Comparing 7 approaches for breast cancer
Official title: A Study of LOXO-783 in Patients With Breast Cancer/Other Solid Tumors
A Study of LOXO-783 Administered as Monotherapy and in Combination With Anticancer Therapies for Patients With Advanced Breast Cancer and Other Solid Tumors With a PIK3CA H1047R Mutation
Interventions
LOXO-783
Oral
Fulvestrant
Intramuscular
Imlunestrant
Oral
Abemaciclib
Oral
Anastrozole, Exemestane, or Letrozole
Oral
Paclitaxel
Intravenous
Canadian Sites (2)
Princess Margaret Hospital (Hong Kong)
Toronto, Canada
BC Cancer Vancouver
Vancouver, Canada
Eligibility Criteria
See who this study is looking for40 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Have advanced breast cancer or another solid tumor with the presence of a phosphatidylinositol 3-kinase catalytic subunit alpha (PIK3CA) H1047R mutation (or other SponsorSponsorThe organisation responsible for the study overall.Read more → and safety review committee (SRC)-approved, activating PIK3CA mutations other than H1047R mutation)
- +Have adequate archival tumor tissue sample available or be approved by the Sponsor for enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more → if no tumor sample is available.
- +Have stopped all cancer treatment and have recovered from the major side effectsSide effectAn unwanted effect thought to be caused by the treatment itself.Read more →
- +Have adequate organ function, as measured by blood tests
- +Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale
- +Patients must have
- +Measurable disease
- +\--- Patients with non-breast tumor types must have at least 1 measurable lesion
- +Non-measurable bone disease (at least 1 bone lesion in breast cancer patients only)
- +For patients with an estrogen receptor (ER)+ breast cancer diagnosis:
- +If female, must be postmenopausal
- +If male, must agree to use hormone suppression
- +\-- Dose escalationDose escalationLater groups receive higher amounts than earlier ones, increased step by step.Read more → and backfill patients:
- +Advanced solid tumor
- +Patients may have had up to 5 prior regimens for advanced disease
- +ER+/human epidermal growth factor receptor 2 (HER2)- advanced breast cancer
- +Patients may have had up to 5 prior regimens for advanced disease ---- Prior cyclin dependent kinase (CDK)4/6 inhibitor therapy required
- +ER+/HER2- advanced breast cancer
- +Patients may have had up to 2 prior regimens for advanced disease.
- +ER+/HER2- advanced breast cancer
- +Patients may have had up to 5 prior regimens for advanced disease.
- +\---- Prior CDK4/6 inhibitor therapy required.
- +Have a diagnosis of diabetes mellitus Type 2
- +Advanced breast cancer
- +Patients may have had up to 5 prior regimens for advanced disease.
- +Advanced solid tumor
- +Patients may have had up to 3 prior regimens for advanced disease advanced disease
- +ER+/HER2- advanced breast cancer
- +Patients may have had up to 5 prior regimens for advanced disease
- +Prior cyclin dependent kinase (CDK)4/6 inhibitor therapy required
Exclusion
- −Medical Conditions
- −Colorectal cancer
- −Endometrial cancers with specific concurrent oncogenic alterations
- −A history of known active or suspected
- −Diabetes mellitus Type 1 or
- −Diabetes mellitus Type 2 requiring antidiabetic medication (Phase 1a and all parts of Phase 1b except Part C).
- −Serious concomitant systemic disorder
- −Known or suspected history of untreated or uncontrolled central nervous system (CNS) involvement.
- −Active uncontrolled systemic bacterial, viral, fungal, or parasitic infection, or other clinically significant active disease process
- −Prior exposure to phosphatidylinositol 3-kinase/protein kinase B/mammalian target of rapamycin (PI3K/AKT/mTOR) inhibitor(s), except in certain circumstances
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 1Phase 1The earliest stage of human testing, in a small group, focused on safety.Read more → — an early safety study in a small group, checking how it is tolerated and at what dose.
What is being given or done in this study: LOXO-783, Fulvestrant, Imlunestrant, Abemaciclib, and 2 more.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
Groups are assigned by the study team using set rules, rather than by chance.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
There are 7 groups in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 260 people.
The study is currently expected to finish around December 2026.
The main measurement is taken over: During the first 28-day cycle of LOXO-783 treatment.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Phase 1Phase 1The earliest stage of human testing, in a small group, focused on safety.Read more → a: To determine the maximum tolerated doseMaximum tolerated doseThe highest amount that can be given before side effects become unacceptable.Read more →/recommended phase 2Phase 2A middle-stage study looking at what a treatment does and watching for side effects.Read more → dose (MTD/RP2D) of LOXO-783: Number of patients with dose-limiting toxicities (DLTs) — measured over During the first 28-day cycle of LOXO-783 treatment.
Phase 1 a: To determine the MTD/RP2D of LOXO-783: Number of patients with DLT-equivalent toxicities — measured over During the first 28-day cycle of LOXO-783 treatment.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT05307705 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About LOXO-783Drug
Oral
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About FulvestrantDrug
Intramuscular
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About ImlunestrantDrug
Oral
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About AbemaciclibDrug
Oral
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Anastrozole, Exemestane, or LetrozoleDrug
Oral
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About PaclitaxelDrug
Intravenous
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Groups are assigned by the study team using set rules, rather than by chance.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: During the first 28-day cycle of LOXO-783 treatment.
The study as a whole is currently expected to finish around 2026-12.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 260 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 5 locations, including: Toronto, Canada; Vancouver, Canada; Rochester, Minnesota, United States; New York, New York, United States; Rochester, New York, United States.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
The main purpose of this study is to learn more about the safety, side effects, and effectiveness of LOXO-783. LOXO-783 may be used to treat breast cancer and other solid tumors that have a change in a particular gene (known as the PIK3CA gene). Participation could last up to 36 months (3 years) and possibly longer if the disease does not get worse.
Other Sites (3)
Mayo Clinic
Rochester, Minnesota, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Wilmot Cancer Institute
Rochester, New York, United States
Worth passing on?
Save it to the Care Package and send it to them, or to their doctor, in one message. Whether they follow it up is theirs to decide.
Review the Care PackageThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.