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The PROMISE Study: Duavee in Women With DCIS

Primary Purpose

Ductal Breast Carcinoma In Situ, Postmenopausal

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Conjugated Estrogens/Bazedoxifene
Laboratory Biomarker Analysis
Pharmacological Study
Placebo
Quality-of-Life Assessment
Questionnaire Administration
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Ductal Breast Carcinoma In Situ

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Women must have newly diagnosed histologically confirmed ER (+) DCIS scheduled to undergo surgical therapy. The pathology report (signed pathology report from attending pathologist) from each individual institution will be used to determine eligibility. Extent of DCIS in imaging per site institutional standard.

Note: After the patient has completed the study and the slides have been sent to NU, our pathologists will review the slides to confirm the diagnosis.

Note: DCIS suspicious for micro invasion is eligible on core biopsy. This is due to the fact that many these patients will not have invasion on final pathology.

Note: Women presenting with bilaterial DCIS are eligible but if both right and left DCIS are ER+, we will only accept tissue from the side with the largest area of DCIS based on imaging and pathology criteria outlined later in the protocol.

  • DCIS must be ≥ 1cm based on extent of calcifications, presence of a mass on ultrasound OR enhancement on MRI OR DCIS must be ≥ 5mm of DCIS on one single core. Can be < 5mm if DCIS is identified on multiple cores (at least 2 cores)
  • Women presenting after excision with positive margins are eligible. Ki-67, Cox-2, P-16, expression in immediately adjacent tissue is similar to what is found in DCIS.

Note: Positive margins are defined as DCIS present at the inked margin or DCIS <1mm from the margin. - Women must be postmenopausal (defined as no menstrual cycle for 12 months or surgical history of bilateral salpingoopherectomy. Postmenopausal women of all races and ethnic groups are eligible to participate for this trial. Men are not eligible.

Note: women who have had a hysterectomy without a bilateral salpingoopherectomy may still be pre-menopausal. Confirmation of postmenopausal status is required for these patients and will be measured by testing levels of estradiol, progesterone and FSH (lab ranges per institutional standards). In addition, confirmation of postmenopausal status may be performed in any patient with unclear menopausal status per treating physician discretion.

  • Women in the age range of ≥18-79 (inclusive)
  • ECOG performance status ≤ 2 (Karnofsky ≥60%, see Appendix A).
  • Patients must have normal organ and marrow function as defined below Leukocytes ≥3,000/mcL Platelets ≥100,000/mcL Hemoglobin ≥ 9g/dl Total Bilirubin ≤ 1.5 x upper limit of normal (ULN) AST (SGOT) and ALT (SGPT)

    • 2.5 × institutional upper limit of normal Serum Creatinine OR Creatinine Clearance
    • 1.5 x ULN ≥60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal (calculated with the Cockcroft-Gault Equation in EPIC)
  • Patients must have the ability to swallow oral medication
  • Ability to understand and the willingness to sign a written informed consent document and comply with all procedures

Exclusion Criteria

  • Patients who are receiving any other investigational agents. A minimum of 4 weeks wash-out period is required for eligibility. Please contact Principal Investigator, Dr. Swati Kulkarni for further clarification
  • Patients with a "currently active" second malignancy other than non-melanoma skin cancers. Patients are not considered to have a "currently active" malignancy if they have completed therapy and are free of disease for ≥ 1 years.
  • History of allergic reactions/hypersensitivity attributed to compounds of similar chemical or biologic composition to CE/BZA. (I.e. same class of drug as CE/BZA)
  • Current HRT, SERM or Aromatase Inhibitor (AI) use. If yes, the wash-out period is 30 days before diagnostic core needle biopsy.

Note: Local therapy (i.e. estrogen cream) will be permitted due to low systemic absorption of estrogen. Note: if patient is registered prior to completed washout, diagnostic core needle biopsy date will need to be provided.

  • Confirmed current of invasive breast cancer Note: Patients who do not currently have a diagnosis of invasive breast cancer but who are planning to undergo additional standard of care testing to rule out a diagnosis of invasive breast cancer (such as future imaging or biopsy) are eligible. If the results of this standard of care testing later confirm that the subject has a diagnosis of invasive breast cancer, the subject should be withdrawn from the study at that time.
  • Patients with recurrent ipsilateral DCIS
  • Any of the following conditions, or a known history of any of the following:

    • deep venous thrombosis,
    • pulmonary embolism,
    • retinal vascular thrombosis,
    • any arterial thrombosis,- Known protein C, protein S, or anti-thrombin deficiency or other known thrombophilic disorders including stroke and myocardial infarction
  • Unexplained/undiagnosed abnormal uterine bleeding (concern for undiagnosed endometrial cancer)
  • Women who are pregnant or lactating. CE/BZA may cause fetal harm when administered to a pregnant woman. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus.
  • Patients receiving any medications or substances that are strong inhibitors or inducers of CYP3A4 and UGT are ineligible. The wash out period for such drugs is a minimum of 7 days or 5 half-lives whichever is shorter. Refer to Appendix C.

