An interventional study of Omission of Radiation in HER2-positive Breast Cancer, sponsored by University of Kansas Medical Center. Active, not recruiting at 1 site in United States. Open to female participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2025-03-27.
Sponsored by University of Kansas Medical Center · Not applicable, Interventional, and Treatment
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Among 31 studies in Breast Neoplasms by University of Kansas Medical Center — 6 open to participants now, 14 under way, none of them phase 3. Breast Neoplasms · University of Kansas Medical Center.
Among the 31 studies in Breast Neoplasms by University of Kansas Medical Center, this one is the 26th largest by enrollment of the 28 interventional ones that give a count, is one of 3 that started in 2018, is one of 9 with no phase, reaches primary completion later than 9 of the 13 other live ones, and was the 18th registered.
14,832 studies on the registry are indexed under Breast Neoplasms; 3,320 are open to participants now.
Browse Breast Neoplasms studies →6 of the 31 studies in Breast Neoplasms by University of Kansas Medical Center are open now, in 1 country. Recruiting first, the newest first:
University of Kansas Medical Center · Sites in United States
Ages 18+
University of Kansas Medical Center · Sites in United States
Ages 65+ · Women only · Healthy volunteers
University of Kansas Medical Center · Sites in United States
Ages 18+
University of Kansas Medical Center · Sites in United States
Healthy volunteers
University of Kansas Medical Center
Ages 18–80
By country, each count listing its studies:
Of the 2,399 Breast Neoplasms studies recruiting now, 1,570 (65%) set no upper age limit and 592 (25%) stop at 75 or younger; 103 take children under 18; 215 take healthy volunteers.
This study: 40 Years and older · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
31 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 4 · Phase 2 17
First in 2000; this study’s year is marked. 3 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 12 is below the median of 72 across 10,903 interventional studies indexed under Breast Neoplasms.
Median enrollment 71 across the 28 interventional studies, 1,750 across the 2 observational. Of the 14 that completed or were terminated, 7 (50%) have results posted.
This tab as a report to print or save as PDF → With an account.
University of Kansas Medical Center is the lead sponsor of 492 studies on the registry; 110 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 24 (63%) have results posted.
5 of the studies in Breast Neoplasms by University of Kansas Medical Center that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT02302742University of Kansas Medical CenterTriple Negative Breast Cancer and Germline Hereditary Breast and Ovarian Cancer Mutation Carrier Registry | 2026-12 |
| NCT05645380University of Kansas Medical CenterNeoadjuvant TIL- and Response-Adapted Chemoimmunotherapy for TNBC | 2026-12 |
| NCT03460067University of Kansas Medical CenterOmission of Radiation in Patients With Her-2 Positive Breast Cancer | 2027-07-16 |
| NCT07242118University of Kansas Medical CenterConformal Ablative Radiotherapy in Older Women (CARMEN) With Breast Cancer Undergoing Non-Operative Management | 2027-09 |
| NCT07220135University of Kansas Medical CenterTrial of Neoadjuvant THP vs TCHP for HER2-Amplified/Positive Breast Cancer | 2027-11-14 |
Add all 5 to your calendar (.ics) → With an account.
Among the 31 studies in Breast Neoplasms by University of Kansas Medical Center, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The primary objective of this study is to describe the rate of local control in patients with her-2 positive early stage breast cancer with a complete response to chemotherapy and lumpectomy alone.
Participants, ages 40 and older diagnosed with stage I or stage II her-2 positive, node negative breast cancer patients will be recommended to continue trastuzumab +/- pertuzumab therapy after surgery to complete a full year of therapy as standard of care under the clinical management of the patient's medical oncologist.
Once neoadjuvant chemotherapy has been completed, the patient will be separated in to one of three arms based on a set of criteria for each. If the patient wishes to take part in the study, but does not have a lumpectomy with sentinel lymph node biopsy showing pCR, the patient will be placed in to Arm C and will proceed with radiation as standard of care. If the patient wishes to take part in the study, and has a lumpectomy with sentinel lymph node biopsy showing pCR, but does not agree to omission of radiation, the patient will be placed in to Arm B and will proceed with radiation as standard of care. If the patient wishes to take part in the study, and has a lumpectomy with sentinel lymph node biopsy showing pCR and agrees to omission of radiation, the patient will be placed in to Arm A with follow up assessments occuring at 1 month post-op, and every 3 months up to 5 years post-op.
