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CDK4/6 Inhibitor
Abemaciclib + Bicalutamide for Breast Cancer
Phase 1 & 2
Recruiting
Led By Amy Tiersten, MD
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
The patient has AR+ breast cancer (defined as > or equal to 1% staining on immunohistochemistry of metastatic breast cancer specimen)
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 neuropathy prior to randomization. A washout period of at least 21 days is required between last chemotherapy dose and randomization (provided the patient did not receive radiotherapy)
Must not have
Any other chemotherapy, immunotherapy or anticancer agents within 21 days of the first dose of study treatment
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
No Placebo-Only Group
Approved for 5 Other Conditions
All Individual Drugs Already Approved
Summary
This trial is testing a new drug, abemaciclib, in combination with bicalutamide for treating metastatic breast cancer that is positive for the androgen receptor and negative for HER2.
Who is the study for?
This trial is for adults with AR-positive, HER2-negative metastatic breast cancer who've recovered from prior chemotherapy and/or radiotherapy. Participants must have measurable disease, an ECOG status of 0-2, and a life expectancy over 12 weeks. Women must be postmenopausal or on ovarian ablation; men/women must agree to contraception. Exclusions include severe lung impairment, recent major surgery, brain metastases requiring steroids, uncontrolled diabetes or other serious medical conditions.
What is being tested?
The study tests Abemaciclib in combination with Bicalutamide for treating certain metastatic breast cancers. It's an open-label Phase IB/II trial where all participants receive the drugs without placebo control to assess effectiveness and safety.
What are the potential side effects?
Potential side effects may include digestive issues like nausea and vomiting, allergic reactions due to drug hypersensitivity, blood sugar level changes leading to diabetes symptoms, increased risk of infection due to bone marrow suppression affecting white blood cells.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My breast cancer is AR+ with at least 1% staining.
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I've recovered from chemotherapy side effects, except for hair loss or mild nerve pain.
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I can care for myself, haven't gotten worse in the past 2 weeks, and am expected to live at least 3 more months.
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I finished radiotherapy at least 14 days ago and have recovered from its immediate effects.
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My breast cancer is HER2 negative, cannot be surgically removed, and has spread.
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I have had 2 or fewer chemotherapy treatments for my cancer after it spread.
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I have ER+ or PR+ breast cancer and received one endocrine therapy for it.
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My cancer's spread was confirmed by a biopsy and tested for hormone receptors.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I haven't taken any cancer treatments in the last 21 days.
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I have severe nausea, vomiting, or gut issues that prevent me from taking pills properly.
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I have been treated with anti-androgen therapy before.
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My lung function is severely impaired.
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I do not have any active infections requiring IV antibiotics or known viral infections like HIV or active hepatitis B or C.
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My blood tests show my bone marrow or organs are not working well.
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I haven't had major surgery in the last 4 weeks.
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I am currently taking hormone therapy for my condition.
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My heart health meets the study's requirements.
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I haven't taken any experimental drugs in the last 28 days.
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I am allergic to abemaciclib, bicalutamide, or similar drugs.
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I have a condition that causes me to bleed easily.
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I am taking medications that can be combined with the trial drugs.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
The Dose-Limiting Toxicity (DLT) and Recommended Phase II Dose (RP2D)
Secondary study objectives
Disease Control Rate (DCR)
Frequency of Adverse Events (AE)
Side effects data
From 2018 Phase 2 trial • 132 Patients • NCT0210249091%
Diarrhoea
67%
Nausea
48%
Fatigue
45%
Decreased appetite
35%
Vomiting
27%
Anaemia
26%
Abdominal pain
23%
Asthenia
23%
Neutrophil count decreased
21%
Cough
20%
Constipation
20%
Headache
19%
Arthralgia
18%
White blood cell count decreased
18%
Neutropenia
15%
Alopecia
14%
Dry mouth
14%
Platelet count decreased
14%
Weight decreased
14%
Dysgeusia
13%
Dyspnoea
12%
Abdominal pain upper
12%
Back pain
12%
Dizziness
11%
Oedema peripheral
11%
Dyspepsia
11%
Pyrexia
11%
Blood creatinine increased
10%
Pain
9%
Stomatitis
9%
Aspartate aminotransferase increased
8%
Thrombocytopenia
8%
Lacrimation increased
8%
Dehydration
8%
Dry skin
8%
Pruritus
8%
Alanine aminotransferase increased
7%
Flatulence
7%
Upper respiratory tract infection
7%
Urinary tract infection
7%
Hypokalaemia
6%
Chills
6%
Musculoskeletal chest pain
6%
Musculoskeletal pain
6%
Anxiety
5%
Gastrooesophageal reflux disease
5%
Rash
5%
Myalgia
2%
Cellulitis
2%
Pleural effusion
1%
Atypical pneumonia
1%
Gastroenteritis viral
1%
Lung infection
1%
Sepsis
1%
Fall
1%
Hip fracture
1%
Pneumonitis
1%
Pneumothorax
1%
Febrile neutropenia
1%
Respiratory tract infection
1%
Haematotoxicity
1%
Sinus bradycardia
1%
Tachycardia
1%
Large intestinal obstruction
1%
Pancreatic enzyme abnormality
1%
Pancreatitis
1%
Varices oesophageal
1%
Electrocardiogram abnormal
1%
Liver function test abnormal
1%
Renal function test abnormal
1%
Bone pain
1%
Muscular weakness
1%
Acute kidney injury
1%
Pulmonary embolism
1%
Arterial thrombosis
1%
Epilepsy
100%
80%
60%
40%
20%
0%
Study treatment Arm
Abemaciclib
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Participants with Androgen Receptor-positive, HER2-negative Metastatic Breast CancerExperimental Treatment2 Interventions
Abemaciclib in Combination with Bicalutamide
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abemaciclib
FDA approved
Bicalutamide
FDA approved
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Icahn School of Medicine at Mount SinaiLead Sponsor
904 Previous Clinical Trials
541,898 Total Patients Enrolled
Amy Tiersten, MDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
8 Previous Clinical Trials
249 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My breast cancer is AR+ with at least 1% staining.My breast cancer is HER2 negative, cannot be surgically removed, and has spread.I haven't taken any cancer treatments in the last 21 days.I agree to use a condom and not father a child or donate sperm during and for 90 days after the study.I am not pregnant, breastfeeding, and if capable of having children, I am using effective non-hormonal birth control.I have severe nausea, vomiting, or gut issues that prevent me from taking pills properly.I am a woman aged 18 or older.I've recovered from chemotherapy side effects, except for hair loss or mild nerve pain.You have evidence of the disease in your chest, abdomen, and pelvis from a recent scan.I am post-menopausal or receiving treatment to stop my ovaries from working.You need to have a negative pregnancy test within a week before starting the treatment.I have triple-negative breast cancer and have had 1 to 4 chemotherapy treatments for it.I can care for myself, haven't gotten worse in the past 2 weeks, and am expected to live at least 3 more months.My lung function is severely impaired.I finished radiotherapy at least 14 days ago and have recovered from its immediate effects.I can choose not to participate in optional research without losing benefits.I have been treated with anti-androgen therapy before.I do not have any active infections requiring IV antibiotics or known viral infections like HIV or active hepatitis B or C.My blood tests show my bone marrow or organs are not working well.I have had 2 or fewer chemotherapy treatments for my cancer after it spread.I haven't had major surgery in the last 4 weeks.Your diabetes is not well controlled, as shown by high fasting blood sugar levels.I am currently taking hormone therapy for my condition.My brain-related cancer symptoms are stable, treated, and I haven't needed steroids for 2 weeks.I have liver disease but am on daily medication for hepatitis B.I have ER+ or PR+ breast cancer and received one endocrine therapy for it.My heart health meets the study's requirements.I haven't taken any experimental drugs in the last 28 days.I am allergic to abemaciclib, bicalutamide, or similar drugs.I have a condition that causes me to bleed easily.I have been treated with a CDK4/6 inhibitor before.My cancer's spread was confirmed by a biopsy and tested for hormone receptors.I am taking medications that can be combined with the trial drugs.You have a serious uncontrolled health condition, such as severe infections or bleeding disorders.I haven't had any cancer except for treated skin cancer or cervical cancer in the last 3 years.
Research Study Groups:
This trial has the following groups:- Group 1: Participants with Androgen Receptor-positive, HER2-negative Metastatic Breast Cancer
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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