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Secondary BRain Metastases Prevention After Isolated Intracranial Progression on Trastuzumab/Pertuzumab or T-DM1 in Patients With aDvanced Human Epidermal Growth Factor Receptor 2+ brEast Cancer With the Addition of Tucatinib (BRIDGET)

Primary Purpose

Brain Metastases, Human Epidermal Growth Factor 2 Positive Carcinoma of Breast, Advanced Breast Cancer

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Trastuzumab
Trastuzumab Emtansine (T-DM1)
Pertuzumab
Tucatinib
Sponsored by
Carey Anders, M.D.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Metastases focused on measuring Brain metastases, HER2+ breast cancer, Trastuzumab, Pertuzumab, T-DM1

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subject must meet all of the following applicable inclusion criteria to participate in this study:

  • Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
  • Age ≥ 18 years at the time of consent.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.
  • Locally advanced/unresectable or metastatic breast cancer with presence of brain metastases.
  • Histologically confirmed HER2+ breast carcinoma by ASCO-CAP guidelines, with HER2+ defined by in situ hybridization (ISH), immunohistochemistry (IHC), or fluorescence in situ hybridization (FISH) methodology on most recent biopsy.
  • Currently receiving: (1) first-line trastuzumab/pertuzumab OR (2) second-line T-DM1 in the metastatic setting OR (3) adjuvant trastuzumab-based therapy or T-DM1 with isolated intracranial recurrence. Patients with de novo metastatic disease and brain metastases or isolated intracranial recurrence can enter upon initiation of maintenance trastuzumab/pertuzumab after chemotherapy if deemed necessary by treating oncologist and meeting other inclusion criteria.
  • Systemic disease otherwise stable per RECIST 1.1 or no evidence of extracranial disease.
  • Adequate hepatic and renal function and hematologic parameters:

    • Absolute neutrophil count (ANC) ≥ 1.0 × 109/L
    • Platelets ≥ 100 × 109/L
    • Hemoglobin ≥ 9 g/dL
    • Total serum bilirubin ≤ 1.5 times upper limit of normal (ULN)
    • Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) ≤ 2.5 × ULN (or ≤ 5 × ULN if liver metastases are present)
    • Serum creatinine ≤ 1.5 x ULN or estimated creatinine clearance ≥ 50 mL/min as calculated using the Cockcroft-Gault (CG) equation
    • Left ventricular ejection fraction (LVEF) ≥ 50%.
  • Central nervous system inclusion - Based on screening brain magnetic resonance imaging (MRI), patients must have ALL of the following:

    • Adequate local therapy to existing brain lesions ≥ 5mm including surgical resection and/or stereotactic radiosurgery
    • Limited to first or second intracranial progression
    • Time since stereotactic radiosurgery (SRS) is ≥ 7 days prior to first dose of study treatment.
    • Time since surgical resection is ≥ 14 days prior to first dose of study treatment.
    • Time since local therapy < 8 weeks. Patients with de novo metastastic breast cancer presenting with brain metastases may enter following cessation of chemotherapy if within 12 weeks of local therapy to the brain.

NOTE: Relevant records of any CNS treatment including radiation must be available to allow for classification of target and non-target lesions

  • Females of childbearing potential must have a negative serum pregnancy test at screening. NOTE: Females are considered of child bearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are naturally postmenopausal for at least 12 consecutive months.
  • Females of childbearing potential and males must be willing to abstain from heterosexual intercourse or to use contraception as outlined in the protocol.

Exclusion Criteria:

Subjects meeting any of the criteria below may not participate in the study:

  • Previously been treated with: Lapatinib, neratinib, afatinib, tucatinib or other investigational HER2/epidermal growth factor receptor (EGFR) or HER2 tyrosine kinase inhibitor (TKI) at any time previously (patients treated with adjuvant neratinib allowed if relapse > 12 months after last dose).
  • Clinically significant cardiopulmonary disease.
  • Clinically significant acute infection requiring systemic antibacterial, antifungal, or antiviral therapy including:

    • tuberculosis (clinical evaluation that includes clinical history, physical examination, and radiographic findings, and TB testing in line with local practice),
    • hepatitis B (known positive HBV surface antigen (HBsAg) result),
    • hepatitis C, or
    • human immunodeficiency virus (positive HIV 1/2 antibodies)

NOTE: Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA. Subjects with HIV/AIDS with adequate antiviral therapy to control viral load would be allowed if they are stable and have been on treatment for ≥ 4 weeks prior to first dose of study drug(s). Subjects with viral hepatitis with controlled viral load would be allowed while on suppressive antiviral therapy. Testing not required.

  • Unable for any reason to undergo MRI of the brain
  • Use of a strong cytochrome P450 (CYP)2C8 inhibitor within 5 half-lives of the inhibitor, or a strong CYP3A4 or CYP2C8 inducer within 5 days prior to first dose of study treatment. See protocol.
  • Central nervous system exclusion - Based on screening brain MRI, patients must not have any of the following:

    • Ongoing use of systemic corticosteroids for control of symptoms of brain metastases at a total daily dose of > 2 mg of dexamethasone (or equivalent)
    • Diffuse leptomeningeal disease or positive CSF cytology; however, discreet dural-based metastases are allowed
    • Poorly controlled seizures. Defined as seizures that continue to occur despite optimal anticonvulsant medications based on investigator discretion.
    • History of whole brain radiation therapy
    • Any untreated brain lesions ≥ 5 mm
  • Active infection requiring intravenous systemic therapy.
  • Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).
  • Patients with a prior or concurrent malignancy within last 3 years whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen, per treating physician discretion, are not eligible for this trial.
  • Treatment with any investigational drug within 30 days prior to registration.

Sites / Locations

  • Dana Farber Cancer InstituteRecruiting
  • University of Michigan Health SystemRecruiting
  • Washington University in St. LouisRecruiting
  • Duke University Medical CenterRecruiting
  • Ohio State University Comprehensive Cancer CenterRecruiting
  • Providence Portland Medical CenterRecruiting
  • MD Anderson Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental Group

Arm Description

Trastuzumab/pertuzumab + tucatinib or T-DM1 + tucatinib 300mg of tucatinib taken orally twice a day. Taken on Days 1-21 of a 21 Day cycle (3 Weeks). Trastuzumab/Biosimilar administered per current package insert based on site standard of care guidelines Pertuzumab or Biosimilar administered per current package insert based on site standard of care guidelines Trastuzumab Emtansine (T-DM1) administered per current package insert based on site standard of care guidelines

Outcomes

Primary Outcome Measures

Progression Free Survival (PFS)
Evaluate the ability of tucatinib in combination with trastuzumab/pertuzumab or TDM-1 to prolong intracranial progression free survival (PFS) in patients compared to historical controls. PFS is defined as the time from the day of study treatment initiation until evidence of intracranial disease progression per RANO-BM or death from any cause.

Secondary Outcome Measures

Progression Free Survival by RECIST 1.1
Evaluate the progression free survival by RECIST 1.1 criteria. PFS is defined as time from the day of study treatment initiation until evidence of disease progression per RECIST v1.1 or death from any cause.
Progression Free Survival of Extracranial Disease
Evaluate PFS of extracranial disease. PFS is defined as time from the day of study treatment initiation until evidence of extracranial disease progression per RECIST v1.1 or death from any cause.
Distant Versus Local Intracranial Progression Free Survival
Evaluate distant versus local intracranial PFS.
Site of First Progression
Evaluate the site of first progression (CNS vs non-CNS). Site of first progression (CNS vs non-CNS) is defined by first site of progression on trial either within the central nervous system or extracranial disease as defined by investigator
Overall Survival (OS)
Evaluate OS. OS defined as day of study treatment initiation until death from any cause.
Assess Adverse Events
Evaluate the toxicity profile of agents in patients with brain metastases. Toxicity will be classified and graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 5.0)

Full Information

First Posted
April 5, 2022
Last Updated
August 23, 2023
Sponsor
Carey Anders, M.D.
Collaborators
Seagen Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05323955
Brief Title
Secondary BRain Metastases Prevention After Isolated Intracranial Progression on Trastuzumab/Pertuzumab or T-DM1 in Patients With aDvanced Human Epidermal Growth Factor Receptor 2+ brEast Cancer With the Addition of Tucatinib
Acronym
BRIDGET
Official Title
Secondary BRain Metastases Prevention After Isolated Intracranial Progression on Trastuzumab/Pertuzumab or T-DM1 in Patients With aDvanced Human Epidermal Growth Factor Receptor 2+ brEast Cancer With the Addition of Tucatinib
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 23, 2023 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Carey Anders, M.D.
Collaborators
Seagen Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Patients with advanced HER2+ breast cancer on maintenance trastuzumab/pertuzumab or T-DM1 with 1st or 2nd intracranial disease event (brain metastases) and stable extracranial disease will be enrolled. They will receive local therapy with stereotactic radiosurgery ± surgical resection if indicated followed by enrollment. Patients will continue standard of care trastuzumab/pertuzumab or T-DM1 with the addition of tucatinib. Hormone receptor positive patients requiring endocrine therapy should continue. Study treatment will continue until disease progression or intolerable side effects. Patients on trial with extracranial disease progression with stable intracranial disease should continue tucatinib into next line of therapy.
Detailed Description
Patients with advanced HER2+ breast cancer on either (1) first-line trastuzumab/pertuzumab OR (2) second-line T-DM1 in the metastatic setting OR (3) adjuvant trastuzumab-based therapy or T-DM1 with isolated intracranial recurrence will be included. Patients with de novo metastatic disease and brain metastases or isolated intracranial recurrence can enter upon initiation of maintenance trastuzumab/pertuzumab after chemotherapy if deemed necessary by treating oncologist and meeting other inclusion criteria. Patients with 1st or 2nd intracranial disease event (brain metastases) and stable extracranial disease will be enrolled. Third intracranial progression would be considered if > 12 month interval between second and third intracranial progression. They will receive local therapy with stereotactic radiosurgery ± surgical resection followed by enrollment. Patients will continue standard of care treatment trastuzumab/pertuzumab or T-DM1 with the addition of tucatinib. Hormone receptor-positive patients requiring endocrine therapy should continue. Study treatment will continue until intercranial disease progression or intolerable side effects. Patients with extracranial disease progression while on trial with stable intracranial disease should continue tucatinib into the next line of therapy as described in protocol. If a subject continues tucatinib into the next line therapy they are still considered on study treatment and will be monitored according to the protocol. Cycles will continue consecutively and not restart. Once the subject comes off tucatinib they are considered off study treatment and will enter the follow up period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Metastases, Human Epidermal Growth Factor 2 Positive Carcinoma of Breast, Advanced Breast Cancer
Keywords
Brain metastases, HER2+ breast cancer, Trastuzumab, Pertuzumab, T-DM1

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
Trastuzumab/pertuzumab + tucatinib or T-DM1 + tucatinib 300mg of tucatinib taken orally twice a day. Taken on Days 1-21 of a 21 Day cycle (3 Weeks). Trastuzumab/Biosimilar administered per current package insert based on site standard of care guidelines Pertuzumab or Biosimilar administered per current package insert based on site standard of care guidelines Trastuzumab Emtansine (T-DM1) administered per current package insert based on site standard of care guidelines
Intervention Type
Drug
Intervention Name(s)
Trastuzumab
Other Intervention Name(s)
Herceptin
Intervention Description
Administer per current package insert based on site standard of care guidelines
Intervention Type
Drug
Intervention Name(s)
Trastuzumab Emtansine (T-DM1)
Intervention Description
Administer per current package insert based on site standard of care guidelines
Intervention Type
Drug
Intervention Name(s)
Pertuzumab
Other Intervention Name(s)
Perjeta
Intervention Description
Administer per current package insert based on site standard of care guidelines
Intervention Type
Drug
Intervention Name(s)
Tucatinib
Other Intervention Name(s)
Tukysa
Intervention Description
300 mg orally twice daily (21 Day Cycle)
Primary Outcome Measure Information:
Title
Progression Free Survival (PFS)
Description
Evaluate the ability of tucatinib in combination with trastuzumab/pertuzumab or TDM-1 to prolong intracranial progression free survival (PFS) in patients compared to historical controls. PFS is defined as the time from the day of study treatment initiation until evidence of intracranial disease progression per RANO-BM or death from any cause.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Progression Free Survival by RECIST 1.1
Description
Evaluate the progression free survival by RECIST 1.1 criteria. PFS is defined as time from the day of study treatment initiation until evidence of disease progression per RECIST v1.1 or death from any cause.
Time Frame
3 years
Title
Progression Free Survival of Extracranial Disease
Description
Evaluate PFS of extracranial disease. PFS is defined as time from the day of study treatment initiation until evidence of extracranial disease progression per RECIST v1.1 or death from any cause.
Time Frame
3 years
Title
Distant Versus Local Intracranial Progression Free Survival
Description
Evaluate distant versus local intracranial PFS.
Time Frame
3 years
Title
Site of First Progression
Description
Evaluate the site of first progression (CNS vs non-CNS). Site of first progression (CNS vs non-CNS) is defined by first site of progression on trial either within the central nervous system or extracranial disease as defined by investigator
Time Frame
3 years
Title
Overall Survival (OS)
Description
Evaluate OS. OS defined as day of study treatment initiation until death from any cause.
Time Frame
3 years
Title
Assess Adverse Events
Description
Evaluate the toxicity profile of agents in patients with brain metastases. Toxicity will be classified and graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 5.0)
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject must meet all of the following applicable inclusion criteria to participate in this study: Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately. Age ≥ 18 years at the time of consent. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2. Locally advanced/unresectable or metastatic breast cancer with presence of brain metastases (Stage IV). Histologically confirmed HER2+ breast carcinoma by ASCO-CAP guidelines, with HER2+ defined by in situ hybridization (ISH), immunohistochemistry (IHC), or fluorescence in situ hybridization (FISH) methodology on most recent biopsy. Currently receiving: (1) first-line trastuzumab/pertuzumab OR (2) second-line T-DM1 in the metastatic setting OR (3) adjuvant trastuzumab-based therapy or T-DM1 with isolated intracranial recurrence. Patients with de novo metastatic disease and brain metastases or isolated intracranial recurrence can enter upon initiation of maintenance trastuzumab/pertuzumab after chemotherapy if deemed necessary by treating oncologist and meeting other inclusion criteria. Systemic disease otherwise stable per RECIST 1.1 or no evidence of extracranial disease. Adequate hepatic and renal function and hematologic parameters: Absolute neutrophil count (ANC) ≥ 1.0 × 109/L Platelets ≥ 100 × 109/L Hemoglobin ≥ 9 g/dL Total serum bilirubin ≤ 1.5 times upper limit of normal (ULN) Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) ≤ 2.5 × ULN (or ≤ 5 × ULN if liver metastases are present) Serum creatinine ≤ 1.5 x ULN or estimated creatinine clearance ≥ 50 mL/min as calculated using the Cockcroft-Gault (CG) equation Left ventricular ejection fraction (LVEF) ≥ 50%. Central nervous system inclusion - Based on screening brain magnetic resonance imaging (MRI), patients must have ALL of the following: Adequate local therapy to existing brain lesions ≥ 5mm including surgical resection and/or stereotactic radiosurgery Limited to first or second intracranial progression. Third intracranial progression would be considered if > 12 month interval between second and third intracranial progression. Time since stereotactic radiosurgery (SRS) is ≥ 7 days prior to first dose of study treatment. Time since surgical resection is ≥ 14 days prior to first dose of study treatment. Time since local therapy < 8 weeks. Patients with de novo metastastic breast cancer presenting with brain metastases