Safety and Efficacy of Sentinel Node Biopsy Omission for Breast Cancer Patients Who Plan to Have Adjuvant Chemotherapy
| Status: | Recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | December 2015 |
| End Date: | April 2020 |
| Contact: | Parisa Mirzadehgan |
| Email: | Parisa.Mirzadehgan@cshs.org |
| Phone: | 310-967-4387 |
IIT2015-11-Giuliano: Safety and Efficacy of Omission of Sentinel Node Biopsy for Breast Cancer Patients Who Plan to Have Adjuvant Chemotherapy
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.
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.
The primary objective of the study is to determine the locoregional recurrence rate in
patients with clinically node negative T1 and T2 breast cancer treated with systemic
chemotherapy and whole breast irradiation in whom biopsy of the sentinel node is not
performed. A locoregional recurrence is defined as any recurrence in the ipsilateral
axillary nodes or in the supraclavicular nodes.
After surgery, a patient will receive standard of care radiation on her affected breast and
chemotherapy. A physical examination of the affected breast and regional lymph nodes will be
conducted every six months for the first two years of follow up and then yearly for the last
3 years of follow up. Imaging of the affected breast will occur every 12 months after
surgery per standard of care.
patients with clinically node negative T1 and T2 breast cancer treated with systemic
chemotherapy and whole breast irradiation in whom biopsy of the sentinel node is not
performed. A locoregional recurrence is defined as any recurrence in the ipsilateral
axillary nodes or in the supraclavicular nodes.
After surgery, a patient will receive standard of care radiation on her affected breast and
chemotherapy. A physical examination of the affected breast and regional lymph nodes will be
conducted every six months for the first two years of follow up and then yearly for the last
3 years of follow up. Imaging of the affected breast will occur every 12 months after
surgery per standard of care.
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
We found this trial at
1
site
8700 Beverly Blvd # 8211
Los Angeles, California 90048
Los Angeles, California 90048
(1-800-233-2771)
Principal Investigator: Armando Giuliano, MD
Phone: 310-967-4387
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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