Your session is about to expire
← Back to Search
CDK 4/6 Inhibitor
Neoadjuvant Palbociclib + Endocrine Therapy for Breast Cancer
Phase 2
Recruiting
Led By Jairam Krishnamurthy, MD
Research Sponsored by University of Nebraska
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically confirmed locally advanced stage ER+ and/or PR+ and HER2- breast cancer [by ASCO/CAP guidelines: primary tumor size 2 cm or greater OR if primary tumor size is <2 cm with lymph node involvement (Stage II)] who are candidates for palbociclib in combination with concurrent ovarian suppression and letrozole per treating physician.
ECOG performance status ≤ 2 (see Appendix A)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Study Summary
This trial is studying a combination of drugs as a neoadjuvant (before surgery) treatment for hormone receptor-positive, HER2-negative breast cancer.
Who is the study for?
This trial is for adults at least 19 years old with advanced stage ER+ and/or PR+, HER2- breast cancer, who can take oral medication and have normal organ function. It's not for those previously treated with CDK inhibitors, allergic to similar compounds, with significant liver disease or absorption issues, unstable heart conditions, pregnant/breastfeeding women, HIV-positive on antiretrovirals, men, those with known metastasis or taking certain other drugs.Check my eligibility
What is being tested?
The study tests Palbociclib (a CDK inhibitor) combined with letrozole (an aromatase inhibitor) +/- Goserelin (GnRH analogue), as a pre-surgery treatment to improve responses in hormone receptor positive breast cancer patients. The goal is better surgical outcomes without chemotherapy.See study design
What are the potential side effects?
Palbociclib may cause low white blood cell counts increasing infection risk; fatigue; nausea; sore mouth; hair thinning; diarrhea and potential liver problems. Letrozole side effects include hot flashes; joint pain and osteoporosis while Goserelin can cause menopause-like symptoms.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My breast cancer is ER+/PR+, HER2-, and either larger than 2 cm or smaller with lymph node involvement.
Select...
I can take care of myself and am up and about more than half of the day.
Select...
I am 19 years old or older.
Select...
I can take pills and keep them down.
Select...
I can understand and am willing to sign a consent form.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall response rate (CR+PR) with neoadjuvant palbociclib in combination with endocrine therapy
Rate of reduction of Ki67 index
Secondary outcome measures
Clinical benefit rate with neoadjuvant palbociclib in combination with endocrine therapy
Rate of grade 3 or higher neutropenia
Tumor down staging rate
Side effects data
From 2023 Phase 2 trial • 180 Patients • NCT0263069386%
Fatigue
52%
Nausea
49%
Insomnia
47%
Constipation
46%
Diarrhea
44%
Dyspnea
42%
Anorexia
42%
Pain in extremity
41%
Bone pain
38%
Headache
36%
Alopecia
30%
Back pain
30%
Peripheral sensory neuropathy
29%
Vomiting
28%
Anxiety
28%
Cough
28%
Hot flashes
26%
Mucositis oral
26%
Hypertension
26%
Pain
24%
Flu like symptoms
24%
Arthralgia
23%
Gastroesophageal reflux disease
23%
Other musculoskeletal and connective tissue disorder
22%
Other skin and subcutaneous tissue disorders
21%
Myalgia
20%
Dysgeusia
20%
Rash maculo-papular
20%
Upper respiratory infection
19%
Abdominal pain
19%
Dizziness
16%
Pruritus
14%
Epistaxis
14%
Sore throat
14%
Dry skin
14%
Edema limbs
14%
Paresthesia
14%
Urinary tract infection
13%
Chest wall pain
13%
Allergic rhinitis
12%
Dyspepsia
12%
Fever
11%
Watering eyes
11%
Skin infection
11%
Blurred vision
10%
Fracture
10%
Productive cough
10%
Thromboembolic event
9%
Dry mouth
9%
Depression
9%
Lung infection
8%
Dry eye
8%
Fall
8%
Memory impairment
8%
Sinusitis
7%
Chills
7%
Weight loss
7%
Other nervous system disorders
7%
Nasal congestion
7%
Rash acneiform
7%
Neck pain
7%
Bloating
6%
Other gastrointestinal disorders
6%
Wound infection
6%
Arthritis
6%
Peripheral motor neuropathy
6%
Confusion
6%
Breast pain
6%
Hoarseness
6%
Toothache
6%
Muscle weakness lower limb
6%
Allergic reaction
6%
Other infections and infestations
6%
Lymphedema
4%
Other eye disorders
4%
Hypothyroidism
4%
Oral pain
4%
Bruising
4%
Postnasal drip
3%
Hemorrhoids
3%
Other respiratory, thoracic and mediastinal disorders
2%
Vertigo
2%
Sepsis
2%
Febrile neutropenia
1%
Pulmonary edema
1%
Death NOS
1%
Other hepatobiliary disorders
1%
Hypercalcemia
1%
Other renal and urinary disorders
1%
Urinary frequency
1%
Non-cardiac chest pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Palbociclib (100mg)
Palbociclib (125mg)
Trial Design
1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment1 Intervention
The following drugs will be taken for six cycles:
Palbociclib at a dose of 125 mg should be taken by mouth with food on 21 days and 7 days off schedule (meaning: on Days 1-21 of each 28-day cycle).
