Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
350 participants
INTERVENTIONAL
2024-02-06
2033-12-31
Brief Summary
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We aimed to determine if axillary surgery could be safely tailored in BC patients based on their molecular subtype and nodal burden, without compromising their oncological outcomes. This could in turn reduce the morbidities associated with the axillary surgery,
Total 350 patients will be enrolled. 50 patients with early BC and favourable molecular subtype will be enrolled in a pilot study A (SentiOMIT), whereby SLNB is omitted. For eligible patients who declined study A and other stage I-II patients, with preoperative N0 status, undergoing upfront surgery but did not meet the inclusion criteria of Study A, these patients will be enrolled into study B (SentiMACRO) to undergo SLNB.
In study B, the patients will be categorized based on SLNB into 3 groups with 100 patients in each arm: B1 with pN0, B2- 1-2 metastatic nodes and B3- \>/=3 metastatic nodes. In Study B, we aim to investigate if the B2 group (100 patients) can be treated with a less invasive procedure of SLNB alone instead of AC, without affecting oncological outcomes. B1 and B3 are controls.
The outcomes for study A and B include short term outcomes such as morbidity rates, cost and operating time savings. Long term outcomes include recurrence and survival rates. This study will allow individualisation of axillary surgery based on the patient's molecular subtype and nodal burden, to benefit patients' care.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
SINGLE
Study Groups
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patients with omission of SLNB
early breast cancer patients with cT1-2N0 Luminal A subtype with omission of SLNB
omission of SLNB in SentiOMIT or omission of ALND in SentiMACRO
Omission of SLNB in cT1-2N0 or Omission of ALND in patients with \</= 2 macrometastasis in SLNB
patients with </=2 macrometastasis and omission of ALND
breast cancer patients with 1-2 macrometastasis on SLNB and had omission of ALND
omission of SLNB in SentiOMIT or omission of ALND in SentiMACRO
Omission of SLNB in cT1-2N0 or Omission of ALND in patients with \</= 2 macrometastasis in SLNB
patients with cT1-2N0 and SLNB
early breast cancer patients with cT1-2N0 Luminal A subtype and SLNB
No interventions assigned to this group
patients with </=2 macrometastasis and ALND
breast cancer patients with 1-2 macrometastasis on SLNB and had ALND
No interventions assigned to this group
Interventions
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omission of SLNB in SentiOMIT or omission of ALND in SentiMACRO
Omission of SLNB in cT1-2N0 or Omission of ALND in patients with \</= 2 macrometastasis in SLNB
Eligibility Criteria
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Inclusion Criteria
* unifocal cancer on imaging
* breast tumour size based on imaging of \</=3cm
* no evidence of axillary adenopathy on imaging
* patients with strongly positive ER and PR and negative HER2 on biopsy
* grade 1-2 tumour on core biopsy
* patient who opt for mastectomy
Exclusion Criteria
21 Years
80 Years
FEMALE
No
Sponsors
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KK Women's and Children's Hospital
OTHER_GOV
Responsible Party
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Locations
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KK Women's and Children's Hospital
Singapore, , Singapore
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CIRB Ref: 2023/2735
Identifier Type: -
Identifier Source: org_study_id
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