Breast CancerPhase 1NCT04504331
Study of Infigratinib in Combination With Tamoxifen in Hormone Receptor Positive, HER2 Negative, FGFR Altered Advanced Breast Cancer
A Phase 1 study testing Infigratinib, Tamoxifen and Omnipaque 350 in people with Breast Cancer and HER2-negative Breast Cancer, run by Jennifer Lee Caswell-Jin at 1 site in United States.
Trial summary
The purpose of the study is identify the dose(s) of infigratinib to use in combination with tamoxifen to treat patients with a particular type of advanced breast cancer (hormone receptor-positive, HER2-negative, FGFR-altered breast cancer) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, HER2-negative Breast Cancer, ER Positive Breast Cancer
- What is being tested?
- Infigratinib, Tamoxifen and Omnipaque 350
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Oct 2020to 22 Oct 2021
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- History of biopsy proven ER positive and/or PR positive, HER2 negative breast cancer and radiographic evidence of metastatic disease, or locally recurrent unresectable disease. ER positivity and PR positivity are defined as ≥ 1% cells staining positive by immunohistochemistry. HER2 negativity is defined by immunohistochemistry (IHC) or Fluorescence in situ hybridization (FISH).
- Cancer subtype: Predicted integrative subtype classification of IC2 or IC6 according classifier on targeted sequencing data from FoundationOne.
- Evaluable or measurable disease, by cohort. Cohort 1 only: Evaluable or measurable disease, as defined by RECIST v1.1. Bone only disease is acceptable.
- Cohort 2 only: Measurable disease, as defined by RECIST v1.1.
- ≥ 18 years old
- Eastern Cooperative Oncology Group (ECOG) 0 to 2
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- Prior cancer therapy (except for endocrine therapy, denosumab, or bisphosphonates) must be discontinued for 2 weeks prior to initiation of study drugs. Recovery from adverse events of previous cancer therapies to baseline or Grade 1 except for alopecia or stable Grade 2 neuropathy. Radiotherapy must also be completed at least 2 weeks prior to initiation of study drugs
- Absolute neutrophil count (ANC) ≥ 1,000/mm3
- Platelets ≥ 75,000/mm3
- Hemoglobin ≥ 9.0 g/dL
- Total bilirubin ≤ 1.8 mg/dL (unless documented Gilbert's disease)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 90 U/L
- Estimated glomerular filtration rate (GFR) ≥ 45 mL/min
- Phosphorus between 2.5 and 4.5 mg/dL, inclusive
- Total corrected (for albumin) serum calcium between 8.5 and 10.5 mg/dL, inclusive
- Amylase < 200 U/L
- Lipase < 120 U/L
- Ability to understand and the willingness to sign a written informed consent document
- Agrees to take sevelamer, if indicated, and has no contraindications to use of this medication (that is: known hypersensitivity to sevelamer or component of the formulation; bowel obstruction; active bowel mucosal injury such as ulcerative colitis or gastrointestinal bleeding).
- Agrees to follow low phosphate diet, if indicated
- Able to swallow and retain oral medication
- Women must be postmenopausal, defined as (at least one of):
- ≥ 60 years of age;
- amenorrhea for at least 24 months;
- amenorrhea for at least 12 months with serum estradiol < 20 pg/mL;
- prior bilateral oophorectomy; OR
- treatment with a luteinizing hormone (LH) releasing hormone agonist (such as goserelin acetate or leuprolide acetate) initiated at least 28 days prior to study enrollment.
- Women being treated with a LH releasing agonist but who are otherwise of childbearing potential (did not undergo total hysterectomy or bilateral tubal ligation at least 6 weeks before first dose of study drug) must have a negative pregnancy test within 7 days of the first dose of study drug.
- Women who are being treated with a LH releasing agonist but are otherwise of childbearing potential must agree to use barrier contraception or an intrauterine device while taking study drug and for 3 months following their last dose of study drug. Alternatively, total abstinence is acceptable if preferred by the subject.
- Sexually active men must agree to use a condom during intercourse while taking drug and for 3 months after the last dose of the study drug and should not father a child during this period. A condom is required to be used also by vasectomized men as well as during intercourse with a male partner to prevent delivery of the drug via seminal fluid.
Who cannot join
- History of another primary malignancy within 3 years except adequately treated in situ carcinoma of the cervix or non melanoma carcinoma of the skin or any other curatively treated malignancy that is not expected to require treatment for recurrence during the course of the study.
- Neurologic symptoms related to central nervous system metastases requiring increasing doses of corticosteroids. Note that subjects with central nervous system metastases are eligible if they are on a stable corticosteroid dose for at least 2 weeks preceding study entry.
- Current evidence of corneal or retinal disorder/keratopathy including, but not limited to, bullous/band keratopathy, corneal abrasion, inflammation/ulceration, keratoconjunctivitis, confirmed by ophthalmologic examination. Subjects with asymptomatic ophthalmologic conditions assessed by the investigator to pose minimal risk for study participation may be enrolled in the study.
- Current evidence of extensive tissue calcification including, but not limited to, the soft tissue, kidneys, intestine, myocardium, and lung with the exception of calcified lymph nodes, minor pulmonary parenchymal calcifications, and asymptomatic coronary calcification.
- Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral infigratinib (eg, ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection).
- Current evidence of endocrine alterations of calcium/phosphate homeostasis, eg, parathyroid disorders, history of parathyroidectomy, tumor lysis, or tumoral calcinosis.
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- Currently receiving or planning during study participation to receive treatment with agents that are known strong inducers or inhibitors of CYP3A4 and medications which increase serum phosphorus and/or calcium concentration. Subjects are not permitted to receive enzyme inducing anti epileptic drugs, including carbamazepine, phenytoin, phenobarbital, and primidone. See Appendix B for a list of prohibited concomitant medications and supplements.
- Has consumed grapefruit, grapefruit juice, grapefruit hybrids, pomegranates, star fruits, pomelos, Seville oranges, or products containing juice of these fruits within 7 days prior to first dose of study drug.
- Have used amiodarone within 90 days prior to first dose of study drug.
- Has used medications known to prolong the QT interval and/or are associated with a risk of Torsades de Pointes (TdP) 7 days prior to first dose of study drug. See Appendix B for a list of prohibited concomitant medications and supplements.
- Has used calcium or vitamin D within 3 days prior to first dose of study drug. Calcium supplementation may subsequently be used as clinically indicated (for hypocalcemia) on study.
- Have clinically significant cardiac disease including any of the following:
- Congestive heart failure requiring treatment (New York Heart Association Grade ≥ 2), left ventricular ejection fraction (LVEF) < 50% or local lower limit of normal as determined by multiple gated acquisition (MUGA) scan or echocardiogram (ECHO), or uncontrolled hypertension (refer to the European Society of Cardiology and European Society of Hypertension guidelines [Williams et al., 2018])
- Presence of Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Grade ≥ 2 ventricular arrhythmias, atrial fibrillation, bradycardia, or conduction abnormality
- Unstable angina pectoris or acute myocardial infarction ≤ 3 months prior to first dose of study drug
- Corrected QT interval Fredericia (QTcF) > 470 msec (males and females). Note: If the QTcF is > 470 msec in the first electrocardiogram (ECG), a total of 3 ECGs separated by at least 5 minutes should be performed. If the average of these 3 consecutive results for QTcF is ≤ 470 msec, the subject meets eligibility in this regard.
- Known history of congenital long QT syndrome
- Have had a recent (≤ 3 months) transient ischemic attack or stroke.
- Pregnant or nursing woman.
- All subject files must include supporting documentation to confirm subject eligibility. The method of confirmation can include, but is not limited to, laboratory test results, radiology test results, subject self report, and medical record review.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1B Study of Infigratinib in Combination With Tamoxifen in Hormone Receptor Positive, HER2 Negative, FGFR Altered Advanced Breast Cancer
The purpose of the study is identify the dose(s) of infigratinib to use in combination with tamoxifen to treat patients with a particular type of advanced breast cancer (hormone receptor-positive, HER2-negative, FGFR-altered breast cancer)
Read the detailed description
Primary Objective: Determine the maximum (no greater than 125 mg) dose of infigratinib used in combination with the FDA-approved dose and schedule of tamoxifen (Cohort 1) in terms of the number of dose-limiting toxicities observed in the first 2 cycles of therapy in subjects with hormone receptor-positive, HER2-negative advanced breast cancer.
Secondary Objective:
- Estimate the incidence of treatment-emergent adverse events (serious and non-serious).
- Estimate the objective tumor response rate (ORR) in subjects with measurable disease.
- Estimate the progression-free survival (PFS).
- Estimate the durable clinical benefit rate.
- Conditions
- Breast Cancer, HER2-negative Breast Cancer, ER Positive Breast Cancer, PR-Positive Breast Cancer
- Being tested
- Infigratinib, Tamoxifen, Omnipaque 350, Iopamidol, Computed tomography (CT)
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InfigratinibDrug
Also called FGFR 1-3-Selective Tyrosine Kinase Inhibitor, 872511-34-7, NVP-BGJ398, BGJ-398
Oral dose
TamoxifenDrug
Also called Nolvadex, Soltamox, Apo-Tamox, Tamofen
Oral Dose
Omnipaque 350Drug
Also called Iohexol, Hexopaque, Nycodenz, Exypaque
IV contrast agent
IopamidolDrug
Also called Isovue 300, Isovue 370, Iopamiro, Iopamiron
IV contrast agent
Computed tomography (CT)Diagnostic test
Computed tomography (CT) to assess disease state using Iopamidol and/or Omnipaque 350.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Infigratinib (100mg) + Tamoxifen | Experimental | In study part 1 (dose exploration), participants will receive up to infigratinib 100 mg. 100 mg of Infigratinib will be administered orally daily, 3 weeks on, 1 week off + 20 mg/day tamoxifen Receives: Drug: Infigratinib; Drug: Tamoxifen; Drug: Omnipaque 350; Drug: Iopamidol; Diagnostic Test: Computed tomography (CT) |
| Cohort 2: Infigratinib (125mg) + Tamoxifen | Experimental | In study part 1 (dose exploration), participants will receive up to infigratinib 125 mg. 125 mg of Infigratinib will be administered orally daily, 3 weeks on, 1 week off + 20 mg/ day tamoxifen Receives: Drug: Infigratinib; Drug: Tamoxifen; Drug: Omnipaque 350; Drug: Iopamidol; Diagnostic Test: Computed tomography (CT) |
| Cohort 3: Infigratinib (75mg) + Tamoxifen | Experimental | In study part 1 (dose exploration), participants will receive up to infigratinib 75 mg. 75 mg of Infigratinib will be administered orally daily, 3 weeks on, 1 week off + 20 mg/day tamoxifen Receives: Drug: Infigratinib; Drug: Tamoxifen; Drug: Omnipaque 350; Drug: Iopamidol; Diagnostic Test: Computed tomography (CT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Dose-limiting Toxicities (DLTs)
The primary outcome for this study is dose-limiting toxicities (DLTs) during the first 2 cycles of therapy. All grades per the Common Terminology Criteria for Adverse Events (CTCAE). DLT is defined as a related and clinically significant adverse event (AE), including missed doses due to a related AE.
Measured: 8 weeks
Secondary outcomes (4)
Number of Treatment Emergent Adverse Events (TEAE)
Treatment emergent adverse events (TEAEs) are defined as adverse events of any grade with initial onset or increasing in severity after the first dose of study treatment until 30 days after last dose of study drug. Pregnancy during the reporting period will be classified as a serious adverse event.
Measured: From first dose to 30 days after the last dose of study drug (up to 94 days)
Objective Tumor Response Rate
Objective tumor response will be assessed as achieving a Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Complete Response (CR) or a Partial Response (PR). The outcome will be reported as the number of subjects that achieve an overall response (OR) to treatment, ie, CR or PR, within 18 months of starting treatment. RECIST criteria are:
- CR = Disappearance of all target lesions
- PR = ≥ 30% decrease in the sum of the longest diameter of target lesions
- Overall Response (OR) = CR + PR
- Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions, and/or the appearance of one or more new lesion(s)
- Stable disease (SD) = Small changes that do not meet any of the above criteria
Measured: From enrollment to day of scan (up to 64 days)
Progression-free Survival (PFS)
Progression free survival (PFS) means the participant remains alive without return or relapse of the tumor. The outcome is defined as the number of days to either progressive disease as defined per RECIST v1.1 or death. RECIST criteria are:
- CR = Disappearance of all target lesions
- PR = ≥ 30% decrease in the sum of the longest diameter of target lesions
- Overall Response (OR) = CR + PR
- Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions, and/or the appearance of one or more new lesion(s)
- Stable disease (SD) = Small changes that do not meet any of the above criteria
Measured: up to 9 months
Clinical Benefit Rate
Clinical benefit (CB) is defined as achieving a Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Complete Response (CR) ; Partial Response (PR); or Stable Disease (SD). The outcome will be reported as the number of subjects that achieve CR, PR, or SD. RECIST criteria are:
