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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03077841
Other study ID # 2016-1035
Secondary ID NCI-2017-0047620
Status Active, not recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date March 6, 2017
Est. completion date August 31, 2024

Study information

Verified date April 2024
Source M.D. Anderson Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This phase II trial studies how well hypofractionated partial breast irradiation works in treating patients with early stage breast cancer. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Treating only the part of the breast where the cancer started may lead to fewer side effects than standard treatment.


Description:

PRIMARY OBJECTIVE: I. The risk of grade 2 or higher toxicity occurring during radiation and through the 6 month post-radiation follow up visit in patients treated with Optimizing Preventative Adjuvant Linac-based Radiation (OPAL) regimen. SECONDARY OBJECTIVES: I. To measure patient-reported cosmetic outcome, functional status, and breast pain with the OPAL regimen at 6 months, one year, two years, three years, four years, and five years after completing the OPAL regimen. II. To measure physician-reported and photographically-assessed cosmetic outcome at 6 months, one year, two years, three years, four years, and five years after completing the OPAL regimen and to compare this to the best performing arm of 2010-0559. III. To determine the 5-year risk of pathologically-confirmed invasive and/or in situ ipsilateral breast tumor recurrence (IBTR) for patients with ductal breast carcinoma in situ (DCIS) and early invasive breast cancer. IV. To determine the 5-year risk of any recurrence of breast cancer, disease-free survival, and overall survival. V. To determine maximal late (within 5 years) toxicities using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4.0 scale. VI. To establish the feasibility of conducting multi-center radiation therapy trials within the MD Anderson Network. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients undergo hypofractionated partial breast irradiation daily for 5 days. Patients may then receive 3 additional boost fractions at the discretion of the doctor. ARM II: Patients undergo standard breast irradiation daily for 15 days. Patients may then receive 5 additional boost fractions at the discretion of the doctor. After completion of study treatment, patients are followed up at 6 months, and at 1.5, 3.5, and 5.5 years.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 928
Est. completion date August 31, 2024
Est. primary completion date August 31, 2024
Accepts healthy volunteers No
Gender Female
Age group 50 Years and older
Eligibility Inclusion Criteria: - Diagnosis of pathologically-confirmed invasive breast cancer or ductal carcinoma in situ - Pathologic T stage of Tis, T1, or T2 with total size of tumor =< 3 cm (this size criteria applies to both pure DCIS and invasive tumors) - For patients with invasive breast cancer, pathologic N stage of N0, N0 (i-), or N0 (i+); pathologic staging of the axilla is not required for patients with pure DCIS - Treatment with breast conserving surgery - Unifocal primary tumor based on imaging and clinical assessment; microscopic multifocality is allowed - Final surgical margins negative defined as no tumor on ink; lobular carcinoma in situ involving the final surgical margin will be disregarded - For invasive cancers, the tumor must be estrogen receptor positive (defined as 10% or greater expression of estrogen receptor) - If the patient has a history of a prior non-breast cancer, all treatment for this cancer must have been completed at least one month prior to study registration and the patient must have no evidence of disease for this prior non-breast cancer - Patients must be enrolled on the trial within 12 weeks of the later of two dates: the final breast conserving surgical procedure or administration of the last cycle of cytotoxic chemotherapy - Final criteria for eligibility established after simulation: The tumor bed can be readily visualized on simulation computed tomography (CT) and is localized to one quadrant or region of the breast that is amenable to partial breast irradiation Exclusion Criteria: - Tumor invasion of the skin including dermis, chest wall, or pectoralis musculature - Any evidence of nodal positivity beyond pathologic stage of pN0(i+) - Systemic chemotherapy prior to final breast conserving surgery - Patient is pregnant or nursing - History of therapeutic irradiation to the breast, lower neck, mediastinum or other area in which there could potentially be overlap with the affected breast - History of prior invasive or in situ cancer in either breast - Current diagnosis of bilateral breast cancer - History of lupus or scleroderma

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Laboratory Biomarker Analysis
Correlative studies
Radiation:
Partial Breast Irradiation
Undergo hypofractionated partial breast irradiation
Other:
Questionnaire Administration
Ancillary studies

Locations

Country Name City State
United States Presbyterian Hospital Albuquerque New Mexico
United States Piedmont Hospital Atlanta Georgia
United States Summit Medical Group Berkeley Heights New Jersey
United States Cooper Hospital University Medical Center Camden New Jersey
United States MD Anderson in The Woodlands Conroe Texas
United States M D Anderson Cancer Center Houston Texas
United States MD Anderson West Houston Houston Texas
United States Community Cancer Center East Indianapolis Indiana
United States Baptist MD Anderson Cancer Center Jacksonville Florida
United States MD Anderson League City League City Texas
United States OhioHealth Mansfield Hospital Mansfield Ohio
United States Covenant Medical Center Harrison Saginaw Michigan
United States Saint Luke's Baptist Health System San Antonio Texas
United States MD Anderson in Sugar Land Sugar Land Texas
United States MD Anderson Cancer Center at Cooper-Voorhees Voorhees New Jersey

Sponsors (2)

