IRB #

STUDY00023469

Title

[NCI CIRB] NRG-BR007 - A Phase III Clinical Trial Evaluating DE-escalation of Breast RAdiation (DEBRA) for Conservative Treatment of Stage I, Hormone Sensitive, HER2-Negative, Oncotype Recurrence Score less than or equal to 18 Breast Cancer

Principal Investigator

Kiri Cook

Study Purpose

The purpose of this study is to compare treatment with hormonal therapy to the usual treatment of radiation and hormonal therapy in women with low-risk breast cancer who have had lumpectomy. This study will help researchers learn if hormonal therapy alone is better or worse than the usual treatment.

Medical Condition(s)

Breast Cancer

Eligibility Criteria

The patient must have an ECOG performance status of 0 or 1.

The patient must have undergone a lumpectomy and the margins of the resected specimen or re-excision must be histologically free of invasive tumor and DCIS with no ink on tumor as determined by the local pathologist.

The tumor must be unilateral invasive adenocarcinoma of the breast on histologic examination.

Patient must have undergone axillary staging (sentinel node biopsy and/or axillary node dissection).

The AJCC 8th edition staging criteria must be met postoperatively: By pathologic evaluation, primary tumor must be pT1 (less than or equal to 2 cm) & ipsilateral nodes must be pN0.

Oncotype DX Recurrence Score of less than or equal to 18 on diagnostic core biopsy or resected specimen.

The tumor must have been determined to be ER and/or PgR positive & HER2-negative per ASCO/CAP guidelines.

Patients may be premenopausal or postmenopausal at the time of study entry.

The interval between the last surgery for breast cancer (including re-excision of margins) and study entry must be no more than 70 days.

The patient must have recovered from surgery with the incision completely healed and no signs of infection.

Patients must be intending to take endocrine therapy for a minimum 5 years duration (tamoxifen or aromatase inhibitor).

Age Range

50 - 70

Healthy Volunteers Needed

No

Duration of Participation

Hormonal therapy will last for at least five years with or without radiation therapy lasting up to 5 weeks. Once finished, patients will be followed for 10 years.

Minors Included

No

Contact

Knight Cancer Institute Clinical Trials
trials@ohsu.edu
503-494-1080

John Minger
mingerj@ohsu.edu
503-494-8756

Sponsor

National Cancer Institute (NCI)

Recruitment End

10/31/2023

Compensation Provided

No


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