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Advanced Breast CarcinomaPhase 2NCT06630325

A Precision Medicine Approach (SMMART-ACT) for the Treatment of Patients With Advanced Sarcoma, Prostate, Breast, Ovarian or Pancreatic Cancer

A Phase 2 study testing Abemaciclib, Biopsy and Bone Scan in people with Advanced Breast Carcinoma and Advanced Malignant Solid Neoplasm, run by OHSU Knight Cancer Institute at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This phase II trial tests the how well a precision medicine approach (serial measurements of molecular and architectural response to therapy [SMMART])-adaptive clinical treatment [ACT]) works in treating patients with sarcoma, prostate, breast, ovarian or pancreatic cancer that may have spread from where it first… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Abemaciclib, Biopsy and Bone Scan
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteUnited States
Study dates
24 Jun 2025to 11 Mar 2026
Phase
Phase 2
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

  • PRE-SCREENING: Written informed consent prior to any Pre-Screening activities, study-specific procedures or interventions
  • PRE-SCREENING: At least 18 years of age at time of informed consent. Persons of all gender identities, biological sexes, races, and ethnicities will be included
  • PRE-SCREENING: A diagnosis of advanced sarcoma or advanced prostate, breast, ovarian, or pancreatic cancer. Change in an individual's cancer can be tracked objectively according to the Prostate Cancer Working Group 3 (PCWG3) criteria for prostate cancer, and Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 criteria for sarcomas and breast, ovarian, and pancreatic cancers
  • PRE-SCREENING: Biospecimen collection, as per institutional standards, must be consented to and collection must be feasible, with the following exceptions for tissue collections:
  • Individuals with a prior tumor tissue sample with successful SMMART-Clinical Analytics Platform (CAP) assays, collected within the last 90 days, may be eligible, so long as ≤ 1 treatment has been received within ≤ 90 days of that biopsy
  • PRE-SCREENING: Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
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  • PRE-SCREENING: Physician-assessed life expectancy of ≥ 6 months
  • PRE-SCREENING: Additional eligibility criteria specific to their disease must also be met
  • PRIMARY TREATMENT: Documented progression after at least 1 line of prior therapy for advanced disease. If recurrence occurred within 6 months of the last dose of an adjuvant/neoadjuvant therapy, that adjuvant/neoadjuvant therapy will count as 1 line of therapy
  • PRIMARY TREATMENT: SMMART-ACT tumor board recommendation of at least one SMMART-ACT therapy regimen defined within this protocol, based on the board's review of SMMART-CAP results on a pre-screening biopsy
  • PRIMARY TREATMENT: Absolute neutrophil count (ANC) ≥ 1,500/uL (1.5 K/cu mm) (assessed at primary [post pre-screening] screening, or by the time that study intervention commences)
  • PRIMARY TREATMENT: Platelets ≥ 100,000/uL (100 K/cu mm) (assessed at primary [post pre-screening] screening, or by the time that study intervention commences)
  • PRIMARY TREATMENT: Hemoglobin ≥ 9 g/dL (or ≥ 5.6 mmol/L) (assessed at primary [post pre-screening] screening, or by the time that study intervention commences)
  • PRIMARY TREATMENT: Creatinine OR measured or calculated creatinine clearance (glomerular filtration rate [GFR] can also be used in place of creatinine or creatinine clearance [CrCl]) ≤ 1.5 x institutional upper limit of normal (ULN) (institutional upper limit of normal [IULN]) OR ≥ 50 mL/min/1.73 m^2 (assessed at primary [post pre-screening] screening, or by the time that study intervention commences)
