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Anatomic Stage III Breast Cancer AJCC v8Phase 2NCT06179303

Functional Imaging in Prediction of Response to Abemaciclib for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer

A Phase 2 study testing Abemaciclib, Anastrozole and Biospecimen Collection in people with Anatomic Stage III Breast Cancer AJCC v8 and Anatomic Stage IV Breast Cancer AJCC v8, run by University of Washington at 3 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial summary

This phase II trial tests the accuracy of functional imaging (FFNP)-positron emission tomography (PET)/computed tomography (CT) to predict response to abemaciclib plus endocrine therapy. Abemaciclib is a drug used to treat certain types of hormone receptor positive (HR+), HER2 negative breast cancer. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Abemaciclib, Anastrozole and Biospecimen Collection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
3 sitesUnited States
Study dates
22 Jul 2024to 1 Jun 2028
Phase
Phase 2

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

  • Men or women with metastatic or locally advanced unresectable breast cancer
  • Histologically confirmed ER+ / HER2-negative, breast cancer who is a candidate for endocrine therapy with pathology from the primary tumor or metastatic/recurrent site. Based on American Society of Clinical Oncology/College of American Pathologists (ASCO CAP) Guidelines: ER+: >= 1% of tumor cell nuclei to be immunoreactive. HER2-negative: HER2 of 0, 1+ by immunohistochemistry (IHC) or negative by fluorescence in situ hybridization (FISH).
  • In the case of bone biopsy which could yield false negative ER or PR status in patients with historically HR+ disease, a patient may be eligible if the treating physician and the study chair both agree that the patient is a candidate for further endocrine therapy (ET) based treatment.
  • Note that baseline PR status by IHC does not influence results of deltaFFNP-PET imaging.
  • If premenopausal, the patient has to be treated with GnRH agonist for at least 6 weeks prior to FFNP-PET.
  • Disease must be present in at least one non-liver site and measurable by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria and be 1.5 cm or greater in longest dimension OR disease can be non-measurable but must be 1.5 cm in longest dimension on functional imaging (fluorodeoxyglucose [FDG]-PET/computed tomography [CT] preferred).
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  • No limits to prior lines of endocrine therapy in the metastatic setting including synergistic targeted therapy such as CDK4/6 inhibitors (other than Abemaciclib), PI3K inhibitor, mTOR inhibitor, etc. One line of prior cytotoxic chemotherapy in the metastatic setting is allowed. Washout from prior systemic anti-cancer therapy of at least 2 weeks from chemotherapy or radiation, 2 weeks or 5 half lives (whichever is longer) from oral selective estrogen receptor degrader (SERD), 8 weeks from oral selective estrogen receptor modulator (SERM), and 16 weeks from intramuscular SERD (Fulvestrant) is required. Recovery of adverse events from the last therapy to grade 1 except alopecia. Patients may continue luteinizing hormone-releasing hormone (LHRH) agonist to remain post-menopausal without a need for washout
  • Eastern Cooperative Oncology Group (ECOG) performance status =< 2
  • At least 18 years of age
  • Absolute neutrophil count >= 1,500/uL
  • Platelets >= 100,000/uL
  • Hemoglobin >= 9g/dL
  • Total bilirubin =< 1.5 x institutional upper limit of normal (ULN).
  • In case of known Gilbert's syndrome, < 2 x ULN is allowed
  • Aspartate aminotransferase (AST) serum glutamic oxaloacetic transaminase (SGOT) /alanine aminotransferase (ALT) serum glutamic pyruvic transaminase (SGPT) =< 2.5x institutional ULN, or =< 5 x ULN for subjects with documented metastatic disease to the liver
  • eGFR (estimated glomerular filtration rate) ≥ 30 mL/min
  • Women of childbearing potential must agree to use adequate contraception (barrier method of birth control, abstinence) prior to study entry and for the duration of study participation
  • Ability to understand and willingness to sign an institutional review board (IRB)-approved written informed consent document (or that of legally authorizes representative, if applicable)
  • Consent to access archival tumor specimens for clinical sequencing data of tumor tissue and blood

Who cannot join

  • Prior abemaciclib in the metastatic setting or within 2 years of completion of adjuvant abemaciclib
  • Hepatic-only metastatic disease
  • A history of other malignancy with the exception of malignancies for which all treatment was completed at least 2 years before registration and the patient has no evidence of disease
  • Currently receiving any other investigational agents
  • Untreated/unstable brain metastases. Patients with treated/stable brain metastases, defines as patients who have received prior therapy for their brain metastases and whose central nervous system (CNS) disease is radiographically stable at study entry, are eligible
  • A history of allergic reactions attributed to compounds of similar chemical or biologic composition to FFNP, abemaciclib, or other agents used in the study
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  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
  • Pregnant and/or breastfeeding women of childbearing potential must have a negative pregnancy test within 14 days of study entry. Male participants and female participants of childbearing potential must utilize adequate contraceptive methods throughout study treatment and for at least 30 days after the last dose of study medications
  • Patients with human immunodeficiency virus (HIV) are eligible unless their CD4+ T-cell counts are < 350 cells/mcL or they have a history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infection within the 12 months prior to registration. Concurrent treatment with effective antiretroviral therapy (ART) according to Department of Health and Human Services (DHHS) treatment guidelines is recommended

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Hannah Linden contact

206-606-2053

hmlinden@uw.edu

United States3 sites, 3 recruiting

  • University of North Carolina

    Chapel Hill, North Carolina, 27599

    Jorge Oldan

    Recruiting

  • Fred Hutch/University of Washington Cancer Consortium

    Seattle, Washington, 98109

    Hannah Linden, 206-606-2053, hmlinden@uw.edu

    Hannah Linden

    Recruiting

  • Siteman Cancer Center at Washington University

    St Louis, Missouri, 63110

    Farrokh Dehdashti, 314-362-2809, dehdashtif@wustl.edu

    Farrokh Dehdashti

    Recruiting

Other trials in United States

About this study

Official title: A Phase II Trial to Evaluate Functional Imaging in Prediction of Response to Abemaciclib for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer

