Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Patients receive endocrine therapy alone without radiotherapy

Patients will not receive radiotherapy, which is the current standard for treatment for their type of breast cancer.

endocrine therapy alone without radiotherapy

Reshma Jagsi, M.D., Ph.D.

This study will collect rates of local/regional recurrence in select patients who do not receive radiation treatment after lumpectomy surgery. These women must be postmenopausal; have hormone receptor-positive, Her2-negative tumors; have Oncotype-DX RS less than or equal to 18; and plan to receive endocrine therapy. In this way, this study seeks to collect prospective data supporting the idea that this is a population at sufficiently low risk of local/regional recurrence that omission of adjuvant radiation might be a reasonable option.

This study's primary aim is to determine rates of recurrence with the innovative approach of considering tumor biology to select patients who may avoid radiation, with restriction of eligibility to women aged 50-69 with hormone-sensitive, Her2-negative tumors with Oncotype-DX RS ≤ 18 who plan to receive endocrine therapy. In this way, this study seeks to collect prospective data supporting the idea that this is a population at low risk of LRR in whom omission of adjuvant radiation is reasonable.

The IDEA Study (Individualized Decisions for Endocrine Therapy Alone)

All patients will be followed for their clinical outcome for at least 10 years, specifically: for development of recurrence (and site), the salvage therapy type if local disease recurs, for development of distant metastasis, and survival - both overall and breast-cancer specific.

Rutgers Cancer Institute of New Jersey

East Carolina University

Stanford University

Harvard University

Yale University

University of Pennsylvania

Medical College of Wisconsin

Memorial Sloan Kettering Cancer Center

University of Texas Southwestern Medical Center

Johns Hopkins University

Loyola University

University of Michigan Rogel Cancer Center

Carcinoma

Patients randomized to Arm A will receive standard radiation therapy and adjuvant endocrine therapy (standard of care).

Patients randomized to Arm B will not receive radiation therapy (omission of radiation therapy) and receive adjuvant endocrine therapy only.

Omission of radiation therapy (adjuvant endocrine therapy only).

Omission of radiation therapy

Heath Badger

Akiko Fong

Marcelo Tatangelo, Dr

Luis Fein, Dr

Ruben Kowalyszsyn, Dr

Lisa Sullivan, Dr

George Papadatos, Dr

Georgia Harris, Dr

Joanne Toohey, Dr

Peter O'Brien, A/Prof

Hester Lieng, Dr

Miriam Boxer, Dr

Jane Ludbrook, Dr

Andrew Spillane, Prof

Carmen Hansen, Dr

Boon H Chua, Prof

Susan Pendlebury, Dr

Verity Ahern, A/Prof

de Leon Jeremiah, Dr

Marie Burke, Dr

Gerard Adams, Dr

Bryan Burmeister, Prof

Margot Lehman, A/Prof

Phuong Tran, Dr

Louise Gorman, Dr

Solveig Grenfell, Dr

Steven David, Dr

Bianca Devitt, Dr

Andrew See, Dr

Melissa Moore, Dr

David Blakey, Dr

Michael Francis, Dr

Michael Chao, Dr

Prue Francis, A/Prof

Louise Nardone, Dr

Mandy Taylor, Dr

Paola Ruiz de Vinaspre, Dr

Paves Gonzalo, Dr

Manuel Manzor, Dr

Rocio Guerra, Dr

Camila Concha, Dr

Sinead Brennan, Dr

Joseph Martin, Dr

Alessandra Crippa, Dr

Marco Colleoni, Prof

Melissa James, Dr

Ian Campbell, A/Prof

Claire Hardie, Dr

Anna Nicholson, Dr

Victoria Reyes, Dr

Meritxell Molla, Dr

Serafin Morales, Dr

Eloisa Bayo, Dr

Javier Salvador Bofill, Dr

Conny Vrieling, Dr

Michail Kouros, Dr

Daniel Zwahlen, Dr

Christoph Tausch, Dr

Linsenmeier Claudia, Dr

Shou-Tung Chen, Dr

Fang-Ming Chen, Dr

Chih-Chiang Hung, Dr

Yao-Lung Kuo, Dr

Chiun-Sheng Huang, Dr

Yuan-ching Chang, Dr

Ling-Ming Tseng, Dr

Guo-Hsiou Liao, Dr

Chin-Sheng Hung, Dr

Wenling Kuo, Dr

This is a randomised, phase III, non-inferiority trial evaluating radiation therapy versus observation following breast conserving surgery and planned endocrine therapy in patients with stage I breast cancer of luminal A subtype defined using the Prosigna (PAM50) Assay.

