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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
Must not have
Active metastatic breast cancer, inflammatory breast cancer, or locally recurrent breast cancer
Chemotherapy, radiotherapy, or any other cancer therapy for current diagnosis of breast cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after treatment ends (14 (+/- 3) days
Awards & highlights
Summary
This trial is studying if hormone therapy and a drug that stops cell growth can improve the immune system's response against hormone-sensitive 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.
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.
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.
Select...
I am 18 years old or older.
Select...
My blood counts and organ functions are within the required ranges.
Select...
I can take pills by mouth.
Select...
I can take care of myself but might not be able to do heavy physical work.
Select...
I stopped taking tamoxifen or raloxifene over 28 days ago.
Select...
My breast cancer is in an early stage, is hormone receptor positive, and HER2 negative.
Select...
I had cancer in one breast before, but it hasn't come back.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My breast cancer has spread, is inflammatory, or has come back in the same area.
Select...
I am currently receiving treatment for breast cancer.
Select...
I do not have any severe illnesses or social situations that would stop me from following the study's requirements.
Select...
I am not pregnant, breastfeeding, or before menopause.
Select...
I have a severe condition that affects how my body absorbs nutrients.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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%
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
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
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Endocrine therapy and cyclin-dependent kinase (CDK) inhibitors are common treatments for hormone receptor-positive breast cancer. Endocrine therapy blocks hormones like estrogen that fuel cancer growth, while CDK inhibitors target enzymes essential for cell division, slowing down cancer cell proliferation.
These mechanisms are crucial as they allow for personalized treatment strategies, improving the effectiveness and outcomes for breast cancer patients.
Find a Location
Who is running the clinical trial?
Cancer Prevention Research Institute of TexasOTHER
52 Previous Clinical Trials
98,884 Total Patients Enrolled
7 Trials studying Breast Cancer
18,845 Patients Enrolled for Breast Cancer
University of Texas Southwestern Medical CenterLead Sponsor
1,077 Previous Clinical Trials
1,056,339 Total Patients Enrolled
22 Trials studying Breast Cancer
6,204 Patients Enrolled for Breast Cancer
Eli Lilly and CompanyIndustry Sponsor
2,651 Previous Clinical Trials
3,224,407 Total Patients Enrolled
63 Trials studying Breast Cancer
36,637 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.
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