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Post-operative Radiotherapy Omission in Selected Patients with Early Breast Cancer Trial International VErsion (PROSPECTIVE)
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 don't have radiotherapy afterwards because the results of an MRI before surgery showed favourable characteristics for not having radiotherapy.
Study details:
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 (427/443 and 193/201, 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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 50 and older
Healthy volunteers accepted : No
Gender eligible for study: Female
Things to know
Study dates
Study start: 2025-01-01
Primary completion: 2032-01-01
Study completion finish: 2039-01-01
Study type
TREATMENT
Phase
NA
Trial ID
NCT06445738
Intervention or treatment
RADIATION: Arm A: Radiotherapy Omission
OTHER: Arm B: Standard Treatment
Conditions
- • Breast Cancer
- • Breast Cancer Female
Find a site
Closest Location:
The Chris O'Brien Lifehouse
Research sites nearby
Select from list below to view details:
The Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia
Lake Macquarie Private Hospital
Gateshead, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: Radiotherapy Omission
| RADIATION: Arm A: Radiotherapy Omission
|
ACTIVE_COMPARATOR: Standard Treatment
| OTHER: Arm B: Standard Treatment
|
What is the study measuring?
Primary outcome
| Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
|---|---|---|
| Ipsilateral Invasive Recurrence Rate (IIRR) in low-risk patients omitting RT at a median of 5 years follow up | To determine the ipsilateral invasive recurrence rate (IIRR) in patients with favourable clinico-pathological features on MRI and unequivocally unifocal breast cancer treated with wide local excision but no adjuvant radiotherapy | Median of 5 years follow up (when 300th low risk patient in Arm A reaches 5 years follow up) |
| Ipsilateral Invasive Recurrence Rate (IIRR) in all patients omitting RT at a median of 5 years follow up | To determine the ipsilateral invasive recurrence rate (IIRR) in patients allocated to omit radiotherapy | Median of 5 years follow up |
Secondary outcome
| Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
|---|---|---|
| Ipsilateral Invasive Recurrence Rate (IIRR) in all patients omitting RT at a median of 10 years follow up | To determine the ipsilateral invasive recurrence rate (IIRR) in patients allocated to omit radiotherapy | Median of 10 years follow up |
| IIRR in higher risk patients omitting RT and the total cohort omitting RT | To determine the ipsilateral invasive recurrence rate (IIRR) in higher risk participants and the total cohort omitting RT. | Median of 5 years follow up |
| IIRR in the breast at 5 and 10 years in the entire cohort undergoing pre-operative MRI and ineligible for RT omission | To determine the ipsilateral invasive recurrence rate (IIRR) in the breast at 5 and 10 years in the entire cohort undergoing preoperative MRI and found to be ineligible for RT omission after BCS (Arm B). | Median of 5 and 10 years follow up. |
| IIR in the breast at 5 and 10 years in the entire cohort undergoing pre-operative MRI | To determine the ipsilateral invasive recurrence rate (IIRR) in the breast at 5 and 10 years in the entire cohort undergoing preoperative MRI (Arms A + B). | Median of 5 and 10 years follow up |
| Ipsilateral DCIS recurrence rate in the entire cohort | To determine the ipsilateral DCIS recurrence rate in the entire cohort undergoing pre-operative MRI (Arms A + B). | Median of 5 and 10 years follow up. |
| Ipsilateral DCIS and invasive recurrence rate in all cohorts separately and combined | Ipsilateral DCIS and invasive recurrence rate in all cohorts separately and combined | Median of 5 and 10 years follow up |
| Regional recurrence rate in all participants | To determine the regional recurrence rate in the entire cohort undergoing preoperative MRI (Arms A + B). | Median of 5 and 10 years follow up |
| Distant recurrence rate in all participants | To determine the distant recurrence rate in the entire cohort undergoing preoperative MRI (Arms A + B). | Median of 5 and 10 years follow up |
| Contralateral DCIS and invasive breast cancer in each arm separately, and combined | To determine the contralateral DCIS and invasive breast cancer in Arm A, Arm B, and the total cohort (Arms A + B) | Median of 5 and 10 years follow up |
| Breast cancer specific survival rate in all groups separately and combined | To determine the breast cancer specific survival rate in all groups separately and combined | Median of 5 and 10 years follow up |
| Overall survival rate | To determine the overall survival rate in all groups separately and combined | Median of 5 and 10 years follow up |
| PRO: Fear of Cancer Recurrence | To determine the difference in Fear of cancer recurrence (FCR) between Arm A and Arm B measured by the Fear of Cancer Recurrence Inventory Short Form (FCRI-SF). A higher score indicates a greater fear of recurrence. | Median 24 months post-surgery |
| PRO: HRQoL (functional and aesthetic outcomes) | To determine the difference in HRQoL (functional and aesthetic outcomes) between Arm A and Arm B measured by the Breast Cancer Treatment Outcomes Scale (BCTOS). A higher score indicates greater morbidity. | 24 months post-surgery |
| PRO: HRQoL (fatigue, body image, financial toxicity) | To determine the difference in HRQoL (fatigue, body image, financial toxicity) between Arm A and Arm B measured by the EORTC ILXX measure (custom measure for this protocol). A higher score indicates greater fatigue, poorer body image and greater financial toxicity. | 24 months post-surgery |
| PRO: Difference over time in FCR | To determine the difference over time in FCR between Arm A and Arm B measured by the FCRI-SF. A higher score indicates a greater fear of recurrence. | From allocation to 3-, 6-, 12-, 24- and 60 months median follow up post-surgery |
| PRO: Difference over time in HRQoL (functional and aesthetic outcomes) | To determine the difference over time in HRQoL (functional and aesthetic outcomes), between Arm A and Arm B measured by the BCTOS. A higher BCTOS score indicates greater morbidity. | From allocation to 6-, 12-, 24- and 60 months median follow up post-surgery |
| PRO: Difference over time in HRQoL (ffatigue, body image, financial toxicity) | To determine the difference over time in HRQoL (fatigue, body image, financial toxicity), between Arm A and Arm B measured by the EORTC ILXX measure (custom measure for this protocol). A higher score indicates greater fatigue, poorer body image and greater financial toxicity. | From allocation to 6-, 12-, 24- and 60 months median follow up post-surgery |
| PRO: Differences in Quality of Life Years (QALYs) | Differences in QALYs between Arm A and Arm B measured by the EQ-5D-5L | 24 months post-surgery |
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