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Recruiting OBSERVATIONAL NCT00477100

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

Inflammatory Breast Cancer (IBC) Registry

Sponsor: M.D. Anderson Cancer Center

Updated 28 times since 2017 Last updated: Apr 10, 2026 Started: Apr 17, 2007 Primary completion: Apr 30, 2030 Completion: Apr 30, 2030
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A observational or N/A phase clinical study on Inflammatory Breast Carcinoma and Invasive Breast Carcinoma, this trial is actively recruiting participants. The trial is conducted by M.D. Anderson Cancer Center and has accumulated 28 data snapshots since 2007. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Study Description(click to expand)

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.

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.

Status Flow

~Jan 2017 – ~Jul 2017 · 6 months · monthly snapshot~Jul 2017 – ~Aug 2017 · 31 days · monthly snapshot~Aug 2017 – ~Mar 2018 · 7 months · monthly snapshot~Mar 2018 – ~Apr 2018 · 31 days · monthly snapshot~Apr 2018 – ~May 2018 · 30 days · monthly snapshot~May 2018 – ~Jun 2018 · 31 days · monthly snapshot~Jun 2018 – ~Jun 2019 · 12 months · monthly snapshot~Jun 2019 – ~Aug 2019 · 2 months · monthly snapshot~Aug 2019 – ~Sep 2019 · 31 days · monthly snapshot~Sep 2019 – ~Mar 2020 · 6 months · monthly snapshot~Mar 2020 – ~Nov 2020 · 8 months · monthly snapshot~Nov 2020 – ~Jan 2021 · 2 months · monthly snapshot~Jan 2021 – ~Sep 2021 · 8 months · monthly snapshot~Sep 2021 – ~Dec 2021 · 3 months · monthly snapshot~Dec 2021 – ~May 2022 · 5 months · monthly snapshot~May 2022 – ~Jan 2023 · 8 months · monthly snapshot~Jan 2023 – ~Feb 2023 · 31 days · monthly snapshot~Feb 2023 – ~Jul 2023 · 5 months · monthly snapshot~Jul 2023 – ~Aug 2023 · 31 days · monthly snapshot~Aug 2023 – ~Oct 2023 · 2 months · monthly snapshot~Oct 2023 – ~May 2024 · 7 months · monthly snapshot~May 2024 – ~Jul 2024 · 2 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Oct 2024 · 30 days · monthly snapshot~Oct 2024 – ~Nov 2024 · 31 days · monthly snapshot~Nov 2024 – ~Dec 2025 · 13 months · monthly snapshot~Dec 2025 – ~Apr 2026 · 4 months · monthly snapshotApr 16, 2026 – present · 2 months · daily API

Change History

28 versions recorded
  1. Apr 16, 2026 — Present [daily]

    Recruiting

  2. Dec 2025 — Apr 2026 [monthly]

    Recruiting

  3. Nov 2024 — Dec 2025 [monthly]

    Recruiting

  4. Oct 2024 — Nov 2024 [monthly]

    Recruiting

  5. Sep 2024 — Oct 2024 [monthly]

    Recruiting

Show 23 earlier versions
  1. Jul 2024 — Sep 2024 [monthly]

    Recruiting

  2. May 2024 — Jul 2024 [monthly]

    Recruiting

  3. Oct 2023 — May 2024 [monthly]

    Recruiting

  4. Aug 2023 — Oct 2023 [monthly]

    Recruiting

  5. Jul 2023 — Aug 2023 [monthly]

    Recruiting

  6. Feb 2023 — Jul 2023 [monthly]

    Recruiting

  7. Jan 2023 — Feb 2023 [monthly]

    Recruiting

  8. May 2022 — Jan 2023 [monthly]

    Recruiting

  9. Dec 2021 — May 2022 [monthly]

    Recruiting

  10. Sep 2021 — Dec 2021 [monthly]

    Recruiting

  11. Jan 2021 — Sep 2021 [monthly]

    Recruiting

  12. Nov 2020 — Jan 2021 [monthly]

    Recruiting

  13. Mar 2020 — Nov 2020 [monthly]

    Recruiting

  14. Sep 2019 — Mar 2020 [monthly]

    Recruiting

  15. Aug 2019 — Sep 2019 [monthly]

    Recruiting

  16. Jun 2019 — Aug 2019 [monthly]

    Recruiting

  17. Jun 2018 — Jun 2019 [monthly]

    Recruiting

  18. May 2018 — Jun 2018 [monthly]

    Recruiting

  19. Apr 2018 — May 2018 [monthly]

    Recruiting

    Phase: NANone

  20. Mar 2018 — Apr 2018 [monthly]

    Recruiting NA

  21. Aug 2017 — Mar 2018 [monthly]

    Recruiting NA

  22. Jul 2017 — Aug 2017 [monthly]

    Recruiting NA

  23. Jan 2017 — Jul 2017 [monthly]

    Recruiting NA

    First recorded

Apr 2007

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility 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.

Contact Information

Sponsor contact:
  • M.D. Anderson Cancer Center
  • National Cancer Institute (NCI)
  • Texas Appropriation for Rare and Aggressive diseases
Data source: ClinicalTrials.gov

For direct contact, visit the study record on ClinicalTrials.gov .