Clinical trial · Interventional
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
NCT03460067CI-TRIAL-00087738active not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HER2-positive Breast Cancer | HER2-Positive Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Omission of Radiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Arm A
- description
- 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.
- interventionNames
- Radiation: Omission of Radiation
- type
- NO_INTERVENTION
- label
- Arm B
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 40 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.