Breast CancerPhase 2NCT05371860
Radiation Omission in Patients With HER2 Overexpressing Tumors With Pathologic Complete Response
A Phase 2 study testing Omit breast radiation in people with Breast Cancer and HER2-positive Breast Cancer, run by Armando Giuliano at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the feasibility, based on recruitment rate over a 3-year period, of enrolling patients for the omission of post-operative breast radiation following breast conserving surgery and sentinel node biopsy or axillary lymph node dissection in women with HER2+ breast cancer who… Read more about this study
- Who is it for?
- Ages 40 years and older, women only
- Conditions the study is for
- Breast Cancer, HER2-positive Breast Cancer
- What is being tested?
- Omit breast radiation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2023to Oct 2028
- 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 40 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female
- Age ≥ 40 years
- Patients must have a tissue diagnosis of HER2+ breast cancer
- Patients must have documented clinical T1-3, N0, M0 disease prior to receiving neo-adjuvant chemotherapy
- Patients must have undergone neo-adjuvant chemotherapy and targeted HER2 therapy prior to surgery and plan for completion of adjuvant systemic therapy as directed by their medical oncologist
- Patients must have completed partial mastectomy/lumpectomy and sentinel node biopsy or axillary node dissection.
- Patient must have documented pathologic complete response (defined as no residual invasive or in situ disease in the breast or axilla, including free of isolated tumor cells or micrometastasis)
Who cannot join
- Breastfeeding
- Prior history of breast cancer (invasive or ductal carcinoma in-situ) in either breast
- Prior adjuvant radiation therapy
- Patients with diagnosis of inflammatory breast cancer
- Patients with known BRCA mutation or other known breast cancer related deleterious mutations
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: Radiation Omission in Patients With HER2 Overexpressing Tumors With Pathologic
The purpose of this study is to evaluate the feasibility, based on recruitment rate over a 3-year period, of enrolling patients for the omission of post-operative breast radiation following breast conserving surgery and sentinel node biopsy or axillary lymph node dissection in women with HER2+ breast cancer who achieve pathologic complete response.
- Conditions
- Breast Cancer, HER2-positive Breast Cancer
- Being tested
- Omit breast radiation
- Keywords
- HER2, partial mastectomy, lumpectomy, sentinel node biopsy, axillary node dissection, pathologic complete response, breast cancer, HER2-positive
- Medical subject headings
- Breast Neoplasms, Pathologic Complete Response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omit breast radiationOther
Omit breast radiation for 3 years after surgery
| Study group | Role | What they receive |
|---|---|---|
| Omit breast radiation | Experimental | Not described Receives: Other: Omit breast radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of enrolling patients measured by proportion of recruited patients to participate in the trial
Measured by the number of recruited patients over the number of patients approached to participate to the trial. Feasibility will be defined as recruitment rate of greater or equal to 25% among patients who are eligible to participate in the trial.
Measured: At time of consent. Assessed up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2022
- Study startJul 2023 (estimated)
- Primary completionOct 2028 (estimated)
- Study completionOct 2028 (estimated)
Why it stopped: PI voluntarily closed the study. Will be reopened as a national cooperative group trial.
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.
- 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
- Armando Giuliano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Armando Giuliano, Cedars-Sinai Medical Center
- Investigators
- Armando Giuliano, MD, FACS, FRCSEd, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05371860
- Sponsor's protocol ID
- IIT2021-10-Giuliano-OmitRT
- Status last verified
- Jul 2023
- First submitted
- 20 Apr 2022
- Last updated
- 22 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiation Omission in Patients With HER2 Overexpressing Tumors With Pathologic
- ClinicalTrials.gov ID
- NCT05371860
- Acronym / sponsor ID
- IIT2021-10-Giuliano-OmitRT
- Conditions
- Breast Cancer, HER2-positive Breast Cancer
- Keywords
- HER2, partial mastectomy, lumpectomy, sentinel node biopsy, axillary node dissection, pathologic complete response, breast cancer, HER2-positive
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI voluntarily closed the study. Will be reopened as a national cooperative group trial.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Armando GiulianoUniversity, hospital or other
- Study start
- Jul 2023 (estimated)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 12 May 2022 (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 purpose of this study is to evaluate the feasibility, based on recruitment rate over a 3-year period, of enrolling patients for the omission of post-operative breast radiation following breast conserving surgery and sentinel node biopsy or axillary lymph node dissection in women with HER2+ breast cancer who achieve pathologic complete response.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Omit breast radiation | Experimental | Other: Omit breast radiation |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Female
- Age ≥ 40 years
- Patients must have a tissue diagnosis of HER2+ breast cancer
- Patients must have documented clinical T1-3, N0, M0 disease prior to receiving neo-adjuvant chemotherapy
- Patients must have undergone neo-adjuvant chemotherapy and targeted HER2 therapy prior to surgery and plan for completion of adjuvant systemic therapy as directed by their medical oncologist
Key exclusion criteria (5 listed)
- Breastfeeding
- Prior history of breast cancer (invasive or ductal carcinoma in-situ) in either breast
- Prior adjuvant radiation therapy
- Patients with diagnosis of inflammatory breast cancer
- Patients with known BRCA mutation or other known breast cancer related deleterious mutations
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 |
|---|---|---|
| Omit breast radiationOmit breast radiation for 3 years after surgery | Other | Omit breast radiation |
Primary outcome
Feasibility of enrolling patients measured by proportion of recruited patients to participate in the trial
Time frame: At time of consent. Assessed up to 3 years
Measured by the number of recruited patients over the number of patients approached to participate to the trial. Feasibility will be defined as recruitment rate of greater or equal to 25% among patients who are eligible to participate in the trial.
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 22 Sep 2023.
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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, FACS, FRCSEd principal investigator
Cedars-Sinai 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 Omit breast radiation in people with Breast Cancer and HER2-positive Breast Cancer, run by Armando Giuliano 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 7 inclusion and 5 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 22 Sep 2023. 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?
Feasibility of enrolling patients measured by proportion of recruited patients to participate in the trial (time frame: At time of consent. Assessed up to 3 years). 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 22 Sep 2023.