Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
drksid header

  DRKS00009615

Trial Description

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Title

Comparison of Axillary Sentinel Lymph Node Biopsy Versus no Axillary Surgery in Patients With Early-stage Invasive Breast Cancer and Breast-conserving Surgery: a Randomized Prospective Surgical Trial. Intergroup-Sentinel-Mamma (INSEMA)-Trial

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Trial Acronym

INSEMA

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Although there is no doubt that the presence of lymph node metastases worsens prognosis of a
patient, unambiguous evidence to support lymph node dissection is still lacking. For many
solid tumors, the role of lymph node dissection is yet controversial, and may depend on the
tumor type and the stage of patient presentation for diagnosis. Axillary surgery for breast
cancer is now considered as staging procedure that does not seem to influence breast cancer
mortality. Women with breast cancer have benefitted greatly from a series of carefully
performed randomized controlled trial focusing on axillary surgery. The objective of INSEMA
is to show that less axillary surgery is better, in that oncological outcomes are the same
and less surgical intervention will result in fewer surgical complications.

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Brief Summary in Scientific Language

Currently, axillary surgery for breast cancer is considered as staging procedure that does
not seem to influence breast cancer mortality, since the risk of developing metastasis
depends mainly on the biological behaviour of the primary (seed-and-soil model). Based on
this, the postsurgical therapy should be considered on the basis of biologic tumor
characteristics rather than nodal involvement.

The goal of the present study is to show that early-stage breast cancer patients with
reduced extent of axillary surgery are not inferior regarding disease-free survival outcome
compared with the standard arm. All patients will be first randomized to either no axillary
surgical intervention or axillary sentinel lymph node biopsy (SLNB). Patients with SLNB and
pN+(sn) status will be secondly randomized to either SLNB alone or completion axillary lymph
node dissection (ALND) in cases with less than three involved nodes (one or two
macrometastases). Patients with three or more metastatic sentinel lymph nodes should undergo
completion ALND.

Postoperative systemic treatment should be based on local multidisciplinary tumor board
recommendation according to the current German AGO and S3 guidelines. For women who are
treated with breast-conserving surgery, the most common site of local recurrence is the
conserved ipsilateral breast itself. Thus, whole-breast radiation therapy after
breast-conserving surgery is mandatory and should be performed according to the current
guidelines (S3, AGO, DEGRO).

During follow-up, patients will be assessed for disease recurrence according to standard
clinical practice. History and physical examination will be performed every 6 months for the
first 36 months and yearly thereafter. Annual mammography and sonography will be required;
other testing will be based on symptoms and investigator preference. The total number of
patients to be randomized into the trial will be approximately 7,095. An event-driven final
efficacy analysis will be performed per-protocol for two primary objectives.

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Organizational Data

  •   DRKS00009615
  •   2015/11/03
  •   2015/06/04
  •   yes
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Secondary IDs

  •   NCT02466737  (ClinicalTrials.gov)
  •   GBG 75  (University of Rostock)
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Health Condition or Problem studied

  •   Breast Cancer
  •   C50 -  Malignant neoplasm of breast
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Interventions/Observational Groups

  •   Procedure: no axillary surgery versus SLNB
  •   Procedure: SLNB versus completion ALND
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
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Primary Outcome

- invasive disease-free survival (IDFS) after breast-conserving surgery; time frame: 5 years; non-inferiority question

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Secondary Outcome

[---]*

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Countries of Recruitment

  •   Austria
  •   Germany
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Locations of Recruitment

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Recruitment

  •   [---]*
  •   2015/09/30
  •   7095
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Female
  •   35   Years
  •   no maximum age
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Additional Inclusion Criteria

- Written informed consent prior to beginning breast-conserving surgery, including
expected cooperation of the patients for follow-up, must be obtained and documented
according to the local regulatory requirements

- Histologically confirmed unilateral primary invasive carcinoma of the breast (core
biopsy). Multifocal tumors are allowed if breast-conserving surgery is planned

- Age at diagnosis at least 35 years

- Preoperative imaging techniques with estimated tumor size of <5 cm (iT1/iT2
irrespective of hormone sensitivity or HER2 status)

- Clinically and sonographically tumor-free axilla prior to core biopsy (cN0/iN0)

- In cases with cN0 and iN+, a negative core biopsy or fine needle aspiration (FNA)
biopsy of the sonographically suspected lymph node is required before randomization

- No clinical evidence for distant metastasis (M0)

- Planned breast-conserving surgery (R0 resection) with postoperative external
whole-breast irradiation (conventional fractionation or hypofractionation)

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Exclusion Criteria

- Secondary malignancy, except curatively treated basalioma of the skin and carcinoma
in situ of the cervix

- Time since core biopsy >3 months (optimal <1 month)

- Previous and already (neoadjuvant) treated invasive breast carcinoma

- Histologically non-invasive breast carcinoma

- cT3/T4 or iT3/T4 tumors

- Patients aged <35 years

- Planned total mastectomy (e.g. multicentric tumors )

- Planned intraoperative radiotherapy (e.g. Intrabeam) or postoperative partial breast
irradiation (e.g. multicatheter technique) alone; both procedures are allowed as
boost techniques

- Male patients

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Addresses

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    • University of Rostock
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    • German Cancer Aid (Deutsche Krebshilfe), funding
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    •   [---]*
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    • German Breast Group (GBG Forschungs GmbH), data analysis
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    •   [---]*
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    • University Medicine Rostock
    • Toralf Reimer, MD, PhD 
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    • Toralf Reimer, MD, PhD 
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Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   2
  •   2016/10/27
* This entry means the parameter is not applicable or has not been set.