- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04281355
Individualized Locoregional Treatment of Initially Biopsy-proven Node-positive Breast Cancer After Primary Systemic Therapy (INDAX)
Individualized Locoregional Treatment of Initially Biopsy-proven Node-positive Breast Cancer After Primary Systemic Therapy: The EUBREAST-2 INDAX Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Phase
- Phase 3
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients with primary invasive breast cancer cT1-cT3
- cN1 status prior to PST
- Cytological or histological proof of axillary metastasis before PST
- Full tumour biology available before initiation of PST
- Oral and written consent
- Age ≥ 18 years
Exclusion Criteria:
- Biopsy-confirmed regional nodal metastases outside of the ipsilateral axilla
- Distant metastases at diagnosis
- Inflammatory breast cancer
- Previous axillary surgery
- Previous radiotherapy to ipsilateral breast, chest or axilla
- History of prior invasive breast cancer
- Ongoing pregnancy or breast-feeding
- Bilateral invasive breast cancer
- Medical contraindication for radiotherapy or inability to receive recommended radiotherapy
- Medical contraindication for adjuvant endocrine treatment, if indicated
- Inability to absorb or understand the meaning of the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
Axillary lymph node dissection will be replaced by axillary radiotherapy in Randomisation B
Regional irradiation will be omitted in the interventional arm of Randomisation A.
|
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.
|
Axillary lymph node dissection will be replaced by axillary radiotherapy in Randomisation B
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
iDFS
Time Frame: 5 years
|
Invasive disease-free survival
|
5 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EUBREAST-2 INDAX
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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