A Phase 1/2 Trial of ARV-471 Alone and in Combination With Palbociclib (IBRANCE®) in Patients With ER+/HER2- Locally Advanced or Metastatic Breast Cancer
NCT ID: NCT04072952
Last Updated: 2026-02-10
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
PHASE1/PHASE2
217 participants
INTERVENTIONAL
2019-08-05
2026-02-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
Dose escalation followed by expansion at a Recommended Phase 2 Dose (RP2D) including a combination cohort with palbociclib (IBRANCE®)
TREATMENT
NONE
Study Groups
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ARV-471
Parts A and B: ARV-471 administered once daily (QD) or twice daily (BID) for 28 day cycles.
ARV-471
Parts A and B: ARV-471 administered QD or BID for 28 day cycles.
ARV-471 and palbociclib (IBRANCE®)
Part C: Daily oral dosages of ARV-471 for 28 days in combination with palbociclib (IBRANCE®) for 21 days.
ARV-471 in combination with palbociclib (IBRANCE®)
Part C: Daily oral dosages of ARV-471 for 28 days in combination with palbociclib (IBRANCE®) for 21 days
Interventions
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ARV-471
Parts A and B: ARV-471 administered QD or BID for 28 day cycles.
ARV-471 in combination with palbociclib (IBRANCE®)
Part C: Daily oral dosages of ARV-471 for 28 days in combination with palbociclib (IBRANCE®) for 21 days
Eligibility Criteria
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Inclusion Criteria
* Patients at least 18 years of age at the time of signing the informed consent.
* Patients must have histologically or cytologically confirmed ER+ and HER2- advanced breast cancer for which standard curative therapy is no longer effective or does not exist.
* Patients must have measurable or non-measurable disease by RECIST criteria (version1.1), with radiologic tumor assessments performed within 28 days of the first dose of therapy.
* Patients must be willing to undergo a core biopsy of accessible tumor within 4 weeks prior to the initiation of study treatment and a follow-up biopsy on treatment for ER immunohistochemistry (IHC) testing and pharmacodynamics (PD) studies. (Patients without accessible tumor tissue may be eligible after discussion with the Medical Monitor.)
* Women must be postmenopausal due to surgical or natural menopause.
Part A:
\- Patients must have received at least 2 prior endocrine regimens in any setting (neoadjuvant, adjuvant or advanced/metastatic) a CDK4/6 inhibitor and up to 3 prior regimens of cytotoxic chemotherapy in the locally advanced or metastatic setting.
Part B:
* Patients must have received at least 1 prior endocrine regimen for a minimum of 6 months in the locally advanced or metastatic setting; if more than 1 prior endocrine regimen has been administered, only one of the regimens must have been administered for a minimum of 6 months in the locally advanced or metastatic setting
* Patients must have received a CDK4/6 inhibitor
* Patients must have received up to 1 prior regimen of cytotoxic chemotherapy in the locally advanced or metastatic setting
* Women must be postmenopausal due to surgical or natural menopause.
Part C:
* Patients must have received at least one prior endocrine regimen.
* Patients must have received no more than two prior chemotherapy regimens for advanced disease.
* Women must be postmenopausal due to surgical or natural menopause.
Exclusion Criteria
* Patients with known symptomatic brain metastases requiring steroids (above physiologic replacement doses). Patients with previously diagnosed brain metastases are eligible if they have completed their treatment and have recovered from the acute effects of radiation therapy or surgery prior to first dose of study drug, have discontinued high-dose corticosteroid treatment for these metastases for at least 4 weeks and are neurologically stable as judged by the Investigator.
* Receipt of prior anti-cancer or other investigational therapy within 14 days prior to the first administration of study drug.
* Radiation therapy within 4 weeks of first dose of study drug or prior irradiation to \>25% of the bone marrow. Palliative radiation for the alleviation of pain due to bone metastasis will be allowed during the study.
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Arvinas Estrogen Receptor, Inc.
INDUSTRY
Responsible Party
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Locations
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Clinical Trial Site
Palo Alto, California, United States
Clinical Trial Site
San Francisco, California, United States
Clinical Trial Site
Santa Monica, California, United States
Clinical Trial Site
Norwalk, Connecticut, United States
Clinical Trial Site
Fort Myers, Florida, United States
Clinical Trial Site
Tampa, Florida, United States
Clinical Trial Site
Chicago, Illinois, United States
Clinical Trial Site
Boston, Massachusetts, United States
Clinical Trial Site
Boston, Massachusetts, United States
Clinical Trial Site
Ann Arbor, Michigan, United States
Clinical Trial Site
St Louis, Missouri, United States
Clinical Trial Site
East Brunswick, New Jersey, United States
Clinical Trial Site
The Bronx, New York, United States
Clinical Trial Site
Charlotte, North Carolina, United States
Clinical Trial Site
Nashville, Tennessee, United States
Clinical Trial Site
Seattle, Washington, United States
Countries
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Other Identifiers
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C4891019
Identifier Type: OTHER
Identifier Source: secondary_id
ARV-471-mBC-101
Identifier Type: -
Identifier Source: org_study_id
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