DESCARTES: De-ESCAlation of RadioTherapy in Patients With Pathologic Complete rESponse to Neoadjuvant Systemic Therapy

Netherlands Cancer Institute (NKI)

Status

Enrolling

Conditions

Breast Cancer

Treatments

Radiation: Omission of radiotherapy

Study type

Interventional

Funder types

Other

NETWORK

Identifiers

NCT05416164

M21CAR

Details and patient eligibility

About

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

Full 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

Enrollment

595 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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