- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01670877
Neratinib +/- Fulvestrant in Metastatic HER2 Non-amplified But HER2 Mutant Breast Cancer
A Phase II Study of Neratinib Alone and in Combination With Fulvestrant in Metastatic HER2 Non-amplified But HER2 Mutant Breast Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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British Columbia
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Vancouver, British Columbia, Canada, V5Z 1L3
- BC Cancer Agency
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Ontario
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Toronto, Ontario, Canada, M5G 2M9
- Princess Margaret Cancer Centre
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Alabama
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Birmingham, Alabama, United States, 35294
- University of Alabama Cancer Center
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Arizona
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Phoenix, Arizona, United States, 85054
- Mayo Clinic
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California
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Los Angeles, California, United States, 90033
- University of Southern California Keck School of Medicine
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Stanford, California, United States, 94305
- Stanford Medicine Cancer Institute
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Florida
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Miami, Florida, United States, 33136
- University of Miami Hospital and Clinics
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Illinois
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Chicago, Illinois, United States, 60612
- Rush University Medical Center
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Chicago, Illinois, United States, 60611
- Northwestern University - Feinberg School of Medicine
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Dana-Farber Cancer Institute, Harvard University
-
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Michigan
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Ann Arbor, Michigan, United States, 48109
- University of Michigan
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Missouri
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Kansas City, Missouri, United States, 64111
- St. Luke's Cancer Institute
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Saint Louis, Missouri, United States, 63110
- Washington University School of Medicine
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North Carolina
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Chapel Hill, North Carolina, United States, 27514
- University of North Carolina at Chapel Hill (Lineberger Comprehensive Cancer Center)
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Durham, North Carolina, United States, 27710
- Duke Cancer Institute at Duke University Medical Center
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South Dakota
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Sioux Falls, South Dakota, United States, 57105
- Avera Cancer Institute
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Texas
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Houston, Texas, United States, 77030
- Baylor College of Medicine
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria for Pre-registration (for patients with unknown HER2 mutation status to have tumor tissue screened centrally by Washington University GPS laboratory):
- Histologically or cytologically confirmed HER2-negative (0 or 1+ by IHC or non-amplified by FISH) breast cancer that is stage IV.
- Agree to provide archival tumor material for research
- There is no limitation on the number of prior lines of systemic therapy.
- Presence of measurable or non-measurable disease by RECIST 1.1 is acceptable, except to be eligible for the Part II fulvestrant-naive ER+ cohort, at least one measurable disease by RECIST 1.1 is required.
- At least 18 years of age.
- ECOG performance status ≤ 2
Adequate organ function as defined below within 8 weeks of pre-registration:
- Serum creatinine ≤1.5 x ULN
- Chil-Pugh class A if with liver disease
- Able to understand and willing to sign an IRB approved written informed consent document.
Note: HER2 mutation testing may be performed while the patient is receiving active systemic therapy for metastatic breast cancer so that the result can be used to determine eligibility for study drug therapy in the future.
Exclusion Criteria for Pre-registration:
- Testing for LVEF is not required for pre-registration, but patient must not have a recent LVEF < LLN or have symptoms of congestive heart failure.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Acute or currently active hepatic or biliary disease requiring antiviral therapy (with the exception of Gilbert's syndrome, asymptomatic gallstones, liver metastases, or stable chronic liver disease per investigator assessment).
- History of significant cardiac disease, cardiac risk factors, or uncontrolled arrhythmias.
- Symptomatic intrinsic lung disease or extensive tumor involvement of the lungs resulting in dyspnea at rest.
Inclusion Criteria for Registration (for patients initially pre-registered and with HER2 mutation identified by Washington University GPS laboratory)
- Tumor tissue tested positive for HER2 mutation. HER2 mutations detected by Guardant360 are also eligible.
- Agree to provide archival tumor material for research
- ECOG performance status ≤2
Adequate organ function as defined below within 2 weeks of registration:
- ANC ≥1.5 x 10^9/L
- Platelet count ≥100 x 10^9/L
- Serum creatinine ≤1.5 x ULN
- Child-Pugh class A if with liver disease
- The patient must have completed radiation therapy and be at least 1 week from the last systemic chemotherapy administration, with adequate recovery of bone marrow and organ functions, before starting neratinib.
- Presence of disease progression on the most recent disease evaluation.
- Patients with known brain metastasis are eligible, but must have received radiation and be off steroids and stable (without evidence of disease progression by imaging or exam) for 3 months.
- QTc interval ≤450 msec for men or < or ≤ 470 msec for women within 2 weeks of registration.
- LVEF > or = institutional ILLN within 4 weeks of registration.
- Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. Men must agree and commit to use a barrier method of contraception while on treatment and for 3 months after the last dose of the investigational product.