Note: As this list is constantly evolving, if a medication is incorrectly documented as prohibited in this protocol, documentation from the site pharmacist to the contrary will be acceptable for the purposes of registration.

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Sites / Locations

  • University of Colorado at Denver/ Department of SurgeryRecruiting
  • Northwestern UniversityRecruiting
  • Northwestern Medicine - Delnor/Warrenville Cancer Centers/Central DuPage HospitalRecruiting
  • Northwestern UniversityRecruiting
  • John's Hopkins UniversityRecruiting
  • Dana Farber/Partners Cancer Care IncRecruiting
  • Washington University in St. Louis/ Siteman Cancer CenterRecruiting
  • Thomas Jefferson UniversityRecruiting
  • University of Pittsburg/ Magee-Womens HospitalRecruiting
  • Huntsman Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm I (conjugated estrogens/bazedoxifene)

Arm II (placebo)

Arm Description

Patients receive conjugated estrogens/bazedoxifene orally (PO) once daily (QD) for 28 +/- 7 days in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery.

Patients receive placebo PO QD for 28 +/- 7 days in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery.

Outcomes

Primary Outcome Measures

Change in Ki-67 protein expression
Evaluating if CE/BZA reduces proliferation as measured by Ki-67 protein expression. Change in Ki-67 between baseline and end of the intervention will be measured.

Secondary Outcome Measures

Expression of ERα
Determine if CE/BZA modulates expression of ERα.
Expression of progesterone receptor (PR)
Evaluate if CE/BZA modulates expression of PR
Expression of human epidermal growth factor receptor 2 (HER-2)
Determine if CE/BZA modulates expression of HER-2.
Epithelial markers of progression
Evaluate if CE/BZA modulates a previously validated set of epithelial markers of progression.
Expression of the stromal marker CD36
Determine if TSECs will restore expression of the stromal marker CD36.
Repression of pro-tumorigenic ECM proteins
Determine if TSECs will repress pro-tumorigenic ECM proteins.
Repression of soluble factors
Determine if TSECs will repress soluble factors.
Quality of Life (QOL)
Evaluate if a short intervention with CE/BZA results in any difference in Quality of Life (QOL) as it relates to menopausal symptoms in postmenopausal women with DCIS.
Breast Cancer Prevention Trial Eight Symptom Scale (BESS) questionnaire
Determine if a short intervention with CE/BZA has a favorable side effect profile compared with other endocrine therapy interventions using the validated Breast Cancer Prevention Trial Eight Symptom Scale (BESS) questionnaire.

Full Information

First Posted
February 24, 2016
Last Updated
February 6, 2023
Sponsor
Northwestern University
Collaborators
National Cancer Institute (NCI), Pfizer, University of Chicago - Department for Cancer Research, University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT02694809
Brief Title
The PROMISE Study: Duavee in Women With DCIS
Official Title
A Large-scale Multicenter Phase II Study Evaluating the Protective Effect of a Tissue Selective Estrogen Complex (TSEC) in Women With Newly Diagnosed Ductal Carcinoma in Situ
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 2017 (undefined)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Northwestern University
Collaborators
National Cancer Institute (NCI), Pfizer, University of Chicago - Department for Cancer Research, University of California, San Francisco

