Clinical Trials /

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

NCT03359954

Description:

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.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 2

URL:

https://clinicaltrials.gov/show/NCT03359954

Trial Eligibility

Document

Title

  • 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

Clinical Trial IDs

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

Conditions

  • Estrogen Receptor Positive
  • HER2/Neu Negative
  • Invasive Breast Carcinoma
  • Progesterone Receptor Positive

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Treatment (radiation therapy, surgery)ExperimentalPatients undergo boost radiation therapy 6-8 days before breast surgery. After surgery, patients continue to receive standard of care radiation therapy.

    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
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:All
    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.
    Measure:Tumor Changes between pre and post boost
    Time Frame:Up to 4 weeks after surgery
    Safety Issue:
    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.
    Measure:Toxicity calculated using the CTCAE v4.0
    Time Frame:6 months after adjuvant RT
    Safety Issue:
    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.
    Measure:Changes in dynamic contrast enhanced (DCE)
    Time Frame:4 weeks after surgery
    Safety Issue:
    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.

    Details

    Phase:Phase 2
    Primary Purpose:Interventional
    Overall Status:Active, not recruiting
    Lead Sponsor:M.D. Anderson Cancer Center

    Last Updated

    April 5, 2021