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New treatment option for Breast Cancer
Official title Abemaciclib in Combination With Bicalutamide for Androgen Receptor-positive, HER2-negative Metastatic Breast Cancer
ClinicalTrials.gov ID: NCT05095207
What this study is testing
What is Abemaciclib?
Abemaciclib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for breast cancer.
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
- This is an open label multicenter, Phase IB/II Study of Abemaciclib in Combination with Bicalutamide for Androgen Receptor-positive, HER2-negative Metastatic Breast Cancer
- 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 to 90. Healthy volunteers may be eligible.
You may be able to join if
- Provision of signed and dated, written informed consent prior to any study specific procedures, sampling and analyses
- If a patient declines to participate in any voluntary exploratory research and/or genetic component of the study, there will be no penalty or loss of...
- Women aged at least 18 years
- The patient has a biopsy-confirmed diagnosis of recurrent, unresectable, locally advanced, or metastatic HER2neu-negative breast cancer (including...
- The patient has AR+ breast cancer (defined as \> or equal to 1% staining on immunohistochemistry of metastatic breast cancer specimen)
You likely can't join if
- Treatment with any of the following:
- Any investigational agents or study drugs from a previous clinical study within 28 days of the first dose of study treatment
- Any other chemotherapy, immunotherapy or anticancer agents within 21 days of the first dose of study treatment
- Any prior exposure to anti-androgen therapy (bicalutamide, abiraterone, and/or enzalutamide)
- Major surgery (excluding placement of vascular access) within 4 weeks of the first dose of study treatment
- Spinal cord compression, leptomeningeal carcinomatosis, or brain metastases - unless asymptomatic, treated and stable and not requiring steroids for...
See the full eligibility criteria
Who can join
- Provision of signed and dated, written informed consent prior to any study specific procedures, sampling and analyses
- If a patient declines to participate in any voluntary exploratory research and/or genetic component of the study, there will be no penalty or loss of benefit to the patient and he/she will not be excluded from other...
- Women aged at least 18 years
- The patient has a biopsy-confirmed diagnosis of recurrent, unresectable, locally advanced, or metastatic HER2neu-negative breast cancer (including bone-only metastatic disease) o The patient must have had biopsy...
- The patient has AR+ breast cancer (defined as \> or equal to 1% staining on immunohistochemistry of metastatic breast cancer specimen)
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2 with no deterioration over the previous 2 weeks and minimum life expectancy of 12 weeks
- If the patient has ER+ or PR+ (\>1% on IHC) metastatic breast cancer: o patient must have had 1 prior line of endocrine therapy in the metastatic setting
- prior CDK4/6 inhibitor exposure allowed (abemaciclib. palbociclib, or ribociclib)
- no more than 2 prior line of cytotoxic chemotherapy in the metastatic setting allowed
- If the patient has ER-,PR-, HER2- metastatic breast cancer ("triple-negative"): o The patient may have had up to 4 prior lines of chemotherapy in the metastatic setting and at least 1 prior line of chemotherapy in the...
- 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...
- Patients who received radiotherapy must have completed and fully recovered from the acute effects of radiotherapy. A washout period of at least 14 days is required between end of radiotherapy and randomization.
- Post-menopausal status or receiving ovarian ablation with a GnRH agonist such as goserelin or leuprolide. Postmenopausal status is defined by any one of the following criteria:
- Prior bilateral oophorectomy.
- Age ≥ 60 years.
- Age \< 60 and amenorrhea for 12 or more months (in the absence of chemotherapy, tamoxifen, or ovarian suppression) and FSH, LH, and estradiol in the postmenopausal range per local normal. If the patient does not meet...
- Women of child-bearing potential and men must agree to use a highly effective method of contraception prior to study entry, for the duration of study participation, and for 3 weeks following completion of therapy...
- Has not undergone a hysterectomy or bilateral oophorectomy; or
- Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
What rules you out
- Treatment with any of the following:
- Any investigational agents or study drugs from a previous clinical study within 28 days of the first dose of study treatment
- Any other chemotherapy, immunotherapy or anticancer agents within 21 days of the first dose of study treatment
- Any prior exposure to anti-androgen therapy (bicalutamide, abiraterone, and/or enzalutamide)
- Major surgery (excluding placement of vascular access) within 4 weeks of the first dose of study treatment
- Spinal cord compression, leptomeningeal carcinomatosis, or brain metastases - unless asymptomatic, treated and stable and not requiring steroids for at least 2 weeks prior to start of study treatment
- Concurrent use of endocrine therapy (tamoxifen, anastrozole, letrozole, exemestane, oral contraceptive pills)
- As judged by the investigator, any evidence of severe or uncontrolled systemic diseases, including active bleeding diatheses, or active infection including hepatitis B, hepatitis C and human immunodeficiency virus...
- Any of the following cardiac criteria:
- Mean resting corrected QT interval (QTc) \> 470 msec obtained from 3 consecutive electrocardiograms (ECGs)
- Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g., complete left bundle branch block, third degree heart block)
- Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, abnormalities in serum electrolytes, congenital long QT syndrome, family history of long QT syndrome or...
- Personal history of syncope of cardiovascular etiology, ventricular arrhythmia (of pathologic origin including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest.
- Experience of any of the following procedures or conditions in the preceding 6 months: coronary artery bypass graft, angioplasty, vascular stent, myocardial infarction, angina pectoris, congestive heart failure NYHA...
- Uncontrolled hypotension - Systolic BP \<90mmHg and/or diastolic BP \<50mmHg
- Left ventricular ejection fraction (LVEF) below lower limit of normal for site
- Prior history of DVT/PE or embolic stroke, unless currently on therapeutic anticoagulation
- Inadequate bone marrow reserve or organ function as demonstrated by any of the following laboratory values:
- Absolute neutrophil count \< 1.5 x 109/L
- Platelet count \< 100 x 109/L
- Hemoglobin \< 8 g/L (Patients may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator. Initial treatment must not begin earlier than the day after the erythrocyte...
- Alanine aminotransferase \> 3 times the upper limit of normal (ULN)
- Aspartate aminotransferase \> 3 times ULN
- Total bilirubin \> 1.5 times ULN (patients with Gilbert's syndrome with a total bilirubin ≤2.0 times ULN and direct bilirubin within normal limits are permitted)
- Creatinine \>1.5 times ULN concurrent with creatinine clearance \ 1.5 times ULN
- Proteinuria 3+ on dipstick analysis or \>500mg/24 hours
- Sodium or potassium outside normal reference range for site
- Liver disease such as cirrhosis, chronic active hepatitis, or chronic persistent hepatitis. Patients who are hepatitis B Core antibody IgG positive are allowed to participate if taking and compliant with daily oral...
- 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...
- Severely impaired lung function as defined as spirometry and DLCO that is 50% of the normal predicted value and/or 02 saturation that is 89% or less at rest on room air
- Uncontrolled diabetes as defined by fasting serum glucose \>1.5 x ULN
- Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption abemaciclib or bicalutamide
- Patients with an active bleeding diathesis
- The patient 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...
- History of hypersensitivity or allergic reaction to abemaciclib or bicalutamide, or drugs with a similar chemical structure or class
- Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements
- Co-administration with CYP3A4 inducers (e.g., phenytoin, rifampin, carbamazepine, St John's Wort, bosentan, efavirenz, etravirine, modafinil, and nafcillin), CYP3A4 inhibitors (e.g., clarithromycin, indinavir...
- Other malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin.
- Female patients who are pregnant or breast feeding/lactating, or adults of reproductive potential who are not using effective birth control methods. If barrier contraceptives are being used, these must be continued...
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, 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 to 90 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, 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.