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Study Summary
No. 2006-1072:.......Breast......Naoto Ueno......Breast Medical Oncology
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Study Summary Title
Study Summary
Number:		2006-1072
Study Title:Inflammatory Breast Cancer (IBC) Registry
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Physician New Patient Referral
Name:Naoto UenoPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Breast Medical OncologyReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-2360
Contact us about clinical trials
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General Information
Disease Group:BreastSupported By:Partially supported by Susan G Komen Promise Grant
Phase of Study:N/AReturn
Visit:		N/A
Treatment
Agents:		NoneHome Care:N/A
Treatment Loc:Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions
Estimated
Length of Stay
in Houston:		N/A
Description/
Intervention:		The goal of this research study is to collect blood and tissue samples and
clinical data from patients with IBC or highly suspicious for IBC. The blood
and tissue samples and clinical data will be stored in a research tissue bank
and used to help researchers try to better understand IBC.
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Study Objectives / Outcomes
    1. To prospectively collect tissue (including primary 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.
    2. 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.
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Study Status Information
Study Activation / Registration Date:04/17/2007
IRB Review and Approval Date:04/17/2007
Study Type:Behavioral
Recruitment Status:Open
Projected Accrual:700
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.
Inclusion Criteria:1) Patients with new clinical diagnosis of primary inflammatory breast cancer (IBC), second primary IBC, or highly suspicious for IBC.

2) Histological diagnosis of invasive breast cancer, or highly suspicious for IBC but pending breast cancer diagnosis.

3) Be either newly diagnosed, or highly suspicious for IBC (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, punch biopsy or lymph node biopsy (Cohort II).

4) Age > 18 years

5) Able to provide informed consent
Exclusion Criteria:1) Have had mastectomy/axillary dissection for primary or secondary IBC without core biopsy performed at initial diagnosis.
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Links
Registration Number: NCT00477100
Study Information on Clinical Trials Registry (clinicaltrials.gov)
Other Links:
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Results

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