Individualized Locoregional Treatment of Initially Biopsy-proven Node-positive Breast Cancer After Primary Systemic Therapy

Sponsor
Karolinska Institutet
Study ID
NCT04281355
Phase
PHASE3
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Omission of axillary lymph node dissection — PROCEDURE
    Axillary lymph node dissection will be replaced by axillary radiotherapy in Randomisation B
  • Omission of regional irradiation — RADIATION
    Regional irradiation will be omitted in the interventional arm of Randomisation A.

Study Details

In clinically node-positive (cN+) breast cancer, preoperative systemic therapy (PST) is common. With increasing rates of complete tumour eradication, there is a need for de-escalation of locoregional treatment in the interest of decreased morbidity. In order to individually adapt postoperative therapies, axillary staging is crucial. Axillary lymph node dissection (ALND) comes at a high risk of arm morbidity. There is extreme divergence in the use of less extensive staging methods, i.e. targeted lymph node biopsy (TLNB), sentinel node biopsy (SNB) or both (TAD), and in the use of subsequent locoregional treatment, since prospective data are largely lacking. The main purpose of the European INDAX trial is to implement de-escalated staging and evaluate which regional treatment, individually adapted to the response after PST, is oncologically safe but least harmful. Population: cN+ breast cancer patients receiving PST, recruited 2021-2025. Staging by TLNB, TAD or SNB. Intervention: Negative staging (ypN0, Randomisation A, N=1433): no regional treatment. Positive staging (ypN+, Randomisation B, N=1513): no ALND but regional radiotherapy (rRT). Control: Randomisation A: rRT only. Randomisation B: ALND plus rRT. Outcome: Invasive disease-free survival (non-inferiority), arm morbidity and quality of life. Drug tests in whole-tumour organoid cultures, algorithm-based digital image analysis and gene expression analysis are performed to improve response prediction, facilitate tailoring of PST and increase eradication rates.

Key Dates

Start date
Jan 1, 2021
Status verified
Feb 2021
Primary completion
Dec 31, 2025
Completion
Dec 31, 2029

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Randomisation A - Intervention
    In pathologically node-negative patients on axillary staging (TAD, TLNB, SLNB) after primary systemic treatment, no regional radiotherapy is given and no axillary lymph node dissection are performed.
  • Experimental: Randomisation B - Intervention
    In pathologically node-positive patients on axillary staging (TAD, TLNB, SLNB) after primary systemic treatment, full axillary and regional radiotherapy is given but no axillary lymph node dissection performed.

Primary Outcome Measure

iDFS [ Time Frame: 5 years ]

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