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The main purpose of this study is to determine if taking the study drug, conjugated estrogens/bazedoxifene (Duavee®) causes any changes in the proliferation markers within the breast tissue of the study subjects. The study drug is approved by the US Food and Drug Administration in healthy postmenopausal women to treat certain symptoms of menopause such as hot flashes. Since it is not approved in women with DCIS, its use in this study is experimental. This study will also look at whether taking the study drug causes any significant or undesirable side effects in women with DCIS. The researchers hope that this study will help them determine if taking the study drug is safe in women taking DCIS and if it can possibly reduce the risk of developing breast cancer in women with DCIS.
Detailed Description
PRIMARY OBJECTIVES; • To determine if CE/BZA reduces proliferation as measured by Ki-67 protein expression Secondary Objectives: To determine if CE/BZA modulates expression of ERα, progesterone receptor (PR) and human epidermal growth factor receptor 2 (HER-2). To determine if CE/BZA modulates a previously validated set of epithelial markers of progression. To determine if TSECs will restore expression of the stromal marker CD36 and repress pro-tumorigenic ECM proteins and soluble factors. To determine if a short intervention with CE/BZA results in any difference in Quality of Life (QOL) as it relates to menopausal symptoms in postmenopausal women with DCIS. To determine if a short intervention with CE/BZA has a favorable side effect profile compared with other endocrine therapy interventions using the validated Breast Cancer Prevention Trial Eight Symptom Scale (BESS) questionnaire. Exploratory Objectives To determine if CE/BZA alters expression of estrogen-modulated genes and elicits novel ER dependent-gene signatures in breast epithelium To demonstrate that CE/BZA does not upregulate Anterior Gradient 2 (AGR2), a marker of ERα agonist activity. To determine if CE/BZA will modulate some aspects of immune function as measured by a switch to a M2-type pro-tumorigenic macrophage signature and an immunosuppressive T cell signature. To determine if a short intervention with CE/BZA alters expression of estrogen-modulated genes and elicits novel ER dependent-gene signatures in the breast stroma. To determine if CE/BZA affects plasma concentrations of BZA in patients with the UGT1A1*28 gene polymorphism. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive conjugated estrogens/bazedoxifene orally (PO) once daily (QD) for 28 +/- 7 days in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery. ARM II: Patients receive placebo PO QD for 28 +/- 7 days in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ductal Breast Carcinoma In Situ, Postmenopausal