- Able to understand and willing to sign an IRB approved written informed consent document.
- There is no limitation on the number of prior lines of systemic therapy.
- To be eligible for the Part II fulvestrant-naive ER+ cohort, prior treatment with fulvestrant is not allowed. In addition, ER and/or PR positivity by institutional standard is required on pathology from the most recent tumor specimen if biopsy was done unless the tissue source (for example, pleural effusion or ascites or bone biopsy) may yield false negative ER and/or PR result, in which case the pathology from an earlier time point could be used and a discussion with the study chair is required.
- To be eligible for the Part II fulvestrant-treated ER+ cohort, prior disease progression on fulvestrant is required. In addition, ER and/or PR positivity by institutional standard is required on pathology from the most recent tumor specimen unless the tissue source (for example, pleural effusion or ascites or bone biopsy) may yield false negative ER and/or PR result, in which case the pathology form an earlier time point could be used and a discussion with the study chair is required.
Inclusion Criteria for Registration (for patients with HER2 mutation identified at an outside CLIA certified location):
- Histologically or cytologically confirmed HER2-negative (0 or 1+ by IHC or non-amplified by FISH) breast cancer that is stage IV.
- Tumor tissue or circulating tumor DNA tested positive for HER2 mutation. Mutations outside the list will be assessed on a case-by-case basis by the study team to determine eligibility.
- Presence of measurable or non-measurable disease by RECIST 1.1 is acceptable, except to be eligible for the Part II fulvestrant-naïve ER+ cohort, at least one measurable disease by RECIST 1.1 is required.
- At least 18 years of age.
- ECOG performance status < 2 (see Appendix A).
Adequate organ function as defined below within 2 weeks of registration:
- Absolute neutrophil count: ≥1.5 × 109/L (1500/mm3)
- Platelet count: ≥100 × 109/L (100,000/mm3)
- Serum creatinine: ≤1.5 x ULN
- Child-Pugh class A if with liver disease
- The patient must have completed radiation therapy and be at least 1 week from the last systemic therapy administration, with adequate recovery of bone marrow and organ functions, before starting neratinib.
- Presence of disease progression on the most recent disease evaluation.
- Patients with known treated brain metastasis are eligible, but must have received radiation and be off steroids and stable (without evidence of disease progression by imaging or exam) for 3 months.
- QTc interval ≤ 450 msec for men or ≤ 470 msec for women within 2 weeks of registration.
- LVEF > institutional LLN within 4 weeks of registration.
- Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. Men must agree and commit to use a barrier method of contraception while on treatment and for 3 months after the last dose of the investigational product
- Able to understand and willing to sign an IRB approved written informed consent document.
- There is no limitation on the number of prior lines of systemic therapy.
- To be eligible for the Part II fulvestrant-naïve ER+ cohort, prior treatment with fulvestrant is not allowed. In addition, ER and/or PR positivity by institutional standard is required on pathology from the most recent tumor specimen if biopsy was done unless the tissue source (for example, pleural effusion or ascites or bone biopsy) may yield false negative ER and/or PR result, in which case the pathology from an earlier time point could be used and a discussion with the study chair is required.
- To be eligible for the Part II fulvestrant-treated ER+ cohort, prior disease progression on fulvestrant is required. In addition, ER and/or PR positivity by institutional standard is required on pathology from the most recent tumor specimen unless the tissue source (for example, pleural effusion or ascites or bone biopsy) may yield false negative ER and/or PR result, in which case the pathology from an earlier time point could be used and a discussion with the study chair is required.
Exclusion Criteria for Registration:
- Currently receiving any other investigational agents or systemic cancer therapy.
- Currently taking medications and herbal or dietary supplements that are strong cytochrome P450 (CYP) 3A4 inducers or inhibitors. The washout period must have been completed prior to the start of neratinib if the patient was taking any of these agents. If unavoidable, patients taking CYP3A4 inhibitors should be monitored closely.
- 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.
- Acute or currently active/requiring antiviral therapy hepatic or biliary disease (with the exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases, or stable chronic liver disease per investigator assessment).
- Pregnant and/or breastfeeding.
- History of significant cardiac disease, cardiac risk factors, or uncontrolled arrhythmias.
- Symptomatic intrinsic lung disease or extensive tumor involvement of the lungs resulting in dyspnea at rest.
- Experiencing grade 2 or greater diarrhea.
- Prior treatment with neratinib
- Child-Pugh class B or C liver dysfunction
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Part I: Neratinib Only
-Patients will receive neratinib PO daily on Days 1-28.
Each cycle is 4 weeks.
Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Other Names:
-Optional at baseline and disease progression
-Baseline, cycle 1 day 15, cycle 2 day 1, cycle 3 day 1, day 1 of each odd cycle, end of treatment (progression)
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Experimental: Part II: Neratinib Only (ER-)
-Patients will receive neratinib PO daily on Days 1-28.
