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

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Netherlands
Antoni van Leeuwenhoek
RECRUITING
Amsterdam
Contact Information
Primary
F.H. van Duijnhoven, MD, PhD
f.v.duijnhoven@nki.nl
+31(0)20 5126170
Backup
J.P. van Olmen, Drs
j.v.olmen@nki.nl
020-5129111
Time Frame
Start Date: 2022-10-07
Estimated Completion Date: 2037-05
Participants
Target number of participants: 595
Treatments
Experimental: Omission of radiotherapy
Related Therapeutic Areas
Sponsors
Collaborators: Borstkanker Onderzoek Groep, Dutch Cancer Society
Leads: The Netherlands Cancer Institute

This content was sourced from clinicaltrials.gov