Lead Sponsor Collaborator
M.D. Anderson Cancer Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Risk of grade 2 or higher toxicity Will evaluate whether or not the risk of this outcome is higher than the risk of grade 2+ toxic events in the best performing arm of our prior clinical trial that evaluated dosing schedules of whole breast irradiation (2010-0559). At 6 months post radiation
Secondary Patient-reported cosmetic outcome Patient-reported cosmetic outcome, functional status, and breast pain will be measured using the Breast Cancer Treatment Outcomes Scale (BCTOS) and will be compared for the IMPORT Low versus OPAL regimens. Each outcome will be evaluated both as a continuous variable and as a dichotomous variable with a cutpoint of >= 2.5, indicating a moderate or greater average change in the treated breast compared to the untreated breast which serves as an internal control. Will use descriptive statistics to summarize patient-reported cosmetic outcome, functional status, and breast pain over time. Box plots and graphical measures will be used to display the distribution of these outcomes over time and by treatment arm. Will conduct linear mixed models to assess changes in patient-reported cosmetic outcome, functional status, and breast pain scores over time. A random intercept will be included to account for within-subject correlations. At 6 months, one year, two years, three years, four years, and five years after completing the optimizing preventative adjuvant linac-based radiation (OPAL) regimen
Secondary Physician-reported and photographically-assessed cosmetic outcome Physician-reported cosmetic outcome, functional status, and breast pain will be measured using the Breast Cancer Treatment Outcomes Scale (BCTOS) and will be compared for the IMPORT Low versus OPAL regimens. Each outcome will be evaluated both as a continuous variable and as a dichotomous variable with a cutpoint of >= 2.5, indicating a moderate or greater average change in the treated breast compared to the untreated breast which serves as an internal control. Will use descriptive statistics to summarize patient-reported cosmetic outcome, functional status, and breast pain over time. Box plots and graphical measures will be used to display the distribution of these outcomes over time and by treatment arm. Will conduct linear mixed models to assess changes in patient-reported cosmetic outcome, functional status, and breast pain scores over time. A random intercept will be included to account for within-subject correlations. At 6 months, one year, two years, three years, four years, and five years after completing the OPAL regimen
Secondary Risk of pathologically-confirmed invasive and/or ipsilateral breast tumor recurrence (IBTR) Will be estimated using Kaplan and Meier product-limit estimator and modeled with Cox proportional hazards regression. IBTR will be measured from the date of treatment initiation to the date of last evaluation or IBTR. The 5-year risk of IBTR and any recurrence will be estimated along with 95% confidence intervals. Differences in each of these outcomes by treatment arm will be assessed using the log-rank test. Cox proportional hazards regression and/or competing risks regression will be used if needed to account for imbalance among treatment arms with respect to risk factors for these outcomes. At 5 years
Secondary Risk of any recurrence of breast cancer Will be estimated using Kaplan and Meier product-limit estimator and modeled with Cox proportional hazards regression. Recurrence-free survival will be measured from the date of radiation treatment initiation to the earliest date of last clinic visit, date of first recurrence, or date of death. Differences in each of these outcomes by treatment arm will be assessed using the log-rank test. Cox proportional hazards regression and/or competing risks regression will be used if needed to account for imbalance among treatment arms with respect to risk factors for these outcomes. At 5 years
Secondary Disease free survival (DFS) Will be estimated using Kaplan and Meier product-limit estimator and modeled with Cox proportional hazards regression. DFS will be measured from date of treatment initiation to the earliest date of last clinic visit, date of progression, date of recurrence, date of metastasis, or date of death. Differences in each of these outcomes by treatment arm will be assessed using the log-rank test. Cox proportional hazards regression and/or competing risks regression will be used if needed to account for imbalance among treatment arms with respect to risk factors for these outcomes. At 5 years
Secondary Overall survival Will be estimated using Kaplan and Meier product-limit estimator and modeled with Cox proportional hazards regression. OS will be measured from the date of treatment initiation to the earliest date of last contact or death. Differences in each of these outcomes by treatment arm will be assessed using the log-rank test. Cox proportional hazards regression and/or competing risks regression will be used if needed to account for imbalance among treatment arms with respect to risk factors for these outcomes. At 5 years
Secondary Incidence of adverse events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4. Differences in National Cancer Institute CTCAE and Subjective, Objective, Management, Analytic (SOMA) toxicity by treatment arm will be evaluated using chi-square test or Fisher's exact test, as appropriate. Up to 5 years
Secondary Feasibility of conducting multi-center radiation therapy trials within the MD Anderson Network The trial will be considered feasible if >= 90% of enrolled and treated patients receive the prescribed radiation dosing per protocol without deviations. 5 years
Secondary TGF-beta analysis For this analysis, the primary outcome is grade 2 or higher breast fibrosis measured using the Subjective, Objective, Management, Analytic/Late Effects Normal Tissue Task Force scale at the 3.5 year follow up visit. The exposure of interest is the presence of at least one copy of the C-509T allele in germline deoxyribonucleic acid (DNA). Will also conduct exploratory analyses to assess the association of TGF-beta genotype with cosmetic outcome, other PROs, and toxicities. T-test or rank-sum test will be used for continuous measures and chi-squared or Fishers exact test will be used for categorical measures. Up to 5 years
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