  • Creatinine clearance should be calculated per institutional standard. For participants with a baseline calculated creatinine clearance below normal institutional laboratory values, a measured baseline creatinine clearance should be determined. Individuals with higher values felt to be consistent with inborn errors of metabolism will be considered on a case-by-case basis.
  • Creatinine clearance of > 30 mL/min may be considered given that renal toxicity is not at increased risk and excretion is not major route of clearance for any chosen SMMART-ACT therapeutic
  • PRIMARY TREATMENT: Total bilirubin ≤ 1.5 x IULN OR direct bilirubin ≤ IULN for individuals with total bilirubin levels > 1.5 x IULN (assessed at primary [post pre-screening] screening, or by the time that study intervention commences)
  • PRIMARY TREATMENT: Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT])/ Alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) ≤ 3 x IULN (assessed at primary [post pre-screening] screening, or by the time that study intervention commences)
  • PRIMARY TREATMENT: International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 x ULN, unless individual is receiving anticoagulant therapy, as long as PT or partial thromboplastin time (PTT) is within intended therapeutic range of intended anticoagulant therapy (assessed at primary [post pre-screening] screening, or by the time that study intervention commences)
  • PRIMARY TREATMENT: Activated partial thromboplastin time (aPTT) or PTT ≤ 1.5 x ULN, unless participant is receiving anticoagulant therapy, as long as PT or PTT is within therapeutic range of intended anticoagulant therapy (assessed at primary [post pre-screening] screening, or by the time that study intervention commences)
  • PRIMARY TREATMENT: Body mass index (BMI) > 16.0 and < 35.0 kg/m^2 (assessed at primary [post pre-screening] screening, or by the time that study intervention commences)
  • Participants with a BMI of ≥ 30.0 will use ideal body weight indices in calculating the delivery of agents that are dosed based upon body surface area (i.e., mg agent/meter squared) or weight (i.e., mg agent/kg body weight)
  • PRIMARY TREATMENT: Toxicities due to prior therapies should be resolved to baseline or grade 1 (per Common Terminology Criteria for Adverse Events [CTCAE] version [v] 5.0) before administration of study intervention. The following exceptions are permitted:
  • Alopecia, fatigue, and lymphopenia due to prior therapies.
  • Toxicities attributed to prior anti-cancer therapy that are not expected to resolve and to result in long lasting sequelae (e.g., neuropathy after platinum-based therapy), may be permitted
  • PRIMARY TREATMENT: Palliative radiation therapy completed ≥ two weeks prior to start of SMMART-ACT treatment to a measurable disease lesion(s)
  • PRIMARY TREATMENT: Study intervention-specific eligibility criteria for the intended, recommended therapy must also be met
  • CANCER-SPECIFIC CRITERIA (BREAST CANCER): Lesion(s) remain measurable after systemic therapies, as follows:
  • At least one prior line of pharmacological therapy for hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2)-negative disease.
  • At least one prior line of targeted therapy for HER2-positive disease
  • At least one prior line of combination therapy for triple negative disease lacking a BRCA1/2 mutation.
  • At least one prior line of therapy with a PARP inhibitor for triple negative disease with a BRCA1/2 mutation

