NCT01279304

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
851

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2011

Longer than P75 for all trials

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

January 17, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 19, 2011

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

October 14, 2022

Status Verified

February 1, 2014

Enrollment Period

6.9 years

First QC Date

January 17, 2011

Last Update Submit

October 11, 2022

Conditions

Breast Cancer

Keywords

breast cancerlocoregional recurrence rateneoadjuvant chemotherapy and surgeryradiotherapyrisk modeloverall survivalrelapse free survivalcT1-2cN0-1 breast cancer

Outcome Measures

Primary Outcomes (1)

  • locoregional recurrence rate

    to evaluate the 5 year 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 neo-adjuvant chemotherapy, breast surgery, and radiotherapy that is protocolised based on the pathology findings after chemotherapy and definitive surgery (ypTNM stage).

    5 Yr

Secondary Outcomes (8)

  • risk model based on rick factors

    5 Yr

  • 10 year LRR

    10 Yr

  • 5 Yr relapse free survival rate

    5 Yr

  • 10 yr relapse free survival rate

    10 Yr

  • 15 Yr relapse free survival rate (all events except lost to follow-up, invasive contralateral cancer, and secondary primary (non-breast) invasive cancer).

    15 Yr

  • +3 more secondary outcomes

Study Arms (3)

Group 1. Low risk

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

Radiation: radiation - no radiation see intervention description

Group 2: Intermediate risk

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)

Radiation: radiation: see intervention description

Group 3. High risk

1. Surgical strategy is full axillary lymph node dissection after primary systemic treatment and in case of: a. 4 or more nodes positive: ypN2 or 2. Surgical strategy is sentinel node procedure only performed prior to primary systemic treatment and in case of: 1. ≤ 2 macrometastases in the sentinel node prior to primary systemic treatment in the presence of risk factors like Grade 3, lymphangioinvasion, tumour size \> 3 cm; or 2. 3 macrometastases, 2 macrometastases and 1 micrometastase, 1 macrometastase and 2 micrometastases. 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 at least one risk factor 2. ≤ 3 macrometastases in the post chemo SN; or 3. 2 macrometastases and 1 micrometastase, 1 macrometastase and 2 micrometastases

Radiation: radiation: see intervention description

Interventions

radiation - no radiation see intervention descriptionRADIATION

after MRM in group 1 (low risk): no radiotherapy after BCT in group 1 (low risk): radiation treatment of the breast with boost (optional)

Group 1. Low risk
radiation: see intervention descriptionRADIATION

after BCT in group 2 (intermediate risk): radiation treatment of the breast with boost (optional) after MRM in group 2 (intermediate risk): radiation treatment of the thoracic wall If no full ALND is performed in group 2 (intermediate risk) add radiation treatment of level 1 and 2 of the axilla.

Group 2: Intermediate risk

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients with cT1-2cN0-1(cytology/histology and/or positive SN, excluding patients with \> 3 pathologic axillary nodes on imaging) breast cancer, treated with at least three cycles of chemotherapy followed by breast surgery are eligible for the study.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

UMC St Radboud Nijmegen

Nijmegen, Gelderland, Netherlands

Location

Maastro clinic

Maastricht, Limburg, 6229 ET, Netherlands

Location

Dr. B. Verbeeten Institute

Tilburg, North Brabant, Netherlands

Location

The Netherlands Cancer Institute

Amsterdam, North Holland, Netherlands

Location

Diakonessen Hospital Utrecht

Utrecht, Netherlands

Location

UMC Utrecht

Utrecht, Netherlands

Location

Related Publications (2)

  • Boersma 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: 32058873BACKGROUND

  • de 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: 35952707DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • L.J Boersma

    Maastricht University Medical Centre

    PRINCIPAL INVESTIGATOR

  • A Voogd

    Maastricht University

    PRINCIPAL INVESTIGATOR

  • R Houben

    Maastricht University Medical Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2011

First Posted

January 19, 2011

Study Start

January 1, 2011

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

October 14, 2022

Record last verified: 2014-02

Locations

NL(6)