Breast CancerNCT02564848
Safety and Efficacy of Omission of Sentinel Node Biopsy in Patients With Estrogen-Positive Breast Cancer Over Age 65
A study testing Lumpectomy without sentinel node biopsy in people with Breast Cancer, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
This study will examine the outcomes of lumpectomy, surgery to remove a tumor, without sentinel node biopsy (SNB) for women at least 65 years of age with clinically node-negative breast cancer. Read more about this study
- Who is it for?
- Ages 65 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Lumpectomy without sentinel node biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jan 2016to Mar 2029
- 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 65 years and older
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- Female age 65 and older
- Staging:
- Patients enrolled prior to surgery: Diagnosis of clinical T1-2N0, ER+, HER2-negative, invasive breast cancer as determined by treating physician. DCIS or LCIS may be present with invasive cancer.
- Patients enrolled after surgery: pT1-2NX, or pT1-2N0, ER+, HER2-negative, invasive breast cancer. DCIS or LCIS may be present with invasive cancer.
- Plan to undergo lumpectomy within 3 months of study registration, or underwent lumpectomy within 60 days of study registration (without sentinel node biopsy)
- Patients in whom lymph nodes are palpable and not suspicious who are found to be nodal tumor-free by nodal core needle biopsy are permitted, but those with biopsy-proven nodal metastases are excluded
Who cannot join
- Patients with diagnosis of ductal or lobular carcinoma in situ
- Patients with diagnosis of inflammatory breast cancer
- Patients who have undergone neoadjuvant chemotherapy for current primary breast cancer (past treatments for other cancers are acceptable)
- Patients planning to have mastectomy or had a mastectomy of the ipsilateral breast
- Prior history of ipsilateral (invasive or DCIS) breast cancer
- Diagnosis of clinical T3 or T4 breast cancer
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars-Sinai Medical Center
Los Angeles, California, 90048
About this study
Official title: IIT2015-06-Chung: Safety and Efficacy of Omission of Sentinel Node Biopsy in Patients With Clinical T1-2 Estrogen-Positive Breast Cancer Over Age 65
This study will examine the outcomes of lumpectomy, surgery to remove a tumor, without sentinel node biopsy (SNB) for women at least 65 years of age with clinically node-negative breast cancer. Clinically node-negative means that during a physical exam your doctor cannot feel or see that any lymph nodes near the breast area are swollen and there is also no imaging evidence, such as from a mammogram, of nodal involvement.
Read the detailed description
The primary objective of the study is to determine whether omission of sentinel node biopsy in patients who meet eligibility criteria results in an acceptable regional recurrence rate over a 6-year period. A regional recurrence is defined as any recurrence in the ipsilateral axillary nodes, supraclavicular nodes or internal mammary nodes.
Eligible patients will undergo standard of care lumpectomy without sentinel node biopsy followed by radiation and hormonal therapy or have already undergone the procedure prior to enrollment in the study. She may also receive chemotherapy as determined by her treating physician. A physical examination of the affected breast and regional lymph nodes will be conducted every six months for the first two years of follow up and then yearly for the last 3 years of follow up. Imaging of the affected breast will occur every 12 months after surgery per standard of care.
- Conditions
- Breast Cancer
- Being tested
- Lumpectomy without sentinel node biopsy
- Keywords
- Clinical T1-2N0 ER+, Invasive breast cancer, estrogen-positive
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumpectomy without sentinel node biopsyProcedure or surgery
Biopsy of the sentinel node is considered standard of care treatment for women with localized breast cancer. The procedure will be eliminated at time of lumpectomy.
| Study group | Role | What they receive |
|---|---|---|
| Lumpectomy without sentinel node biopsy | Experimental | Subjects will undergo standard of care lumpectomy. A biopsy of the sentinel node will not be performed. After surgery, subjects will receive standard of care radiation on the affected breast and hormonal therapy. Receives: Procedure: Lumpectomy without sentinel node biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regional recurrence
A regional recurrence is defined as any recurrence in the ipsilateral axillary nodes, supraclavicular nodes or internal mammary nodes and will be determined by physical exam and breast imaging
Measured: A regional recurrence during six years of follow-up after lumpectomy.
Secondary outcomes (2)
Disease-free survival
Measured: From date of diagnosis until the date of locoregional or distant recurrence assessed up to 5 years.
Overall survival
Measured: From date of diagnosis until the date of death from any cause assessed up to 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2015 (estimated)
- Study start22 Jan 2016
- Primary completionMar 2029 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alice Chung, Cedars-Sinai Medical Center
- Investigators
- Alice Chung, MD, Principal investigator, Cedars-Sinal Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02564848
- Sponsor's protocol ID
- IIT2015-06-Chung-SNBO
- Status last verified
- Aug 2026
- First submitted
- 25 Sep 2015
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Chung AP, Dang CM, Karlan SR, Amersi FF, Phillips EM, Boyle MK, Cui Y, Giuliano AE. A Prospective Study of Sentinel Node Biopsy Omission in Women Age >/= 65 Years with ER+ Breast Cancer. Ann Surg Oncol. 2024 May;31(5):3160-3167. doi: 10.1245/s10434-024-15000-w. Epub 2024 Feb 12.
