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NCT Number: NCT03359954

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

radiation therapy

Radiation

Undergo radiation therapy

Other names: Cancer Radiotherapy, Irradiate, Irradiated, irradiation, Radiation, Radiotherapeutics, RADIOTHERAPY, RT, Therapy, Radiation

therapeutic conventional surgery

Procedure

Undergo breast surgery

Primary outcomes

  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 outcomes

  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.

  2. Tumor Changes between pre and post boost

    Time frame: Up to 4 weeks after surgery

    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.

  3. Toxicity calculated using the CTCAE v4.0

    Time frame: 6 months after adjuvant RT

    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.

  4. Changes in dynamic contrast enhanced (DCE)

    Time frame: 4 weeks after surgery

    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.

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

PRECISE: Preoperative Radiotherapy to Elicit Critical Immune Stimulating Effects

Important dates

Study start
2017
Primary completion
2027
Study completion
2027
First posted
Dec 2, 2017
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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