Who cannot join

  • PRE-SCREENING: Evidence of active malignancy of another cancer with a natural history or treatment history that may affect safety or efficacy assessments of this study or impose unacceptable risk to the participant. Guiding examples for those who can be enrolled include: individuals who have been disease free for ≥ two years; cancers with high cure rates (e.g., prior history of stage 1 rectal cancer and currently otherwise disease free); adequately treated, localized nonmelanomatous skin cancer
  • PRE-SCREENING: Absence of biopsiable lesion, AND unavailable/insufficient archival tissue
  • PRIMARY TREATMENT: Any brain/central nervous system (CNS) metastasis that progresses within ≤ four weeks of CNS directed treatment as ascertained by clinical examination(s) and MRI or CT during the main eligibility screening period
  • PRIMARY TREATMENT: One or more new, active brain/CNS metastasis or the presence of known leptomeningeal disease (LMD) that requires immediate treatment. If treatment within the first cycle of therapy is unlikely to be required, enrollment may be considered, as per the investigator
  • PRIMARY TREATMENT: Concurrent forms of anti-cancer therapy that have the potential to interfere with efficacy and safety assessments or that may pose increased risk to the participant while on a SMMART-ACT treatment, and as per the investigator (Select hormone therapies are allowed)
  • PRIMARY TREATMENT: More than one intervening line of therapy for treatment of their cancer since the time of the pre-screening biopsy, exclusive of most maintenance hormone therapies
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  • Note: Participants who have a pre-screening biopsy while receiving a standard of care (SOC) treatment will not be eligible if they receive any additional lines of treatment prior to the start of SMMART-ACT treatment. This treatment will count as one line of intervening therapy
  • PRIMARY TREATMENT: Untreated and/or uncured hepatitis C virus (HCV) infection, as evidenced by detectable hepatitis B core (HBC) ribonucleic acid (RNA) by polymerase chain reaction (PCR). Prior treatment, concurrent treatment, and natural resolution of HCV infection are not exclusionary given (1) no risk for hepatic decompensation and (2) the intended SMMART-ACT treatment is not expected to exacerbate HCV infection
  • PRIMARY TREATMENT: Uncontrolled intercurrent illness and infection that may interfere with planned treatment, including, but not limited to, the following:
  • Symptomatic congestive heart failure (New York Heart Association [NYHA] class III or IV),
  • Unstable angina pectoris or coronary angioplasty, or stenting within < six months prior to enrollment,
  • Cardiac arrhythmia (ongoing cardiac dysrhythmias of grade ≥ 2 [National Cancer Institute (NCI) CTCAE v 5.0]),
  • Conditions that require intra-cardiac defibrillators,
  • Known cardiac metastases,
  • History of abnormal cardiac valve morphology (≥ grade 2),
  • Chronic graft versus host disease (GVHD) or immunosuppressive therapy for the control of GVHD
  • PRIMARY TREATMENT: Severe infection within < four weeks prior to initiation of study therapy, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia
  • PRIMARY TREATMENT: Inability or unwillingness to take oral medication (only for assigned oral study interventions)
  • PRIMARY TREATMENT: History of allergy to an assigned study agent or its excipients
  • PRIMARY TREATMENT: Current pregnancy, current breastfeeding, or unwillingness to not breastfeed while receiving study drug(s) or for the minimum required time after the last dose of study drug(s) as specified by the SMMART-ACT drug agents
  • PRIMARY TREATMENT: Any condition that, in the opinion of the investigator, could jeopardize the participant's safety or adherence to the study protocol
  • CANCER-SPECIFIC CRITERIA (PROSTATE CANCER): If the screening bone scan shows a "superscan" participants will be excluded from participation. This is defined as an intense symmetric activity in the bones and diminished renal parenchymal activity, such that the presence of additional metastases in the future could not be evaluated

Trial locations and contacts

1 site in 1 country.

United States1 site

  • OHSU Knight Cancer Institute

    Portland, Oregon, 97239

Other trials in United States

About this study

Official title: Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART): Adaptive Clinical Treatment (ACT)

This phase II trial tests the how well a precision medicine approach (serial measurements of molecular and architectural response to therapy [SMMART])-adaptive clinical treatment [ACT]) works in treating patients with sarcoma, prostate, breast, ovarian or pancreatic cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). SMMART testing uses genetic and protein tests to learn how cancer changes and to understand what drugs may work against a person's cancer or why drugs stop working. These test results are reviewed by a group of physicians and scientists during a SMMART tumor board who then recommend precision therapy.

Read the detailed description

PRIMARY OBJECTIVE:

  1. Feasibility of utilizing a SMMART-adaptive clinical treatment (ACT) tumor board to select personalized advanced cancer treatment plans based on a pre-determined set of drug agents with recommended phase 2 doses (RP2Ds).

SECONDARY OBJECTIVES:

  1. Safety and tolerability of assigned ACT intervention per cancer type. II. Preliminary indications of efficacy based on disease-specific responses. III. Estimated survival benefit per cancer type.

EXPLORATORY OBJECTIVES:

  1. Durability of response compared to the most recent therapy on which progression occurred.

II. Changes in ability to conduct activities of daily living (ADL). III. Changes in quality of life (QoL).

IV. Feasibility of SMMART-centric assessments of ongoing responses to treatment to identify mechanisms of therapy induced change, per investigator discretion. Such mechanisms may include, but will not be limited to, the following:

IVa. Changes in tumor and tumor ecosystem biology; IVb. Response and resistance to therapy.

OUTLINE: Patients are assigned to 1 of 14 arms. Participants may re-enter the study and receive a new arm assignment in the event of progressive disease or unacceptable toxicity.

ARM I: Patients receive abemaciclib orally (PO) twice per day (BID) on days 1-21 and gemcitabine intravenously (IV) over 30 minutes on days 1 and 8 of each cycle. Cycles repeat every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection throughout the study. Patients also undergo tumor biopsy on study and optionally at the end of treatment. Additionally, prostate cancer patients undergo bone scan on study.

ARM II: Patients receive abemaciclib PO BID on days 1-21 and pemetrexed IV over 10 minutes on day 1 of each cycle. Cycles repeat every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection throughout the study. Patients undergo blood sample collection throughout the study. Patients also undergo tumor biopsy on study and optionally at the end of treatment. Additionally, prostate cancer patients undergo bone scan on study.

ARM III: Patients receive abemaciclib PO BID on days 1-28 of each cycle. Cycles repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection throughout the study. Patients also undergo tumor biopsy on study and optionally at the end of treatment. Additionally, prostate cancer patients undergo bone scan on study.

ARM IV: Patients receive abemaciclib PO BID and exemestane PO once per day (QD) on days 1-28 of each cycle. Cycles repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection throughout the study. Patients also undergo tumor biopsy on study and optionally at the end of treatment. Additionally, prostate cancer patients undergo bone scan on study.

ARM V: Patients receive abemaciclib PO BID and letrozole PO QD on days 1-28 of each cycle. Cycles repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection throughout the study. Patients also undergo tumor biopsy on study and optionally at the end of treatment. Additionally, prostate cancer patients undergo bone scan on study.

ARM VI: Patients receive abemaciclib PO BID and tamoxifen PO QD on days 1-28 of each cycle. Cycles repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection throughout the study. Patients also undergo tumor biopsy on study and optionally at the end of treatment. Additionally, prostate cancer patients undergo bone scan on study.

ARM VII: Patients receive osimertinib PO QD on days 1-28 of each cycle. Cycles repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo echocardiography or MUGA scan and blood sample collection throughout the study. Patients also undergo tumor biopsy on study and optionally at the end of treatment. Additionally, prostate cancer patients undergo bone scan on study.

After completion of study treatment, patients are followed up 30 days, every 3 months for 1 year then every 6 months until year 5.

Being tested
Abemaciclib, Biopsy, Bone Scan, Echocardiography, Exemestane
Medical subject headings
Ovarian Neoplasms, Pancreatic Neoplasms, Prostatic Neoplasms

What participants receive

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

  • AbemaciclibDrug

    Also called LY 2835219, LY-2835219, LY2835219, Verzenio

    Given PO

  • BiopsyProcedure or surgery

    Also called BIOPSY_TYPE, Bx

    Undergo tumor biopsy

  • Bone ScanProcedure or surgery

    Also called Bone Scintigraphy

    Undergo bone scan

  • EchocardiographyProcedure or surgery

    Also called EC

    Undergo echocardiography

  • ExemestaneDrug

    Also called Aromasin, FCE-24304

    Given PO

  • GemcitabineDrug

    Also called dFdC, dFdCyd, Difluorodeoxycytidine

    Given IV

  • LetrozoleDrug

    Also called CGS 20267, CGS-20267, CGS20267, Femara

    Given PO

  • Multigated Acquisition ScanProcedure or surgery

    Also called Blood Pool Scan, Equilibrium Radionuclide Angiography, Gated Blood Pool Imaging, Gated Heart Pool Scan

