Safety and Efficacy of Omission of Sentinel Node Biopsy in Patients With Estrogen-Positive Breast Cancer Over Age 65
| Status: | Recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 65 - Any |
| Updated: | 12/1/2018 |
| Start Date: | January 2016 |
| End Date: | January 2025 |
| Contact: | Parisa Mirzadehgan |
| Email: | Parisa.Mirzadehgan@cshs.org |
| Phone: | 310-967-4387 |
IIT2015-06-Chung: Safety and Efficacy of Omission of Sentinel Node Biopsy in Patients With Clinical T1-2 Estrogen-Positive Breast Cancer Over Age 65
This study will examine the outcomes of lumpectomy, surgery to remove a tumor, without
sentinel node biopsy (SNB) for women at least 65 years of age with clinically node-negative
breast cancer. Clinically node-negative means that during a physical exam your doctor cannot
feel or see that any lymph nodes near the breast area are swollen and there is also no
imaging evidence, such as from a mammogram, of nodal involvement.
sentinel node biopsy (SNB) for women at least 65 years of age with clinically node-negative
breast cancer. Clinically node-negative means that during a physical exam your doctor cannot
feel or see that any lymph nodes near the breast area are swollen and there is also no
imaging evidence, such as from a mammogram, of nodal involvement.
The primary objective of the study is to determine whether omission of sentinel node biopsy
in patients who meet eligibility criteria results in an acceptable regional recurrence rate
over a 6-year period. A regional recurrence is defined as any recurrence in the ipsilateral
axillary nodes, supraclavicular nodes or internal mammary nodes.
Eligible patients will undergo standard of care lumpectomy without sentinel node biopsy
followed by radiation and hormonal therapy or have already undergone the procedure prior to
enrollment in the study. She may also receive chemotherapy as determined by her treating
physician. 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.
in patients who meet eligibility criteria results in an acceptable regional recurrence rate
over a 6-year period. A regional recurrence is defined as any recurrence in the ipsilateral
axillary nodes, supraclavicular nodes or internal mammary nodes.
Eligible patients will undergo standard of care lumpectomy without sentinel node biopsy
followed by radiation and hormonal therapy or have already undergone the procedure prior to
enrollment in the study. She may also receive chemotherapy as determined by her treating
physician. 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 65 and older
- Staging:
1. Patients enrolled prior to surgery: Diagnosis of clinical T1-2N0 ER+ invasive
breast cancer as determined by treating physician. DCIS or LCIS may be present
with invasive cancer.
2. Patients enrolled after surgery: pT1-2N0 ER+ invasive breast cancer. DCIS or LCIS
may be present with invasive cancer.
- Plan to undergo lumpectomy within 6 weeks of study registration, or underwent
lumpectomy within 60 days of study registration (without sentinel node biopsy)
- Patients in whom lymph nodes are palpable and not suspicious who are found to be nodal
tumor-free by nodal core needle biopsy are permitted, but those with biopsy-proven
nodal metastases are excluded
Exclusion Criteria:
- Patients with diagnosis of ductal or lobular carcinoma in situ
- Patients with diagnosis of inflammatory breast cancer
- Patients who have undergone neoadjuvant chemotherapy for current primary breast cancer
(past treatments for other cancers are acceptable)
- Patients planning to have mastectomy or had a mastectomy
- Prior history of ipsilateral (invasive or DCIS) breast cancer
- Diagnosis of clinical T3 or T4 breast cancer
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: Alice Chung, 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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