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Endocrine + CDK4/6 Inhibitor Therapy for Breast Cancer
Phase 2
Recruiting
Led By Sangeetha Reddy, MD
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Breast tumor ≥1cm in diameter by either physical exam or ultrasound and suitable for pre and post-treatment tissue sampling
At least 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after treatment ends (14 (+/- 3) days
Awards & highlights
Study Summary
This trial is to study if improving the immune system's response to breast cancer with endocrine and cyclin dependent kinase inhibitor therapy can improve outcomes for patients with hormone receptor positive breast cancer.
Who is the study for?
This trial is for post-menopausal women with hormone receptor positive, HER2 negative breast cancer that's operable and not yet treated. They must have good organ function, be able to take oral meds, and agree to use effective contraception. Excluded are those with dementia, uncontrolled illnesses, ongoing infections or heart issues, prior treatment for current breast cancer diagnosis, active metastatic disease or severe allergies to study drugs.Check my eligibility
What is being tested?
The study tests if the immune response against breast cancer can be improved using endocrine therapy (Letrozole) combined with a cyclin dependent kinase inhibitor (Abemaciclib). Tumor tissue and blood samples will be collected before and after two weeks of this combination treatment to analyze the effects.See study design
What are the potential side effects?
Potential side effects include reactions related to Letrozole such as hot flashes, joint pain and nausea; Abemaciclib may cause diarrhea, fatigue and low white blood cell counts which could increase infection risk. Individual experiences may vary.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My breast tumor is at least 1cm big and can be biopsied before and after treatment.
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I am 18 years old or older.
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My blood counts and organ functions are within the required ranges.
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I can take pills by mouth.
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I can take care of myself but might not be able to do heavy physical work.
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I stopped taking tamoxifen or raloxifene over 28 days ago.
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My breast cancer is in an early stage, is hormone receptor positive, and HER2 negative.
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I had cancer in one breast before, but it hasn't come back.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ after treatment ends (14 (+/- 3) days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after treatment ends (14 (+/- 3) days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in T cell activation
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%
Platelet count decreased
14%
Dry mouth
14%
Weight decreased
14%
Dysgeusia
13%
Dyspnoea
12%
Abdominal pain upper
12%
Back pain
12%
Dizziness
11%
Pyrexia
11%
Dyspepsia
11%
Oedema peripheral
11%
Blood creatinine increased
10%
Pain
9%
Stomatitis
9%
Aspartate aminotransferase increased
8%
Dry skin
8%
Thrombocytopenia
8%
Pruritus
8%
Lacrimation increased
8%
Dehydration
8%
Alanine aminotransferase increased
7%
Flatulence
7%
Urinary tract infection
7%
Upper respiratory tract infection
7%
Hypokalaemia
6%
Chills
6%
Musculoskeletal chest pain
6%
Musculoskeletal pain
6%
Anxiety
5%
Rash
5%
Gastrooesophageal reflux disease
5%
Myalgia
2%
Cellulitis
2%
Pleural effusion
1%
Atypical pneumonia
1%
Gastroenteritis viral
1%
Sepsis
1%
Hip fracture
1%
Pneumonitis
1%
Fall
1%
Lung infection
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
Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm B: LetrozoleExperimental Treatment1 Intervention
Patient will take daily letrozole only (Arm B) according to treatment arm for 2 weeks prior to your planned standard treatment for breast cancer. In addition to tests and procedures that are part of your standard care, you will have a biopsy and blood draw for study purposes prior to starting study treatment.
Group II: Arm A: Abemaciclib + LetrozoleExperimental Treatment2 Interventions
Patient will take twice daily abemaciclib and daily letrozole (Arm A) for 2 weeks prior to your planned standard treatment for breast cancer. In addition to tests and procedures that are part of your standard care, you will have a biopsy and blood draw for study purposes prior to starting study treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Letrozole
FDA approved
Abemaciclib
FDA approved
Find a Location
Who is running the clinical trial?
Cancer Prevention Research Institute of TexasOTHER
50 Previous Clinical Trials
98,378 Total Patients Enrolled
7 Trials studying Breast Cancer
18,845 Patients Enrolled for Breast Cancer
University of Texas Southwestern Medical CenterLead Sponsor
1,048 Previous Clinical Trials
1,053,751 Total Patients Enrolled
21 Trials studying Breast Cancer
6,202 Patients Enrolled for Breast Cancer
Eli Lilly and CompanyIndustry Sponsor
2,618 Previous Clinical Trials
3,206,488 Total Patients Enrolled
63 Trials studying Breast Cancer
36,844 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My breast tumor is at least 1cm big and can be biopsied before and after treatment.I stopped hormone replacement therapy at least a week ago.I am post-menopausal, either by age, lack of menstruation for 12 months, or hormone levels.I am 18 years old or older.My breast cancer has spread, is inflammatory, or has come back in the same area.I am currently receiving treatment for breast cancer.You have a condition that makes it hard for you to understand or make decisions about participating in the study, such as dementia or severe mental illness.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.My blood counts and organ functions are within the required ranges.I am not pregnant and agree to use effective birth control during and 3 weeks after treatment.I can take pills by mouth.I can take care of myself but might not be able to do heavy physical work.I stopped taking tamoxifen or raloxifene over 28 days ago.I do not have serious health issues that would stop me from joining this study.I am eligible for hormone therapy before surgery to shrink my tumor.You have had allergic reactions to drugs similar to abemaciclib or other drugs used in the study.I am not pregnant, breastfeeding, or before menopause.You are currently taking any other experimental drugs for your cancer.I have a severe condition that affects how my body absorbs nutrients.My breast cancer is in an early stage, is hormone receptor positive, and HER2 negative.I had cancer in one breast before, but it hasn't come back.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A: Abemaciclib + Letrozole
- Group 2: Arm B: Letrozole
Awards:
This trial has 3 awards, including:- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 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.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the primary reason that patients are prescribed Abemaciclib?
"Abemaciclib can be used to manage breast, anovulatory cycle, and tamoxifen related issues."
Answered by AI
Are patients currently being recruited for this medical study?
"The latest information on clinicaltrials.gov suggests that this trial is still recruiting patients. The study was originally posted on April 15th, 2021 and was last updated September 30th, 2022."
Answered by AI
What is the United States government's stance on Abemaciclib?
"Abemaciclib's safety is based on Phase 2 trial data, meaning that while there is some evidence to support its safety, none exists yet for efficacy. Consequently, our team at Power estimated a score of 2."
Answered by AI
Can you give me some more information on other clinical tests that have used Abemaciclib?
"Currently, there are 245 ongoing studies involving Abemaciclib. 55 of those are Phase 3 trials. The majority of the research is being conducted in San Francisco, California; however, there are 16773 total locations running these sorts of tests."
Answered by AI
How many people are included in the data sample for this research?
"Yes, this is an ongoing study that was first posted on April 15th, 2021. The most recent update to the trial information was on September 30th, 2022. Presently, the researchers are looking for 60 participants who will be seen at two different locations."
Answered by AI
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