Sentinel Node Biopsy in Breast Cancer: Omission of Axillary Clearance After Macrometastases. A Randomized Trial.
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| ClinicalTrials.gov Identifier: NCT02240472 |
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Recruitment Status :
Active, not recruiting
First Posted : September 15, 2014
Last Update Posted : October 6, 2023
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Since the introduction of sentinel node biopsy in breast cancer, it has become clear that its use is reliable and reproducible. Today, it is clinical routine to not remove further lymph nodes from the axilla (arm pit) in case the sentinel node (which is the first lymph node/s reached by lymphatic flow from the breast) is free of tumor deposits. It is also routine to leave remaining lymph nodes behind in case the sentinel node contains a minimal cluster of tumor cells, called isolated tumor cells (formerly submicrometastasis). Even in slightly larger tumor deposits, so called micrometastasis (up to 2 mm in size), it has been shown that a completion axillary clearance (removal of further lymph nodes from the arm pit) does not contribute to a better survival. Data from a randomized study indicate that it seems safe to omit axillary clearance even if the sentinel node biopsy shows up to 2 nodes with tumor deposits over 2 mm in size (macrometastasis). These studies have changed clinical practice in many countries, however, it is still debated whether it is safe to omit axillary clearance in the case of sentinel node macrometastasis due to under-recruitment in the aforementioned study. The rationale for omitting extensive axillary surgery is the avoidance of postoperative morbidity such as arm lymphedema, loss of sensation, pain and swelling.
The hypothesis is that refraining from axillary clearance in breast cancer patients with 1-2 sentinel nodes with macrometastasis will not worsen breast cancer-specific survival by more than a maximum of 2.5% after 5 years.
This study is a prospective international randomized trial including 3500 patients.
Breast cancer patients without signs of axillary nodal involvement will be eligible for sentinel node biopsy. Those who are found to have up to two sentinel node containing macrometastasis will be informed about this trial Those wishing to participate will be randomized to either undergo further axillary surgery (clearance) or not. Outcome measures are breast cancer-specific survival, disease-free survival, axillary recurrence rate and overall survival.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Breast Cancer | Procedure: Omission of axillary clearance | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 2700 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Survival and Axillary Recurrence Following Sentinel Node-positive Breast Cancer Without Completion Axillary Lymph Node Dissection - a Randomized Study of Patients With Macrometastases in the Sentinel Node |
| Actual Study Start Date : | January 27, 2015 |
| Actual Primary Completion Date : | December 31, 2021 |
| Estimated Study Completion Date : | December 31, 2026 |
| Arm | Intervention/treatment |
|---|---|
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No Intervention: Axillary clearance
Patients in this arm will be treated by completion axillary clearance after a sentinel node biopsy showing 1-2 nodes with macrometastasis
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Experimental: No axillary clearance
Patients in this arm will not undergo further axillary surgery after a sentinel node biopsy showing 1-2 nodes with macrometastasis
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Procedure: Omission of axillary clearance
The intervention is the omission of completion axillary clearance after the detection of sentinel node macrometastasis |
- breast cancer-specific survival [ Time Frame: up to 15 years ]death due to breast cancer in both arms measured at a median follow-up of 5, 10 and 15 years
- disease-free survival [ Time Frame: 5, 10 and 15 years ]Breast cancer recurrence rate in both arms after a median follow-up of 5, 10 and 15 years
- axillary recurrence rate [ Time Frame: 5, 10 and 15 years ]The rate of axillary relapse in specific after a median follow-up of 5, 10 and 15 years
- overall survival [ Time Frame: 5, 10 and 15 years ]The rate of overall deaths after a median follow-up of 5, 10 and 15 years
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients with invasive breast cancer (T1-T3)
- N0 on palpation
- Preoperative ultrasound performed
- Pathology report shows macrometastasis in 1-2 sentinel lymph nodes
- Patients undergo breast-conserving therapy or mastectomy
- The patient must have provided oral and written consent
- Age ≥ 18 years
Exclusion Criteria:
- Metastases outside of the ipsilateral axilla
- Prior history of invasive breast cancer
- Pregnancy
- Bilateral breast cancer if one side meets exclusion criteria
- Medical contraindication for radiotherapy or systemic treatment
- Inability to absorb or understand the meaning of the study information; for example, through disability, inadequate language skills or dementia.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02240472
Show 33 study locations
| Principal Investigator: | Jana de Boniface, PhD | Karolinska Institutet | |
| Study Chair: | Jan Frisell, Professor | Karolinska University Hospital | |
| Study Chair: | Leif Bergkvist, Professor | Central Hospital Västerås | |
| Study Chair: | Yvette Andersson, PhD | Central Hospital Västerås | |
| Study Chair: | Lisa Ryden, Professor | Lund University | |
| Study Chair: | Malin Sund, Professor | Umeå University Hospital | |
| Study Chair: | Olofsson Roger, PhD | Sahlgrenska University Hospital, Sweden | |
| Study Chair: | Johan Ahlgren, PhD | Region Örebro County | |
| Study Chair: | Dan Lundstedt, PhD | Sahlgrenska University Hospital, Sweden | |
| Principal Investigator: | Peer Christiansen, Professor | Aarhus University Hospital, Denmark | |
| Study Chair: | Tove Tvedskov Filtenborg, MD | Rigshospitalet Copenhagen, Dnmark | |
| Study Chair: | Michalis Kontos, PhD | University of Athens | |
| Study Chair: | Birgitte Offersen, Professor | University of Aarhus | |
| Principal Investigator: | Thorsten Kühn, Professor | Klinikum Esslingen | |
| Principal Investigator: | Toralf Reimer, Professor | Universität Rostock | |
| Principal Investigator: | Oreste Gentilini | San Raffaele Hospital, Milano | |
| Principal Investigator: | Roland Reitsamer | Universitätsklinikum Salzburg |
Documents provided by Jana de Boniface, Karolinska Institutet:
Study Data/Documents: Study Protocol
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Jana de Boniface, Associate Professor, Karolinska Institutet |
| ClinicalTrials.gov Identifier: | NCT02240472 |
| Other Study ID Numbers: |
SENOMAC |
| First Posted: | September 15, 2014 Key Record Dates |
| Last Update Posted: | October 6, 2023 |
| Last Verified: | October 2023 |
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sentinel node biopsy, lymph node metastasis, survival |
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Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |