Cytokine Expression During Radiation for Breast Cancer

NCT00836186 | Completed Results DMC

• 2 other identifiers: J08130NA_00024399
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 2

Brief Summary

To assess the magnitude and frequency of changes in chemo/cytokine expression in women receiving radiation treatment. To asses the impact of race/ethnicity on the magnitude and frequency of changes in chemo/cytokine expression during radiation therapy for breast cancer. And finally to assess the interaction between radiation-induced chemo/cytokine expression changes, and race/ethnicity, with respect to normal tissue reactions to radiation and tumor-associated outcomes.

Conditions

Breast Cancer

Keywords

Cytokine; Tumor Marker; Disparities

Outcome Measures

Primary Outcomes (1)

• Number of Proteins Expressed Differently in Response to Receiving Radiation Therapy

  Number of proteins that are expressed differently in response to receiving radiation therapy for breast cancer. The data reflect the total number of proteins pooled across all participants.

  2 - 4 weeks post radiation therapy

Secondary Outcomes (2)

• Number of Proteins With Differential Expression by Race/Ethnicity

  2 - 4 weeks post radiation therapy

• Number of Metabolites That Changed Differentially on the Basis of Patient Toxicity

  2 - 4 weeks post radiation therapy

Study Arms (1)

Radiation therapy

OTHER

Women with non-metastatic breast cancer status post lumpectomy to negative margins and who are receiving whole breast irradiation as per standard treatment plan.

Radiation: Radiation therapy

Interventions

Radiation therapy RADIATION

Patients will receive whole breast radiation therapy at a dose of 180-200 centigray (cGy) per fraction for 23-27 fractions to a total dose of 4600 - 4860 cGy. Additional radiation to the lumpectomy bed (Boost) is at the discretion of the treating physician. The total dose to the tumor bed cannot exceed 6600 cGy.

Radiation therapy

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient must be 18 years of age or older
• Patients must have histologically confirmed (by routine H\&E staining) adenocarcinoma of the breast any T, any N, M0 disease
• Patients must have undergone a segmental mastectomy (SM) with a level I and ll axillary dissection or sentinel lymph node biopsy. Surgical margins at time of local surgery must be negative greater or equal to 2mm for both invasive carcinoma and for non-invasive ductal carcinoma Patients who have post-operative margins which are negative but less than 2mm will be considered eligible if the surgeon states that the margin in question cannot be improved.
• Patients must be registered such that radiation therapy begins within 10 weeks of last surgery
• Patients must have a performance status 0 or 1 by Eastern Cooperative Oncology Group (ECOG) criteria or a 80-100 Karnofsky Performance Scale at time of consult
• Women of all races and ethnic groups are eligible for this trial

You may not qualify if:

• Patients must not have received prior radiation therapy to the breast at any time for any reason
• Patients with squamous carcinomas or sarcomas of the breast cancer are not eligible
• Patients treated with a mastectomy are NOT eligible
• Any patient with active local-regional disease prior to registration is not eligible
• No other prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or any other cancer from which the patient has been disease-free for at least 5 years
• Patients must not be pregnant due to the potential for fetal harm as a result of this treatment regimen. Women of child-bearing potential must use effective non hormonal contraception while undergoing radiation therapy
• Patients must not have a serious medical or psychiatric illness which prevents informed consent or compliance with treatment

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• Breast Cancer Research Foundation: collaborator

Study Sites (2)

Johns Hopkins Hospital

Baltimore, Maryland, 21231, United States

Location

The Johns Hopkins University School of Medicne

Baltimore, Maryland, 21231, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

• Title: Jean Wright, MD PI
• Organization: Johns Hopkins University

jwrigh71@jhmi.edu

410-614-3950

Study Officials

• Jean Wright, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a prospective study designed to analyze tumor markers and pathologic data in order to examine the prediction of tumor response to radiation therapy.

Study Record Dates

• First Submitted: February 3, 2009
• First Posted: February 4, 2009
• Study Start: November 13, 2009
• Primary Completion: November 26, 2014
• Study Completion: November 1, 2019
• Last Updated: October 8, 2020
• Results First Posted: October 8, 2020

Record last verified: 2020-09

Locations

US (2)