Radiation therapy (RT) after breast conserving surgery to improve local control and survival is the current standard of care for patients with early breast cancer. However, breast cancer is a heterogeneous disease, and the absolute benefit of RT in individual patients varies substantially. Thus, a pressing priority in contemporary breast cancer management is to tailor RT utilisation to the individual recurrence risks by identifying patients who are unlikely to benefit from RT, thereby avoiding the morbidity and costs of over-treatment.

It is recognised that selected patients with early breast cancer are unlikely to derive benefits from RT after breast conserving surgery. However, randomised trials have not consistently identified patients who may safely omit RT using conventional clinical-pathologic characteristics.

Breast cancer intrinsic subtypes distinguished by gene expression profiling are shown to be associated with distinct clinical outcomes. There is substantial evidence supporting the clinical validity of multigene assays including the PAM50-based Prosigna Assay that identifies intrinsic subtypes and generates a Risk of Recurrence score (ROR) to quantify individual risks of distant relapse. Multigene assays are increasingly integrated into clinical practice to inform chemotherapy decision, highlighting their substantial practice changing potential in personalising the use of RT for early breast cancer.

A recent analysis of archived tumour specimens of 1,308 patients with early breast cancer has shown significant associations between local recurrence risk and the PAM50-defined intrinsic subtypes and ROR score. EXPERT presents a unique opportunity of clinical and public health importance to optimise personalised local therapy for early breast cancer through precise, individualised quantification of local recurrence risk to identify low-risk patients for whom RT after breast conserving surgery may be safely omitted.

EXamining PErsonalised Radiation Therapy for Low-risk Early Breast Cancer

A Randomised Phase III Trial of Adjuvant Radiation Therapy Versus Observation Following Breast Conserving Surgery and Endocrine Therapy in Patients With Molecularly Characterised Luminal A Early Breast Cancer

Anonymised Individual Patient Data (IPD) collected during the trial as per BCT Data Sharing Guidelines.

Visual Analogue Scales (convenience and impact of treatment)

The time from randomisation to the date of local recurrence (LR) as a site of first recurrence.

Time from randomisation to the date of local or regional recurrence as a site of first recurrence.

Time from randomisation to the date of distant recurrence, regardless of occurrence of any intervening local or regional recurrence, contralateral breast cancer or second (non-breast) primary invasive cancer.

Time from randomisation to date of first evidence of local (invasive breast carcinoma or DCIS), regional or distanct recurrence; contralateral breast cancer (invasive breast carcinoma or DCIS); second (non-breast) primary invasive cancer; or death.

Time from randomisation to date of first evidence of local (invasive breast carcinoma), regional or distanct recurrence; contralateral breast cancer (invasive breast carcinoma); second (non-breast) primary invasive cancer; or death.

Time from randomisation to the date of local, regional or distant recurrence as a site of first recurrence.

Time from randomisation to date of death from any cause.

Time from randomisation to the receipt of salvage RT or mastectomy, individually and in combination (one or the other) as a composite endpoint.

Adverse events during treatment (up to 5 years of endocrine therapy) assessed using NCI CTCAE v4.0.

Breast International Group

ETOP IBCSG Partners Foundation

Breast Cancer Trials, Australia and New Zealand

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The IDEA Study (Individualized Decisions for Endocrine Therapy Alone)	NCT02400190	Breast Neoplasm...	endocrine thera...	50 Years - 69 Years	University of Michigan Rogel Cancer Center
The IDEA Study (Individualized Decisions for Endocrine Therapy Alone)	NCT02400190	Breast Neoplasm...	endocrine thera...	50 Years - 69 Years	University of Michigan Rogel Cancer Center
EXamining PErsonalised Radiation Therapy for Low-risk Early Breast Cancer	NCT02889874	Early Stage Bre...	Omission of rad...	50 Years -	Breast Cancer Trials, Australia and New Zealand

Spots Global Cancer Trial Database for omission

Every month we try and update this database with for omission cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for omission

Every month we try and update this database with for omission cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for omission cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.