Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Carcinoma

Carcinoma in Situ

Carcinoma, Ductal

Carcinoma, Intraductal, Noninfiltrating

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Breast Neoplasms

Breast Carcinoma In Situ

The Aim 1 Cohort is constructed to perform analysis to address study objective Aim 1. This cohort includes patients diagnosed at ages 67-94 years with DCIS between January 1998 and December 2011, and received BCS as their first surgery. Patients in this cohort include those who received sentinel lymph node biopsy (SLNB) and who didn't receive SLNB.

The Aim 1 Cohort and the Aim 2 Cohort can overlap.

The Aim 2 Cohort is constructed to perform analysis to address study objective Aim 2. This cohort includes patients diagnosed at ages 67-94 years with DCIS between January 2001 and December 2013, and received BCS as their first surgery. Patients in this cohort include those who received sentinel lymph node biopsy (SLNB) and who didn't receive SLNB.

The Aim 1 Cohort and the Aim 2 Cohort can overlap.

Intervention is defined as that the DCIS patient has undergone SLNB. Patients in each cohort (group) include those who underwent SLNB (intervention) and those who did not (control).

Sentinel lymph node biopsy (SLNB)

Shi-Yi Wang, MD, PhD

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. Using distance to the nearest provider that uses SLNB for DCIS or surgeon's tendency in using SLNB for stage I/II breast cancer, the investigators also plan to conduct instrument variable analyses if necessary. Stratifying patients by key DCIS characteristics (including grade, comedonecrosis, and tumor size) and their predicted life expectancy (given their age and comorbidities), the investigators also hope to identify patient subgroups who may safely forgo SLNB. The study would provide evidence on the efficacy and safety outcome of SLNB for DCIS management.

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. not receiving SLNB among older DCIS patients who received BCS. With this data, the investigators also aim to identify sub-populations for whom less intensive treatments may be appropriate. Using the Surveillance, Epidemiology, and End Result (SEER)-Medicare linked data, our project's overarching aims are:

Among older women with DCIS who have received BCS as their first surgery, to compare the outcomes of receiving sentinel lymph node biopsy (SLNB) vs. not receiving SLNB within 6 months of DCIS diagnosis:

Aim 1: 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 BCS 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 the study period.

Our study is a retrospective cohort study with the study population being DCIS patients older than 67 years (hereafter referred to as older women) who were enrolled in a fee-for-service Medicare program and resided in the SEER areas from 1998 to 2011 (2001 to 2013 for Aim 2) and who were followed up to 2012 (2015 for Aim 2). The investigators selected age 67 years as a cut-off value because the investigators plan to use two years of claims data to identify patient comorbidities and control for them in our statistical models, and data is first available at age 65. 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. Using distance to the nearest provider that uses SLNB for DCIS or surgeon's tendency in using SLNB for stage I/II breast cancer, the investigators also plan to conduct instrument variable analyses if necessary. Stratifying patients by key DCIS characteristics (including grade, comedonecrosis, and tumor size) and their predicted life expectancy (given their age and comorbidities), the investigators also hope to identify patient subgroups who may safely forgo SLNB.

In comparisons of baseline characteristics between intervention and control groups, the investigators will conduct standard descriptive statistics using chi-square tests for categorical variables and t-tests for continuous variables. The investigators will tabulate the frequencies of outcomes of interests by the intervention vs. control group. For multivariable analyses, the investigators will apply proportional hazards models to test whether the intervention is associated with better outcomes.

the investigators plan to control for this issue using propensity score matching methodology. Prior literature has suggested inclusion of either all measured variables or those variables that are associated with treatment selection (SLNB status) when conducting an analysis using the propensity score method. Specifically, our approach to matching will be based on the Mahalanobis distance calculated using age, race, residence in a metropolitan county, comorbidity, prior influenza vaccination or prior visit to a primary care physician (both as proxies for access to care), income, preoperative MRI use, and tumor characteristics. Tumor characteristics include size, grade, comedonecrosis, and estrogen receptor status. By incorporating these factors in matching, the investigators expect to substantially decrease bias and balance the risk for outcomes of interest between the SLNB and non-SLNB groups. The difference in outcomes between the control and intervention groups will be estimated in a Kaplan-Meier curve. The investigators will estimate the relative risk in the propensity score matched sample using the standard method for matched-pair data. The investigators will use the Cox proportional hazards models to investigate the association between various factors (grade, tumor size, and estrogen receptor status) and outcomes.

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

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

Primary outcomes for Aim 1: Acute and subacute side effects include any complication, lymphedema, seroma, wound infection, and pain.

Secondary outcomes for Aim 1: receipt of mastectomy with and without SLNB after initial BCS through 6 months after DCIS diagnosis.

Secondary outcomes for Aim 1: Receipt of radiation therapy within 9 months of DCIS diagnosis.

Secondary outcomes for Aim 2: unadjusted side effects (any side effects, lymphedema, any infection, seroma, pain) in the matched sample by use of sentinel lymph node biopsy (SLNB). Any side effects refer to the occurrence of one or more of the following complications since diagnosis of DCIS: lymphedema related complications, any infection, seroma, and any pain.

Primary outcomes for Aim 2: Breast cancer specific mortality from 9 months post-diagnosis to death or the end of the study period (December, 2014).

Primary outcomes for Aim 2: Ipsilateral invasive breast cancer occurrence after 9 months of a DCIS diagnosis, per SEER reports.

Primary outcomes for Aim 2: Treated recurrence was defined by the receipt of mastectomy after 9 months of a DCIS diagnosis in the Aim 2 matched cohort.

Patient-Centered Outcomes Research Institute

Yale University

We do not collect adverse event information.

As a retrospective data analysis, we do not collect adverse event information.

The Aim 1 Cohort is constructed to perform analysis to address study objective Aim 1. The cohort population includes patients diagnosed at age 67-94 years with DCIS between January 1998 and December 2011, and had received BCS as their first surgery within 6 months of diagnosis.

Only those who did not receive sentinel lymph node biopsy (SLNB) were included (control group).

Aim 1 Cohort: No SLNB

The Aim 1 Cohort is constructed to perform analysis to address study objective Aim 1. The cohort population includes patients diagnosed at age 67-94 years with DCIS between January 1998 and December 2011, and had received BCS as their first surgery within 6 months of diagnosis.

Only those who received sentinel lymph node biopsy (SLNB) were included (intervention group).

Aim 1 Cohort: SLNB

The Aim 2 Cohort is constructed to perform analysis to address study objective Aim 2.The cohort population includes patients diagnosed at age 67-94 years with DCIS between January 2001 and December 2013, and had received BCS as their first surgery within 6 months of diagnosis.

Only those who did not receive sentinel lymph node biopsy (SLNB) were included (control group).

Aim 2 Cohort: No SLNB

The Aim 2 Cohort is constructed to perform analysis to address study objective Aim 2.The cohort population includes patients diagnosed at age 67-94 years with DCIS between January 2001 and December 2013, and had received BCS as their first surgery within 6 months of diagnosis.

Only those who received sentinel lymph node biopsy (SLNB) were included (intervention group).

Aim 2 Cohort: SLNB

Total

67-69 years old

70-74 years old

75-79 years old

80-84 years old

85+ years old

Age, Customized

Sex: Female, Male

Ethnicity (NIH/OMB)

White

Black

Other

Race/Ethnicity, Customized

United States

Region of Enrollment

Married

Unmarried

Marital Status

Well differentiated

Moderately differentiated

Poorly differentiated

Undifferentiated

Unknown

Tumor Grade

<2.0 cm

2.0-<5.0 cm

>5.0 cm

Missing

Tumor size

ER- and PR-

ER+ and PR+

Hormone receptors

Comedonecrosis

Not assigned

"Surgeon volume" reflects women who saw a provider who performed breast conserving surgery on a certain number of women in our sample for the year of this woman's surgery. The larger the number, the larger the provider's patient volume.

