Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06445738
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-06
First Post:
2024-05-24
Brief Title:
Post-operative Radiotherapy Omission in Selected Patients With Early Breast Cancer Trial International VErsion
Sponsor:
Breast Cancer Trials Australia and New Zealand
Organization:
Breast Cancer Trials Australia and New Zealand
Study Overview
Official Title:
A Two-arm Non-randomised Prospective Multicentre Study Using Magnetic Resonance Imaging MRI Findings and Pathology Features to Select Patients With Early Breast Cancer for Omission of Post-operative Radiotherapy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROSPECTIVE
Brief Summary:
The PROSPECTIVE trial aims to find out if using the results of Magnetic Resonance Imaging MRI for early breast cancer can select people to not have radiotherapy and still have a low chance of the cancer coming back after surgery
The main question it aims to answer is
Will cancer come back in the same breast as the original cancer in patients who have surgery for their breast cancer but who dont have radiotherapy afterwards because the results of an MRI before surgery showed favourable characteristics for not having radiotherapy
The main question it aims to answer is
Will cancer come back in the same breast as the original cancer in patients who have surgery for their breast cancer but who dont have radiotherapy afterwards because the results of an MRI before surgery showed favourable characteristics for not having radiotherapy
Detailed Description:
Breast cancer is the most common serious malignancy in women and most patients are suitable for therapy involving surgery and adjuvant radiotherapy RT For most patients there is a lack of evidence that breast conserving surgery without adjuvant RT is safe and therefore patients bear the costs inconvenience and morbidity of RT Prior attempts to identify large subsets of patients for whom RT can be safely omitted based on clinicopathological features of the index cancer have had limited success and so RT is currently omitted only in some women over 65 or 70 with small low risk cancers Identification of a much larger subset of patients in whom adjuvant RT could be safely omitted would be hugely significant not only to the patients but to the entire health system
The ANZ 1002 PROSPECT study was a two-arm phase II study that used breast MRI findings and pathological features to identify a group of patients with low risk early breast cancer in whom RT may be safely omitted The findings at the primary strongly support the hypothesis and suggest that the combination of preoperative MRI and pathological features can identify a substantial group of early breast cancer patients in whom adjuvant RT can be safely omitted
A Health Economic analysis of PROSPECT found that the avoided costs of RT and its potential side effects is likely to substantially outweigh the extra cost of MRI scans and associated investigations Parallel cross-sectional studies assessing Fear of Cancer Recurrence FCR and Health Related Quality of Life HRQoL in patients taking part in PROSPECT who either did or did not receive RT and a control group found a substantially lower FCR in PROSPECT patients who omitted RT as well as improved HRQoL
The majority of screened and eligible patients 427443 and 193201 respectively for PROSPECT were recruited from two Australian sites Before the PROSPECT approach can be widely adopted the findings need to be replicated in a multicentre international study In addition patient reported outcomes and health economic assessments need to be performed prospectively and longitudinally
PROSPECTIVE is the follow-up to PROSPECT which will address these issues and also include translational research aspects to further study the natural history and outcomes of this group of lower risk early breast cancers
The ANZ 1002 PROSPECT study was a two-arm phase II study that used breast MRI findings and pathological features to identify a group of patients with low risk early breast cancer in whom RT may be safely omitted The findings at the primary strongly support the hypothesis and suggest that the combination of preoperative MRI and pathological features can identify a substantial group of early breast cancer patients in whom adjuvant RT can be safely omitted
A Health Economic analysis of PROSPECT found that the avoided costs of RT and its potential side effects is likely to substantially outweigh the extra cost of MRI scans and associated investigations Parallel cross-sectional studies assessing Fear of Cancer Recurrence FCR and Health Related Quality of Life HRQoL in patients taking part in PROSPECT who either did or did not receive RT and a control group found a substantially lower FCR in PROSPECT patients who omitted RT as well as improved HRQoL
The majority of screened and eligible patients 427443 and 193201 respectively for PROSPECT were recruited from two Australian sites Before the PROSPECT approach can be widely adopted the findings need to be replicated in a multicentre international study In addition patient reported outcomes and health economic assessments need to be performed prospectively and longitudinally
PROSPECTIVE is the follow-up to PROSPECT which will address these issues and also include translational research aspects to further study the natural history and outcomes of this group of lower risk early breast cancers
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None