Letrozole should be taken daily by mouth, every day of each 28-day cycle, at a dose of 2.5 mg.
Goserelin is given as subcutaneous injection every 28 days at a dose of 3.6 mg. It is to be given on Day 1 of each cycle. Goserelin will only be administered to pre-menopausal subjects.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Palbociclib 125mg
2016
Completed Phase 3
~700
Find a Location
Who is running the clinical trial?
University of NebraskaLead Sponsor
539 Previous Clinical Trials
1,144,688 Total Patients Enrolled
14 Trials studying Breast Cancer
1,006,256 Patients Enrolled for Breast Cancer
Jairam KrishnamurthyLead Sponsor
Jairam Krishnamurthy, MDPrincipal InvestigatorUniversity of Nebraska
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My breast cancer is ER+/PR+, HER2-, and either larger than 2 cm or smaller with lymph node involvement.I do not have any conditions that affect how my body absorbs medication.I am male.I am on hormone therapy, but only use topical vaginal estrogen.I do not have any uncontrolled illnesses like infections or heart problems.My cancer has spread to other parts of my body.I am HIV-positive and on antiretroviral therapy.I have a serious liver condition, like active hepatitis or cirrhosis.I can take care of myself and am up and about more than half of the day.I am 19 years old or older.My blood tests for bone marrow and organ function are normal.I can take pills and keep them down.I can understand and am willing to sign a consent form.I have been treated with a CDK inhibitor before.You have had allergic reactions to drugs similar to palbociclib.I haven't taken strong CYP3A affecting drugs in the last week.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment
Awards:
This trial has 1 awards, including:- 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.
Are there precedents of Palbociclib 125mg being studied through a clinical trial?
"Currently, there are 133 trials underway researching Palbociclib 125mg of which 16 have reached Phase 3. Primarily situated in Burgas, New jersey, these medical studies span 6577 locations worldwide."
Answered by AI
Has the FDA approved Palbociclib 125mg for medicinal use?
"Taking into account that Palbociclib 125mg is part of a Phase 2 trial, our team at Power felt confident assigning it a score of two as there is evidence suggesting its safety but not necessarily its efficacy."
Answered by AI
What is the participant count for this experimental research?
"Affirmative. The clinical trial is open for recruitment, as evidenced by the information hosted on clinicaltrials.gov. Initially posted on March 2nd 2022 and last updated three days later, this medical study is seeking 46 patients from one location."
Answered by AI
Are there opportunities for individuals to join this clinical trial?
"According to clinicaltrials.gov, this medical trial is currently recruiting participants. The original posting was made on March 2nd 2022 while the most recent update occurred a day later on March 3rd 2022."
Answered by AI
To what clinical conditions is Palbociclib 125mg commonly prescribed?
"Palbociclib 125mg is a popular treatment for breast cancer, but it additionally has applications in multiple other medical scenarios including malignant neoplasms, postmenopause and advance directives."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger