Breast CancerPhase 2NCT02610621
Safety and Efficacy of Sentinel Node Biopsy Omission for Breast Cancer Patients Who Plan to Have Adjuvant Chemotherapy
A Phase 2 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
Eligible patients will be female, ages 18 and older and have a diagnosis of Clinical T1 or T2 invasive breast cancer with no suspicious palpable adenopathy. Patients will undergo standard of care lumpectomy without sentinel node biopsy and whole breast radiation, followed by chemotherapy. Read more about this study
- Who is it for?
- Ages 18 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
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to Apr 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female age 18 and older, not pregnant or lactating
- Clinical T1 or T2 invasive cancer with no suspicious palpable adenopathy
- If abnormal axillary nodes are seen on preoperative imaging, a negative fine needle aspiration or core biopsy is required for study entry.
- Planned treatment with breast conserving surgery and whole breast irradiation
- Chemotherapy required postoperatively based on patient and tumor characteristics at diagnosis
Who cannot join
- Patients with suspicious palpable axillary adenopathy
- Patients with biopsy demonstrating axillary nodal metastases
- Patients with treatment by mastectomy
- Patients who have undergone neoadjuvant chemotherapy
- Patients with co-morbidities rendering the patient not a candidate for chemotherapy, surgery, or irradiation
- Patients treated with accelerated partial breast irradiation (APBI)
- Patients with contraindication to radiation
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: IIT2015-11-Giuliano: Safety and Efficacy of Omission of Sentinel Node Biopsy for Breast Cancer Patients Who Plan to Have Adjuvant Chemotherapy
Eligible patients will be female, ages 18 and older and have a diagnosis of Clinical T1 or T2 invasive breast cancer with no suspicious palpable adenopathy. Patients will undergo standard of care lumpectomy without sentinel node biopsy and whole breast radiation, followed by chemotherapy.
Sentinel node biopsy is also considered standard care when patients have localized breast cancer. Treatment can often be influenced by whether the results of the biopsy show cancer or not. However, the biologic factors of the primary tumor have become more important in determining treatment recommendations in women with clinically node negative breast cancer.
Read the detailed description
The primary objective of the study is to determine the locoregional recurrence rate in patients with clinically node negative T1 and T2 breast cancer treated with systemic chemotherapy and whole breast irradiation in whom biopsy of the sentinel node is not performed. A locoregional recurrence is defined as any recurrence in the ipsilateral axillary nodes or in the supraclavicular nodes.
After surgery, a patient will receive standard of care radiation on her affected breast and chemotherapy. 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
- Clinically node negative, T1 and T2 invasive breast cancer
- 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 chemotherapy. Receives: Procedure: Lumpectomy without sentinel node biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
A determination of the locoregional recurrence rate in patients with clinically node negative T1 and T2 breast cancer treated with systematic chemotherapy and whole breast radiation in whom sentinel node biopsy is not performed
Measured: Assessed up to 5 years from date of lumpectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study startDec 2015
- Primary completionApr 2017 (estimated)
- Study completionApr 2020 (estimated)
Why it stopped: Study may not be clinically relevant at this time.
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 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Armando Giuliano, Cedars-Sinai Medical Center
- Investigators
- Armando Giuliano, MD, Principal investigator, Cedars-Sinal Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02610621
- Sponsor's protocol ID
- IIT2015-11-Giuliano-SNBO
- Status last verified
- Oct 2016
- First submitted
- 18 Nov 2015
- Last updated
- 13 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IIT2015-11-Giuliano: Safety and Efficacy of Omission of Sentinel Node Biopsy for Breast Cancer Patients Who Plan to Have Adjuvant Chemotherapy
- ClinicalTrials.gov ID
- NCT02610621
- Acronym / sponsor ID
- IIT2015-11-Giuliano-SNBO
- Conditions
- Breast Cancer
- Keywords
- Clinically node negative, T1 and T2 invasive breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study may not be clinically relevant at this time.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 20 Nov 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.
Eligible patients will be female, ages 18 and older and have a diagnosis of Clinical T1 or T2 invasive breast cancer with no suspicious palpable adenopathy. Patients will undergo standard of care lumpectomy without sentinel node biopsy and whole breast radiation, followed by chemotherapy.
Sentinel node biopsy is also considered standard care when patients have localized breast cancer. Treatment can often be influenced by whether the results of the biopsy show cancer or not. However, the biologic factors of the primary tumor have become more important in determining treatment recommendations in women with clinically node negative breast cancer.
Detailed description
The primary objective of the study is to determine the locoregional recurrence rate in patients with clinically node negative T1 and T2 breast cancer treated with systemic chemotherapy and whole breast irradiation in whom biopsy of the sentinel node is not performed. A locoregional recurrence is defined as any recurrence in the ipsilateral axillary nodes or in the supraclavicular nodes.
After surgery, a patient will receive standard of care radiation on her affected breast and chemotherapy. 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 chemotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female age 18 and older, not pregnant or lactating
- Clinical T1 or T2 invasive cancer with no suspicious palpable adenopathy
- If abnormal axillary nodes are seen on preoperative imaging, a negative fine needle aspiration or core biopsy is required for study entry.
- Planned treatment with breast conserving surgery and whole breast irradiation
- Chemotherapy required postoperatively based on patient and tumor characteristics at diagnosis
Key exclusion criteria (7 listed)
- Patients with suspicious palpable axillary adenopathy
- Patients with biopsy demonstrating axillary nodal metastases
- Patients with treatment by mastectomy
- Patients who have undergone neoadjuvant chemotherapy
- Patients with co-morbidities rendering the patient not a candidate for chemotherapy, surgery, or irradiation
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
A determination of the locoregional recurrence rate in patients with clinically node negative T1 and T2 breast cancer treated with systematic chemotherapy and whole breast radiation in whom sentinel node biopsy is not performed
Time frame: Assessed up to 5 years from date of lumpectomy
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2016.
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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.
Armando Giuliano, 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 Phase 2 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 5 inclusion and 7 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: withdrawn, as of the sponsor's last update on 13 Oct 2016. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
A determination of the locoregional recurrence rate in patients with clinically node negative T1 and T2 breast cancer treated with systematic chemotherapy and whole breast radiation in whom sentinel node biopsy is not performed (time frame: Assessed up to 5 years from date of lumpectomy). 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 13 Oct 2016.