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Radiation Therapy Before Surgery in Treating Patients With Hormone Receptor Positive, HER2 Negative Breast Cancer

Primary Purpose

Estrogen Receptor Positive, HER2/Neu Negative, Invasive Breast Carcinoma

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Radiation Therapy
Therapeutic Conventional Surgery
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Estrogen Receptor Positive

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Inclusion:

  • Age >/=18 years at time of study entry
  • Histologically confirmed HR+/HER2- (according to American Society of Clinical Oncology/College of American Pathologists guidelines) invasive carcinoma of the breast
  • Presence of a clip in the primary breast cancer
  • Biopsy-amenable residual disease in the breast measuring >/= 1cm in at least one dimension on ultrasound cm in at least one dimension on ultrasound
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
  • Signed written informed consent
  • Planned for multidisciplinary evaluation by a Breast Surgical Oncologist and Breast Radiation Oncologist. For patients undergoing mastectomy and desirous of reconstruction or those undergoing breast conservation in whom oncoplastic local tissue rearrangement or reduction mammoplasty is being considered, this multidisciplinary evaluation will also include a plastic surgeon.

Exclusion:

  • Women who are pregnant or breast-feeding
  • Contraindication to receive radiotherapy

Sites / Locations

  • M D Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (radiation therapy, surgery)

Arm Description

Patients undergo boost radiation therapy 6-8 days before breast surgery. After surgery, patients continue to receive standard of care radiation therapy.

Outcomes

Primary Outcome Measures

Evaluation of Change in Percent of Tumor-Infiltrating Lymphocytes (TIL)
With 20 patients, a 95% confidence interval for the mean difference between TIL measurements would extend 0.44*s units from the mean (where "s" is the standard deviation of the TIL differences). If the differences are not normally distributed, researchers will report the median difference along with appropriate 95% confidence intervals. Appropriate graphs used to visualize the data.

Secondary Outcome Measures

Delay Rate of Surgery Following Boost RT
Delay rate defined as the proportion of patients experiencing a > 4 week interval between boost RT and surgery. The method of Thall, Simon, and Estey employed to perform interim delay rate monitoring.
Tumor Changes between pre and post boost
For tumor measures, descriptive statistics including plots, tabulations, mean, median, and standard deviations will be used to summarize data. Differences and/or percentage changes will be calculated between pre- and post- therapy samples from each patient and described as continuous measures by using paired t-tests will be explored to evaluate the changes in markers pre- and post-boost therapy. Scatter plots will be used to visualize how correlated between changes in immune markers and extent of tumor cell apoptosis, and the Spearman correlation coefficients will be calculated to evaluate the association between changes in immune markers and extent of tumor cell death markers.
Toxicity calculated using the CTCAE v4.0
Toxicity and cosmesis will be calculated and reported, to enable comparisons to other published reports of breast cancer-related toxicity using the CTCAE v4.0.
Changes in dynamic contrast enhanced (DCE)
Changes in DCE, internal texture, ADC values, z-spectrum asymmetry on CEST measures will be assessed between the simulation MRI and the MRI obtained following radiation boost.

Full Information

First Posted
November 28, 2017
Last Updated
September 11, 2023
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT03359954
Brief Title
Radiation Therapy Before Surgery in Treating Patients With Hormone Receptor Positive, HER2 Negative Breast Cancer
Official Title
PRECISE: Preoperative Radiotherapy to Elicit Critical Immune Stimulating Effects
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 16, 2017 (Actual)
Primary Completion Date
October 31, 2025 (Anticipated)
Study Completion Date
October 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

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

5. Study Description

Brief Summary
This phase II trial studies how well radiation therapy before surgery works in treating patients with hormone receptor positive, HER2 negative breast cancer. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
Detailed Description
PRIMARY OBJECTIVES: I. To evaluate the change in percent tumor-infiltrating lymphocytes (TIL) as a continuous variable before and after preoperative boost radiotherapy (RT) in hormone receptor (HR)+/human epidermal growth factor receptor2 (HER2)- breast cancers. SECONDARY OBJECTIVES: I. To evaluate the safety of preoperative boost RT administered to patients with HR+/HER2- breast cancer. EXPLORATORY OBJECTIVES: I. To assess the mechanisms of cell death induced by preoperative boost RT. II. To assess immunologic and molecular responses to preoperative boost RT. III. To assess the correlations between immune markers, cell death markers, and their changes during treatment. IV. To determine if magnetic resonance imaging (MRI) can be used to predict breast tumor response to neoadjuvant radiation. OUTLINE: Patients undergo boost radiation therapy 6-8 days before breast surgery. After surgery, patients continue to receive standard of care radiation therapy. After completion of study treatment, patients are followed up at 6 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Estrogen Receptor Positive, HER2/Neu Negative, Invasive Breast Carcinoma, Progesterone Receptor Positive

