DESCARTES: De-ESCAlation of RadioTherapy in Patients With Pathologic Complete rESponse to Neoadjuvant Systemic Therapy
Primary Purpose
Breast Cancer
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Omission of radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring Neoadjuvant Chemotherapy, Breast cancer, Complete response, Radiotherapy
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Omission of radiotherapy
Arm Description
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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)).
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)
Overall survival
Disease-specific survival
Locoregional recurrence
Full Information
NCT ID
NCT05416164
First Posted
April 19, 2022
Last Updated
June 8, 2022
Sponsor
The Netherlands Cancer Institute
Collaborators
Dutch Cancer Society, Borstkanker Onderzoek Groep
1. Study Identification
Unique Protocol Identification Number
NCT05416164
Brief Title
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
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 2022 (Anticipated)
Primary Completion Date
May 2032 (Anticipated)
Study Completion Date
May 2037 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Netherlands Cancer Institute
Collaborators
Dutch Cancer Society, Borstkanker Onderzoek Groep
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Neoadjuvant Chemotherapy, Breast cancer, Complete response, Radiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
595 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Omission of radiotherapy
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
Omission of radiotherapy
Intervention Description
Omission of radiotherapy
Primary Outcome Measure Information:
Title
Local recurrence
Description
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).
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Level of cancer worry
Description
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)).
Time Frame
4 years
Title
Satisfaction reported by PROM (patient reported outcome measures)
Description
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)
Time Frame
4 years
Title
Overall survival
Time Frame
5 and 10 years
Title
Disease-specific survival
Time Frame
5 and 10 years
Title
Locoregional recurrence
Time Frame
5 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Learn more about this trial
DESCARTES: De-ESCAlation of RadioTherapy in Patients With Pathologic Complete rESponse to Neoadjuvant Systemic Therapy
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