The REPEAT trial is a feasibility trial of repeat breast-conserving therapy consisting of preoperative single-dose partial breast irradiation and breast conserving surgery to assess the rate of grade 2 or higher acute radiotherapy- and surgery-…
ID
Source
Brief title
Condition
- Breast neoplasms malignant and unspecified (incl nipple)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Rate of grade >= 2 acute radiation-induced toxicity within 3 months following
preoperative radiotherapy and postoperative complications within 30 days using
Common Terminology Criteria for Adverse Events v.5.0 (skin toxicity, breast
edema, breast pain and chest wall pain) and the Clavien-Dindo Classification
(wound infection)
Secondary outcome
Other acute and late radiotherapy- and surgery-associated toxicity, mastectomy
rates, quality of life, cosmetic outcomes, patient satisfaction, local
recurrence, regional recurrence, distant metastases, disease-free survival,
breast cancer specific- and overall survival rates, radiologic and pathologic
response.
Background summary
The standard of care of patients with an ipsilateral recurrent breast event is
a salvage mastectomy after previous breast-conserving therapy
(bresat-conserving surgery+radiotherapy). Interest in repeat brest-conserving
therapy is rising in order to avoid mastectomy and improve quality of life in
these patients.Several previous studies suggest that repeat BCS and
post-operative re-irradiation (5-25 sessions) is safe in patients with a
low-risk ipsilateral recurrent breast event. The 5-year local control rate is
76% in patients treated with repeat breast-conserving surgery alone and 89%
after repeat breast-conserving surgery followed by re-irradiation. The 5-year
overall survival rates were 77% and 87%, respectively. A repeat sentinel node
procedure will be performed based on the decision of the multidisciplinary
tumor board of the relevant hospital according to standard of care.
Interest is also rising in preoperative PBI in patients with primary breast
cancer. Preoperative radiotherapy allows a more precise and less
observer-dependent definition of the target volume, and smaller irradiated
volume of the breast compared to postoperative radiotherapy, which might
translate in lower treatment-related toxicity and improved cosmetic outcome. In
addition, smaller irradiated volumes allow a reduced number of radiotherapy
sessions, to even a single-dose radiotherapy. Thus, it is highly relevant to
explore whether preoperative PBI can also be applied in the recurrent low-risk
setting.
Study objective
The REPEAT trial is a feasibility trial of repeat breast-conserving therapy
consisting of preoperative single-dose partial breast irradiation and breast
conserving surgery to assess the rate of grade 2 or higher acute radiotherapy-
and surgery-induced toxicity. In addition, tumor response will be assessed
using MRI, tumor tissue and blood. Toxicity, patient-reported outcome measures,
cosmetic results and oncological outcomes prior to, during and following
treatment will be evaluated.
Study design
This is a single-arm prospective cohort study. Patients who fulfill the
inclusion criteria will be treated with single-dose partial breast irradiation.
After 3 weeks a preoperative MRI-scan will be performed to assess acute tumor
response. Prior to and 3 weeks after radiotherapy, blood samples will be taken
voor response monitoring. After 3 weeks breast-conserving surgery will be
performed. A repeat sentinel node procedure will be performed based on the
decision of the multidisciplinary tumor board of the relevant hospital
according to standard of care. A consultation at the outpatient department with
physical examination will take place 2, 6 and 12 weeks after treatment.
Patients will be followed for a total of 5 years through mammography and
physical examination. During the entire study, the patients will be asked to
fill out questionnaires to evaluate patient-reported outcomes including quality
of life and cosmetic outcome. In addition, toxicity will be evaluated and
digital photographs of the breasts will be taken to evaluate cosmetic outcome.
Intervention
Single dose preoperative radiotherapy of 20 Gy to the tumor
Study burden and risks
The burden for participating patients consists of 1 additional MRI-scan, two
additional blood samples and one optional additional tumor biopsy. The
additoinal blood samples will be combined with placing IV entrance for the
MRI-scan. The additional biopsy can be combined with marker insertion, which is
standard of care. The patient can give additional consent for the biopsy.
Furthermore, 10 questionnaires are filled out by the patients for evaluation of
patient-reported outcomes, toxicity and cosmetic outcome.
Breast-conserving surgery will be less burdensome than the standard mastectomy.
The first surgery is in day care, while for the mastectomy the patient is
submitted in the hospital for another day.
The treatment burden of a single-dose preoperative PBI is reduced compared to
standard postoperative multiple-fractionated re-irradiation (i.e. 5-25
sessions).
De Boelelaan 1117
Amsterdam 1081 HV
NL
De Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
Female, 50 years or older, ipsilateral recurrent invasive breast cancer tumor
size <= 2 cm, unifocal on MRI, Bloom Richardson grade 1 or 2, ER-positive tumor,
HER2-negative tumor, non-lobular, clinical node negative on
PET-CT/ultrasound/MRI, no distant metastasis, repeat breast-conserving surgery
is feasible due to no or mild late toxicity from previous breast-conserving
therapy
Exclusion criteria
Ipsilateral breast cancer event less than 2 years after first breast-conserving
therapy, other malignancy within 5 years before ipsilateral bresat recurrence
diagnosis, bresat cancer mutation gene carrier, previous ipsilateral
mastectomy, MRI contra-indication, indication for neoadjuvant chemotherapy
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL85983.018.24 |