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

M.D. Anderson Cancer Center

Status and phase: Active, not recruiting; Phase 2

Conditions: Invasive Breast Carcinoma; Progesterone Receptor Positive; HER2/Neu Negative; Estrogen Receptor Positive

Treatments: Procedure: Therapeutic Conventional Surgery; Radiation: Radiation Therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03359954

NCI-2018-00993 (Registry Identifier)

2017-0362 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Treatment (radiation therapy, surgery)

Experimental group

Description:

Patients undergo boost radiation therapy 6-8 days before breast surgery. After surgery, patients continue to receive standard of care radiation therapy.

Treatment:

Radiation: Radiation Therapy

Procedure: Therapeutic Conventional Surgery