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PRECISE: Preoperative Radiotherapy to Elicit Critical Immune Stimulating Effects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03359954
Recruitment Status : Recruiting
First Posted : December 2, 2017
Last Update Posted : July 24, 2018
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

The goal of this clinical research study is to compare changes to the tumor(s) in your breast before and after radiation.

Radiation treatment is standard treatment after surgery for women with breast cancer. This radiation treatment is typically delivered to the larger breast area for 3-5 weeks of treatment, followed by 1 week of treatment (called a radiation boost) to the area where the tumor used to be. In this study, the radiation boost will be given before surgery rather than after it.

Researchers want to learn about how radiation changes the immune system's response to the tumor, about side effects that develop after radiation treatment, and how radiation kills breast cancer cells.

This is an investigational study. The radiation treatment will be delivered using FDA-approved and commercially available methods. The timing of the radiation boost is considered investigational.

Up to 20 participants will be enrolled in this study. All will be enrolled at MD Anderson.

Condition or disease Intervention/treatment Phase
Malignant Neoplasm of Breast Radiation: Preoperative Boost (RT) Procedure: Breast Surgery Radiation: XRT Phase 2

Detailed Description:

If you agree to take part in this study, you will have an ultrasound of the breast to check the status of the disease.

Leftover tumor tissue from the biopsy performed to diagnose you (called a diagnostic biopsy), if available, will be collected. This is collected so researchers have a baseline (control) sample to compare to the results of testing performed later in this study.

Then, if there is enough tissue to biopsy, image-guided biopsies will be taken of the tumor in the breast. Depending on how you feel, up to 6 biopsies will be performed. To perform an image-guided biopsy, a needle is inserted into the affected area using an ultrasound to collect cells or tissue from the tumor. The doctor will use the imaging to guide the needle into the area. Two (2) types of samples will be collected. A single fine needle aspirate will collect cells and up to 5 core biopsies will be performed to collect small pieces of tissue.

If it is found that there is not enough tissue to biopsy, then you will not have these biopsies, and you will be taken off study.

You will have blood drawn (about 1 teaspoon each time) for tests of your immune system:

  • On the same day as your biopsies
  • At the time of surgery, while you are in the operating room

About 6 to 8 days before your surgery, you will receive the radiation boost. The radiation boost will be delivered in a similar way it would if you were to receive it after surgery.

You will have an MRI done before surgery.

You will then have your surgery and radiation therapy as scheduled.

You will receive separate consent forms for the radiation therapy and surgery that explains the procedures and the risks.

Information about any side effects you may be having from radiation and/or surgery will be collected from your medical record for up to 6 months after the end of radiation.

Length of Study:

Your participation on this study will be over after your standard, 6-month follow-up visit after the end of radiation therapy.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: PRECISE: Preoperative Radiotherapy to Elicit Critical Immune Stimulating Effects
Actual Study Start Date : November 16, 2017
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Preoperative Boost Radiotherapy (RT)

Participants receive preoperative boost RT after completion of neoadjuvant systemic therapy. Participants then undergo definitive oncologic breast surgery followed by standard of practice breast or chest wall RT.

Preoperative boost RT scheduled to occur 6-8 days prior to the date of the participant's definitive breast surgery. Radiation boost delivered to a dose of 7.5Gy in 1 fraction using conformal treatment.

Radiation: Preoperative Boost (RT)
Participants receive preoperative boost RT to breast after completion of neoadjuvant systemic therapy. Preoperative boost RT scheduled to occur 6-8 days prior to the date of the participant's definitive breast surgery. Radiation boost delivered to a dose of 7.5Gy in 1 fraction using conformal treatment.
Other Names:
  • XRT
  • RT

Procedure: Breast Surgery
Participants undergo definitive oncologic breast surgery after preoperative boost RT.

Radiation: XRT
Participants undergo standard of practice breast or chest wall radiation therapy (RT) after definitive oncologic breast surgery.
Other Name: RT

Primary Outcome Measures :
  1. Evaluation of Change in Percent of Tumor-Infiltrating Lymphocytes (TIL) [ Time Frame: 6 to 8 days after preoperative radiotherapy ]
    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 :
  1. Delay Rate of Surgery Following Boost RT [ Time Frame: 4 weeks after 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Age >/=18 years at time of study entry
  2. Histologically confirmed HR+/HER2- (according to American Society of Clinical Oncology/College of American Pathologists guidelines) invasive carcinoma of the breast
  3. Presence of a clip in the primary breast cancer
  4. Biopsy-amenable residual disease in the breast measuring >/= 1cm in at least one dimension on ultrasound cm in at least one dimension on ultrasound
  5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
  6. Signed written informed consent
  7. 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 Criteria:

  1. Women who are pregnant or breast-feeding
  2. Contraindication to receive radiotherapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03359954

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Contact: Simona F. Shaitelman, MD 713-563-2300

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United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
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Principal Investigator: Simona F. Shaitelman, MD M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center Identifier: NCT03359954     History of Changes
Other Study ID Numbers: 2017-0362
NCI-2018-00993 ( Registry Identifier: NCI CTRP )
First Posted: December 2, 2017    Key Record Dates
Last Update Posted: July 24, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by M.D. Anderson Cancer Center:
Malignant neoplasm of breast
Preoperative boost radiotherapy
Breast surgery

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases