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New treatment option for ER-Positive Breast Cancer
Official title Fulvestrant+Abemaciclib With Run-In of Fulvestrant in Er-Positive, Her2-Negative Metastatic Breast Cancer
ClinicalTrials.gov ID: NCT05305924
What this study is testing
What is Fulvestrant Run-In?
Fulvestrant Run-In is an investigational medicine, being studied as a potential treatment for er-positive breast cancer.
Also referred to as Abemaciclib, Fulvestrant.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study will investigate if CDK4/6 inhibitor holiday will reset the cell cycle process to respond to the combination of fulvestrant and abemaciclib, and this approach may represent an effective therapeutic strategy to manage such patients.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Male or Female \>18 years of age on the day of informed consent signing.
- Progression on a CDK4/6 inhibitor in combination with an AI immediately prior to the enrollment on this study
- Histologically confirmed ER-positive, HER2-negative metastatic breast cancer. ER-positive is defined as ≥1% immunohistochemical (IHC) staining of any...
- IHC 1+ or 0
- In situ hybridization negative based on:
You likely can't join if
- Currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an...
- Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to trial treatment administration or who has not...
- The patient has had major surgery within 14 days prior to starting the study.
- Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous...
- The patient has serious and/or uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation...
- History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the...
See the full eligibility criteria
Who can join
- Male or Female \>18 years of age on the day of informed consent signing.
- Progression on a CDK4/6 inhibitor in combination with an AI immediately prior to the enrollment on this study
- Histologically confirmed ER-positive, HER2-negative metastatic breast cancer. ER-positive is defined as ≥1% immunohistochemical (IHC) staining of any intensity. HER2 test result is negative if a single test (or both...
- IHC 1+ or 0
- In situ hybridization negative based on:
- Single-probe average HER2 copy number \<4.0 signals/cell
- Dual-probe HER2/CEP17 ratio \<2.0 with an average HER2 copy number \<4.0 signals/cell.
- Measurable disease according to the RECIST 1.1 or bone-only disease.
- Postmenopausal status or receiving ovarian ablation with a gonadotropin-releasing hormone (GnRH) agonist. Postmenopausal status is defined by any one of the following criteria:
- Prior bilateral oophorectomy
- Age ≥55 years
- Age \<55 years and amenorrheic for at least 12 months (spontaneous cessation of menses for 12 consecutive months or more in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression) and...
- Eastern Cooperative Oncology Group performance status of 0 or 1.
- Life expectancy ≥6 months.
- Patients who received chemotherapy must have recovered (Common Terminology Criteria for Adverse Events [CTCAE] Grade ≤1) from the acute effects of chemotherapy except for residual alopecia or Grade 2 peripheral...
- Adequate organ function:
- Absolute neutrophil count ≥1500/µL (without granulocyte colony stimulating factor support within 2 weeks of laboratory test used to determine eligibility)
- Platelets ≥100,000/µL (without transfusion within 2 weeks of laboratory test used to determine eligibility)
- Hemoglobin ≥9 g/dL (without blood transfusion)
- White blood cell count \>2,500/µL and \<15,000/µL
- Lymphocyte count ≥500/µL
- Serum bilirubin ≤1.5x upper limit of normal (ULN; patients with known Gilbert's disease who have serum bilirubin level ≤3 x ULN may be enrolled)
- Serum transaminases (aspartate transaminase [AST] or alanine transaminase [ALT]) activity ≤3.0 x ULN with normal alkaline phosphatase ([ALP]; patients with liver metastases ≤5 x ULN) OR AST and ALT ≤1.5 x ULN with ALP...
- International normalized ratio and activated partial thromboplastin time ≤1.5 x ULN
- Serum creatinine at or below the institutional normal value.
- Able to swallow oral medication.
- Patients who are made postmenopausal through use of GNRH agonists must be willing to use an adequate method of contraception for the course of the trial through 1 year after the last dose of trial treatment.
- Patients who are made postmenopausal through use of GNRH agonists should have a negative serum pregnancy (β-human chorionic gonadotropin) within 7 days prior to trial treatment administration.
- Willing and able to provide written informed consent/assent for the trial.
What rules you out
- Currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 3 weeks of trial treatment...
- Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to trial treatment administration or who has not recovered (i.e., ≤ Grade 1 or at baseline) from AEs due to a previously...
- The patient has had major surgery within 14 days prior to starting the study.
- Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative...
- The patient has serious and/or uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study (for example, interstitial lung disease, severe dyspnea...
- History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in...
- Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Concurrent use of strong cytochrome P450 (CYP)3A inhibitors or inducers.
- Hypersensitivity to fulvestrant, abemaciclib, or any of their excipients.
- Manifestations of malabsorption due to prior gastrointestinal surgery, gastrointestinal surgery disease, or an unknown reason.
- Has a bleeding disorder or currently taking anticoagulants.
- Has active hepatitis B (detectable hepatitis B surface antigen) or active hepatitis C infection (detectable hepatitis C RNA).
- Has active systemic bacterial infection (requiring intravenous [IV] antibiotics at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus...
- Has a personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular...
- Documented brain metastases that are untreated, symptomatic, or require therapy to control symptoms. Patients with previously diagnosed brain metastases are eligible if they have completed treatment at least one month...
- Any corticosteroid use for brain metastases must have been discontinued without the subsequent appearance of symptoms for ≥2 weeks before trial treatment administration.
- Treatment for brain metastases may have included whole brain radiotherapy, radiosurgery, or a combination as was deemed appropriate by the treating physician.
- Patients who meet the above criteria and are clinically stable on anticonvulsant medication are eligible only if their anticonvulsant does not alter hepatic CYP activity in a way that might interfere with the metabolism...
- Have received any live vaccination within 28 days of trial treatment administration.
- History within the last 12 months of any of the following conditions: syncope of cardiovascular etiology, ventricular tachycardia, ventricular fibrillation, or sudden cardiac arrest.
- Pregnant or breastfeeding.
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.