Data

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 (ANZ 1601/BIG 16-02: EXPERT).

Breast Cancer Trials (BCT)

Dataset description

THIS DATASET IS NOT YET AVAILABLE FOR SHARING. Dataset of around 1000 luminal A early breast cancer patients in a randomised phase III trial. Female patients aged >= 50 years, histologically confirmed invasive breast carcinoma <= 2 cm, grade 1 or 2, ER/PR positive, HER2 negative, primary tumour characterised by Prosigna (PAM50) assay as Luminal A intrinsic subtype and risk of recurrence score <= 60. Treated by breast conserving surgery with negative margins for invasive carcinoma and any associated ductal carcinoma in situ (DCIS). Negative axillary nodal status determined by sentinel node biopsy or axillary dissection. Eligible for and willing to have adjuvant endocrine therapy. Not planned for adjuvant chemotherapy or biologic anti-cancer therapy. Participants are randomised to ARM A: RT + endocrine therapy or ARM B: no RT (endocrine therapy only). Primary indpoint is local recurrence free interval. Patient Reported Outcomes: data is available from 433 English-speaking patients from PROM measuring Fear of Cancer Recurrence (FCR Inventory), Convenience of Care (study specific), Fatigue (Brief Fatigue Inventory), Endocrine Therapy (19 endocrine-symptom items from the FACT-ES), Anxiety and Depression (Hospital Anxiety and Depression Scale), QALY (EQ-5D-5L). A health economic analysis will also be performed.
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Subjects

Radiation Therapy |

Source Study

Trial acronym

Not available

Trial ID

NCT02889874

Purpose

Not available

Phase

Not available

Funding

Not available

Scientific enquiries

Not available

Brief Summary

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.

Key Inclusion Criteria

Inclusion Criteria: for registration in the study: 1. Female patients aged = 50 years of any menopausal status. 2. Primary tumour characteristics as assessed by conventional histopathology: - Unifocal histologically confirmed invasive breast carcinoma - Maximum microscopic size =2 cm - Grade 1 or 2 histology - ER and PR positive in =10% of tumour cells in either the biopsy or breast conserving surgical specimen - HER2 negative on IHC (score 0 or 1+) or in situ hybridisation (ERBB2-amplification ....
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Key Exclusion Criteria

Can healthy volunteers participate?

No

 

Population

Sample Size    Not Available

Min. age    50 Years

Max. age    N/A

Sex    Female

Condition category    Radiation therapy , breast cancer , non-inferiority , omission

Condition code    Early Stage Breast Carcinoma

Intervention

Intervention code Treatment: Other - Omission of radiation therapy

Comparison

Control group Not available

Comparison not available.

Outcomes

Not Available

The data-sharing statement for this study is currently unavailable.

Source study information is derived from the ClinicalTrials.gov. For more information, please see ClinicalTrials.gov