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Evaluation of a Once Per Day Regimen of Accelerated Partial Breast Irradiation for Improved Breast Appearance in Patients With Low Risk, Hormone Responsive Breast Cancer

Primary Purpose

Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Estrogen Receptor-Positive Breast Carcinoma

Status
Not yet recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Accelerated Partial Breast Irradiation
Sponsored by
City of Hope Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anatomic Stage 0 Breast Cancer AJCC v8

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Documented informed consent of the participant and/or legally authorized representative Age: >= 40 years Female Ability to read and understand English or Spanish for questionnaires Anatomic pathologic stage 0 (ductal carcinoma in situ [DCIS]) or stage IA (invasive) breast cancer Malignancy must be epithelial. Non-epithelial breast malignancies such as lymphoma or sarcoma are not allowed Tissue from core biopsy or resection must show hormone sensitive receptors. Hormone sensitive receptors are defined as the following: - DCIS: Estrogen receptor (ER) positive (>= 60%) Invasive breast cancer: Oncotype DX =< 25 (if performed) OR If Oncotype DX is not performed an Allred score of 7 or 8. The following combinations of proportion of ER positive cells and staining intensity are allowed: ER positive (34-66% of cells) and staining intensity is strong (Allred 7) ER positive (>= 67% of cells) and staining intensity is intermediate (Allred 7) ER positive (>= 67% of cells) and staining intensity is strong (Allred 8) Tissue from core biopsy or resection must be HER2 negative by current American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines Patients must have undergone breast conserving surgery with resulting negative surgical margins (no tumor on ink). Re-excision for negative margins is allowed. Patients with pathologically involved surgical margins are excluded Patients must have pathologic Tis or T1 disease Patients with invasive breast cancer, including patients with microinvasion, must have undergone surgical staging of the axilla (sentinel lymph node biopsy or axillary lymph node dissection) and have pathologically confirmed uninvolved lymph nodes. All lymph nodes must be pathologically negative (pN0[i-]). pN0(i+), pN1mic, pN1-pN3 axillary lymph nodes are not allowed Although an axillary lymph node dissection is not anticipated for low-risk ER positive breast cancers, axillary lymph node dissection is permissible Patient must have physician-reported "excellent" or "good" cosmesis post-lumpectomy and prior to radiation therapy based on the 4-point Global Cosmetic Score Women of childbearing potential (WOCBP): Negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required Agreement by females of childbearing potential* to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 1 month after the last dose of protocol therapy Childbearing potential is defined as not being surgically sterilized or have not been free from menses for > 1 year Exclusion Criteria: Any prior treatment with radiation therapy, anti-endocrine/hormone therapy, chemotherapy or biologic therapy for the currently diagnosed breast cancer PRIOR to surgical resection Prior radiation to the region of the involved breast that in the opinion of the investigator would preclude partial breast irradiation Clinically significant uncontrolled illness Diagnosis of Paget's disease of the nipple Other prior or active malignancy. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial Pregnant or breastfeeding Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

Sites / Locations

  • City of Hope Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Supportive care (APBI)

Arm Description

Patients undergo APBI QD on consecutive business days for 5 treatments.

Outcomes

Primary Outcome Measures

Proportion of women that rate the cosmetic appearance of the breast as acceptable ("excellent" or "good")
Measured by the 4-point Global Cosmetic Score (GCS). The exact test will be used to test the hypothesis that the rate of cosmesis is >= 90% versus the null hypothesis that cosmesis is 74% or lower, at the 5% significance level.

Secondary Outcome Measures

Cosmetic outcome by the patient post-APBI QD
Measured by the GCS. Will be summarized and the percent and 95% confidence limits of the estimate will be calculated. Will also examine at cosmesis scores over time using analysis of variance (ANOVA).
Cosmetic outcome assessed by the physician post-APBI QD
Measured by the GCS. Will explore also examine change in scores over time using ANOVA. Appropriate graphical methods will be used for visualization. Association between the assessment rating of cosmetic outcome based on photographic image by medical doctor (MD) and blinded reviewers will be calculated at each time point using Pearson's product-moment correlation coefficient.
Cosmetic outcome assessed by the physician post-APBI QD
Measured by the GCS. Will explore also examine change in scores over time using ANOVA. Association between the assessment rating of cosmetic outcome based on photographic image by MD and blinded reviewers will be calculated at each time point using Pearson's product-moment correlation coefficient.
Incidence of adverse events-patients reported
Scored by the Patient-Reported Outcome Common Terminology Criteria for Adverse Events (CTCAE). Will be summarized using standard methods.
Incidence of adverse events-treatment team reported
As scored by the treatment team using CTCAE version 5.0. Will be summarized using standard methods.
In-breast recurrence
The Kaplan-Meier method will be used along with 95% confidence intervals.
Regional recurrence
The Kaplan-Meier method will be used along with 95% confidence intervals.
Distant metastases
The Kaplan-Meier method will be used along with 95% confidence intervals.
Disease-free survival
The Kaplan-Meier method will be used along with 95% confidence intervals.
Overall survival
The Kaplan-Meier method will be used along with 95% confidence intervals.

Full Information

First Posted
August 18, 2023
Last Updated
August 18, 2023
Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT06008158
Brief Title
Evaluation of a Once Per Day Regimen of Accelerated Partial Breast Irradiation for Improved Breast Appearance in Patients With Low Risk, Hormone Responsive Breast Cancer
Official Title
Prospective Evaluation of a Once Per Day Regimen of Accelerated Partial Breast Irradiation in Low-Risk, Hormone-Responsive Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 9, 2023 (Anticipated)
Primary Completion Date
April 9, 2025 (Anticipated)
Study Completion Date
April 9, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This phase II trial tests how well accelerated partial breast irradiation (APBI) delivered once per day works in ensuring an acceptable breast appearance in patients with low risk, hormone responsive breast cancer. APBI uses precise radiation beams to kill cancerous cells in a smaller area of the breast (partial breast) instead of the whole breast or chest area as in standard therapy. Additionally, APBI is given in a shorter course of treatment than whole breast radiation therapy, over fewer days instead of several weeks, with a lower total dose of radiation. APBI is currently given every other business day for a total of 5 treatments with excellent results; however, a shorter treatment duration could have similar or even better results. Undergoing APBI every day on consecutive business days for 5 treatments may result in an improved breast appearance for patients with low risk hormone responsive breast cancer.
Detailed Description
PRIMARY OBJECTIVES: I. To establish that APBI delivered once per day (APBI QD) for low-risk breast cancer patients results in acceptable patient-reported cosmetic appearance of the breast at 1 year after completion of APBI QD. SECONDARY OBJECTIVES: I. To determine the long-term patient-reported cosmetic appearance of the breast in patients treated with APBI QD. II. To determine the short-term and long-term physician reported cosmetic appearance of the breast in patients treated with APBI QD. III. To determine the acute and late patient-reported radiation toxicity of APBI QD. IV. To determine the acute and late physician-reported radiation toxicity of APBI QD. V. To determine the cancer control outcomes of APBI QD. EXPLORATORY OBJECTIVES: I. To assess the health-related quality of life in patients treated with APBI QD. II. To determine the long-term blinded physician review of cosmetic appearance of the breast in patients treated with APBI. III. To assess dosimetric parameters associated with cosmesis in patients undergoing APBI QD. OUTLINE: Patients undergo APBI QD on consecutive business days for 5 treatments. Patients follow up at 1 month, 6 months, and 1 year post-APBI and then yearly until 5 years post-APBI.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Estrogen Receptor-Positive Breast Carcinoma, HER2-Negative Breast Carcinoma

