Omission of Radiation in Patients With Her-2 Positive Breast Cancer

Selective Use of Observation After Lumpectomy and Sentinel Lymph Node Biopsy in Her-2 Positive Patients With Pathologic Complete Response to Neoadjuvant Chemotherapy

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.

Study Overview

• Status: Active, not recruiting
• Conditions: HER2-positive Breast Cancer
• Intervention / Treatment: Radiation: Omission of Radiation

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66190
      • University of Kansas Medical Center/ Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Ability to understand and the willingness to sign a written informed consent.
• Karnofsky Performance Status 50% to 100% (Appendix A).
• Women 40 years of age or older with a diagnosis of invasive ductal carcinoma
• Her-2 3+ or FISH ratio of 2.2 or higher, background gene expression with normal copy number

• Only postmenopausal women will be eligible. Subjects will be classified as being postmenopausal if they have had:

  • No spontaneous menses > 1 year, or
  • Bilateral surgical oophorectomy, or
  • No menses for < 1 year with FSH and estradiol levels in according to institutional standards
• cT1-2N0 on clinical staging (verified to have no suspicious axillary or internal mammary nodes on MRI or ultrasound)
• Undergo neoadjuvant chemotherapy with a trastuzumab based regimen prior to surgery and plan for completion of one year of trastuzumab
• Patients are required to undergo lumpectomy with sentinel lymph node biopsy
• Pathologic review shows no evidence of residual disease in the tumor bed (to also include no evidence of residual DCIS)
• Tumor bed should be no larger than 5 cm in size on pathologic review
• Fibrotic area of prior tumor located at least 3 mm away from surgical margins
• No evidence of treatment related change in the lymph nodes on pathologic review

Exclusion Criteria

• Diagnosis of inflammatory breast cancer
• Previously diagnosed malignancy excluding basal or squamous cell carcinoma of the skin (unless disease-free for 5 years or more)
• Diagnosis of metastatic disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A; 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; 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
No Intervention: Arm B; 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.
No Intervention: Arm C; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ipsilateral Breast Cancer Recurrence	Defined as biopsy positive her-2 positive tumor in the same breast	up to 5 year post-op

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Regional Nodal Recurrence	Will include recurrence in the ipsilateral draining axilla, supraclavicular fossa, or internal mammary nodes.	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.	1 month post-op, every three months post-op for 5 years
Overall Survival	Defined as death from any cause	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	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.	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	1 month post-op, every three months post-op for 5 years

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center
• Investigators: Principal Investigator: Shane Stecklein, MD, PhD, University of Kansas Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2018
• Primary Completion (Estimated): July 16, 2027
• Study Completion (Estimated): July 16, 2027

Study Registration Dates

• First Submitted: February 24, 2018
• First Submitted That Met QC Criteria: March 8, 2018
• First Posted (Actual): March 9, 2018

Study Record Updates

• Last Update Posted (Actual): March 27, 2025
• Last Update Submitted That Met QC Criteria: March 24, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: trastuzumab; pertuzumab; lumpectomy; omission of radiation; biospecimen collection
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: IIT-2017-MM-BRST-Her2noRT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No