Clinical trial NCT05416164: DESCARTES: De-ESCAlation of RadioTherapy in Patients With Pathologic Complete rESponse to Neoadjuvant Systemic Therapy
Official title: DESCARTES: De-ESCAlation of RadioTherapy in Patients With Pathologic Complete rESponse to Neoadjuvant Systemic Therapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: Neoadjuvant Chemotherapy
Breast cancer
Complete response
Radiotherapy
Lead sponsor: The Netherlands Cancer Institute
Sponsor class: OTHER
Collaborators: name: Dutch Cancer Society
name: Borstkanker Onderzoek Groep
First posted: 2022-06-13
Enrollment: 595
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study evaluates whether radiotherapy can safely be omitted in breast cancer patients with T1-2N0 tumors who achieve a pathologic complete response after neoadjuvant systemic therapy and breast-conserving surgery

Detailed description: The proportion of women diagnosed with breast cancer who are treated with neoadjuvant systemic therapy is increasing. Depending on the subtype, 10-75% of these patients will have a pathologic complete response. Currently breast conserving surgery with pathologic complete response is followed by radiotherapy. In this patient group risk of local recurrence is low, but radiotherapy may cause considerable morbidity.

The aim of this study is to investigate whether omitting radiotherapy is safe for patients with a node-negative breast tumor \<5cm treated with neoadjuvant systemic therapy and breast conserving surgery who achieve a pathologic complete response

Eligibility criteria: 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, contrast-enhanced mammography or breast-specific gamma imaging 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
* Patients without axillary ultrasound or FDG-PET/CT pre-NST
* History of breast cancer or DCIS
* Synchronous contralateral breast cancer or DCIS
* Synchronous M1 disease
* Carrier of gene mutation associated with increased risk of breast cancer, i.e. BRCA1, BRCA2, CHEK2, TP53 or PALB-2

Primary outcomes:
measure: Local recurrence
timeFrame: 5 years
Secondary outcomes:
measure: Level of cancer worry
timeFrame: 4 years
measure: Satisfaction reported by PROM (patient reported outcome measures)
timeFrame: 4 years
measure: Overall survival
timeFrame: 5 and 10 years
measure: Disease-specific survival
timeFrame: 5 and 10 years
measure: Locoregional recurrence
timeFrame: 5 years
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Antoni van Leeuwenhoek
state: Noord-Holland
Study officials:
References: