Brain MetastasesPhase 2BRIDGETNCT05323955
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
A Phase 2 study testing Trastuzumab, Trastuzumab Emtansine (T-DM1) and Pertuzumab in people with Brain Metastases and Human Epidermal Growth Factor 2 Positive Carcinoma of Breast, run by Carey Anders, M.D. at 8 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Metastases, Human Epidermal Growth Factor 2 Positive Carcinoma of Breast, Advanced Breast Cancer
- What is being tested?
- Trastuzumab, Trastuzumab Emtansine (T-DM1) and Pertuzumab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 8 sitesUnited States
- Study dates
- 23 Mar 2023to Nov 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 (primary tissue).
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- Currently receiving: (1) first-line trastuzumab/pertuzumab with or without endocrine therapy 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 metastatic disease to the brain can enroll at time of initiation of trastuzumab/pertuzumab. Induction taxane therapy is not required and need to administer can be determined by the treating physician. Patients on trastuzumab alone are allowed if pertuzumab not tolerated.
- 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 < 12 weeks. Patients with de novo metastastic breast cancer presenting with brain metastases may enter following cessation of chemotherapy if within 24 weeks of local therapy to the brain and brain metastases have remained stable based on brain MRI.
- Prior radiation is required within 12 weeks of enrollment to at least 1 brain lesion. Other brain lesions under 5mm do not require treatment.
- 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. If a urine test is done and it is positive or cannot be confirmed as negative, a serum pregnancy test will be required. 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.
Who cannot join
- 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),
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- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
University of Michigan Health System
Ann Arbor, Michigan, 48109
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Duke University Medical Center
Durham, North Carolina, 27710
MD Anderson Cancer Center
Houston, Texas, 77030
Providence Portland Medical Center
Portland, Oregon, 97213
University of California San Francisco
San Francisco, California, 94158
Washington University in St. Louis
St Louis, Missouri, 63130
About this study
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.
Read the 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.
- Conditions
- Brain Metastases, Human Epidermal Growth Factor 2 Positive Carcinoma of Breast, Advanced Breast Cancer
- Being tested
- Trastuzumab, Trastuzumab Emtansine (T-DM1), Pertuzumab, Tucatinib
- Keywords
- Brain metastases, HER2+ breast cancer, Trastuzumab, Pertuzumab, T-DM1
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrastuzumabDrug
Also called Herceptin
Administer per current package insert based on site standard of care guidelines
Trastuzumab Emtansine (T-DM1)Drug
Administer per current package insert based on site standard of care guidelines
PertuzumabDrug
Also called Perjeta
Administer per current package insert based on site standard of care guidelines
TucatinibDrug
Also called Tukysa
300 mg orally twice daily (21 Day Cycle)
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | 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 Receives: Drug: Trastuzumab; Drug: Trastuzumab Emtansine (T-DM1); Drug: Pertuzumab; Drug: Tucatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Secondary outcomes (6)
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.
Measured: 3 years
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.
Measured: 3 years
Distant Versus Local Intracranial Progression Free Survival
Evaluate distant versus local intracranial PFS.
Measured: 3 years
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
Measured: 3 years
Overall Survival (OS)
Evaluate OS. OS defined as day of study treatment initiation until death from any cause.
Measured: 3 years
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)
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2022
- Study start23 Mar 2023
- Primary completionNov 2026 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain MetastasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carey Anders, M.D.
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor-investigator, Carey Anders, M.D., Duke University
- Investigators
- Carey Anders, MD, Principal investigator, Duke Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05323955
- Sponsor's protocol ID
- Pro00109777
- Acronym
- BRIDGET
- Status last verified
- Mar 2026
- First submitted
- 5 Apr 2022
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05323955
- Acronym / sponsor ID
- BRIDGET / Pro00109777
- Conditions
- Brain Metastases, Human Epidermal Growth Factor 2 Positive Carcinoma of Breast, Advanced Breast Cancer
- Keywords
- Brain metastases, HER2+ breast cancer, Trastuzumab, Pertuzumab, T-DM1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Carey Anders, M.D.University, hospital or other
- Collaborators
- Pfizer
- Study start
- 23 Mar 2023 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 12 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Drug: Trastuzumab, Drug: Trastuzumab Emtansine (T-DM1), Drug: Pertuzumab, Drug: TucatinibTrastuzumab/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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- 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).
Key exclusion criteria (21 listed)
- 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:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TrastuzumabAlso: HerceptinAdminister per current package insert based on site standard of care guidelines | Drug | Experimental Group |
| Trastuzumab Emtansine (T-DM1)Administer per current package insert based on site standard of care guidelines | Drug | Experimental Group |
| PertuzumabAlso: PerjetaAdminister per current package insert based on site standard of care guidelines | Drug | Experimental Group |
| TucatinibAlso: Tukysa300 mg orally twice daily (21 Day Cycle) | Drug | Experimental Group |
Primary outcome
Progression Free Survival (PFS)
Time frame: 3 years
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.
6 secondary outcomes
Progression Free Survival by RECIST 1.1
Time frame: 3 years
Progression Free Survival of Extracranial Disease
Time frame: 3 years
Distant Versus Local Intracranial Progression Free Survival
Time frame: 3 years
Site of First Progression
Time frame: 3 years
Overall Survival (OS)
Time frame: 3 years
Assess Adverse Events
Time frame: 2 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carey Anders, MD principal investigator
Duke Cancer Institute
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Trastuzumab, Trastuzumab Emtansine (T-DM1) and Pertuzumab in people with Brain Metastases and Human Epidermal Growth Factor 2 Positive Carcinoma of Breast, run by Carey Anders, M.D. at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 26 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (PFS) (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.