PubMed 38345718
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IIT2015-06-Chung: Safety and Efficacy of Omission of Sentinel Node Biopsy in Patients With Clinical T1-2 Estrogen-Positive Breast Cancer Over Age 65
- ClinicalTrials.gov ID
- NCT02564848
- Acronym / sponsor ID
- IIT2015-06-Chung-SNBO
- Conditions
- Breast Cancer
- Keywords
- Clinical T1-2N0 ER+, Invasive breast cancer, estrogen-positive
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- 22 Jan 2016 (actual)
- Primary completion
- Mar 2029 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 1 Oct 2015 (estimated)
- 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.
This study will examine the outcomes of lumpectomy, surgery to remove a tumor, without sentinel node biopsy (SNB) for women at least 65 years of age with clinically node-negative breast cancer. Clinically node-negative means that during a physical exam your doctor cannot feel or see that any lymph nodes near the breast area are swollen and there is also no imaging evidence, such as from a mammogram, of nodal involvement.
Detailed description
The primary objective of the study is to determine whether omission of sentinel node biopsy in patients who meet eligibility criteria results in an acceptable regional recurrence rate over a 6-year period. A regional recurrence is defined as any recurrence in the ipsilateral axillary nodes, supraclavicular nodes or internal mammary nodes.
Eligible patients will undergo standard of care lumpectomy without sentinel node biopsy followed by radiation and hormonal therapy or have already undergone the procedure prior to enrollment in the study. She may also receive chemotherapy as determined by her treating physician. A physical examination of the affected breast and regional lymph nodes will be conducted every six months for the first two years of follow up and then yearly for the last 3 years of follow up. Imaging of the affected breast will occur every 12 months after surgery per standard of care.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lumpectomy without sentinel node biopsy | Experimental | Procedure: Lumpectomy without sentinel node biopsySubjects will undergo standard of care lumpectomy. A biopsy of the sentinel node will not be performed. After surgery, subjects will receive standard of care radiation on the affected breast and hormonal therapy. |
Who may qualify
- Ages
- 65 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Female age 65 and older
- Staging:
- Plan to undergo lumpectomy within 3 months of study registration, or underwent lumpectomy within 60 days of study registration (without sentinel node biopsy)
- Patients in whom lymph nodes are palpable and not suspicious who are found to be nodal tumor-free by nodal core needle biopsy are permitted, but those with biopsy-proven nodal metastases are excluded
Key exclusion criteria (6 listed)
- Patients with diagnosis of ductal or lobular carcinoma in situ
- Patients with diagnosis of inflammatory breast cancer
- Patients who have undergone neoadjuvant chemotherapy for current primary breast cancer (past treatments for other cancers are acceptable)
- Patients planning to have mastectomy or had a mastectomy of the ipsilateral breast
- Prior history of ipsilateral (invasive or DCIS) breast cancer
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 |
|---|---|---|
| Lumpectomy without sentinel node biopsyBiopsy of the sentinel node is considered standard of care treatment for women with localized breast cancer. The procedure will be eliminated at time of lumpectomy. | Procedure or surgery | Lumpectomy without sentinel node biopsy |
Primary outcome
Regional recurrence
Time frame: A regional recurrence during six years of follow-up after lumpectomy.
A regional recurrence is defined as any recurrence in the ipsilateral axillary nodes, supraclavicular nodes or internal mammary nodes and will be determined by physical exam and breast imaging
2 secondary outcomes
Disease-free survival
Time frame: From date of diagnosis until the date of locoregional or distant recurrence assessed up to 5 years.
Overall survival
Time frame: From date of diagnosis until the date of death from any cause assessed up to 5 years.
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 10 Aug 2026.
- Derived from this study: PubMed 38345718Chung AP, Dang CM, Karlan SR, Amersi FF, Phillips EM, Boyle MK, Cui Y, Giuliano AE. A Prospective Study of Sentinel Node Biopsy Omission in Women Age >/= 65 Years with ER+ Breast Cancer. Ann Surg Oncol. 2024 May;31(5):3160-3167. doi: 10.1245/s10434-024-15000-w. Epub 2024 Feb 12.
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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. This study is not recruiting at the moment.
Alice Chung, MD principal investigator
Cedars-Sinal Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lumpectomy without sentinel node biopsy in people with Breast Cancer, run by Cedars-Sinai Medical Center at 1 site in United States.
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 6 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 10 Aug 2026. 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 United States. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Regional recurrence (time frame: A regional recurrence during six years of follow-up after lumpectomy.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02564848, which also lists 1 linked publication.
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 10 Aug 2026; AzTrials last refreshed its copy on 8 Nov 2026.