Clinical trial · Interventional
Safety and Efficacy of Sentinel Node Biopsy Omission for Breast Cancer Patients Who Plan to Have Adjuvant Chemotherapy
IIT2015-11-Giuliano: Safety and Efficacy of Omission of Sentinel Node Biopsy for Breast Cancer Patients Who Plan to Have Adjuvant Chemotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study may not be clinically relevant at this time.
Summary
Brief summary (as posted)
Eligible patients will be female, ages 18 and older and have a diagnosis of Clinical T1 or T2 invasive breast cancer with no suspicious palpable adenopathy. Patients will undergo standard of care lumpectomy without sentinel node biopsy and whole breast radiation, followed by chemotherapy. Sentinel node biopsy is also considered standard care when patients have localized breast cancer. Treatment can often be influenced by whether the results of the biopsy show cancer or not. However, the biologic factors of the primary tumor have become more important in determining treatment recommendations in women with clinically node negative breast cancer.
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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lumpectomy without sentinel node biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Lumpectomy without sentinel node biopsy
- description
- Subjects will undergo standard of care lumpectomy. A biopsy of the sentinel node will not be performed. After surgery, subjects will receive standard of care radiation on the affected breast and chemotherapy.
- interventionNames
- Procedure: Lumpectomy without sentinel node biopsy
Primary outcomes (1)
- measure
- A determination of the locoregional recurrence rate in patients with clinically node negative T1 and T2 breast cancer treated with systematic chemotherapy and whole breast radiation in whom sentinel node biopsy is not performed
- timeFrame
- Assessed up to 5 years from date of lumpectomy
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Female age 18 and older, not pregnant or lactating * Clinical T1 or T2 invasive cancer with no suspicious palpable adenopathy * If abnormal axillary nodes are seen on preoperative imaging, a negative fine needle aspiration or core biopsy is required for study entry. * Planned treatment with breast conserving surgery and whole breast irradiation * Chemotherapy required postoperatively based on patient and tumor characteristics at diagnosis Exclusion Criteria: * Patients with suspicious palpable axillary adenopathy * Patients with biopsy demonstrating axillary nodal metastases * Patients with treatment by mastectomy * Patients who have undergone neoadjuvant chemotherapy * Patients with co-morbidities rendering the patient not a candidate for chemotherapy, surgery, or irradiation * Patients treated with accelerated partial breast irradiation (APBI) * Patients with contraindication to radiation
References
Publications (0)
Data not yet available