Clinical trial · Observational
Radiotherapy After Primary Chemotherapy for Breastcancer
Radiotherapy After Primary CHEMotherapy for cT1-2cN1M0 Breast Cancer.: a Multicentre Prospective Registration Study.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The primary aim of the study is to evaluate the 5 yr locoregional recurrence rate (LRR) in cT1-2cN0-1(cytology/histology and/or positive SN, excluding patients with \> 3 pathologic axillary nodes on imaging) breast cancer patients, treated with neoadjuvant chemotherapy, breast surgery, and radiotherapy that is protocolized based on the pathology findings after chemotherapy and definitive surgery (ypTNM stage).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| radiation - no radiation see intervention description | Radiation | — | UNRESOLVED |
| radiation: see intervention description | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Group 1. Low risk
- description
- 1. Surgical strategy is full axillary lymph node dissection after primary systemic treatment and in case of: a. all nodes negative: ycN0 or 2. Surgical strategy is sentinel node procedure only performed prior to primary systemic treatment and in case of: a. only micrometastases in the SN, and no risk factors (grade 3, LVI, tumour size \> 3 cm) or 3. Surgical strategy is sentinel node procedure only performed after primary systemic treatment and in case of: 1. no metastases in the post chemo SN
- interventionNames
- Radiation: radiation - no radiation see intervention description
- label
- Group 2: Intermediate risk
- description
- 1. Surgical strategy is full axillary lymph node dissection after primary systemic treatment and in case of: a. 1-3 nodes positive: ypN1 or 2. Surgical strategy is sentinel node procedure only performed prior to primary systemic treatment and in case of: 1. micrometastases in the SN and at least 1 risk factor; or 2. ≤ 2 macrometastases and no risk factor or 3. Surgical strategy is sentinel node procedure only performed after primary systemic treatment and in case of: 1. micrometastases in the post chemo SN and no risk factors (grade 3, LVI, tumour size \> 3 cm)
- interventionNames
- Radiation: radiation: see intervention description
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion criteria: * cT1-2 invasive breast cancer, without or with one or more pathologically proven tumour positive axillary lymph nodes (either by sentinel node biopsy, ultrasound/palpation guided biopsy or fine needle aspiration) * At least 3 cycles of primary systemic treatment have been given (irrespective of the regimen) * No standard axillary lymph node dissection is performed prior to chemotherapy Exclusion criteria: * cT3-T4 invasive breast cancer prior to any treatment * Patients with \> 3 suspicious axillary nodes on imaging * cN2-3 prior to any treatment * More than focally irradical surgery and breast conserving therapy To investigate whether a patient is eligible for the RAPCHEM study, a meticulous examination of the axilla is necessary. Therefore each patient should undergo an ultrasound of the axilla and if possible an ultrasound guided needle biopsy UNB (FNA or core). The US/UNB can be performed instantly or as second look in case of enlarged nodes on MRI. The criteria for performing an UNB are: * Cortex \>2.3 mm not measured at the poles of the node; or * Disappearance of the fatty hilum; or * Asymmetric bulging of the cortex of a lymph node; If a PET-CT is performed the worst outcome of the two studies is accepted as the real clinical stage of the axilla (i.e. 1 PA proven positive lymph node on ultrasound and 3 on PET-CT; means 3 positive lymph nodes) The N status of the axilla prior to chemotherapy is based upon: * Positive PET-CT of more than one but less than 4 axillary nodes; since the specificity of PET positive nodes in a proven breast cancer patient is very high, pathology confirmation is not absolutely required * Positive US of axillary nodes; at least one should be pathology proven tumour positive * The worst outcome of 1 and 2 represents the most reliable clinical axillary staging.
References
Publications (3)
- BACKGROUNDBoersma LJ, Verloop J, Voogd AC, Elkhuizen PHM, Houben R, van Leeuwen AE, Linn S, de Munck L, Pijnappel R, Strobbe L, van Dalen T, Wesseling J, Poortmans P. Radiotherapy after primary CHEMotherapy (RAPCHEM): Practice variation in a Dutch registration study (BOOG 2010-03). Radiother Oncol. 2020 Apr;145:201-208. doi: 10.1016/j.radonc.2020.01.018. Epub 2020 Feb 10. PMID 32058873
- DERIVEDMauritz AJW, de Munck L, Simons JM, Verloop J, van Dalen T, Elkhuizen PHM, Scholten A, Houben RMA, van Leeuwen-Stok AE, Linn SC, Pijnappel RM, Poortmans PMP, Strobbe LJA, Wesseling J, Voogd AC, Boersma LJ. Tailoring radiotherapy in cT1-2N1 breast cancer to nodal response on primary chemotherapy (RAPCHEM: BOOG 2010-03): 10-year follow-up results of a Dutch, prospective, registry study. Lancet Oncol. 2026 Jul;27(7):808-816. doi: 10.1016/S1470-2045(26)00216-0. PMID 42372742
- DERIVEDde Wild SR, de Munck L, Simons JM, Verloop J, van Dalen T, Elkhuizen PHM, Houben RMA, van Leeuwen AE, Linn SC, Pijnappel RM, Poortmans PMP, Strobbe LJA, Wesseling J, Voogd AC, Boersma LJ. De-escalation of radiotherapy after primary chemotherapy in cT1-2N1 breast cancer (RAPCHEM; BOOG 2010-03): 5-year follow-up results of a Dutch, prospective, registry study. Lancet Oncol. 2022 Sep;23(9):1201-1210. doi: 10.1016/S1470-2045(22)00482-X. Epub 2022 Aug 8. PMID 35952707