HER2-positive Breast CancerSuperHERONCT07895511
A Study of Skipping Radiation Therapy in People With Breast Cancer
A study testing HER2-targeted therapy, Tamoxifen and No Radiation Therapy in people with HER2-positive Breast Cancer and Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial summary
The purpose of this study is to find out whether it is safe to skip (omit) radiation therapy to the breast after lumpectomy in people with low-risk HER2-positive breast cancer who are receiving HER2-targeted therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HER2-positive Breast Cancer, Breast Cancer
- What is being tested?
- HER2-targeted therapy, Tamoxifen and No Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 7 sitesUnited States
- Study dates
- 16 Oct 2026to 16 Oct 2031
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A patient cannot be considered eligible for this study unless ALL of the following conditions are met. Please contact the study PI for exceptions, or if uncertainties arise.
- The trial is open to female and male patients who have undergone breast conserving surgery and have received neoadjuvant* or adjuvant systemic therapy with a HER2-targeted therapeutic regimen.
- The maximum window between surgery (neoadjuvant cohort) or last chemotherapy (adjuvant cohort) and enrollment is 90 days.
- While the standard duration of neoadjuvant or adjuvant systemic therapy is at least 12 weeks, patients will be eligible if they receive a minimum of 8 weeks of systemic therapy. Patients treated with an antibody-drug conjugate (ADC; eg. T-DM1 or T-DXd) must have received at least 6 cycles of this treatment.
- For the neoadjuvant cohort: Patients are eligible if they achieved pCR with HER2-targeted preoperative treatment. Pathologic complete response is defined as ypT0/TisN0 based on surgical pathology. Patients treated with and ADC must have received at least 6 cycles of this treatment.
- The patient must be ≥18 years of age.
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- The patient must have an ECOG performance status of 0, 1, or 2/Karnofsky performance status above 60.
- Histologically or cytologically confirmed invasive breast carcinoma.
- The tumor must have been determined to be HER2-positive by current ASCO/CAP guidelines based on local testing results.
- The tumor must have ER and PgR status assessed.
- The following staging criteria must be met according to AJCC 8th edition criteria:
- Adjuvant cohort
- Following resection, the patient's primary tumor must be ≤ 3 cm.
- Surgical axillary evaluation via sentinel node biopsy or axillary dissection
- Surgical lumpectomy margins must be negative for invasive cancer and ductal carcinoma in situ (no ink on tumor).
- Neoadjuvant cohort:
- Prior to neoadjuvant therapy, the patient's primary tumor must be <5 cm by imaging studies with negative axillary nodes (cN0) based on axillary U/S, CT, PET or MRI. Physical examination alone is not sufficient documentation of cN0 status.
- The patient must have undergone surgical axillary nodal evaluation demonstrating ypN0 (eg. axillary node dissection, sentinel node biopsy with at least 3 sentinel lymph nodes removed, or sentinel node biopsy followed by axillary node dissection).
- Must be ypT0/TisN0 at surgery (lumpectomy); patients with residual non invasive disease (DCIS) in the surgical specimen (ypTis), are only eligible if residual DCIS spans ≤1 cm, and surgical margins are negative for DCIS.
- Bilateral mammogram or MRI within 52 weeks prior to enrollment.
Who cannot join
- Definitive clinical or radiologic evidence of metastatic disease.
- On the Adjuvant cohort, patients with a primary tumor >3 cm on pathologic examination of the surgical specimen. On the Neoadjuvant cohort, patients with a primary tumor >5 cm or with abnormal or suspicious ipsilateral axillary nodes by pretreatment imaging, unless demonstrated to be negative by cytologic or histologic examination.
- Pathologically positive axillary nodes at any time including of pN0(i+) or pN0(mol+) ypN0(i+) or ypN0(mol+) disease.
- Patient planning for or status-post mastectomy.
- Radiographically suspicious ipsilateral or contralateral axillary, supraclavicular, infraclavicular, or internal mammary lymph nodes, unless there is histological confirmation that these nodes are negative for metastatic disease.
