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

NCT03460067 | Active Not Recruiting DMC FDA Device

• 1 other identifier: IIT-2017-MM-BRST-Her2noRT
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HER2-positive Breast Cancer

Keywords

omission of radiation; trastuzumab; pertuzumab; biospecimen collection; lumpectomy

Outcome Measures

Primary Outcomes (1)

• Ipsilateral Breast Cancer Recurrence

  Defined as biopsy positive her-2 positive tumor in the same breast

  up to 5 year post-op

Secondary Outcomes (6)

• Regional Nodal Recurrence

  1 month post-op, every three months post-op for 5 years

• Distance Metastasis

  1 month post-op, every three months post-op for 5 years

• Overall Survival

  1 month post-op, every three months post-op for 5 years

• Quality of Life using FACT-B+4

  1 month post-op, every three months post-op for 5 years

• Cosmetic (Breast) Outcomes

  1 month post-op, every three months post-op for 5 years

Study Arms (3)

Arm A

EXPERIMENTAL

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

Arm B

NO INTERVENTION

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.

Arm C

NO INTERVENTION

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.

Interventions

Omission of Radiation 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

Arm A

Eligibility Criteria

• Age: 40 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas Medical Center/ Cancer Center

Kansas City, Kansas, 66190, United States

Location

Study Officials

• Shane Stecklein, MD, PhD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 24, 2018
• First Posted: March 9, 2018
• Study Start: February 23, 2018
• Primary Completion (Estimated): July 16, 2027
• Study Completion (Estimated): July 16, 2027
• Last Updated: March 27, 2025

Record last verified: 2025-03

Locations

US (1)