Trial Outcomes & Findings for Cytokine Expression During Radiation for Breast Cancer (NCT NCT00836186)

Last Updated: 2020-10-08

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

82 participants

Primary outcome timeframe

2 - 4 weeks post radiation therapy

Results posted on

2020-10-08

Participant Flow

Participant milestones

Participant milestones
Measure	Radiation Therapy Women with any non-metastatic breast cancer status post lumpectomy to negative margins and who are receiving whole breast irradiation as per standard treatment plan. Radiation therapy: 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.
Overall Study STARTED	82
Overall Study COMPLETED	81
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Radiation Therapy Women with any non-metastatic breast cancer status post lumpectomy to negative margins and who are receiving whole breast irradiation as per standard treatment plan. Radiation therapy: 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.
Overall Study Blood could not be drawn	1

Baseline Characteristics

Cytokine Expression During Radiation for Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Radiation Therapy n=82 Participants Women with any non-metastatic breast cancer status post lumpectomy to negative margins and who are receiving whole breast irradiation as per standard treatment plan. Radiation therapy: Patients will receive whole breast radiation therapy at a dose of 180-200 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	66 Participants n=5 Participants
Age, Categorical >=65 years	16 Participants n=5 Participants
Age, Continuous	65 Years STANDARD_DEVIATION 9.6 • n=5 Participants
Sex: Female, Male Female	82 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	41 Participants n=5 Participants
Race (NIH/OMB) White	38 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	81 Participants n=5 Participants
Region of Enrollment Canada	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 - 4 weeks post radiation therapy

Population: Analysis of blood samples were completed on 65 patients and therefore data was only available for these 65 participants.

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.

Outcome measures

Outcome measures
Measure	Radiation Therapy n=65 Participants Women with any non-metastatic breast cancer status post lumpectomy to negative margins and who are receiving whole breast irradiation as per standard treatment plan. Radiation therapy: Patients will receive whole breast radiation therapy at a dose of 180-200 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.
Number of Proteins Expressed Differently in Response to Receiving Radiation Therapy	31 Proteins

SECONDARY outcome

Timeframe: 2 - 4 weeks post radiation therapy

Population: Analysis of blood samples were completed on 65 patients and therefore data was only available for these 65 participants.

To asses the impact of race/ethnicity on the expression of proteins after radiation therapy for breast cancer. The data reflect the total number of proteins pooled across all participants.

Outcome measures

Outcome measures
Measure	Radiation Therapy n=65 Participants Women with any non-metastatic breast cancer status post lumpectomy to negative margins and who are receiving whole breast irradiation as per standard treatment plan. Radiation therapy: Patients will receive whole breast radiation therapy at a dose of 180-200 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.
Number of Proteins With Differential Expression by Race/Ethnicity	4 Proteins

SECONDARY outcome

Timeframe: 2 - 4 weeks post radiation therapy

Population: Analysis of blood samples were completed on 65 patients and therefore data was only available for these 65 participants.

The chemo/cytokine expression changes with respect to radiation toxicities as assessed by number of metabolites that changed differentially on the basis of patient toxicity. The data reflect the total number of metabolites pooled across all participants.

Outcome measures

Outcome measures
Measure	Radiation Therapy n=65 Participants Women with any non-metastatic breast cancer status post lumpectomy to negative margins and who are receiving whole breast irradiation as per standard treatment plan. Radiation therapy: Patients will receive whole breast radiation therapy at a dose of 180-200 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.
Number of Metabolites That Changed Differentially on the Basis of Patient Toxicity	39 metabolites

Adverse Events

Radiation Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jean Wright, MD PI

Johns Hopkins University

Phone: 410-614-3950

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place