- Suspicious microcalcifications, densities, or palpable abnormalities (in the ipsilateral or contralateral breast), or mass or non-mass enhancement on MRI (if performed) aside from the known cancer, unless biopsied and found to be benign.
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- Non-epithelial breast malignancies such as sarcoma or lymphoma.
- Multicentric carcinoma (invasive cancer or DCIS) in more than one quadrant or multifocal disease spanning >4 cm. If multifocal, all foci should be confined to a maximum summed tumor extent of 3 cm determined by pathological assessment.
- Paget's disease of the nipple.
- Synchronous contralateral invasive breast cancer or DCIS or synchronous ipsilateral invasive breast cancer of a different histology. (Patients with synchronous and/or previous contralateral LCIS are eligible).
- On the Adjuvant cohort, surgical margins that cannot be microscopically assessed or are positive at pathologic evaluation. (If surgical margins are rendered free of disease by re-excision, the patient is eligible).
- Treatment plan that includes regional nodal irradiation.
- Patients treated for a prior invasive breast malignancy are excluded. Contralateral DCIS ≥10 years prior to enrollment is permissible.
- Patients on oral, transdermal, or subdermal estrogen replacement (including all estrogen only and estrogen-progesterone formulas) are not eligible unless discontinued prior to enrollment.
- Use of any investigational product within 30 days prior to enrollment.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Memorial Sloan Kettering at Basking Ridge (All protocol activities)
Basking Ridge, New Jersey, 07920
Lior Braunstein, MD, 201-775-7446
- Recruiting
Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities )
Commack, New York, 11725
Lior Braunstein, MD, 201-775-7446
- Recruiting
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York, 10604
Lior Braunstein, MD, 201-775-7446
- Recruiting
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, 07748
Lior Braunstein, MD, 201-775-7446
- Recruiting
Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey, 07645
Lior Braunstein, MD, 201-775-7446
- Recruiting
Memorial Sloan Kettering Cancer Center (All protocol activites)
New York, New York, 10065
Lior Braunstein, MD, 201-775-7446
- Recruiting
Memorial Sloan Kettering Nassau (All protocol activities)
Rockville Centre, New York, 11553
Lior Braunstein, MD, 201-775-7446
About this study
Official title: SuperHERO: A Phase II Trial Evaluating Radiotherapy Omission for Low-risk HER2-positive Breast Cancer
The purpose of this study is to find out whether it is safe to skip (omit) radiation therapy to the breast after lumpectomy in people with low-risk HER2-positive breast cancer who are receiving HER2-targeted therapy.
- Conditions
- HER2-positive Breast Cancer, Breast Cancer
- Being tested
- HER2-targeted therapy, Tamoxifen, No Radiation Therapy
- Keywords
- HER2-positive Breast Cancer, Breast Cancer, Memorial Sloan Kettering Cancer Center, 26-385
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HER2-targeted therapyDrug
Participants will continue to receive standard HER2-targeted therapy as part of their usual care
TamoxifenDrug
If participants' cancer is hormone receptor-positive, participants may also receive endocrine therapy as part of their usual care.
No Radiation TherapyRadiation
Participants will not receive radiation therapy to their breast after their lumpectomy.
| Study group | Role | What they receive |
|---|---|---|
| HER2-positive Breast Cancer | Experimental | Participants have HER2-positive Breast Cancer Receives: Drug: HER2-targeted therapy; Drug: Tamoxifen; Radiation: No Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ipsilateral breast recurrence/IBR rate
To assess whether omission of adjuvant breast radiotherapy among patients with early-stage, low risk HER2+ breast cancer who undergo breast conserving surgery and receive HER2-directed therapy, results in an acceptable rate of 5 year ipsilateral breast recurrence (IBR).