Surgeon Volume

None

1 to 2

3 or more

Elixhauser comorbidity measure: 0 (no comorbidity) to 30 (multiple comorbidities), is a claim-based comorbidity index, that requires the diagnosis code to appear on either an inpatient claim or \>= 2 outpatient claims greater than 30 days apart in order for the condition to be considered present.

Elixhauser Comorbidity

1998-1999

2000-2003

2004-2005

2006-2007

2008-2009

2010-2011

2012-2013

Year of Diagnosis

Midwest

Northeast

South

West

Geographic Region

Mahalanobis matching was used to adjust for baseline characteristics and account for potential treatment bias, where those who receive sentinel lymph node biopsy (SLNB) might be systematically different from those who do not. The final matched Aim 1 \& 2 cohorts were used for analyses.

Testing the association between use of sentinel lymph node biopsy (SLNB) and any complication in the Aim 1 matched cohort.

Testing the association between use of sentinel lymph node biopsy (SLNB) and lymphedema in the Aim 1 matched cohort.

Testing the association between use of sentinel lymph node biopsy (SLNB) and wound infection in the Aim 1 matched cohort.

Testing the association between use of sentinel lymph node biopsy (SLNB) and seroma in the Aim 1 matched cohort.

Testing the association between use of sentinel lymph node biopsy (SLNB) and pain in the Aim 1 matched cohort.

Number of participants with any side effects

Number of participants with lymphedema

Number of participants with wound Infection

Number of participants with seroma

Number of participants with pain

The Aim 1 Cohort was constructed to perform analysis to address study objective Aim 1. The cohort population includes patients diagnosed at age 67-94 years with DCIS between January 1998 and December 2011, and had received BCS as their first surgery within 6 months of diagnosis.

Only those who did not receive sentinel lymph node biopsy (SLNB) were included (control group).

Matched Aim 1 Cohort: No SLNB

The Aim 1 Cohort was constructed to perform analysis to address study objective Aim 1. The cohort population includes patients diagnosed at age 67-94 years with DCIS between January 1998 and December 2011, and had received BCS as their first surgery within 6 months of diagnosis.

Only those who received sentinel lymph node biopsy (SLNB) were included (intervention group).

Matched Aim 1 Cohort: SLNB

Mahalanobis matching was used to adjust for baseline characteristics to account for potential treatment selection bias, where those who received SLNB might be systematically different from those who did not. Matches were assigned by choosing the two best non-SLNB patient matches for each SLNB patient. The final matched cohort was used for analyses.

Side Effects (Claim-based Measure), Including Lymphedema, Seroma, Wound Infection, or Pain

Testing the association between receipt of SLNB and receipt of mastectomy within 6 months of DCIS diagnosis.

Mahalanobis matching was used to adjust for baseline characteristics and account for potential treatment selection bias, where those who receive SLNB might be systematically different from those who do not. Matches were assigned by choosing the two best non-SLNB patient matches for each SLNB patient. The final matched sample was used for analyses.

Receipt of Mastectomy

Testing the association between receipt of SLNB and receipt of radiation therapy within 9 months of DCIS diagnosis.

Mahalanobis matching was used to adjust for baseline characteristics and account for potential treatment selection bias, where those who receive SLNB might be systematically different from those who do not. Matches were assigned by choosing the two best non-SLNB patient matches for each SLNB patient. The final matched cohort was used for analyses.

Receipt of Radiation Therapy

Testing the association between use of sentinel lymph node biopsy (SLNB) and overall mortality in the Aim 2 matched cohort.

Matched Aim 2 Cohort: No SLNB

Matched Aim 2 Cohort: SLNB

Overall Survival

Testing the association between use of sentinel lymph node biopsy (SLNB) and any side effects in the matched Aim 2 cohort.

Testing the association between use of sentinel lymph node biopsy (SLNB) and lymphedema related complications in the Aim 2 matched cohort.

Testing the association between use of sentinel lymph node biopsy (SLNB) and any infection in the Aim 2 matched cohort.

Testing the association between use of sentinel lymph node biopsy (SLNB) and seroma in the Aim 2 matched cohort.

Testing the association between use of sentinel lymph node biopsy (SLNB) and pain in the Aim 2 matched cohort.

