Trials Sponsors Conditions Drugs Pricing

Conditions

HER2-positive Breast Cancer Breast Cancer

Keywords

HER2-positive Breast CancerBreast CancerMemorial Sloan Kettering Cancer Center26-385

Outcome Measures

Primary Outcomes (1)

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).
5 years

Study Arms (1)

HER2-positive Breast Cancer

EXPERIMENTAL

Participants have HER2-positive Breast Cancer

Drug: HER2-targeted therapyDrug: TamoxifenRadiation: No Radiation Therapy

Interventions

HER2-targeted therapyDrug

Participants will continue to receive standard HER2-targeted therapy as part of their usual care

HER2-positive Breast Cancer

TamoxifenDrug

If participants' cancer is hormone receptor-positive, participants may also receive endocrine therapy as part of their usual care.

HER2-positive Breast Cancer

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

Sponsors & Collaborators

Memorial Sloan Kettering Cancer Center
Otherlead

Study Sites (7)

Memorial Sloan Kettering at Basking Ridge (All protocol activities)

Basking Ridge, New Jersey, 07920, United States

RECRUITING

Lior Braunstein, MDCONTACT201-775-7446

Memorial Sloan Kettering Monmouth (All Protocol Activities)

Middletown, New Jersey, 07748, United States

RECRUITING

Lior Braunstein, MDCONTACT201-775-7446

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Tamoxifen

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

StilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

Lior Braunstein, MD
Memorial Sloan Kettering Cancer Center
PRINCIPAL INVESTIGATOR

Central Study Contacts

Lior Braunstein, MD

CONTACT

201-775-7446 braunstl@mskcc.org

Diana Roth O'Brien, MD

CONTACT

201-775-7605

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

October 19, 2026

First Posted

October 26, 2026

Study Start

October 16, 2026

Actual (reported)

Primary Completion

October 16, 2031

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

You may not qualify if:

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.
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.

A Study of Skipping Radiation Therapy in People With Breast Cancer

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

HER2-positive Breast Cancer

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (7)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

HER2-positive Breast Cancer

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (7)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations