Clinical trial NCT03359954: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Estrogen Receptor Positive
HER2/Neu Negative
Invasive Breast Carcinoma
Progesterone Receptor Positive
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2017-12-02
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Evaluation of Change in Percent of Tumor-Infiltrating Lymphocytes (TIL)
timeFrame: 6 to 8 days after preoperative radiotherapy
Secondary outcomes:
measure: Delay Rate of Surgery Following Boost RT
timeFrame: 4 weeks after boost RT
measure: Tumor Changes between pre and post boost
timeFrame: Up to 4 weeks after surgery
measure: Toxicity calculated using the CTCAE v4.0
timeFrame: 6 months after adjuvant RT
measure: Changes in dynamic contrast enhanced (DCE)
timeFrame: 4 weeks after surgery
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Simona F Shaitelman
role: PRINCIPAL_INVESTIGATOR
References: