No Sentinel Node Biopsy for Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the safety and effectiveness of skipping a sentinel node biopsy (a test for cancer spread) in women aged 65 and older with clinically node-negative breast cancer. Participants will undergo a lumpectomy, which removes the tumor, followed by standard treatments like radiation and hormone therapy. Suitable candidates have been diagnosed with specific types of breast cancer (ER+, HER2-negative) and either have had or plan to have a lumpectomy without a sentinel node biopsy. As an unphased trial, this study provides an opportunity to contribute to research that could simplify treatment for future patients.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications.
What prior data suggests that lumpectomy without sentinel node biopsy is safe for women with clinically node-negative breast cancer?
Research has shown that lumpectomy, a surgery to remove a breast tumor, is a safe treatment for breast cancer. Studies have found that breast-conserving surgeries like lumpectomy, followed by radiation, are generally well-tolerated. Large trials have demonstrated that these surgeries are safe compared to more extensive surgeries like mastectomy, which removes the entire breast.
In this trial, lumpectomy is performed without checking the lymph nodes for cancer spread, a procedure known as sentinel node biopsy. Research suggests that omitting this step may be safe for certain patients, such as those with small tumors that haven't spread to the lymph nodes. After surgery, patients receive standard radiation and hormonal therapy, which are common and well-known treatments.
Overall, evidence supports the safety of lumpectomy without sentinel node biopsy for women with breast cancer that hasn't spread to the lymph nodes.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it explores a new approach to treating breast cancer that might simplify the surgical process. Typically, breast cancer treatment includes a procedure called a sentinel node biopsy to check if cancer has spread to the lymph nodes. However, this trial investigates the possibility of skipping this biopsy during a lumpectomy, while still providing standard radiation and hormonal therapy afterward. By potentially eliminating the need for this additional surgical step, the approach may reduce surgery time and associated risks, making the treatment less invasive and possibly more comfortable for patients.
What evidence suggests that lumpectomy without sentinel node biopsy is effective for clinically node-negative breast cancer?
Research has shown that a lumpectomy, which involves removing just the tumor and a small amount of nearby tissue, is as effective as a mastectomy (removal of the whole breast) for early-stage breast cancer in terms of survival. Studies have found that this breast-conserving surgery is safe and has low rates of cancer recurrence. For older women with early-stage breast cancer, long-term results are similar whether they choose a lumpectomy or a mastectomy. When followed by radiation, a lumpectomy offers survival rates comparable to a mastectomy, effectively treating the cancer while preserving more of the breast.
In this trial, participants will undergo a lumpectomy without a sentinel node biopsy, followed by standard care radiation and hormonal therapy.678910Who Is on the Research Team?
Alice Chung, MD
Principal Investigator
Cedars-Sinal Medical Center
Are You a Good Fit for This Trial?
This trial is for women aged 65 or older with estrogen-positive, HER2-negative breast cancer that hasn't spread to lymph nodes. They should be planning a lumpectomy or have had one recently without sentinel node biopsy. Women with advanced cancer stages, those who've had mastectomy, inflammatory breast cancer, or prior treatments like chemotherapy for the current cancer are not eligible.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Surgery
Participants undergo standard of care lumpectomy without sentinel node biopsy
Radiation and Hormonal Therapy
Participants receive standard of care radiation on the affected breast and hormonal therapy
Follow-up
Participants are monitored for regional recurrence with physical exams every six months for the first two years and then yearly for the last three years
What Are the Treatments Tested in This Trial?
Interventions
- Lumpectomy
Lumpectomy is already approved in European Union, United States, Canada, Japan for the following indications:
- Early-stage breast cancer
- Low-risk breast cancer
- Early-stage breast cancer
- Low-risk breast cancer
- Ductal carcinoma in situ (DCIS)
- Early-stage breast cancer
- Low-risk breast cancer
- Early-stage breast cancer
- Low-risk breast cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Cedars-Sinai Medical Center
Lead Sponsor