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New treatment option for Triple Negative Breast Neoplasms
Official title Bicalutamide and Abemaciclib in Inoperable or Metastatic Androgen Receptor-positive Triple-negative Breast Cancer
ClinicalTrials.gov ID: NCT06365788
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 triple negative breast neoplasms.
Also referred to as Verzenios.
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 study has as goal to evaluate the use of abemaciclib and bicalutamide in androgen receptor positive metastatic triple negative 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 and older, women only
You may be able to join if
- Provision of signed and dated, written informed consent prior to any study specific procedures, sampling and analysis. If a patient declines to...
- Women aged at least 18 years
- The patient has a biopsy-confirmed diagnosis of recurrent, unresectable, locally advanced, or metastatic AR+ TNBC
- AR+ assessed locally and defined as ≥1% of cells staining on IHC of last recurrent/metastatic breast cancer specimen
- Local biopsy confirmation of last recurrent/metastatic site with positive IHC for ER and/or PR in ≤10% of cells and negative for HER2 per...
You likely can't join if
- Treatment with any of the following: a. Any experimental treatment in a clinical trial within the last 30 days or 5 half-lives, whichever is longer...
- 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, stable at baseline imaging and not...
- Concurrent use of endocrine therapy (tamoxifen, anastrozole, letrozole, exemestane, oral contraceptive pills)
- The patient has serious and/or uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation...
- As judged by the investigator, any evidence of severe or uncontrolled systemic diseases, including active bleeding diatheses, or active infection...
See the full eligibility criteria
Who can join
- Provision of signed and dated, written informed consent prior to any study specific procedures, sampling and analysis. If a patient declines to participate in any voluntary exploratory research of the study, there will...
- Women aged at least 18 years
- The patient has a biopsy-confirmed diagnosis of recurrent, unresectable, locally advanced, or metastatic AR+ TNBC
- AR+ assessed locally and defined as ≥1% of cells staining on IHC of last recurrent/metastatic breast cancer specimen
- Local biopsy confirmation of last recurrent/metastatic site with positive IHC for ER and/or PR in ≤10% of cells and negative for HER2 per ASCO/CAP-guidelines
- Prior invasive (metastatic) breast cancer with positive IHC for ER and/or PR in \>10% of cells is allowed, provided the last biopsy of recurrent/metastatic disease has positive IHC for ER and/or PR in ≤10% of cells
- Prior invasive (metastatic) HER2-positive breast cancer per ASCO/CAP-guidelines is not allowed
- The patient has measurable disease per RECIST 1.1 or evaluable bone-only disease with lytic or mixed component that is progressive as evidenced on pre-treatment baseline imaging
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2 with no deterioration over the previous 2 weeks and minimum life expectancy of 12 weeks
- The patient must have had prior treatment with at least 1 prior cytostatic regimen in advanced setting setting unless treatment with a cytostatic regimen is contraindicated as judged by Investigator. There is no upper...
- Patients with known germline BRCA1/2 pathogenic variants should have received previous treatment with PARP inhibitors in the early/locally advanced or metastatic setting, unless contraindicated.
- Prior treatment with palbociclib or ribociclib is allowed, provided at least 6 months have elapsed between last administration and start of study treatment
- Patients must have recovered (Common Terminology Criteria for Adverse Events [CTCAE] Grade ≤1) from the acute effects of prior anticancer treatment except for residual Grade 2 alopecia, anemia or peripheral neuropathy...
- 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.
- In females of child-bearing potential, a negative serum or urine pregnancy test within 7 days prior to starting treatment is required. Women of child-bearing potential must agree to use a highly effective method of...
- 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: a. Any experimental treatment in a clinical trial within the last 30 days or 5 half-lives, whichever is longer, prior to randomization. b) Currently enrolled in any other type of...
- 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, stable at baseline imaging and not requiring corticosteroids \>10 mg prednisolone daily (or equivalent) for at...
- Concurrent use of endocrine therapy (tamoxifen, anastrozole, letrozole, exemestane, oral contraceptive pills)
- 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...
- 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 (eg, 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, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under...
- 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
- Known 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/dL (Patients may receive transfusions to achieve this hemoglobin level at the discretion of the investigator. Initial treatment must not begin earlier than the day after the erythrocyte transfusion.)
- 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
- Known proteinuria 3+ on dipstick analysis or \>500mg/24 hours
- Sodium or potassium outside normal reference range for site. Grade 1 abnormality of sodium and potassium (as defined by CTCAE v5.0) can be included if judged clinically not significant by the investigator, based on the...
- 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...
- Severely impaired lung function defined as spirometry and DLCO that is less than or equal to 50% of the normal predicted value and/or 02 saturation that is 89% or less at rest on room air and/or serious /uncontrolled...
- 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 of abemaciclib and/or...
- 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 abemacliclib, bicalutamide or goserelin, 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 strong CYP3A4 inducers (e.g., phenytoin, rifampin, carbamazepine, St John's Wort, bosentan, efavirenz, etravirine, modafinil, and nafcillin) or strong CYP3A4 inhibitors (e.g., clarithromycin...
- Other invasive 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 females of reproductive potential who are not using effective birth control methods. Hormonal contraceptives are not acceptable as a method of...
- Patients with hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption
The study team makes the final eligibility decision.
Where it's taking place
- Antwerp, Belgium
- Brussels, Belgium
- Ghent, Belgium
- Hasselt, Belgium
- Leuven, Belgium
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 female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Antwerp, Belgium; Brussels, Belgium; Ghent, Belgium; Hasselt, Belgium; Leuven, Belgium. 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.