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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05416164
• Other study ID #: M21CAR
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2022
• Est. completion date: May 2037

Study information

• Verified date: June 2022
• Source: The Netherlands Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 595
• Est. completion date: May 2037
• Est. primary completion date: May 2032
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Women, aged = 18 years

• Invasive HR positive/Her2 negative, Her2+ (ER/PR +/-) or TN breast cancer

• Primary tumor (T) clinical stage cT1-2

• Unifocal disease

• Clinical nodal stage 0; absence of lymph node metastases should be confirmed by ultrasound or FDG-PET/CT

• Neoadjuvant systemic treatment (NST) and breast-conserving surgery

• Sentinel node biopsy performed before or after NST

• Pathologic complete response in breast and lymph nodes, i.e. no residual tumor cells detected

• Written informed consent

Exclusion Criteria:

• Primary tumor (T) clinical stage cT3-4

• DCIS associated with invasive carcinoma or elsewhere in ipsilateral breast

• 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 ipsilateral breast

• 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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Radiation:
• Omission of radiotherapy
Omission of radiotherapy

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
The Netherlands Cancer Institute	Borstkanker Onderzoek Groep, Dutch Cancer Society

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local recurrence	To show that radiotherapy after neoadjuvant systemic therapy and breast-conserving surgery can be omitted in T1-2N0 breast cancer patients who achieve pathologic complete response without compromising the 5 - year local recurrence rate (i.e, < 6% axillary recurrences within 5 years).	5 years
Secondary	Level of cancer worry	The patients' experienced level of cancer worry will be measured using the validated 8-item Cancer Worry Scale (i.e., low (Cancer Worry Scale score = 13 at each assessment) and high (Cancer Worry Scale score =14 at each assessment)).	4 years
Secondary	Satisfaction reported by PROM (patient reported outcome measures)	The patients´experienced quality of life and satisfaction will be measured using the validated questionnaire EORTC-QLQ-C30 (Quality of life in cancer patients) and EORTC-QLQ-BR23 (Quality of life of patients with breast cancer)	4 years
Secondary	Overall survival		5 and 10 years
Secondary	Disease-specific survival		5 and 10 years
Secondary	Locoregional recurrence		5 years