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

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ClinicalTrials.gov Identifier: NCT05416164
Recruitment Status : Not yet recruiting
First Posted : June 13, 2022
Last Update Posted : June 13, 2022
Dutch Cancer Society
Borstkanker Onderzoek Groep
Information provided by (Responsible Party):
The Netherlands Cancer Institute

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

Condition or disease Intervention/treatment Phase
Breast Cancer Radiation: Omission of radiotherapy Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 595 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: DESCARTES: De-ESCAlation of RadioTherapy in Patients With Pathologic Complete rESponse to Neoadjuvant Systemic Therapy
Estimated Study Start Date : July 2022
Estimated Primary Completion Date : May 2032
Estimated Study Completion Date : May 2037

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Omission of radiotherapy Radiation: Omission of radiotherapy
Omission of radiotherapy

Primary Outcome Measures :
  1. Local recurrence [ Time Frame: 5 years ]
    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 :
  1. Level of cancer worry [ Time Frame: 4 years ]
    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)).

  2. Satisfaction reported by PROM (patient reported outcome measures) [ Time Frame: 4 years ]
    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)

  3. Overall survival [ Time Frame: 5 and 10 years ]
  4. Disease-specific survival [ Time Frame: 5 and 10 years ]
  5. Locoregional recurrence [ Time Frame: 5 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
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Responsible Party: The Netherlands Cancer Institute
ClinicalTrials.gov Identifier: NCT05416164    
Other Study ID Numbers: M21CAR
First Posted: June 13, 2022    Key Record Dates
Last Update Posted: June 13, 2022
Last Verified: June 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The Netherlands Cancer Institute:
Neoadjuvant Chemotherapy
Breast cancer
Complete response
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases