Nrg-Br007 A Phase III Clinical Trial Evaluating De-Escalation Of Breast Radiation For Conservative Treatment Of Stage I, Hormone Sensitive, Her-2 Negative, Oncotype Recurrence Score Less Than Or Equal To 18 Breast Cancer
Posted Date: Nov 16, 2021
- Investigator: Teresa Meier
- Specialties: Breast Cancer, Cancer, Oncology
- Type of Study: Drug
This Phase III Trial will evaluate whether breast conservation surgery and endocrine therapy result in a non-inferior rate of invasive or non-invasive ipsilateral breast tumor recurrence (IBTR) compared to breast conservation with breast radiation and endocrine therapy. This study will consist of 2 arms. Arm 1 will consist of breast radiation therapy plus endocrine therapy. Arm 2 will consist of no radiation therapy, only the hormonal drug for at least 5 years. Efficacy will be determined by time to invasive or noninvasive IBTR or last follow up.
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). Oncotype Dx Recurrence Score Of Less Than Or Equal To 18 On Diagnostic Core Biopsy Or Resected Specimen. By Pathologic Evaluation, Ipsilateral Nodes Must Be Pn0. The Tumor Must Have Been Determined To Be Er And/Or Pgr Positive Assessed By Current Asco/Cap Guideline Recommendations For Hormone Receptor Testing. The Tumor Must Have Been Determined To Be Her2-Negative By Current Asco/Cap Guidelines. 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. Bilateral Mammogram Or Mri Within 6 Months Prior To Study Entry. No Pt2 - Pt4 Tumors Including Inflammatory Breast Cancer. No Pathologic Staging Of Pn0(I+) Or Pn0(Mol+), Pn1, Pn2, Or Pn3 Disease. No Palpable Or Radiographically Suspicious Ipsilateral Or Contralateral Axillary, Supraclavicular, Infraclavicular, Or Internal Mammary Nodes, Unless There Is Histologic Confirmation That These Nodes Are Negative For Tumor. No Suspicious Microcalcifications, Densities, Or Palpable Abnormalities (In The Ipsilateral Or Contralateral Breast) Unless Biopsied And Found To Be Benign. No Non-Epithelial Breast Malignancies Such As Sarcoma Or Lymphoma. No Proven Multicentric Carcinoma (Invasive Cancer Or Dcis) In More Than One Quadrant Or Separated By 4 Or More Centimeters. No Paget's Disease Of The Nipple. No Synchronous Or Previous Contralateral Invasive Breast Cancer Or Dcis. No Treatment Plan That Includes Regional Nodal Irradiation. No History Of Non-Breast Malignancies (Except For In Situ Cancers Treated Only By Local Excision And Basal Cell And Squamous Cell Carcinomas Of The Skin) Within 5 Years Prior To Study Entry. No Current Therapy With Any Endocrine Therapy Such As Raloxifene (Evista®), Tamoxifen, Or Other Selective Estrogen Receptor Modulators (Serms), Either For Osteoporosis Or Breast Cancer Prevention. No Prior Breast Or Thoracic Rt For Any Condition. No Active Collagen Vascular Disease, Specifically Dermatomyositis With A Cpk Level Above Normal Or With An Active Skin Rash, Systemic Lupus Erythematosis, Or Scleroderma. No Pregnancy Or Lactation At The Time Of Study Entry Or Intention To Become Pregnant During Treatment.
Breast Cancer, Cancer, Stage 1
For More Information:
Uc Cancer Center