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm I (conjugated estrogens/bazedoxifene)
Arm Type
Experimental
Arm Description
Patients receive conjugated estrogens/bazedoxifene orally (PO) once daily (QD) for 28 +/- 7 days in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery.
Arm Title
Arm II (placebo)
Arm Type
Placebo Comparator
Arm Description
Patients receive placebo PO QD for 28 +/- 7 days in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery.
Intervention Type
Drug
Intervention Name(s)
Conjugated Estrogens/Bazedoxifene
Intervention Description
Given PO
Intervention Type
Other
Intervention Name(s)
Laboratory Biomarker Analysis
Intervention Description
Correlative studies
Intervention Type
Other
Intervention Name(s)
Pharmacological Study
Intervention Description
Correlative studies
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
placebo therapy, PLCB, sham therapy
Intervention Description
Given PO
Intervention Type
Procedure
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Change in Ki-67 protein expression
Description
Evaluating if CE/BZA reduces proliferation as measured by Ki-67 protein expression. Change in Ki-67 between baseline and end of the intervention will be measured.
Time Frame
Up to 5 weeks
Secondary Outcome Measure Information:
Title
Expression of ERα
Description
Determine if CE/BZA modulates expression of ERα.
Time Frame
Up to 5 weeks
Title
Expression of progesterone receptor (PR)
Description
Evaluate if CE/BZA modulates expression of PR
Time Frame
Up to 5 weeks
Title
Expression of human epidermal growth factor receptor 2 (HER-2)
Description
Determine if CE/BZA modulates expression of HER-2.
Time Frame
Up to 5 weeks
Title
Epithelial markers of progression
Description
Evaluate if CE/BZA modulates a previously validated set of epithelial markers of progression.
Time Frame
Up to 5 weeks
Title
Expression of the stromal marker CD36
Description
Determine if TSECs will restore expression of the stromal marker CD36.
Time Frame
Up to 5 weeks
Title
Repression of pro-tumorigenic ECM proteins
Description
Determine if TSECs will repress pro-tumorigenic ECM proteins.
Time Frame
Up to 5 weeks
Title
Repression of soluble factors
Description
Determine if TSECs will repress soluble factors.
Time Frame
Up to 5 weeks
Title
Quality of Life (QOL)
Description
Evaluate if a short intervention with CE/BZA results in any difference in Quality of Life (QOL) as it relates to menopausal symptoms in postmenopausal women with DCIS.
Time Frame
Up to 5 weeks
Title
Breast Cancer Prevention Trial Eight Symptom Scale (BESS) questionnaire
Description
Determine if a short intervention with CE/BZA has a favorable side effect profile compared with other endocrine therapy interventions using the validated Breast Cancer Prevention Trial Eight Symptom Scale (BESS) questionnaire.
Time Frame
Up to 5 weeks
Other Pre-specified Outcome Measures:
Title
Expression of estrogen-modulated genes in breast epithelium
Description
Determine if CE/BZA alters expression of estrogen-modulated genes in breast epithelium.
Time Frame
Up to 5 weeks
Title
Novel ER dependent-gene signatures in breast epithelium
Description
Evaluate if CE/BZA elicits novel ER dependent-gene signatures in breast epithelium.
Time Frame
Up to 5 weeks
Title
Anterior Gradient 2 (AGR2)
Description
Demonstrate that CE/BZA does not upregulate Anterior Gradient 2 (AGR2), a marker of ERα agonist activity.
Time Frame
Up to 5 weeks
Title
M2-type pro-tumorigenic macrophage signature
Description
Determine if CE/BZA will modulate some aspects of immune function as measured by a switch to a M2-type pro-tumorigenic macrophage signature.
Time Frame
Up to 5 weeks
Title
Immunosuppressive T cell signature
Description
Determine if CE/BZA will modulate some aspects of immune function as measured by a switch to a an immunosuppressive T cell signature.
Time Frame
Up to 5 weeks
Title
Estrogen-modulated genes in the breast stroma
Description
Evaluate if a short intervention with CE/BZA alters expression of estrogen-modulated genes in the breast stroma.
Time Frame
Up to 5 weeks
Title
Novel ER dependent-gene signatures in the breast stroma
Description
Determine if a short intervention with CE/BZA elicits novel ER dependent-gene signatures in the breast stroma.
Time Frame
Up to 5 weeks
Title
plasma concentrations of BZA
Description
Evaluate if CE/BZA affects plasma concentrations of BZA in patients with the UGT1A1*28 gene polymorphism.
Time Frame
Up to 5 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women must have newly diagnosed histologically confirmed ER (+) DCIS scheduled to undergo surgical therapy. The pathology report (signed pathology report from attending pathologist) from each individual institution will be used to determine eligibility. Extent of DCIS in imaging per site institutional standard. Note: After the patient has completed the study and the slides have been sent to NU, our pathologists will review the slides to confirm the diagnosis. Note: DCIS suspicious for micro invasion is eligible on core biopsy. This is due to the fact that many these patients will not have invasion on final pathology. Note: Women presenting with bilaterial DCIS are eligible but if both right and left DCIS are ER+, we will only accept tissue from the side with the largest area of DCIS based on imaging and pathology criteria outlined later in the protocol. DCIS must be ≥ 1cm based on extent of calcifications, presence of a mass on ultrasound OR enhancement on MRI OR DCIS must be ≥ 5mm of DCIS on one single core. Can be < 5mm if DCIS is identified on multiple cores (at least 2 cores) Women presenting after excision with positive margins are eligible. Ki-67, Cox-2, P-16, expression in immediately adjacent tissue is similar to what is found in DCIS. Note: Positive margins are defined as DCIS present at the inked margin or DCIS <1mm from the margin. - Women must be postmenopausal (defined as no menstrual cycle for 12 months or surgical history of bilateral salpingoopherectomy. Postmenopausal women of all races and ethnic groups are eligible to participate for this trial. Men are not eligible. Note: women who have had a hysterectomy without a bilateral salpingoopherectomy may still be pre-menopausal. Confirmation of