This phase II trial tests the accuracy of functional imaging (FFNP)-positron emission tomography (PET)/computed tomography (CT) to predict response to abemaciclib plus endocrine therapy. Abemaciclib is a drug used to treat certain types of hormone receptor positive (HR+), HER2 negative breast cancer. Abemaciclib blocks certain proteins, which may help keep tumor cells from growing. Endocrine therapy adds, blocks, or removes hormones that can cause cancer to grow. FFNP PET imaging is a form of x-ray that uses FFNP as an imaging agent that may provide more precise information about the location of tumors that "light up" with FFNP than a PET scan alone can provide.

Read the detailed description

OUTLINE:

Patients receive FFNP intravenously (IV) and undergo PET/CT imaging at baseline. Patients then receive estradiol orally every 8 hours (Q8H) over a 24-hour period, followed again by FFNP IV and PET/CT imaging. Patients then receive abemaciclib orally (PO) twice daily (BID) on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive endocrine therapy (ET) of the treating physician choice. Patients also receive FDG IV and undergo PET/CT imaging at baseline, with additional diagnostic imaging for tumor assessment every 3 cycles, and undergo blood sample collection throughout the study.

After study completion of study, patients are followed every 3 months.

Being tested
Abemaciclib, Anastrozole, Biospecimen Collection, Computed Tomography, Diagnostic Imaging Testing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AbemaciclibDrug

    Also called LY-2835219, LY2835219, Verzenio

    Given PO

  • AnastrozoleDrug

    Also called Anastrazole, Arimidex, ICI D1033, ICI-D1033

    Given PO

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo blood sample collection

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo PET/CT

  • Diagnostic Imaging TestingProcedure or surgery

    Also called Diagnostic Imaging, Medical Imaging

    Undergo clinical imaging for tumor assessment

  • ExemestaneDrug

    Also called Aromasin, FCE-24304

    Given PO

  • Fludeoxyglucose F-18Other

    Also called 18FDG, FDG, Fludeoxyglucose (18F), fludeoxyglucose F 18

    Given IV

  • Fluorine F 18 Fluoro Furanyl NorprogesteroneDrug

    Also called [18F]FFNP

    Given IV

  • FulvestrantDrug

    Also called Faslodex, Faslodex(ICI 182,780), ICI 182,780, ICI 182780

    Given IM injection

  • Gonadotropin-releasing Hormone AnalogBiological

    Also called GnRH Agonist, GnRH Analog, Gonadotropin-Releasing Hormone Agonist, Gonadotropin-Releasing Hormone Analogue

    Given GnRH analog

  • LetrozoleDrug

    Also called CGS 20267, Femara, Fempro

    Given PO

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)

    Undergo PET/CT

  • TamoxifenDrug

    Also called TMX

    Given PO

  • Therapeutic EstradiolDrug

    Also called 17 Beta-Estradiol, Aquadiol, Climara, Dimenformon

    Given PO

Study groups in NCT06179303
Study groupRoleWhat they receive
Treatment (FFNP-PET/CT, estradiol, abemaciclib, ET)ExperimentalPatients receive FFNP IV and undergo PET/CT imaging at baseline. Patients then receive estradiol orally Q8H over a 24-hour period, followed again by FFNP IV and PET/CT imaging. Patients then receive abemaciclib PO BID on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive ET of the treating physician choice. Patients also receive FDG IV and undergo PET/CT imaging at baseline, with additional diagnostic imaging for tumor assessment every 3 cycles, and undergo blood sample collection throughout the study.
Receives: Drug: Abemaciclib; Drug: Anastrozole; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Diagnostic Imaging Testing; Drug: Exemestane; Other: Fludeoxyglucose F-18; Drug: Fluorine F 18 Fluoro Furanyl Norprogesterone; Drug: Fulvestrant; Biological: Gonadotropin-releasing Hormone Analog; Drug: Letrozole; Procedure: Positron Emission Tomography; Drug: Tamoxifen; Drug: Therapeutic Estradiol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response to abemaciclib + endocrine therapy

    Non-responding: progression within 24 weeks by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or death due to disease within 24 weeks or stable disease but lasting less than 24 weeks. Responding: defined as complete response (CR), partial response (PR) or stable disease lasting >= 24 weeks. Quantitative deltaFFNP will be summarized by descriptive statistics (mean, median, standard deviation [SD], etc.) and tested against 0 by Wilcoxon signed rank test or paired t-test as appropriate, overall and by response. The dichotomized deltaFFNP will be summarized by count and percentages, overall and by response.

    Measured: Up to 2 years

Secondary outcomes (3)

  1. Overall response rate (ORR)

    Defined by RECIST 1.1

    Measured: Up to 2 years

  2. Progression free survival rate (PFS)

    Defined from date on study to date of progression or date of death or date of last clinical follow up with imaging evidence showing no progression if a patient did not progress or die, whichever the earliest. PFS events include progression and death.

    Measured: Up to 2 years

  3. Overall survival rate (OS)

    Defined from date on study to date of death or last follow up if a patient is still alive.

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Dec 2023
  2. Study start22 Jul 2024
  3. Primary completion1 Mar 2027 (estimated)
  4. Study completion1 Jun 2028 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06179303
Sponsor's protocol ID
RG1122019
Other IDs
NCI-2022-06409, FHIRB0020029
Status last verified
Apr 2026
First submitted
8 Dec 2023
Last updated
24 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

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