Clinical Trial: Comparative Effectiveness of Sentinel Lymph Node Biopsy for Ductal Carcinoma In Situ

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Observational

Official Title: Comparative Effectiveness of Sentinel Lymph Node Biopsy (SLNB) for Ductal Carcinoma In Situ (DCIS)

Brief Summary:

Patients with ductal carcinoma in situ (DCIS) treated with available therapies have experienced excellent outcomes and very low mortality rates due to the disease's non-invasive nature. However, considerable debate exists as to how the DCIS lesion should be treated. As a result, determining strategies to manage DCIS has been identified as a research priority. The role of sentinel lymph node biopsy (SLNB) for DCIS management is controversial in general and needs further scrutiny. Our study addresses this evidence gap as the investigators propose a retrospective cohort study to investigate the outcome of SLNB among DCIS patients. Specifically, the investigators will compare the outcomes, including survival outcomes and treatment side effects, among women older than 67 years of age with DCIS receiving SLNB vs. not receiving SLNB within 6 months of DCIS diagnosis. The investigators have two primary aims in this study: Aim 1: the investigators select our study sample using SEER-Medicare database. The investigators will determine associations between SLNB and acute/subacute side effects, including lymphedema, pain, and limitation of movement of upper extremity from the first breast conserving surgery to 9 months post-diagnosis. Aim 2: the investigators will determine associations between SLNB and long-term outcomes, including breast cancer specific mortality, ipsilateral invasive breast cancer diagnosis, subsequent mastectomy as treated recurrence, and lasting side effects, from >9 months post-diagnosis to death or the end of this study period.

Given the nature of our observational study design, the investigators will apply standard multivariate analyses and propensity score methodology to reduce the influence from confounders. The investigators will control for patient demographics, comorbidities, functional status, tumor characteristics, and prior healthcare utilization. U

Detailed Summary:

Because of the non-invasive nature of ductal carcinoma in situ (DCIS), patients treated with available therapies have excellent outcomes and very low rates of breast cancer mortality. Considerable debate exists as to how the DCIS lesion should be treated, although there is a movement toward less intensive intervention by the identification of patient subsets with favorable prognoses. Some prospective studies have found that the rate of ipsilateral invasive cancer occurrence is still high after receiving breast conserving surgery (BCS) alone, even among patients with favorable pathologic characteristics. Such findings argue against active surveillance for DCIS treatment. However, evidence exists that older DCIS patients have a lower rate of ipsilateral recurrence because DCIS among older patients tends to be indolent. Identifying suitable subgroups among this lower risk group who may be safe to receive a less aggressive treatment could change the current practice pattern of aggressive treatment.

Even when DCIS patients opt to receive a less intensive treatment such as BCS without radiation therapy, they and their providers need to decide whether to undergo sentinel lymph node biopsy (SLNB). A systematic review has shown that evidence gaps exist regarding the benefits of SLNB for DCIS. Given that the likelihood of axillary recurrence is low among DCIS patients who received radiation therapy, routine SLNB is not recommended for DCIS patients. Of note, radiation therapy can control axillary disease if present. If the investigators plan to empower DCIS patients to choose less intensive management options, such as BCS forgoing radiation therapy (RT), it will be crucial for patients and providers to understand the role of SLNB.

The overarching goals of this study are to compare side effects and outcomes between receiving SLNB vs.
Sponsor: Yale University

Current Primary Outcome: Side effects [ Time Frame: From the first BCS to 9 months post-diagnosis. ]

Primary outcomes for Aim 1. Acute and subacute side effects include lymphedema, pain and limitation of movement extremities.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Mastectomy received [ Time Frame: 6 months within DCIS diagnosis ]
    Secondary outcomes for Aim 1.
  • Radiation therapy received [ Time Frame: 9 months within DCIS diagnosis ]
    Secondary outcomes for Aim 1.
  • Overall survival [ Time Frame: From 9 months post-diagnosis to death/end of study period (up to 1.5 years) ]
    Secondary outcomes for Aim 2.
  • Lasting side effects [ Time Frame: From 9 months post-diagnosis to death/end of study period (up to 1.5 years) ]
    Secondary outcomes for Aim 2.
  • Breast cancer specific survival [ Time Frame: From 9 months post-diagnosis to death/end of study period (up to 1.5 years) ]
    Primary outcomes for Aim 2.
  • Ipsilateral invasive breast cancer occurence [ Time Frame: From 9 months post-diagnosis to death/end of study period (up to 1.5 years) ]
    Primary outcomes for Aim 2.
  • Subsequent mastectomy as treated recurrence [ Time Frame: From 9 months post-diagnosis to death/end of study period (up to 1.5 years) ]
    Primary outcomes for Aim 2.


Original Secondary Outcome: Same as current

Information By: Yale University

Dates:
Date Received: August 30, 2016
Date Started: September 2016
Date Completion: February 2018
Last Updated: September 15, 2016
Last Verified: September 2016