Safety and Efficacy of Sentinel Node Biopsy Omission for Breast Cancer Patients Who Plan to Have Adjuvant Chemotherapy
Withdrawn before enrolling · Phase 2
Conditions studied: Breast Cancer
In brief
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.
Key facts
- Study ID
- NCT02610621
- Run by
- Cedars-Sinai Medical Center
- People needed
- 0
- Starts
- 2015-12-01
- Expected to finish
- 2020-04-01
- Last updated by the study team
- 2016-10-13
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Cedars-Sinai Medical Center — Los Angeles, California, United States
Full record on ClinicalTrials.gov
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