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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
The Netherlands Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Neoadjuvant Chemotherapy, Breast cancer, Complete response, Radiotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

    First Posted
    April 19, 2022
    Last Updated
    June 8, 2022
    Sponsor
    The Netherlands Cancer Institute
    Collaborators
    Dutch Cancer Society, Borstkanker Onderzoek Groep
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    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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