Determinants of Resistance to Endocrine Therapy and a Cyclin-dependent Kinases 4 and 6 (CDK4/6) Inhibitor for HR+ MBC
NCT ID: NCT03439735
Last Updated: 2025-08-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
45 participants
INTERVENTIONAL
2018-07-20
2026-11-01
Brief Summary
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Subjects will have archived tissue or new biopsy collected at study enrollment. This tissue will undergo special molecular testing. Subjects will also have blood collected at study enrollment and periodically thereafter. This blood will also undergo special molecular testing. Information from this testing will not be available to subjects or their treating physicians as the investigators do not know how this information should impact treatment.
The investigators will collect information about which treatment the subjects receive and how their cancer responds.
Any man or woman being seen at Johns Hopkins for treatment of newly diagnosed estrogen receptor positive (ER+) and/or progesterone receptor positive (PR+) metastatic breast cancer may be eligible.
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Detailed Description
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Investigators will determine the prevalence of genomic alterations at baseline in the primary tumor, metastatic tissue and plasma tumor DNA (ptDNA), including in the gene encoding estrogen receptor- alpha (ESR1). The mutational tumor burden in the primary tumor, metastatic tumor and blood will be assessed. Blood samples will be collected at several time points, allowing the detection of changes in molecular markers over time. We will further characterize tissue markers associated with progression and duration of response by evaluating these markers in available tissue obtained at progression. Investigators goal is to evaluate the prevalence and role of known alterations determining endocrine resistance in patients with metastatic disease, as knowledge regarding this population remains limited.The investigators also hope to unveil novel markers of endocrine resistance.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort A: Participants with untreated metastatic disease receiving ET and a CDK 4/6
Participants will undergo blood collection (intervention) at time of initiating treatment with endocrine therapy and palbociclib, at 4 weeks after initiating this treatment, and every 3-4 months while on treatment. If a participant progresses on this treatment, they will have a blood collection at that time.
Endocrine Therapy and a CDK 4/6 inhibitor
Participants with untreated metastatic disease receiving ET and a CDK 4/6 i as first line therapy.
Endocrine Therapy and a CDK 4/6 inhibitor
Participants initiating a CDK 4/6 i after progression on ET.
Cohort B: Participants initiating a CDK 4/6 i after progression on ET.
Participants will undergo blood collection (intervention) at time of initiating treatment with endocrine therapy and palbociclib, at 4 weeks after initiating this treatment, and every 3-4 months while on treatment. If a participant progresses on this treatment, they will have a blood collection at that time.
Endocrine Therapy and a CDK 4/6 inhibitor
Participants with untreated metastatic disease receiving ET and a CDK 4/6 i as first line therapy.
Endocrine Therapy and a CDK 4/6 inhibitor
Participants initiating a CDK 4/6 i after progression on ET.
Interventions
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Endocrine Therapy and a CDK 4/6 inhibitor
Participants with untreated metastatic disease receiving ET and a CDK 4/6 i as first line therapy.
Endocrine Therapy and a CDK 4/6 inhibitor
Participants initiating a CDK 4/6 i after progression on ET.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 18 years or older
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
* Metastatic (stage IV) breast cancer or locally advanced breast cancer
* Estrogen Receptor (ER) and/or Progesterone Receptor (PR) positive, HER2- negative
* Treatment naïve in metastatic or locally advanced setting and planning to undergo treatment with endocrine therapy (ET) and palbociclib OR receiving first-line ET and palbociclib for metastatic or locally advanced disease.
* Premenopausal women and men must be treated with concurrent luteinizing hormone-releasing hormone (LHRH) agonist as would be standard-of-care.
* Evaluable or measurable disease.
* Tissue from a metastatic site must be available within past 6 months prior to therapy initiation.
* Ability to give voluntary informed consent
Exclusion Criteria
* No history of another primary malignancy within past 5 years. Patients with prior history of in situ cancer or basal or localized squamous cell skin cancer are eligible.
18 Years
100 Years
ALL
No
Sponsors
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Safeway Foundation
UNKNOWN
Biovica International AB
UNKNOWN
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
OTHER
Responsible Party
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Principal Investigators
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Jessica Tao, M.D.
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Locations
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Johns Hopkins University
Baltimore, Maryland, United States
Countries
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Other Identifiers
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IRB00143030
Identifier Type: OTHER
Identifier Source: secondary_id
J17118
Identifier Type: -
Identifier Source: org_study_id
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