may enter following cessation of chemotherapy if within 12 weeks of local therapy to the brain. NOTE: Relevant records of any CNS treatment including radiation must be available to allow for classification of target and non-target lesions Females of childbearing potential must have a negative serum pregnancy test at screening. NOTE: Females are considered of child bearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are naturally postmenopausal for at least 12 consecutive months. Females of childbearing potential and males must be willing to abstain from heterosexual intercourse or to use contraception as outlined in the protocol. Exclusion Criteria: Subjects meeting any of the criteria below may not participate in the study: Previously been treated with: Lapatinib, neratinib, afatinib, tucatinib or other investigational HER2/epidermal growth factor receptor (EGFR) or HER2 tyrosine kinase inhibitor (TKI) at any time previously (patients treated with adjuvant neratinib allowed if relapse > 12 months after last dose). Clinically significant cardiopulmonary disease. Clinically significant acute infection requiring systemic antibacterial, antifungal, or antiviral therapy including: tuberculosis (clinical evaluation that includes clinical history, physical examination, and radiographic findings, and TB testing in line with local practice), hepatitis B (known positive HBV surface antigen (HBsAg) result), hepatitis C, or human immunodeficiency virus (positive HIV 1/2 antibodies) NOTE: Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA. Subjects with HIV/AIDS with adequate antiviral therapy to control viral load would be allowed if they are stable and have been on treatment for ≥ 4 weeks prior to first dose of study drug(s). Subjects with viral hepatitis with controlled viral load would be allowed while on suppressive antiviral therapy. Testing not required. Unable for any reason to undergo MRI of the brain Use of a strong cytochrome P450 (CYP)2C8 inhibitor within 5 half-lives of the inhibitor, or a strong CYP3A4 or CYP2C8 inducer within 5 days prior to first dose of study treatment. See protocol. Central nervous system exclusion - Based on screening brain MRI, patients must not have any of the following: Ongoing use of systemic corticosteroids for control of symptoms of brain metastases at a total daily dose of > 2 mg of dexamethasone (or equivalent) Diffuse leptomeningeal disease or positive CSF cytology; however, discreet dural-based metastases are allowed Poorly controlled seizures. Defined as seizures that continue to occur despite optimal anticonvulsant medications based on investigator discretion. History of whole brain radiation therapy Any untreated brain lesions ≥ 5 mm Active infection requiring intravenous systemic therapy. Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study). Patients with a prior or concurrent malignancy within last 3 years whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen, per treating physician discretion, are not eligible for this trial. Treatment with any investigational drug within 30 days prior to registration.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carey Anders, MD
Phone
919-684-5301
Email
carey.anders@duke.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Rae Richards
Phone
317-634-5842
Ext
38
Email
rrichards@hoosiercancer.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carey Anders, MD
Organizational Affiliation
Duke Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Sammons, MD
Phone
919-668-5247
Email
sarahl_sammons@dfci.harvard.edu
First Name & Middle Initial & Last Name & Degree
Hugh Meadows
Email
hughw_meadows@dfci.harvard.edu
Facility Name
University of Michigan Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Munira Hussain
Phone
734-936-8349
Email
hussain@med.umich.edu
First Name & Middle Initial & Last Name & Degree
Aki Morikawa, MD
Facility Name
Washington University in St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63130
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samantha Ruzicka, LMSW
Phone
314-747-5209
Email
ruzicka@wustl.edu
First Name & Middle Initial & Last Name & Degree
Nusayba Bagegni, MD
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carey Anders, MD
Phone
919-684-5301
Email
dukebrain1@dm.duke.edu
First Name & Middle Initial & Last Name & Degree
Kelly Moulton
Phone
919-684-5301
Email
dukebrain1@dm.duke.edu
Facility Name
Ohio State University Comprehensive Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean Koutou Essan, MPH
Phone
614-293-5637
Email
JeanMartial.KoutouEssan@osumc.edu
First Name & Middle Initial & Last Name & Degree
Sasha Beyer, MD
Facility Name
Providence Portland Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alison K Conlin, MD MPH
Phone
503-215-5696
Email
alison.conlin@providence.org
First Name & Middle Initial & Last Name & Degree
Larisa Lundgren
Phone
503-215-0610
Email
larisa.lundgren@providence.org
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rashmi Murthy, MD MBE
Phone
713-563-8453
Email
rmurthy1@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Jill Swartz-Gomez, RN CCRP
Phone
713-792-2768
Email
jschwartzgomez@mdanderson.org

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Secondary BRain Metastases Prevention After Isolated Intracranial Progression on Trastuzumab/Pertuzumab or T-DM1 in Patients With aDvanced Human Epidermal Growth Factor Receptor 2+ brEast Cancer With the Addition of Tucatinib

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