Each cycle is 4 weeks.
Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Other Names:
-Optional at baseline and disease progression
-Baseline, cycle 1 day 15, cycle 2 day 1, cycle 3 day 1, day 1 of each odd cycle, end of treatment (progression)
|
Experimental: Part II: Neratinib + Fulvestrant (ER+, fulvestrant-naive)
-Patients will receive neratinib PO daily on Days 1-28 and fulvestrant on Day 1 of each cycle (and C1D15).
Each cycle is 4 weeks.
Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Other Names:
Other Names:
-Optional at baseline and disease progression
-Baseline, cycle 1 day 15, cycle 2 day 1, cycle 3 day 1, day 1 of each odd cycle, end of treatment (progression)
|
Experimental: Part II: Neratinib + Fulvestrant (ER+. prior fulvestrant-tx)
-Patients will receive neratinib PO daily on Days 1-28 and fulvestrant on Day 1 of each cycle (and C1D15).
Each cycle is 4 weeks.
Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Other Names:
Other Names:
-Optional at baseline and disease progression
-Baseline, cycle 1 day 15, cycle 2 day 1, cycle 3 day 1, day 1 of each odd cycle, end of treatment (progression)
|
Experimental: Crossover: Neratinib + Trastuzumab
-If a participant experiences disease progression during Part I or Part II following neratinib, trastuzumab (or FDA approved biosimilar) may be added to the treatment regimen.
Trastuzumab may be administered intravenously with a loading dose of 6 mg/kg then 4 mg/kg every 2 weeks.
A cycle will be defined as 28 days.
Patients will continue to receive neratinib PO daily on Days 1-28.
Each cycle is 4 weeks.
|
Other Names:
Other Names:
-Optional at baseline and disease progression
-Baseline, cycle 1 day 15, cycle 2 day 1, cycle 3 day 1, day 1 of each odd cycle, end of treatment (progression)
|
Experimental: Crossover: Neratinib + Fulvestrant + Trastuzumab
-If a participant experiences disease progression during Part I or Part II following neratinib, trastuzumab (or FDA approved biosimilar) may be added to the treatment regimen.
Trastuzumab may be administered intravenously with a loading dose of 6 mg/kg then 4 mg/kg every 2 weeks.
A cycle will be defined as 28 days.
Patients will receive neratinib PO daily on Days 1-28 and fulvestrant on Day 1 of each cycle (and C1D15).
Each cycle is 4 weeks.
|
Other Names:
Other Names:
Other Names:
-Optional at baseline and disease progression
-Baseline, cycle 1 day 15, cycle 2 day 1, cycle 3 day 1, day 1 of each odd cycle, end of treatment (progression)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Part I Only: Clinical Benefit Rate (CR+PR+SD≥6months) of Patients Who Received Neratinib Alone
Time Frame: Through completion of treatment (median treatment time of 90 days, full range 54-716 days)
|
|
Through completion of treatment (median treatment time of 90 days, full range 54-716 days)
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Part II ER-cohort Only: Clinical Benefit Rate (CR+PR+SD≥6months) of Neratinib in Patients With Metastatic HER2-, ER- Breast Cancer That Carry HER2 Mutation
Time Frame: Through completion of treatment (median treatment time of 62 days, full range 56-413 days)
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Through completion of treatment (median treatment time of 62 days, full range 56-413 days)
|
Part II Fulvestrant-naive ER+ Cohort Only: Clinical Benefit (CR+PR+SD≥6 Months) of Neratinib + Fulvestrant in Patients With Metastatic HER2- ER+ Fulvestrant-naive Breast Cancer That Carry HER2 Mutation
Time Frame: Through completion of treatment (median treatment time of 140.5 days, full range 48-770 days)
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Through completion of treatment (median treatment time of 140.5 days, full range 48-770 days)
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Part II Fulvestrant-treated ER+ Cohort Only: Clinical Benefit Rate (CR+PR+SD≥6months) of Neratinib + Fulvestrant in Patients With Metastatic HER2- ER+ Fulvestrant-treated Breast Cancer That Carry HER2 Mutation
Time Frame: Through completion of treatment (median treatment time of 168 days, full range 28-671 days)
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Through completion of treatment (median treatment time of 168 days, full range 28-671 days)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free Survival (PFS) of Patients Treated With Neratinib Alone in Patients With Metastatic HER2- But HER2 Mutated Breast Cancer by ER Status and by HER2 Mutations (Activating Versus Unknown Significance)
Time Frame: Through completion of follow-up; follow-up was through 30 days following completion of treatment (median follow-up of 92 days, full range 86 days-443 days)
|
|
Through completion of follow-up; follow-up was through 30 days following completion of treatment (median follow-up of 92 days, full range 86 days-443 days)
|
Number of Participants With HER2 Mutation Subtype and Histology Subtype
Time Frame: At the time of enrollment
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At the time of enrollment
|
|
Number of Participants With HER2 Mutation Subtype and Tumor Grade
Time Frame: A time of enrollment
|
-Cancer cells are graded when they are removed from the breast. The grade is based on how much the cancer cells look like normal cells.
