Breast CancerNCT06259513
Omission of Axillary Surgery in Breast Cancer Patients
A study testing omission of SLNB in SentiOMIT or omission of ALND in SentiMACRO in people with Breast Cancer and Sentinel Lymph Node, run by KK Women's and Children's Hospital at 1 site in Singapore.
Trial summary
The treatment and prognosis of breast cancer (BC) are dependent on its molecular subtype and nodal burden. In early BCs with favourable molecular subtype, the incidence of axillary node involvement is low. Read more about this study
- Who is it for?
- Ages 21 to 80 years, women only
- Conditions the study is for
- Breast Cancer, Sentinel Lymph Node, Breast Neoplasms
- What is being tested?
- omission of SLNB in SentiOMIT or omission of ALND in SentiMACRO
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteSingapore
- Study dates
- 6 Feb 2024to 31 Dec 2033
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- female patients aged >/=55 years old
- 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
Who cannot join
- patients with T3/T4 or stage IV disease, patients with preoperative known N+ disease, bilateral breast cancers, patients planned for neoadjuvant chemotherapy, patients with other malignancies.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore1 site, 1 recruiting
- Recruiting
KK Women's and Children's Hospital
Singapore
Geok H Lim, lim.gh@singhealth.com.sg
About this study
Official title: Feasibility of Tailoring Axillary Surgery Based on the Molecular Subtype and Nodal Burden of Breast Cancer Patients- SentiOMIT and SentiMACRO Trial
The treatment and prognosis of breast cancer (BC) are dependent on its molecular subtype and nodal burden. In early BCs with favourable molecular subtype, the incidence of axillary node involvement is low. However, these patients are still subjected to an axillary operation, which can result in additional cost, operating time and morbidities. Similarly, in patients with limited nodal burden of 1-2 metastatic nodes, there is emerging evidence that these patients may need sentinel lymph node biopsy (SLNB) only, instead of an axillary clearance (AC), which has more surgical morbidities.
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,
Read more
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.
- Conditions
- Breast Cancer, Sentinel Lymph Node, Breast Neoplasms
- Being tested
- omission of SLNB in SentiOMIT or omission of ALND in SentiMACRO
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
omission of SLNB in SentiOMIT or omission of ALND in SentiMACROProcedure or surgery
Omission of SLNB in cT1-2N0 or Omission of ALND in patients with </= 2 macrometastasis in SLNB
| Study group | Role | What they receive |
|---|---|---|
| patients with omission of SLNB | Experimental | early breast cancer patients with cT1-2N0 Luminal A subtype with omission of SLNB Receives: Procedure: omission of SLNB in SentiOMIT or omission of ALND in SentiMACRO |
| patients with </=2 macrometastasis and omission of ALND | Experimental | breast cancer patients with 1-2 macrometastasis on SLNB and had omission of ALND Receives: Procedure: omission of SLNB in SentiOMIT or omission of ALND in SentiMACRO |
| patients with cT1-2N0 and SLNB | No intervention | early breast cancer patients with cT1-2N0 Luminal A subtype and SLNB |
| patients with </=2 macrometastasis and ALND | No intervention | breast cancer patients with 1-2 macrometastasis on SLNB and had ALND |
What is being measured
The primary outcome is the main question the study is designed to answer.
short term outcomes
complications
Measured: from date of surgery, assessed up to 6 months after operation
short term outcomes
pain score
Measured: from date of surgery, assessed up to 1 months after operation
short term outcomes
cost
Measured: from date of surgery, assessed up to 1 months after operation
long term outcomes
axillary recurrence
Measured: from date of surgery, assessed up to 5 years after operation
long term outcomes
survival
Measured: from date of surgery, assessed up to 5 years after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start6 Feb 2024 (estimated)
- Primary completion28 Feb 2033 (estimated)
- Study completion31 Dec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by KK Women's and Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KK Women's and Children's Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06259513
- Sponsor's protocol ID
- CIRB Ref: 2023/2735
- Status last verified
- Feb 2024
- First submitted
- 6 Feb 2024
- Last updated
- 14 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Tailoring Axillary Surgery Based on the Molecular Subtype and Nodal Burden of Breast Cancer Patients- SentiOMIT and SentiMACRO Trial
- ClinicalTrials.gov ID
- NCT06259513
- Acronym / sponsor ID
- CIRB Ref: 2023/2735
- Conditions
- Breast Cancer, Sentinel Lymph Node, Breast Neoplasms
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- KK Women's and Children's HospitalOther government
- Study start
- 6 Feb 2024 (estimated)
- Primary completion
- 28 Feb 2033 (estimated)
- Study completion
- 31 Dec 2033 (estimated)
- First posted
- 14 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The treatment and prognosis of breast cancer (BC) are dependent on its molecular subtype and nodal burden. In early BCs with favourable molecular subtype, the incidence of axillary node involvement is low. However, these patients are still subjected to an axillary operation, which can result in additional cost, operating time and morbidities. Similarly, in patients with limited nodal burden of 1-2 metastatic nodes, there is emerging evidence that these patients may need sentinel lymph node biopsy (SLNB) only, instead of an axillary clearance (AC), which has more surgical morbidities.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| patients with omission of SLNB | Experimental | Procedure: omission of SLNB in SentiOMIT or omission of ALND in SentiMACROearly breast cancer patients with cT1-2N0 Luminal A subtype with omission of SLNB |
| patients with </=2 macrometastasis and omission of ALND | Experimental | Procedure: omission of SLNB in SentiOMIT or omission of ALND in SentiMACRObreast cancer patients with 1-2 macrometastasis on SLNB and had omission of ALND |
| patients with cT1-2N0 and SLNB | No intervention | –early breast cancer patients with cT1-2N0 Luminal A subtype and SLNB |
| patients with </=2 macrometastasis and ALND | No intervention | –breast cancer patients with 1-2 macrometastasis on SLNB and had ALND |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- female patients aged >/=55 years old
- 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
Key exclusion criteria (1 listed)
- patients with T3/T4 or stage IV disease, patients with preoperative known N+ disease, bilateral breast cancers, patients planned for neoadjuvant chemotherapy, patients with other malignancies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| omission of SLNB in SentiOMIT or omission of ALND in SentiMACROOmission of SLNB in cT1-2N0 or Omission of ALND in patients with </= 2 macrometastasis in SLNB | Procedure or surgery | patients with </=2 macrometastasis and omission of ALND, patients with omission of SLNB |
Primary outcome
short term outcomes
Time frame: from date of surgery, assessed up to 6 months after operation
complications
short term outcomes
Time frame: from date of surgery, assessed up to 1 months after operation
pain score
short term outcomes
Time frame: from date of surgery, assessed up to 1 months after operation
cost
long term outcomes
Time frame: from date of surgery, assessed up to 5 years after operation
axillary recurrence
long term outcomes
Time frame: from date of surgery, assessed up to 5 years after operation
survival
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing omission of SLNB in SentiOMIT or omission of ALND in SentiMACRO in people with Breast Cancer and Sentinel Lymph Node, run by KK Women's and Children's Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Geok hoon Lim (96392353, lim.gh@singhealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
short term outcomes (time frame: from date of surgery, assessed up to 6 months after operation). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2024.