    Undergo MUGA

  • OsimertinibDrug

    Also called AZD 9291, AZD-9291, AZD9291, Mereletinib

    Given PO

  • PemetrexedDrug

    Also called MTA, Multitargeted Antifolate, Pemfexy

    Given IV

  • Survey AdministrationOther

    Ancillary studies

  • TamoxifenDrug

    Also called TMX

    Given PO

  • Biospecimen CollectionProcedure or surgery

    Biological Sample Collection, Biological Sample Collection, Biospecimen Collected, Biospecimen Collection, Specimen Collection

Study groups in NCT06630325
Study groupRoleWhat they receive
Arm I (abemaciclib, gemcitabine)ExperimentalPatients receive abemaciclib PO BID on days 1-21 and gemcitabine IV over 30 minutes on days 1 and 8 of each cycle. Cycles repeat every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection throughout the study. Patients also undergo tumor biopsy on study and optionally at the end of treatment. Additionally, prostate cancer patients undergo bone scan on study.
Receives: Drug: Abemaciclib; Procedure: Biopsy; Procedure: Bone Scan; Drug: Gemcitabine; Other: Survey Administration; Procedure: Biospecimen Collection
Arm II (abemaciclib, pemetrexed)ExperimentalPatients receive abemaciclib PO BID on days 1-21 and pemetrexed IV over 10 minutes on day 1 of each cycle. Cycles repeat every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection throughout the study. Patients also undergo tumor biopsy on study and optionally at the end of treatment. Additionally, prostate cancer patients undergo bone scan on study.
Receives: Drug: Abemaciclib; Procedure: Biopsy; Procedure: Bone Scan; Drug: Pemetrexed; Other: Survey Administration; Procedure: Biospecimen Collection
Arm III (abemaciclib)ExperimentalPatients receive abemaciclib PO BID on days 1-28 of each cycle. Cycles repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection throughout the study. Patients also undergo tumor biopsy on study and optionally at the end of treatment. Additionally, prostate cancer patients undergo bone scan on study.
Receives: Drug: Abemaciclib; Procedure: Biopsy; Procedure: Bone Scan; Other: Survey Administration; Procedure: Biospecimen Collection
Arm IV (abemaciclib, exemestane)ExperimentalPatients receive abemaciclib PO BID and exemestane PO QD on days 1-28 of each cycle. Cycles repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection throughout the study. Patients also undergo tumor biopsy on study and optionally at the end of treatment. Additionally, prostate cancer patients undergo bone scan on study.
Receives: Drug: Abemaciclib; Procedure: Biopsy; Procedure: Bone Scan; Drug: Exemestane; Other: Survey Administration; Procedure: Biospecimen Collection
Arm V (abemaciclib, letrozole)ExperimentalPatients receive abemaciclib PO BID and letrozole PO QD on days 1-28 of each cycle. Cycles repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection throughout the study. Patients also undergo tumor biopsy on study and optionally at the end of treatment. Additionally, prostate cancer patients undergo bone scan on study.
Receives: Drug: Abemaciclib; Procedure: Biopsy; Procedure: Bone Scan; Drug: Letrozole; Other: Survey Administration; Procedure: Biospecimen Collection
Arm VI (abemaciclib, tamoxifen)ExperimentalPatients receive abemaciclib PO BID and tamoxifen PO QD on days 1-28 of each cycle. Cycles repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection throughout the study. Patients also undergo tumor biopsy on study and optionally at the end of treatment. Additionally, prostate cancer patients undergo bone scan on study.
Receives: Drug: Abemaciclib; Procedure: Biopsy; Procedure: Bone Scan; Other: Survey Administration; Drug: Tamoxifen; Procedure: Biospecimen Collection
Arm VII (osimertinib)ExperimentalPatients receive osimertinib PO QD on days 1-28 of each cycle. Cycles repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo echocardiography or MUGA scan and blood sample collection throughout the study. Patients also undergo tumor biopsy on study and optionally at the end of treatment. Additionally, prostate cancer patients undergo bone scan on study.
Receives: Procedure: Biopsy; Procedure: Bone Scan; Procedure: Echocardiography; Procedure: Multigated Acquisition Scan; Drug: Osimertinib; Other: Survey Administration; Procedure: Biospecimen Collection