- CR = Disappearance of all target lesions
- PR = ≥ 30% decrease in the sum of the longest diameter of target lesions
- SD = Small changes that do not meet any of the above criteria
- Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions, and/or the appearance of one or more new lesion(s)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2020
- Study start13 Oct 2020
- Primary completion22 Oct 2021
- Study completion22 Oct 2021
Why it stopped: Drug manufacturer decision to terminate development.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jennifer Lee Caswell-Jin
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), QED Therapeutics, a BridgeBio company
- Responsible party
- Sponsor-investigator, Jennifer Lee Caswell-Jin, Stanford University
- Investigators
- Jennifer Lee Caswell-Jin, Principal investigator, Stanford Universiy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04504331
- Sponsor's protocol ID
- IRB-53650
- Other IDs
- BRS0113, K08CA252457, NCI-2020-13784
- Status last verified
- Jan 2026
- First submitted
- 5 Aug 2020
- Last updated
- 12 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1B Study of Infigratinib in Combination With Tamoxifen in Hormone Receptor Positive, HER2 Negative, FGFR Altered Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT04504331
- Acronym / sponsor ID
- IRB-53650
- Conditions
- Breast Cancer, HER2-negative Breast Cancer, ER Positive Breast Cancer, PR-Positive Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Drug manufacturer decision to terminate development.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Jennifer Lee Caswell-JinUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), QED Therapeutics, a BridgeBio company
- Study start
- 13 Oct 2020 (actual)
- Primary completion
- 22 Oct 2021 (actual)
- Study completion
- 22 Oct 2021 (actual)
- First posted
- 7 Aug 2020 (actual)
- Results
- Posted 1 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is identify the dose(s) of infigratinib to use in combination with tamoxifen to treat patients with a particular type of advanced breast cancer (hormone receptor-positive, HER2-negative, FGFR-altered breast cancer)
Detailed description
Primary Objective: Determine the maximum (no greater than 125 mg) dose of infigratinib used in combination with the FDA-approved dose and schedule of tamoxifen (Cohort 1) in terms of the number of dose-limiting toxicities observed in the first 2 cycles of therapy in subjects with hormone receptor-positive, HER2-negative advanced breast cancer.
Secondary Objective:
- Estimate the incidence of treatment-emergent adverse events (serious and non-serious).
- Estimate the objective tumor response rate (ORR) in subjects with measurable disease.
- Estimate the progression-free survival (PFS).
- Estimate the durable clinical benefit rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Infigratinib (100mg) + Tamoxifen | Experimental | Drug: Infigratinib, Drug: Tamoxifen, Drug: Omnipaque 350, Drug: Iopamidol, Diagnostic Test: Computed tomography (CT)In study part 1 (dose exploration), participants will receive up to infigratinib 100 mg. 100 mg of Infigratinib will be administered orally daily, 3 weeks on, 1 week off + 20 mg/day tamoxifen |
| Cohort 2: Infigratinib (125mg) + Tamoxifen | Experimental | Drug: Infigratinib, Drug: Tamoxifen, Drug: Omnipaque 350, Drug: Iopamidol, Diagnostic Test: Computed tomography (CT)In study part 1 (dose exploration), participants will receive up to infigratinib 125 mg. 125 mg of Infigratinib will be administered orally daily, 3 weeks on, 1 week off + 20 mg/ day tamoxifen |
| Cohort 3: Infigratinib (75mg) + Tamoxifen | Experimental | Drug: Infigratinib, Drug: Tamoxifen, Drug: Omnipaque 350, Drug: Iopamidol, Diagnostic Test: Computed tomography (CT)In study part 1 (dose exploration), participants will receive up to infigratinib 75 mg. 75 mg of Infigratinib will be administered orally daily, 3 weeks on, 1 week off + 20 mg/day tamoxifen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (30 listed)
- History of biopsy proven ER positive and/or PR positive, HER2 negative breast cancer and radiographic evidence of metastatic disease, or locally recurrent unresectable disease. ER positivity and PR positivity are defined as ≥ 1% cells staining positive by immunohistochemistry. HER2 negativity is defined by immunohistochemistry (IHC) or Fluorescence in situ hybridization (FISH).
- Cancer subtype: Predicted integrative subtype classification of IC2 or IC6 according classifier on targeted sequencing data from FoundationOne.
- Evaluable or measurable disease, by cohort. Cohort 1 only: Evaluable or measurable disease, as defined by RECIST v1.1. Bone only disease is acceptable.
- Cohort 2 only: Measurable disease, as defined by RECIST v1.1.
- ≥ 18 years old
Key exclusion criteria (20 listed)
- History of another primary malignancy within 3 years except adequately treated in situ carcinoma of the cervix or non melanoma carcinoma of the skin or any other curatively treated malignancy that is not expected to require treatment for recurrence during the course of the study.
- Neurologic symptoms related to central nervous system metastases requiring increasing doses of corticosteroids. Note that subjects with central nervous system metastases are eligible if they are on a stable corticosteroid dose for at least 2 weeks preceding study entry.
- Current evidence of corneal or retinal disorder/keratopathy including, but not limited to, bullous/band keratopathy, corneal abrasion, inflammation/ulceration, keratoconjunctivitis, confirmed by ophthalmologic examination. Subjects with asymptomatic ophthalmologic conditions assessed by the investigator to pose minimal risk for study participation may be enrolled in the study.
- Current evidence of extensive tissue calcification including, but not limited to, the soft tissue, kidneys, intestine, myocardium, and lung with the exception of calcified lymph nodes, minor pulmonary parenchymal calcifications, and asymptomatic coronary calcification.
- Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral infigratinib (eg, ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection).
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 |
|---|---|---|
| InfigratinibAlso: FGFR 1-3-Selective Tyrosine Kinase Inhibitor, 872511-34-7, NVP-BGJ398, BGJ-398Oral dose | Drug | Cohort 1: Infigratinib (100mg) + Tamoxifen, Cohort 2: Infigratinib (125mg) + Tamoxifen, Cohort 3: Infigratinib (75mg) + Tamoxifen |
| TamoxifenAlso: Nolvadex, Soltamox, Apo-Tamox, TamofenOral Dose | Drug | Cohort 1: Infigratinib (100mg) + Tamoxifen, Cohort 2: Infigratinib (125mg) + Tamoxifen, Cohort 3: Infigratinib (75mg) + Tamoxifen |
| Omnipaque 350Also: Iohexol, Hexopaque, Nycodenz, ExypaqueIV contrast agent | Drug | Cohort 1: Infigratinib (100mg) + Tamoxifen, Cohort 2: Infigratinib (125mg) + Tamoxifen, Cohort 3: Infigratinib (75mg) + Tamoxifen |
| IopamidolAlso: Isovue 300, Isovue 370, Iopamiro, IopamironIV contrast agent | Drug | Cohort 1: Infigratinib (100mg) + Tamoxifen, Cohort 2: Infigratinib (125mg) + Tamoxifen, Cohort 3: Infigratinib (75mg) + Tamoxifen |
| Computed tomography (CT)Computed tomography (CT) to assess disease state using Iopamidol and/or Omnipaque 350. | Diagnostic test | Cohort 1: Infigratinib (100mg) + Tamoxifen, Cohort 2: Infigratinib (125mg) + Tamoxifen, Cohort 3: Infigratinib (75mg) + Tamoxifen |
Primary outcome
Number of Dose-limiting Toxicities (DLTs)
Time frame: 8 weeks
The primary outcome for this study is dose-limiting toxicities (DLTs) during the first 2 cycles of therapy. All grades per the Common Terminology Criteria for Adverse Events (CTCAE). DLT is defined as a related and clinically significant adverse event (AE), including missed doses due to a related AE.
4 secondary outcomes
Number of Treatment Emergent Adverse Events (TEAE)
Time frame: From first dose to 30 days after the last dose of study drug (up to 94 days)
Objective Tumor Response Rate
Time frame: From enrollment to day of scan (up to 64 days)
Progression-free Survival (PFS)
Time frame: up to 9 months
Clinical Benefit Rate
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Jennifer Lee Caswell-Jin principal investigator
Stanford Universiy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Infigratinib, Tamoxifen and Omnipaque 350 in people with Breast Cancer and HER2-negative Breast Cancer, run by Jennifer Lee Caswell-Jin at 1 site 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 30 inclusion and 20 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: stopped early, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Dose-limiting Toxicities (DLTs) (time frame: 8 weeks). 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 12 Feb 2026.