Data will be collected on local, regional and distant recurrence at each follow-up.The self-administered FACT-B+4 quality of life questionnaire will be given to patients at baseline, at first postoperative visit, and at the one year post-operative visit.
Patients enrolling prior to chemotherapy will be asked to fill out the Breast-Q™ at the time of their first surgical consultation. Patients enrolled post-surgery will be asked to fill out the Breast-Q™ at their first post-operative visit. All patients will be asked to fill out the Breast-Q™ at their yearly postoperative visits. The Breast-Q™ is a validated patient assessment of breast cosmesis. This tool has both pre operative and post-operative components. Pre-operative Breast-Q™ questionnaire data is not required of participants in this study who enroll postoperatively.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Only women will be eligible. Subjects will be classified as being postmenopausal if they have had:
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patient is required to have lumpectomy with sentinel lymph node biopsy shows pCR and will complete 1 year of trastuzumab +/- pertuzumab treatment. No radiation, or an omission of radiation, will be given on this arm, including external beam, brachytherapy or intraoperative radiation. Patients will be required to follow up with a medical, surgical, or radiation oncologist every 3 months for 5 years. At these follow up visits, a physical exam will be performed to assess for any disease recurrence. Screening mammogram or MRI is recommended every 6 months for patients on this arm.
Radiation: Omission of Radiation
Patient is required to have her-2 positive breast cancer, clinically node negative from exam. Patient will complete neoadjuvant chemotherapy per Medical Oncologist. This arm will undergo lumpectomy with sentinel lymph node biopsy shows pCR. The patient will proceed with radiation as standard of care. This arm includes a review of outcomes in the patient's medical chart as well as a collection of biospecimens such as blood and urine, for correlative studies.
Patient is required to have her-2 positive breast cancer, clinically node negative from exam. patient will complete neoadjuvant chemotherapy per Medical Oncologist. This arm will not undergo lumpectomy with sentinel lymph node biopsy shows pCR. The patient will proceed with radiation as standard of care. This arm includes a review of outcomes in the patient's medical chart as well as a collection of biospecimens, such as blood and urine, for correlative studies.
No Radiation will be given. 1 year of trastuzumab +/- pertuzumab treatment will be given with 5 years of follow up occurring every 3 months to check for recurrence
This study also gives Trastuzumab, Pertuzumab. No intervention listed here names it: that was found by reading the record.
Ipsilateral Breast Cancer Recurrence
Defined as biopsy positive her-2 positive tumor in the same breast
Time frame: up to 5 year post-op
Regional Nodal Recurrence
Will include recurrence in the ipsilateral draining axilla, supraclavicular fossa, or internal mammary nodes.
Time frame: 1 month post-op, every three months post-op for 5 years
Distance Metastasis
Defined as biopsy proven disease outside of the affected breast and draining lymphatics, or definitive radiographical evidence of distant disease, to include a positive bone scan or enhancing lesions on MRI brain.
Time frame: 1 month post-op, every three months post-op for 5 years
Overall Survival
Defined as death from any cause
Time frame: 1 month post-op, every three months post-op for 5 years
Quality of Life using FACT-B+4
Measured using scores from patient reported outcomes from FACT-B+4 questionnaire
Time frame: 1 month post-op, every three months post-op for 5 years
Cosmetic (Breast) Outcomes
Measured using scores from patient reported outcomes using the Breast Q questionnaire
Time frame: 1 month post-op, every three months post-op for 5 years
Lymphedema Rate
Assessed by a diagnosis of Lymphedema in the medical record by trained lymphedema nurse.
Time frame: 1 month post-op, every three months post-op for 5 years
Started Feb 2018 (actual). Primary completion is estimated for Jul 2027, 112 months after the start.
Of 2,663 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 66. This study's planned 112 months is above that.
Counting every sponsor, half of 2,773 studies reached it within 33 months; a quarter within 15 and three quarters within 66.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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