What is being measured

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

  1. Proportion of Participants Who Receive an ACT Therapy Based on a SMMART-ACT Tumor Board Recommendation.

    A threshold of the posterior probability rate of 75% will be utilized for declaring feasibility to support the analysis of the primary objective in this pilot.

    Measured: From SMMART-ACT tumor board review to the first dose of ACT study drug per unique treatment regimen. This is expected to take up to approximately 30 days.

Secondary outcomes (6)

  1. Incidence of Treatment Emergent Adverse Events (TEAEs) Suspected or Confirmed as Attributed to Study Therapy

    The incidence of TEAEs experienced that are suspected or confirmed as attributable to a study drug or procedure will be tabulated

    Measured: From first dose of study drug to 30 days after last dose of study drug(s). This is expected to be approximately 7 months, but could be shorter if participant stops treatment early for any reason.

  2. Rate of Treatment Discontinuation Due to Toxicities and/or Intolerability

    The incidence of discontinuation from study therapy due to intolerability and/or toxicities will be reported.

    Measured: From first dose of study drug to last dose of study drug(s). This is expected to be approximately 6 months, but could be shorter if participant stops treatment early for any reason.

  3. Overall Response Rate (ORR)

    ORR is defined as complete response + partial response. Will be assessed per Response Evaluation Criteria in Solid Tumors (RECIST). An exact 95% confidence interval will be provided.

    Measured: At 24 weeks from cycle 1 day 1

  4. Progression Free Survival

    Will be estimated using the Kaplan-Meier method.

    Measured: From first dose of study drug to first date of documented progression or recurrence (RECIST 1.1), end-of-study, or death due to any cause, whichever occurs first, up to 5 years

  5. Disease Specific Survival (DSS)

    Will be estimated using the Kaplan-Meier method. Analysis will also fit DSS and subdistribution hazard models for both DSS death and non-DSS death.

    Measured: From first dose of study drug to death as a result of the disease, up to 5 years

  6. Overall Survival

    Will be summarized descriptively using the Kaplan-Meier method. The median and 95% confidence interval will be included in the estimations, if possible.

    Measured: From first dose of study drug to date of death from any cause, up to 5 years

Timeline

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

  1. First posted8 Oct 2024
  2. Study start24 Jun 2025
  3. Primary completion11 Mar 2026
  4. Study completion11 Mar 2026

Why it stopped: Loss of support.

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06630325
Sponsor's protocol ID
STUDY00026643
Other IDs
NCI-2024-07664, STUDY00026643
Status last verified
Apr 2026
First submitted
26 Sep 2024
Last updated
28 Apr 2026
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Abemaciclib, Biopsy and Bone Scan in people with Advanced Breast Carcinoma and Advanced Malignant Solid Neoplasm, run by OHSU Knight Cancer Institute 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 32 inclusion and 22 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 28 Apr 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 28 Apr 2026). 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?

Proportion of Participants Who Receive an ACT Therapy Based on a SMMART-ACT Tumor Board Recommendation. (time frame: From SMMART-ACT tumor board review to the first dose of ACT study drug per unique treatment regimen. This is expected to take up to approximately 30 days.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06630325.

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 28 Apr 2026.

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