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study start16 Oct 2026
- Primary completion16 Oct 2031 (estimated)
- Study completion16 Oct 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-positive Breast CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lior Braunstein, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07895511
- Sponsor's protocol ID
- 26-385
- Acronym
- SuperHERO
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SuperHERO: A Phase II Trial Evaluating Radiotherapy Omission for Low-risk HER2-positive Breast Cancer
- ClinicalTrials.gov ID
- NCT07895511
- Acronym / sponsor ID
- SuperHERO / 26-385
- Conditions
- HER2-positive Breast Cancer, Breast Cancer
- Keywords
- HER2-positive Breast Cancer, Breast Cancer, Memorial Sloan Kettering Cancer Center, 26-385
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 16 Oct 2026 (actual)
- Primary completion
- 16 Oct 2031 (estimated)
- Study completion
- 16 Oct 2031 (estimated)
- First posted
- 26 Oct 2026 (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 find out whether it is safe to skip (omit) radiation therapy to the breast after lumpectomy in people with low-risk HER2-positive breast cancer who are receiving HER2-targeted therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HER2-positive Breast Cancer | Experimental | Drug: HER2-targeted therapy, Drug: Tamoxifen, Radiation: No Radiation TherapyParticipants have HER2-positive Breast Cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- A patient cannot be considered eligible for this study unless ALL of the following conditions are met. Please contact the study PI for exceptions, or if uncertainties arise.
- The trial is open to female and male patients who have undergone breast conserving surgery and have received neoadjuvant* or adjuvant systemic therapy with a HER2-targeted therapeutic regimen.
- The maximum window between surgery (neoadjuvant cohort) or last chemotherapy (adjuvant cohort) and enrollment is 90 days.
- While the standard duration of neoadjuvant or adjuvant systemic therapy is at least 12 weeks, patients will be eligible if they receive a minimum of 8 weeks of systemic therapy. Patients treated with an antibody-drug conjugate (ADC; eg. T-DM1 or T-DXd) must have received at least 6 cycles of this treatment.
- For the neoadjuvant cohort: Patients are eligible if they achieved pCR with HER2-targeted preoperative treatment. Pathologic complete response is defined as ypT0/TisN0 based on surgical pathology. Patients treated with and ADC must have received at least 6 cycles of this treatment.
Key exclusion criteria (15 listed)
- Definitive clinical or radiologic evidence of metastatic disease.
- On the Adjuvant cohort, patients with a primary tumor >3 cm on pathologic examination of the surgical specimen. On the Neoadjuvant cohort, patients with a primary tumor >5 cm or with abnormal or suspicious ipsilateral axillary nodes by pretreatment imaging, unless demonstrated to be negative by cytologic or histologic examination.
- Pathologically positive axillary nodes at any time including of pN0(i+) or pN0(mol+) ypN0(i+) or ypN0(mol+) disease.
- Patient planning for or status-post mastectomy.
- Radiographically suspicious ipsilateral or contralateral axillary, supraclavicular, infraclavicular, or internal mammary lymph nodes, unless there is histological confirmation that these nodes are negative for metastatic disease.
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 |
|---|---|---|
| HER2-targeted therapyParticipants will continue to receive standard HER2-targeted therapy as part of their usual care | Drug | HER2-positive Breast Cancer |
| TamoxifenIf participants' cancer is hormone receptor-positive, participants may also receive endocrine therapy as part of their usual care. | Drug | HER2-positive Breast Cancer |
| No Radiation TherapyParticipants will not receive radiation therapy to their breast after their lumpectomy. | Radiation | HER2-positive Breast Cancer |
Primary outcome
Ipsilateral breast recurrence/IBR rate
Time frame: 5 years
To assess whether omission of adjuvant breast radiotherapy among patients with early-stage, low risk HER2+ breast cancer who undergo breast conserving surgery and receive HER2-directed therapy, results in an acceptable rate of 5 year ipsilateral breast recurrence (IBR).
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 29 Oct 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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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.
Lior Braunstein, MD principal investigator
Memorial Sloan Kettering Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HER2-targeted therapy, Tamoxifen and No Radiation Therapy in people with HER2-positive Breast Cancer and Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 7 sites 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 20 inclusion and 15 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 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
Contact Lior Braunstein, MD (201-775-7446, braunstl@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ipsilateral breast recurrence/IBR rate (time frame: 5 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 29 Oct 2026.