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Preoperative Single-Fraction Radiotherapy in Early Stage Breast Cancer

Primary Purpose

Breast Cancer

Status

Active

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Stereotactic body radiotherapy ( SBRT)

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

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

Inclusion Criteria:

Women with a biopsy proven diagnosis of ductal carcinoma in situ or invasive carcinoma of the breast
a. Biopsy tissue (either slides or block) from outside institutions will be reviewed to confirm diagnosis.
Breast preservation candidates (no prior breast or nodal radiotherapy, no imaging evidence of multicentric or multifocal disease, no pregnant women, and no comorbid conditions precluding surgery)
Clinical T1N0M0 invasive carcinoma or Ductal carcinoma in situ (DCIS) < or equal to 2cm
60 years of age or older or 50-59 with a low Oncotype score (0-17) Oncotype is not required for women diagnosed with DCIS.
Estrogen receptor positive (ER+), Human epidermal growth factor 2 negative (HER2-) HER-2 status is not required for women diagnosed with DCIS.
Women of child-bearing potential must consent to use adequate contraception during the course of the study. Female subjects must agree to use a medically acceptable contraceptives including: (1) surgical sterilization (such as a tubal ligation or hysterectomy), (2) approved hormonal contraceptives (such as birth control pills, patches, implants or injections), (3) barrier methods (such as a condom or diaphragm) used with a spermicide, or (4) an intrauterine device (IUD). Contraceptive measures such as Plan B (TM), sold for emergency use after unprotected sex, are not acceptable methods for routine use.
White blood cells (WBC) > 3000, Hemoglobin ( Hgb) > 9, platelets >100000 within 30 days of consent
Eligible for contrasted magnetic resonance imaging (MRI) on initial evaluation with glomerular filtration rate (GFR) ≥ 60 ml/min. A diagnostic MRI ordered within one month will be considered an acceptable alternative and will not be repeated.
Outside breast imaging will be reviewed at Duke to confirm findings are consistent with trial eligibility.

Exclusion Criteria:

Neoadjuvant chemotherapy
Breast implant in the breast to be treated with SBRT
Medical conditions that may increase risk for poor cosmetic outcome (i.e. Lupus, rheumatoid arthritis, scleroderma)
Subjects unable to receive study treatment planning secondary to body habitus or inability to lie flat on the stomach at length
HER2 positive
Positive serum pregnancy test
Insufficient breast imaging to judge clinical stage
Subjects without placement of a biopsy clip at the diagnostic procedure who are unwilling to undergo clip placement.
Subjects in whom treatment planning constraints cannot be met

Sites / Locations

Duke Cancer Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Single arm 21Gy stereotactic radiotherapy

Arm Description

Subjects will receive a single fraction of 21Gy of stereotactic radiotherapy before proceeding to surgery.

Outcomes

Primary Outcome Measures

Physician reported rates of good/excellent cosmesis.

Physician will independently complete the physician NRG Oncology cosmesis scale at the designated time points

Secondary Outcome Measures

Ki-67 will be assessed as a measure of tumor response

Ki-67 will be assessed in the pre and post radiotherapy tissue samples

Patient reported rates of good/excellent cosmesis

Patients will independently complete the patient NRG Oncology cosmesis scale at designated timepoints

The impact of radiation on gene expression

Gene expression will be assessed using the Affymetrix Human Transcriptome Array (HTA) arrays designed for formalin fixed paraffin embedded (FFPE) samples on pre and post radiation therapy tissue samples.

Local control in the treated breast relative to historic controls

Annual clinical examination combined with breast imaging

Assess the impact of RT on circulating cell free DNA

Oxidative stress biomarkers will be measured in serum and urine collected at the same timepoints

Full Information

NCT ID

NCT02482376

First Posted

June 22, 2015

Last Updated

October 20, 2023

Sponsor

Duke University

Collaborators

Gateway for Cancer Research

1. Study Identification

Unique Protocol Identification Number

NCT02482376

Brief Title

Preoperative Single-Fraction Radiotherapy in Early Stage Breast Cancer

Official Title

A Phase II Preoperative Single-Fraction Partial Breast Radiotherapy in Early Stage Breast Cancer: Analysis of Pathologic Response

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

October 21, 2015 (Actual)

Primary Completion Date

March 2025 (Anticipated)

Study Completion Date

March 2032 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Duke University

Collaborators

Gateway for Cancer Research

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This protocol seeks to build on the favorable results of the investigators' phase I trial (Pro00015617) by extending the findings to a larger cohort of subjects.In this study, the investigators hypothesize that 21Gy (Gray) as a single fraction can be delivered preoperatively to a larger group of subjects (n100). The primary objective is to determine physician reported rates of good/excellent cosmesis at baseline and 6 months, 1, 2, and 3 years post-treatment as measured by the NRG cosmesis scale