Number of participants with any infection

Mahalanobis matching was used to adjust for baseline characteristics and account for potential treatment selection bias, where those who receive SLNB might be systematically different from those who do not. Matches were assigned by choosing the two best non-SLNB patient matches for each patient. The final matched cohort was used for analyses.

Lasting Side Effects (Claim-based Measure), Including Lymphedema, Seroma, Wound Infection, or Pain

Testing the association between between use of sentinel lymph node biopsy (SLNB) and breast cancer specific mortality.

Breast Cancer Specific Mortality

Testing the association between use of sentinel lymph node biopsy (SLNB) and ipsilateral invasive breast cancer occurrence for the Aim 2 matched cohort.

Ipsilateral Invasive Breast Cancer Occurrence

Testing the association between use of sentinel lymph node biopsy (SLNB) and treated recurrence in the Aim 2 matched cohort.

Treated Recurrence

The Aim 1 Cohort is constructed to perform analysis to address study objective Aim 1. The cohort population include patients older than 67 years old who have received BCS as their first surgery. The time period for defining the cohort is between January 1998 and December 2011. Patients in this group received SLNB.

Sentinel lymph node biopsy (SLNB): Intervention is defined as that the DCIS patient has undergone SLNB. Patients in each cohort (group) include those who underwent SLNB (intervention) and those who did not (control).

Aim 1 Cohort - SLNB

The Aim 1 Cohort is constructed to perform analysis to address study objective Aim 1. The cohort population include patients older than 67 years old who have received BCS as their first surgery. The time period for defining the cohort is between January 1998 and December 2011. Patients in this group did not receive SLNB.

Sentinel lymph node biopsy (SLNB): Intervention is defined as that the DCIS patient has undergone SLNB. Patients in each cohort (group) include those who underwent SLNB (intervention) and those who did not (control).

Aim 1 Cohort - No SLNB

The Aim 2 Cohort is constructed to perform analysis to address study objective Aim 2.The cohort population include patients older than 67 years old who have received BCS as the final treatment for their DCIS. The time period for defining the cohort is between January 2001 and December 2013. Patients in this group received sentinel lymph node biopsy (SLNB).

Sentinel lymph node biopsy (SLNB): Intervention is defined as that the DCIS patient has undergone SLNB. Patients in each cohort (group) include those who underwent SLNB (intervention) and those who did not (control).

Aim 2 Cohort - SLNB

The Aim 2 Cohort is constructed to perform analysis to address study objective Aim 2.The cohort population include patients older than 67 years old who have received BCS as the final treatment for their DCIS. The time period for defining the cohort is between January 2001 and December 2013. Patients in this group did not receive sentinel lymph node biopsy (SLNB).

Sentinel lymph node biopsy (SLNB): Intervention is defined as that the DCIS patient has undergone SLNB. Patients in each cohort (group) include those who underwent SLNB (intervention) and those who did not (control).

Aim 2 Cohort - No SLNB

Overall Study

Breast Diseases

Skin Diseases

Reproductive Control Agents

All Drugs and Chemicals

Oxytocin

Subjects would receive 4 IU of intranasal oxytocin; one spray in each nostril, single-use.

Intranasal spray, one spray or 4 IU of oxytocin will be administered into each nostril of each patient about 15-30 minutes before NAF collection

Intranasal Oxytocin

Sheldon Feldman, MD

The purpose of this study is to examine the genetic material called microRNA of three types of specimens from women with breast cancer. The study also seeks to examine the effectiveness of using a new agent called oxytocin to increase the amount of nipple fluid that can be collected during surgery.

Vast majority of breast cancers arise from ductal epithelium. Ductal cells can be collected through the nipple orifice very early in breast cancer development. The nipple aspirate ﬂuid (NAF) can be used to identify biomarkers that predict risk of breast cancer. To date, the biomarkers identified in nipple aspirate ﬂuid (NAF) have limited utility due to the large volume of NAF required for data analysis. Recent studies show intranasal oxytocin's utility in enhancing the yield of nipple aspirate ﬂuid (NAF) among healthy, non-lactating female patients as well as those at high risk for breast cancer. This capability is crucial for the analysis of various markers associated with breast disease and cancer such as microRNAs. The primary aim of the study is to determine whether the microRNA profile characterization is feasible with the collection of tissue, serum and NAF in patients with in situ and invasive breast cancer. Intranasal oxytocin will be used to enhance ﬂuid yielding of the NAF.

