Omitting radiotherapy for breast cancer patients with complete response to treatment
DESCARTES: De-ESCAlation of RadioTherapy in Patients With Pathologic Complete rESponse to Neoadjuvant Systemic Therapy
This study is testing if women with early-stage breast cancer who have no signs of the disease after treatment can skip radiation therapy safely.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 595 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | The Netherlands Cancer Institute Academic / other |
| Locations | 1 site (Amsterdam, North Holland) |
| Trial ID | NCT05416164 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety of omitting radiotherapy in breast cancer patients with T1-2N0 tumors who achieve a pathologic complete response after receiving neoadjuvant systemic therapy and undergoing breast-conserving surgery. The research focuses on a growing population of women diagnosed with breast cancer who are treated with neoadjuvant systemic therapy, where a significant percentage may achieve a complete response. By investigating the potential to forgo radiotherapy, the study aims to reduce treatment-related morbidity while maintaining low local recurrence rates in this specific patient group.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older with node-negative breast tumors less than 5 cm who have achieved a pathologic complete response after neoadjuvant systemic therapy.
Not a fit: Patients with extensive DCIS or those who do not achieve a pathologic complete response may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could reduce unnecessary radiotherapy exposure and its associated side effects for certain breast cancer patients.
How similar studies have performed: Other studies have explored similar approaches, but this specific investigation into omitting radiotherapy for this patient group is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Amsterdam, North Holland
- Antoni van Leeuwenhoek — Amsterdam, North Holland, Netherlands (Recruiting)
Study contacts
- Study coordinator: F.H. van Duijnhoven, MD, PhD
- Email: f.v.duijnhoven@nki.nl
- Phone: +31(0)20 5126170
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.