Clinical Trials /

PRECISE: Preoperative Radiotherapy to Elicit Critical Immune Stimulating Effects

NCT03359954

Description:

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.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: PRECISE: Preoperative Radiotherapy to Elicit Critical Immune Stimulating Effects
  • Official Title: PRECISE: Preoperative Radiotherapy to Elicit Critical Immune Stimulating Effects

Clinical Trial IDs

  • ORG STUDY ID: 2017-0362
  • SECONDARY ID: NCI-2018-00993
  • NCT ID: NCT03359954

Conditions

  • Malignant Neoplasm of Breast

Purpose

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.

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.
    

Trial Arms

NameTypeDescriptionInterventions
Preoperative Boost Radiotherapy (RT)ExperimentalParticipants 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.

    Eligibility Criteria

            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
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:Female
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Evaluation of Change in Percent of Tumor-Infiltrating Lymphocytes (TIL)
    Time Frame:6 to 8 days after preoperative radiotherapy
    Safety Issue:
    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.

    Secondary Outcome Measures

    Measure:Delay Rate of Surgery Following Boost RT
    Time Frame:4 weeks after boost RT
    Safety Issue:
    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.

    Details

    Phase:Phase 2
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:M.D. Anderson Cancer Center

    Trial Keywords

    • Malignant neoplasm of breast
    • Preoperative boost radiotherapy
    • RT
    • XRT
    • HR+/HER2-
    • Breast surgery

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