Detailed Description

The study team hypothesizes that a single fraction of 21Gy can be delivered preoperatively to the intact breast tumor with acceptable cosmetic outcomes. Furthermore, the investigators anticipate that pre- and post-radiation breast tumor samples will provide an avenue for understanding breast cancer radiation response Rationale for single-fraction preoperative technique This trial is proposed to build on the favorable results of the investigators' phase I trial by extending the findings to a larger cohort of subjects. The preoperative approach has several advantages: a small intact breast tumor results in significantly less uninvolved breast tissue receiving high radiation doses which likely decreases toxicity; more accurate targeting of the high-risk areas of subclinical disease surrounding the tumor is possible, smaller treatment volumes are amenable to dose escalation which can further accelerate treatment and improve accessibility for subjects, this technical approach is widely utilized in other tumor sites and can be delivered at most radiation facilities the pre-operative approach provides a novel opportunity to study breast cancer radiation response.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

68 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Single arm 21Gy stereotactic radiotherapy

Arm Type

Other

Arm Description

Subjects will receive a single fraction of 21Gy of stereotactic radiotherapy before proceeding to surgery.

Intervention Type

Radiation

Intervention Name(s)

Stereotactic body radiotherapy ( SBRT)

Other Intervention Name(s)

SBRT

Intervention Description

Single fraction of 21 Gy stereotactic radiotherapy (SBRT)delivered pre-operatively to subjects with early stage breast cancer

Primary Outcome Measure Information:

Title

Physician reported rates of good/excellent cosmesis.

Description

Physician will independently complete the physician NRG Oncology cosmesis scale at the designated time points

Time Frame

Through study completion estimated to be 3 years

Secondary Outcome Measure Information:

Title

Ki-67 will be assessed as a measure of tumor response

Description

Ki-67 will be assessed in the pre and post radiotherapy tissue samples

Time Frame

Through study completion estimated to be 3 years

Title

Patient reported rates of good/excellent cosmesis

Description

Patients will independently complete the patient NRG Oncology cosmesis scale at designated timepoints

Time Frame

Through study completion estimated to be 3 years

Title

The impact of radiation on gene expression

Description

Time Frame

Through study completion estimated to be 3 years

Title

Local control in the treated breast relative to historic controls

Description

Annual clinical examination combined with breast imaging

Time Frame

Through study completion estimated to be 5-10 years

Title

Assess the impact of RT on circulating cell free DNA

Description

Oxidative stress biomarkers will be measured in serum and urine collected at the same timepoints

Time Frame

Through study completion estimated to be 3 years

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Women with a biopsy proven diagnosis of ductal carcinoma in situ or invasive carcinoma of the breast a. Biopsy tissue (either slides or block) from outside institutions will be reviewed to confirm diagnosis. Breast preservation candidates (no prior breast or nodal radiotherapy, no imaging evidence of multicentric or multifocal disease, no pregnant women, and no comorbid conditions precluding surgery) Clinical T1N0M0 invasive carcinoma or Ductal carcinoma in situ (DCIS) < or equal to 2cm 60 years of age or older or 50-59 with a low Oncotype score (0-17) Oncotype is not required for women diagnosed with DCIS. Estrogen receptor positive (ER+), Human epidermal growth factor 2 negative (HER2-) HER-2 status is not required for women diagnosed with DCIS. Women of child-bearing potential must consent to use adequate contraception during the course of the study. Female subjects must agree to use a medically acceptable contraceptives including: (1) surgical sterilization (such as a tubal ligation or hysterectomy), (2) approved hormonal contraceptives (such as birth control pills, patches, implants or injections), (3) barrier methods (such as a condom or diaphragm) used with a spermicide, or (4) an intrauterine device (IUD). Contraceptive measures such as Plan B (TM), sold for emergency use after unprotected sex, are not acceptable methods for routine use. White blood cells (WBC) > 3000, Hemoglobin ( Hgb) > 9, platelets >100000 within 30 days of consent Eligible for contrasted magnetic resonance imaging (MRI) on initial evaluation with glomerular filtration rate (GFR) ≥ 60 ml/min. A diagnostic MRI ordered within one month will be considered an acceptable alternative and will not be repeated. Outside breast imaging will be reviewed at Duke to confirm findings are consistent with trial eligibility. Exclusion Criteria: Neoadjuvant chemotherapy Breast implant in the breast to be treated with SBRT Medical conditions that may increase risk for poor cosmetic outcome (i.e. Lupus, rheumatoid arthritis, scleroderma) Subjects unable to receive study treatment planning secondary to body habitus or inability to lie flat on the stomach at length HER2 positive Positive serum pregnancy test Insufficient breast imaging to judge clinical stage Subjects without placement of a biopsy clip at the diagnostic procedure who are unwilling to undergo clip placement. Subjects in whom treatment planning constraints cannot be met

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rachel Blitzblau, MD PhD

Organizational Affiliation

Duke Health

Official's Role

Principal Investigator

Facility Information:

Facility Name

Duke Cancer Center

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Preoperative Single-Fraction Radiotherapy in Early Stage Breast Cancer

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