|
A time of enrollment
|
Correlate the Presence of HER2 Mutation Subtype With Tumor Staging at Initial Diagnosis
Time Frame: At time of enrollment
|
|
At time of enrollment
|
Correlate the Presence of HER2 Mutation Subtype With Progression-free Survival
Time Frame: Through completion of follow-up; follow-up was through 30 days following completion of treatment (median follow-up of 142 days, full range 54-800 days)
|
|
Through completion of follow-up; follow-up was through 30 days following completion of treatment (median follow-up of 142 days, full range 54-800 days)
|
Part II ER-cohort Only: Progression-free Survival (PFS)
Time Frame: Through completion of treatment (median treatment time of 62 days, full range 56-413 days)
|
|
Through completion of treatment (median treatment time of 62 days, full range 56-413 days)
|
Part II Fulvestrant-naive ER+ Cohort Only: Progression-free Survival (PFS)
Time Frame: Through completion of treatment (median treatment time of 140.5 days, full range 48-770 days)
|
|
Through completion of treatment (median treatment time of 140.5 days, full range 48-770 days)
|
Part II Fulvestrant-treated ER+ Cohort Only: Progression-free Survival (PFS)
Time Frame: Through completion of treatment (median treatment time of 168 days, full range 28-671 days)
|
|
Through completion of treatment (median treatment time of 168 days, full range 28-671 days)
|
Safety and Tolerability of Neratinib in Combination With Fulvestrant in Patients With HER2- ER+ HER2 Mutated Breast Cancer as Measured by Number of Participants With Related Adverse Events
Time Frame: Through completion of follow-up; follow-up was through 28 days following completion of treatment (median follow-up of 140 days, full range 52-798 days)
|
-CTCAE v 4.0 will be used to record adverse events.
Related includes those possibly, probably, or definitely related to the treatment regimen.
|
Through completion of follow-up; follow-up was through 28 days following completion of treatment (median follow-up of 140 days, full range 52-798 days)
|
Part II Fulvestrant-naive ER+ Cohort Only: Response Rate (RR)
Time Frame: Through completion of treatment (median treatment time of 140.5 days, full range 48-770 days)
|
|
Through completion of treatment (median treatment time of 140.5 days, full range 48-770 days)
|
Part II Fulvestrant-treated ER+ Cohort Only: Response Rate (RR)
Time Frame: Through completion of treatment (median treatment time of 168 days, full range 28-671 days)
|
|
Through completion of treatment (median treatment time of 168 days, full range 28-671 days)
|
Collaborators and Investigators
Investigators
- Principal Investigator: Cynthia Ma, M.D., Ph.D, Washington University School of Medicine
Publications and helpful links
General Publications
- Shishido SN, Masson R, Xu L, Welter L, Prabakar RK, D' Souza A, Spicer D, Kang I, Jayachandran P, Hicks J, Lu J, Kuhn P. Disease characterization in liquid biopsy from HER2-mutated, non-amplified metastatic breast cancer patients treated with neratinib. NPJ Breast Cancer. 2022 Feb 18;8(1):22. doi: 10.1038/s41523-022-00390-5.
- Exman P, Garrido-Castro AC, Hughes ME, Freedman RA, Li T, Trippa L, Bychkovsky BL, Barroso-Sousa R, Di Lascio S, Mackichan C, Lloyd MR, Krevalin M, Cerami E, Merrill MS, Santiago R, Crowley L, Kuhnly N, Files J, Lindeman NI, MacConaill LE, Kumari P, Tolaney SM, Krop IE, Bose R, Johnson BE, Ma CX, Dillon DA, Winer EP, Wagle N, Lin NU. Identifying ERBB2 Activating Mutations in HER2-Negative Breast Cancer: Clinical Impact of Institute-Wide Genomic Testing and Enrollment in Matched Therapy Trials. JCO Precis Oncol. 2019 Nov 15;3:PO.19.00087. doi: 10.1200/PO.19.00087. eCollection 2019.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Physiological Effects of Drugs
- Antineoplastic Agents
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Antineoplastic Agents, Immunological
- Hormone Antagonists
- Estrogen Antagonists
- Estrogen Receptor Antagonists
- Trastuzumab
- Fulvestrant
Other Study ID Numbers
- 201209135
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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