Pilot Study of Oxytocin and microRNA Identification in NAF, Serum, and Tissue in Women With Breast Cancer

Identifying the miR Fingerprint in NAF, Serum, and Tissue in Patients With Ductal Carcinoma in Situ (DCIS) or Invasive Breast Cancer

Montefiore Medical Center

Subjects would receive 4 IU of intranasal oxytocin; one spray in each nostril, single-use.

Intranasal Oxytocin: Intranasal spray, one spray or 4 IU of oxytocin will be administered into each nostril of each patient about 15-30 minutes before NAF collection

Age, Categorical

Race (NIH/OMB)

Dr. Sheldon Feldman, Chief Breast Surgery and Breast Surgery Oncology

The study was voluntarily suspended as documented in IND Annual Report (Serial Number 0007). Data was not collected/aggregated and no interim analyses were conducted.

Percentage of Patients With Detection of microRNA in NAF, Serum, or Tissue

Percentage of Patients With Collection of ≥ 5 μL of Nipple Aspirate Fluid

7.5 gray (Gy) × 3 fractions via multicatheter brachytherapy

Accelerated partial breast irradiation

Lindsey Gwaltney, RN

CTO Breast Team

Bridget Quinn, MD, Ph.D

The purpose of this study is to compare any good and bad effects of giving radiation treatment for breast cancer in 3 treatments over about 2 days.

This phase 2, single-arm prospective study has been designed to determine the safety of delivering accelerated partial breast irradiation (APBI) with a multicatheter interstitial implant in a short course over 1.5 days

ASHBY: Accelerated Super-Hypofractionated Breast Brachytherapy

Accelerated Super-Hypofractionated Breast Brachytherapy - ASHBY Trial

Determine the incidence of accelerated partial breast irradiation (APBI) related toxicities, adverse events, of interest occurring at grade ≥3 within 1 year and 3 years after APBI. The APBI-related toxicities specified in Section 10.1 will be explicitly evaluated at all follow-up appointments. All APBI-related toxicities of interest will be captured, regardless of grade, beginning with the start of study treatment and continuing until the patient is off study utilizing study-specific grading criteria in place of Common Terminology Criteria for Adverse Events (CTCAE) v5.0.

Cosmesis will be assessed utilizing the Breast Cancer Treatment Outcome Scale (BCTOS-12), a self-report instrument that evaluated the aesthetic outcome after breast conserving surgery (BCS). the Aesthetic Status, is composed of eight items referring to the breast. the new Aesthetic Status comprises eight items: (1) "breast shape", (2) "breast texture", (3) "nipple appearance", (4) "breast tenderness", (5) "scar tissue", (6) "breast swelling", (7) "fit of bra", and (8) "breast sensitivity".

Patients are instructed to rate each item of the BCTOS questionnaire on a four-point rating scale evaluating the differences between the treated and untreated breast (1 = no difference to 4 = large difference). The score for each subscale is calculated as the mean of its items, with the score ranging from 1.00 to 4.00. A higher score reflects a poorer status.

Cosmesis will be assessed utilizing the Breast Cancer Treatment Outcome Scale (BCTOS-12), a self-report instrument that evaluated the functional outcome after breast conserving surgery (BCS). The questionnaire comprises 12 items and assesses various aspects of patients' subjective perception of the surgical result. The new Functional Status comprises four items: (1) "arm heaviness", (2) "shoulder discomfort", (3) "arm discomfort", (4) "arm swelling". Patients are instructed to rate each item of the BCTOS questionnaire on a four-point rating scale evaluating the differences between the treated and untreated breast

(1 = no difference to 4 = large difference). The score for each subscale is calculated as the mean of its items, with the score ranging from 1.00 to 4.00. A higher score reflects a poorer status.

