Primary aim: to assess whether local recurrence is acceptable when radiotherapy is omitted after breast conserving surgery in patients treated with NAC who achieve a pathologic complete response.Secondary aim: to assess quality of life and cancer…
ID
Source
Brief title
Condition
- Breast neoplasms malignant and unspecified (incl nipple)
- Breast therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is the local recurrence rate (LRR) at 5 years.
Secondary outcome
Secondary determinants are local non-salvageable recurrence free survival,
quality of life, regional recurrence rate, distant recurrence free survival,
disease-specific survival and overall survival.
Background summary
Over 60% of the women who are diagnosed with breast cancer in the Netherlands
are treated with systemic treatment, which may be administered before
(neoadjuvant chemotherapy, NAC) or after (adjuvant) locoregional treatment.
Depending on the subtype, 10-75% of patients will have a pathologic complete
response (pCR) after NST. In this patient group, risk of local recurrence is
extremely low. The administration of adjuvant radiotherapy in these patients is
not expected to contribute significantly to overall survival, but may cause
considerable morbidity.
Study objective
Primary aim: to assess whether local recurrence is acceptable when radiotherapy
is omitted after breast conserving surgery in patients treated with NAC who
achieve a pathologic complete response.
Secondary aim: to assess quality of life and cancer worry after omitting
radiotherapy.
Study design
DESCARTES is a national, multicentre, non-randomized, single-arm prospective
cohort study.
Study burden and risks
The immediate impact for participants is to be spared intensive radiotherapy
and subsequent risk of side effects (such as pain, fatigue, possible lung
damage). An expected 4% will develop a local recurrence within 5 years, about
half of which would not have happened with standard radiotherapy. The majority
of these local recurrences can however effectively be treated with salvage
breast-conserving or ablative surgery and previous studies indicated that
patient survival will not be affected.
Plesmanlaan 121
Amsterdam 1066CX
NL
Plesmanlaan 121
Amsterdam 1066CX
NL
Listed location countries
Age
Inclusion criteria
• Women, aged >= 18 years
• Invasive HR positive/Her2 negative, Her2+ (ER/PR +/-) or TN breast cancer
• Concurrent DCIS in pre-NST biopsy is allowed if there is no suspicion of
extensive component i.e. absence of non-mass enhancement on pre-NST MRI (if
performed) and/or absence of calcifications on pre-NST mammography
• Primary tumour (T) clinical stage cT1-2
• Unifocal disease; confirmed by pre-NST MRI, contrast-enhanced mammography or
breast-specific gamma imaging
• Clinical nodal stage 0; absence of lymph node metastases should be confirmed
by ultrasound or FDG-PET/CT
• Neoadjuvant systemic treatment (NST)
• Marker placed in breast tumour prior to NST
• Breast conserving surgery performed, i.e. no mastectomy
• Sentinel node biopsy performed before or after NST
• Pathologic complete response in breast and lymph nodes, i.e. no residual
tumour cells or DCIS detected
• Written informed consent
Exclusion criteria
• Primary tumour (T) clinical stage cT3-4
• Pre- or post-NST diagnosis of nodal disease including isolated tumour cells
• Concurrent LCIS of any type in either pre-NST biopsy or surgical specimen
• Patients without axillary ultrasound or FDG-PET/CT pre-NST
• History of breast cancer DCIS or LCIS
• Synchronous contralateral breast cancer DCIS or LCIS
• Synchronous M1 disease
• Carrier of gene mutation associated with increased risk of breast cancer,
i.e. BRCA1, BRCA2, CHEK2, TP53 or PALB-2
Design
Recruitment
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 |
|---|---|
| ClinicalTrials.gov | NCT05416164 |
| CCMO | NL79099.031.21 |