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
Cosmetic outcome assessed by blinded medical doctor review.
Allocation
N/A
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Supportive care (APBI)
Arm Type
Experimental
Arm Description
Patients undergo APBI QD on consecutive business days for 5 treatments.
Intervention Type
Radiation
Intervention Name(s)
Accelerated Partial Breast Irradiation
Other Intervention Name(s)
Accelerated Partial Breast Radiation Therapy, APBI
Intervention Description
Undergo APBI
Primary Outcome Measure Information:
Title
Proportion of women that rate the cosmetic appearance of the breast as acceptable ("excellent" or "good")
Description
Measured by the 4-point Global Cosmetic Score (GCS). The exact test will be used to test the hypothesis that the rate of cosmesis is >= 90% versus the null hypothesis that cosmesis is 74% or lower, at the 5% significance level.
Time Frame
At 1 year post accelerated partial breast irradiation once daily (APBI QD)
Secondary Outcome Measure Information:
Title
Cosmetic outcome by the patient post-APBI QD
Description
Measured by the GCS. Will be summarized and the percent and 95% confidence limits of the estimate will be calculated. Will also examine at cosmesis scores over time using analysis of variance (ANOVA).
Time Frame
Over time at baseline, day 5, 1 month, 6 months, 1 year, 2 years and 3 years
Title
Cosmetic outcome assessed by the physician post-APBI QD
Description
Measured by the GCS. Will explore also examine change in scores over time using ANOVA. Appropriate graphical methods will be used for visualization. Association between the assessment rating of cosmetic outcome based on photographic image by medical doctor (MD) and blinded reviewers will be calculated at each time point using Pearson's product-moment correlation coefficient.
Time Frame
At 1 year
Title
Cosmetic outcome assessed by the physician post-APBI QD
Description
Measured by the GCS. Will explore also examine change in scores over time using ANOVA. Association between the assessment rating of cosmetic outcome based on photographic image by MD and blinded reviewers will be calculated at each time point using Pearson's product-moment correlation coefficient.
Time Frame
Over time at baseline, day 5, 1 month, 6 months 1 year, 2 years and 3 years
Title
Incidence of adverse events-patients reported
Description
Scored by the Patient-Reported Outcome Common Terminology Criteria for Adverse Events (CTCAE). Will be summarized using standard methods.
Time Frame
Up to 3 years post-APBI
Title
Incidence of adverse events-treatment team reported
Description
As scored by the treatment team using CTCAE version 5.0. Will be summarized using standard methods.
Time Frame
Up to 3 years post-APBI
Title
In-breast recurrence
Description
The Kaplan-Meier method will be used along with 95% confidence intervals.
Time Frame
Up to 5 years post-APBI QD
Title
Regional recurrence
Description
The Kaplan-Meier method will be used along with 95% confidence intervals.
Time Frame
Up to 5 years post-APBI QD
Title
Distant metastases
Description
The Kaplan-Meier method will be used along with 95% confidence intervals.
Time Frame
Up to 5 years post-APBI QD
Title
Disease-free survival
Description
The Kaplan-Meier method will be used along with 95% confidence intervals.
Time Frame
Up to 5 years post-APBI QD
Title
Overall survival
Description
The Kaplan-Meier method will be used along with 95% confidence intervals.
Time Frame
Up to 5 years post-APBI QD

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Documented informed consent of the participant and/or legally authorized representative Age: >= 40 years Female Ability to read and understand English or Spanish for questionnaires Anatomic pathologic stage 0 (ductal carcinoma in situ [DCIS]) or stage IA (invasive) breast cancer Malignancy must be epithelial. Non-epithelial breast malignancies such as lymphoma or sarcoma are not allowed Tissue from core biopsy or resection must show hormone sensitive receptors. Hormone sensitive receptors are defined as the following: - DCIS: Estrogen receptor (ER) positive (>= 60%) Invasive breast cancer: Oncotype DX =< 25 (if performed) OR If Oncotype DX is not performed an Allred score of 7 or 8. The following combinations of proportion of ER positive cells and staining intensity are allowed: ER positive (34-66% of cells) and staining intensity is strong (Allred 7) ER positive (>= 67% of cells) and staining intensity is intermediate (Allred 7) ER positive (>= 67% of cells) and staining intensity is strong (Allred 8) Tissue from core biopsy or resection must be HER2 negative by current American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines Patients must have undergone breast conserving surgery with resulting negative surgical margins (no tumor on ink). Re-excision for negative margins is allowed. Patients with pathologically involved surgical margins are excluded Patients must have pathologic Tis or T1 disease Patients with invasive breast cancer, including patients with microinvasion, must have undergone surgical staging of the axilla (sentinel lymph node biopsy or axillary lymph node dissection) and have pathologically confirmed uninvolved lymph nodes. All lymph nodes must be pathologically negative (pN0[i-]). pN0(i+), pN1mic, pN1-pN3 axillary lymph nodes are not allowed Although an axillary lymph node dissection is not anticipated for low-risk ER positive breast cancers, axillary lymph node dissection is permissible Patient must have physician-reported "excellent" or "good" cosmesis post-lumpectomy and prior to radiation therapy based on the 4-point Global Cosmetic Score Women of childbearing potential (WOCBP): Negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required Agreement by females of childbearing potential* to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 1 month after the last dose of protocol therapy Childbearing potential is defined as not being surgically sterilized or have not been free from menses for > 1 year Exclusion Criteria: Any prior treatment with radiation therapy, anti-endocrine/hormone therapy, chemotherapy or biologic therapy for the currently diagnosed breast cancer PRIOR to surgical resection Prior radiation to the region of the involved breast that in the opinion of the investigator would preclude partial breast irradiation Clinically significant uncontrolled illness Diagnosis of Paget's disease of the nipple Other prior or active malignancy. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial Pregnant or breastfeeding Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose G Bazan
Organizational Affiliation
City of Hope Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose G. Bazan
Phone
626-505-7901
Email
jbazan@coh.org
First Name & Middle Initial & Last Name & Degree
Jose G. Bazan

12. IPD Sharing Statement

Learn more about this trial

Evaluation of a Once Per Day Regimen of Accelerated Partial Breast Irradiation for Improved Breast Appearance in Patients With Low Risk, Hormone Responsive Breast Cancer

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