The radiation-specific module of this patient-reported outcome measure evaluates patient satisfaction with the cosmetic effects of radiation by utilizing the BREAST-Q© (intellectual property of Drs Andrea Pusic, Anne Klassen and Stefan Cano. The BREAST-Q© is owned by Memorial Sloan Kettering Cancer Center and The University of British Columbia (Copyright ©2012, Memorial Sloan Kettering Cancer Center and The University of British Columbia). There is no overall or total BREAST-Q© score, only scores for each independent scale. All BREAST-Q© scales are transformed into scores that range from 0-100. The scores are computed by adding the response items together and then converting the raw sum scale score to a score from 0-100. For all BREAST-Q© scales, a higher score means greater satisfaction or better QOL.

This physician-rated form will be used by the treating surgeon or radiation oncologist to score cosmesis at baseline and annually for 5 years, where Excellent= treated breast looks essentially the same as the contralateral breast as it relates to radiation effects. This includes patients with grade 1 punctate scarring. Good= minimal but identifiable radiation effects of the treated breast. This includes patients with grade 2 punctate scarring.

Fair= significant radiation effects readily observable. Poor= severe sequelae of breast tissue secondary to radiation effect

The number of participants that achieve complete responses, partial response, or relapse. Disease control will be assessed by physical examination and mammography.

The number of participants that have a reportable adverse event (AE) per protocol criteria.

Virginia Commonwealth University

Antineoplastic Agents

Trastuzumab

Vaccines

Pertuzumab

Antineoplastic Agents, Immunological

Combination Therapy: HER-2 pulsed DC1 vaccine with trastuzumab and pertuzumab.

Vaccine administered weekly, with no more than 4 weeks delay over the course of 6 vaccines.

HER-2 pulsed DC1

The loading dose of Trastuzumab will be 8 mg/kg and the maintenance dose given week 4 will be 6 mg/kg, both standard doses of trastuzumab.

trastuzumab

Pertuzumab 420 mg IV will be given at the same time as trastuzumab.

pertuzumab

Brian Czerniecki, M.D., Ph.D.

The purpose of the study is to treat patients with Ductal carcinoma in situ (DCIS) with a combined treatment of DC1 vaccine with Trastuzumab. In this study the investigators will assess the safety and immunogenicity of the combination therapy. The target population is women over 18 years of age and have a diagnosis of DCIS that express HER-2 3 positive. Participants will receive 6 vaccines along with 2 doses of trastuzumab.

This study began at the Abramson Cancer Center of the University of Pennsylvania and will continue at H. Lee Moffitt Cancer Center and Research Institute.

A Phase I/II Trial of HER-2/Neu Pulsed DC1 Vaccine Combined With Trastuzumab for Patients With DCIS

Occurrence of AEs related to study treatment. Adverse Events will be graded according to NCI Common Toxicity Criteria for Adverse Events (CTCAE) V 4.02.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Comparative Effectiveness of Sentinel Lymph Node Biopsy for Ductal Carcinoma In Situ	NCT02908178	Ductal Carcinom...	Sentinel lymph ...	67 Years - 94 Years	Yale University
Pilot Study of Oxytocin and microRNA Identification in NAF, Serum, and Tissue in Women With Breast Cancer	NCT02127073	Breast Cancer Ductal Carcinom...	Intranasal Oxyt...	18 Years -	Montefiore Medical Center
ASHBY: Accelerated Super-Hypofractionated Breast Brachytherapy	NCT06185205	Breast Cancer	Accelerated par...	45 Years - 79 Years	Virginia Commonwealth University
A Phase I/II Trial of HER-2/Neu Pulsed DC1 Vaccine Combined With Trastuzumab for Patients With DCIS	NCT02336984	Breast Cancer	HER-2 pulsed DC... trastuzumab pertuzumab	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
MRI in Ductal Carcinoma in Situ (DCIS)	NCT03543397	Ductal Carcinom...		18 Years -	University Hospital, Strasbourg, France

Spots Global Cancer Trial Database for ductal carcinoma in situ (dcis)