postmenopausal status is required for these patients and will be measured by testing levels of estradiol, progesterone and FSH (lab ranges per institutional standards). In addition, confirmation of postmenopausal status may be performed in any patient with unclear menopausal status per treating physician discretion. Women in the age range of ≥18-79 (inclusive) ECOG performance status ≤ 2 (Karnofsky ≥60%, see Appendix A). Patients must have normal organ and marrow function as defined below Leukocytes ≥3,000/mcL Platelets ≥100,000/mcL Hemoglobin ≥ 9g/dl Total Bilirubin ≤ 1.5 x upper limit of normal (ULN) AST (SGOT) and ALT (SGPT) 2.5 × institutional upper limit of normal Serum Creatinine OR Creatinine Clearance 1.5 x ULN ≥60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal (calculated with the Cockcroft-Gault Equation in EPIC) Patients must have the ability to swallow oral medication Ability to understand and the willingness to sign a written informed consent document and comply with all procedures Exclusion Criteria Patients who are receiving any other investigational agents. A minimum of 4 weeks wash-out period is required for eligibility. Please contact Principal Investigator, Dr. Swati Kulkarni for further clarification Patients with a "currently active" second malignancy other than non-melanoma skin cancers. Patients are not considered to have a "currently active" malignancy if they have completed therapy and are free of disease for ≥ 1 years. History of allergic reactions/hypersensitivity attributed to compounds of similar chemical or biologic composition to CE/BZA. (I.e. same class of drug as CE/BZA) Current HRT, SERM or Aromatase Inhibitor (AI) use. If yes, the wash-out period is 30 days before diagnostic core needle biopsy. Note: Local therapy (i.e. estrogen cream) will be permitted due to low systemic absorption of estrogen. Note: if patient is registered prior to completed washout, diagnostic core needle biopsy date will need to be provided. Confirmed current of invasive breast cancer Note: Patients who do not currently have a diagnosis of invasive breast cancer but who are planning to undergo additional standard of care testing to rule out a diagnosis of invasive breast cancer (such as future imaging or biopsy) are eligible. If the results of this standard of care testing later confirm that the subject has a diagnosis of invasive breast cancer, the subject should be withdrawn from the study at that time. Patients with recurrent ipsilateral DCIS Any of the following conditions, or a known history of any of the following: deep venous thrombosis, pulmonary embolism, retinal vascular thrombosis, any arterial thrombosis,- Known protein C, protein S, or anti-thrombin deficiency or other known thrombophilic disorders including stroke and myocardial infarction Unexplained/undiagnosed abnormal uterine bleeding (concern for undiagnosed endometrial cancer) Women who are pregnant or lactating. CE/BZA may cause fetal harm when administered to a pregnant woman. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus. Patients receiving any medications or substances that are strong inhibitors or inducers of CYP3A4 and UGT are ineligible. The wash out period for such drugs is a minimum of 7 days or 5 half-lives whichever is shorter. Refer to Appendix C. Note: As this list is constantly evolving, if a medication is incorrectly documented as prohibited in this protocol, documentation from the site pharmacist to the contrary will be acceptable for the purposes of registration. - Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Coordinator
Phone
(312)695-1301
Email
cancertrials@northwestern.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Swati Kulkarni, MD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado at Denver/ Department of Surgery
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gretchen McGuire Ahrendt, MD FACS
Phone
303-724-8366
First Name & Middle Initial & Last Name & Degree
Gretchen McGuire Ahrendt, MD FACS
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Swati A. Kulkarni
Phone
312-503-2899
Email
skulkarn@nm.org
First Name & Middle Initial & Last Name & Degree
Swati A. Kulkarni, MD
First Name & Middle Initial & Last Name & Degree
Seema Khan, MD
First Name & Middle Initial & Last Name & Degree
Luis S. Blanco Jr., MD
Facility Name
Northwestern Medicine - Delnor/Warrenville Cancer Centers/Central DuPage Hospital
City
Geneva
State/Province
Illinois
ZIP/Postal Code
60134
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mary Ahn, MD, FACS
Phone
630-307-7799
First Name & Middle Initial & Last Name & Degree
Mary Ahn, MD, FACS
Facility Name
Northwestern University
City
Lake Forest
State/Province
Illinois
ZIP/Postal Code
60045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Denise Monahan, MD, FACS
Email
dmonahan@nm.org
First Name & Middle Initial & Last Name & Degree
Denise M. Monahan, MD, FACS
Facility Name
John's Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David M. Euhus, MD
Phone
410-502-0197
First Name & Middle Initial & Last Name & Degree
David M. Euhus, MD
Facility Name
Dana Farber/Partners Cancer Care Inc
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Judy E. Garber, MD, MPH
Phone
617-632-2282
First Name & Middle Initial & Last Name & Degree
Judy E. Garber, MD, MPH
Facility Name
Washington University in St. Louis/ Siteman Cancer Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rebecca Aft, MD, PhD
Phone
314-362-2280
First Name & Middle Initial & Last Name & Degree
Rebecca Aft, MD, PhD
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melissa Lazar, MD
Phone
215-955-6999
First Name & Middle Initial & Last Name & Degree
Melissa Lazar, MD
Facility Name
University of Pittsburg/ Magee-Womens Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emilia Diego, MD
Phone
412-641-4274
First Name & Middle Initial & Last Name & Degree
Emilia Diego, MD
Facility Name
Huntsman Cancer Institute
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kirstyn Brownson, MD
Phone
801-581-4477
First Name & Middle Initial & Last Name & Degree
Kirstyn Brownson, MD

12. IPD Sharing Statement

Learn more about this trial

The PROMISE Study: Duavee in Women With DCIS

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