Breast Cancer Clinical Trial
Official title:
DESCARTES: De-ESCAlation of RadioTherapy in Patients With Pathologic Complete rESponse to Neoadjuvant Systemic Therapy
NCT number | NCT05416164 |
Other study ID # | M21CAR |
Secondary ID | |
Status | Not yet recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | July 2022 |
Est. completion date | May 2037 |
Verified date | June 2022 |
Source | The Netherlands Cancer Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
The Netherlands Cancer Institute | Borstkanker Onderzoek Groep, Dutch Cancer Society |
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 |
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