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (radiation therapy, surgery)
Arm Type
Experimental
Arm Description
Patients undergo boost radiation therapy 6-8 days before breast surgery. After surgery, patients continue to receive standard of care radiation therapy.
Intervention Type
Radiation
Intervention Name(s)
Radiation Therapy
Other Intervention Name(s)
Cancer Radiotherapy, Irradiate, Irradiated, irradiation, Radiation, Radiotherapeutics, RADIOTHERAPY, RT, Therapy, Radiation
Intervention Description
Undergo radiation therapy
Intervention Type
Procedure
Intervention Name(s)
Therapeutic Conventional Surgery
Intervention Description
Undergo breast surgery
Primary Outcome Measure Information:
Title
Evaluation of Change in Percent of Tumor-Infiltrating Lymphocytes (TIL)
Description
With 20 patients, a 95% confidence interval for the mean difference between TIL measurements would extend 0.44*s units from the mean (where "s" is the standard deviation of the TIL differences). If the differences are not normally distributed, researchers will report the median difference along with appropriate 95% confidence intervals. Appropriate graphs used to visualize the data.
Time Frame
6 to 8 days after preoperative radiotherapy
Secondary Outcome Measure Information:
Title
Delay Rate of Surgery Following Boost RT
Description
Delay rate defined as the proportion of patients experiencing a > 4 week interval between boost RT and surgery. The method of Thall, Simon, and Estey employed to perform interim delay rate monitoring.
Time Frame
4 weeks after boost RT
Title
Tumor Changes between pre and post boost
Description
For tumor measures, descriptive statistics including plots, tabulations, mean, median, and standard deviations will be used to summarize data. Differences and/or percentage changes will be calculated between pre- and post- therapy samples from each patient and described as continuous measures by using paired t-tests will be explored to evaluate the changes in markers pre- and post-boost therapy. Scatter plots will be used to visualize how correlated between changes in immune markers and extent of tumor cell apoptosis, and the Spearman correlation coefficients will be calculated to evaluate the association between changes in immune markers and extent of tumor cell death markers.
Time Frame
Up to 4 weeks after surgery
Title
Toxicity calculated using the CTCAE v4.0
Description
Toxicity and cosmesis will be calculated and reported, to enable comparisons to other published reports of breast cancer-related toxicity using the CTCAE v4.0.
Time Frame
6 months after adjuvant RT
Title
Changes in dynamic contrast enhanced (DCE)
Description
Changes in DCE, internal texture, ADC values, z-spectrum asymmetry on CEST measures will be assessed between the simulation MRI and the MRI obtained following radiation boost.
Time Frame
4 weeks after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Inclusion: Age >/=18 years at time of study entry Histologically confirmed HR+/HER2- (according to American Society of Clinical Oncology/College of American Pathologists guidelines) invasive carcinoma of the breast Presence of a clip in the primary breast cancer Biopsy-amenable residual disease in the breast measuring >/= 1cm in at least one dimension on ultrasound cm in at least one dimension on ultrasound Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 Signed written informed consent Planned for multidisciplinary evaluation by a Breast Surgical Oncologist and Breast Radiation Oncologist. For patients undergoing mastectomy and desirous of reconstruction or those undergoing breast conservation in whom oncoplastic local tissue rearrangement or reduction mammoplasty is being considered, this multidisciplinary evaluation will also include a plastic surgeon. Exclusion: Women who are pregnant or breast-feeding Contraindication to receive radiotherapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simona F Shaitelman
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
University of Texas MD Anderson Cancer Center Website

Learn more about this trial

Radiation Therapy Before Surgery in Treating Patients With Hormone Receptor Positive, HER2 Negative Breast Cancer

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