasive breast cancer
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biospecimen CollectionUndergo collection of blood, tissue, and stool | Procedure or surgery | Observational (biospecimen and medical data collection) |
| InterviewParticipate in interview | Other | Observational (biospecimen and medical data collection) |
| Medical Chart ReviewAlso: Chart ReviewUndergo collection of medical data | Other | Observational (biospecimen and medical data collection) |
| Questionnaire AdministrationAncillary Studies | Other | Observational (biospecimen and medical data collection) |
Primary outcome
Data, serum, tissue, peripheral blood mononuclear cells, and plasma sample collection
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
VIcente Valero, MD principal investigator
M.D. Anderson Cancer Center
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Breast Carcinoma and Invasive Breast Carcinoma, run by M.D. Anderson Cancer Center at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jie Willey (713-792-3965, jwilley@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Data, serum, tissue, peripheral blood mononuclear cells, and plasma sample collection (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.