What side effects are associated with this type of intervention?

Common treatments for breast cancer, such as endocrine therapy and cyclin-dependent kinase (CDK) inhibitors, have distinct side effect profiles. Endocrine therapy, including tamoxifen and aromatase inhibitors, can cause hot flashes, fatigue, mood swings, and increase the risk of blood clots and bone density loss. CDK inhibitors, like palbociclib, ribociclib, and abemaciclib, are associated with neutropenia, fatigue, nausea, diarrhea, and liver function abnormalities. Patients should discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

FDA-approved treatments for hormone receptor-positive breast cancer include endocrine therapies like tamoxifen and aromatase inhibitors (anastrozole, letrozole, exemestane), which block hormones that fuel cancer growth. Additionally, cyclin-dependent kinase (CDK) inhibitors such as palbociclib, ribociclib, and abemaciclib have been approved for use in combination with endocrine therapy to inhibit CDKs and slow down cancer cell proliferation in advanced or metastatic cases.

What other types of research exist?

Promising novel alternatives to Endocrine Therapy and Cyclin Dependent Kinase Inhibitor Therapy for breast cancer patients include: 1) PARP inhibitors (e.g., olaparib) for patients with BRCA mutations, which target DNA repair mechanisms; 2) PI3K inhibitors (e.g., alpelisib) for patients with PIK3CA mutations, which target the PI3K/AKT/mTOR pathway; 3) Immune checkpoint inhibitors (e.g., pembrolizumab) for patients with high PD-L1 expression or microsatellite instability-high (MSI-H) tumors, which enhance the immune system's ability to fight cancer; and 4) Antibody-drug conjugates (e.g., trastuzumab deruxtecan) for HER2-positive breast cancer, which deliver cytotoxic agents directly to cancer cells. These therapies represent cutting-edge approaches that may offer new hope for patients in 2024.

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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

Approved for 10 Other Conditions

All Individual Drugs Already Approved

No Placebo-Only Group

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My breast cancer has spread, is inflammatory, or has come back in the same area.

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I am currently receiving treatment for breast cancer.

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I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

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I am not pregnant, breastfeeding, or before menopause.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and after treatment ends (14 (+/- 3) days for reporting.

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 • NCT02102490

91%

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

Stomatitis

Aspartate aminotransferase increased

Thrombocytopenia

Lacrimation increased

Dehydration

Dry skin

Pruritus

Alanine aminotransferase increased

Flatulence

Upper respiratory tract infection

Urinary tract infection

Hypokalaemia

Chills

Musculoskeletal chest pain

Musculoskeletal pain

Anxiety

Gastrooesophageal reflux disease

Rash

Myalgia

Cellulitis

Pleural effusion

Atypical pneumonia

Gastroenteritis viral

Lung infection

Sepsis

Fall

Hip fracture

Pneumonitis

Pneumothorax

Febrile neutropenia

Respiratory tract infection

Haematotoxicity

Sinus bradycardia

Tachycardia

Large intestinal obstruction

Pancreatic enzyme abnormality

Pancreatitis

Varices oesophageal

Electrocardiogram abnormal

Liver function test abnormal

Renal function test abnormal

Bone pain

Muscular weakness

Acute kidney injury

Pulmonary embolism

Arterial thrombosis

Epilepsy

100%

80%

60%

40%

20%

Study treatment Arm

Abemaciclib

Awards & Highlights

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.

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

0 / 13Eligibility criteria met

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.