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CDK4/6 Inhibitor
Preoperative Palbociclib for Ductal Carcinoma (WI223281 Trial)
Phase 2
Waitlist Available
Led By Candace Mainor, MD
Research Sponsored by Georgetown University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 - 40 days
Awards & highlights
WI223281 Trial Summary
This trial will help researchers learn if pre-operative treatment of DCIS of the breast with palbociclib is effective. There will be two groups of twelve patients each, with one group receiving the treatment and the other group not receiving the treatment.
Who is the study for?
This trial is for adults with a type of breast condition called DCIS, who are fit enough for surgery and have not used certain hormone therapies or other investigational drugs recently. People with invasive cancer in their biopsy (except microinvasion) or serious health issues that could affect study participation cannot join.Check my eligibility
What is being tested?
The study tests the drug Palbociclib on patients before they undergo breast surgery. There are two groups: one receiving the drug (Group A) and another not treated but providing samples for research (Group B). Each group will have 12 participants.See study design
What are the potential side effects?
Palbociclib can cause side effects like low white blood cell counts which may increase infection risk, fatigue, nausea, sore mouth, hair thinning, diarrhea and blood clots. Not everyone experiences these side effects.
WI223281 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 14 - 40 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 - 40 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Feasibility: recruitment rates
Secondary outcome measures
Pathology: descriptive findings on H&E
Pathology: descriptive findings on IHC
Toxicity based on CTCAE
Side effects data
From 2023 Phase 2 trial • 55 Patients • NCT0300797996%
White blood cell count decreased
87%
Neutrophil count decreased
80%
Anemia
74%
Lymphocyte count decreased
67%
Hypertension
61%
Fatigue
56%
Diarrhea
54%
Nausea
43%
Platelet count decreased
41%
Alopecia
39%
Headache
39%
Hot flashes
37%
Dizziness
37%
Insomnia
37%
Dyspepsia
35%
Anorexia
35%
Hyponatremia
35%
Cough
35%
Arthralgia
35%
Aspartate aminotransferase increased
33%
Edema limbs
33%
Alanine aminotransferase increased
33%
Creatinine increased
31%
Hyperkalemia
31%
Hypercalcemia
31%
Mucositis oral
31%
Vomiting
31%
Hypocalcemia
30%
Dyspnea
30%
Alkaline phosphatase increased
30%
Back pain
28%
Constipation
26%
Pain
26%
Hypokalemia
24%
Chills
20%
Hyperglycemia
20%
Dysgeusia
20%
Depression
20%
Myalgia
20%
Fall
19%
Pain in extremity
19%
Rash maculopapular
17%
Sinusitis
17%
Upper respiratory infection
17%
Peripheral sensory neuropathy
17%
Fever
17%
Anxiety
17%
Sore throat
15%
Hypoalbuminemia
13%
Hyperhidrosis
13%
Urinary tract infection
13%
Bone pain
13%
Nasal congestion
13%
Dry skin
11%
Hypernatremia
11%
Allergic rhinitis
11%
Weight loss
9%
Hypophosphatemia
9%
Epistaxis
9%
COVID-19
9%
Dysphagia
7%
Blurred vision
7%
Tooth infection
7%
Skin infection
7%
Non-cardiac chest pain
7%
Vertigo
7%
Breast pain
7%
Bronchitis
7%
Postnasal drip
7%
Common cold
7%
Neck pain
7%
Lymphedema
6%
Cellulitis
6%
Death
6%
Cataract
6%
Itchy skin
6%
Dehydration
6%
Knee pain
6%
Psoriasis
6%
Body aches
6%
Buttock pain
6%
Lung infection
6%
Allergic reaction
6%
Hypoglycemia
6%
Urinary frequency
6%
Osteopenia
6%
Rash acneiform
6%
Gout
6%
Bug bite
6%
Arthritis
6%
Thromboembolic event
4%
Back spasms
4%
Vaginal dryness
4%
Flu-like symptoms
4%
Burn
4%
Watering eyes
4%
Edema trunk
4%
Dry eye
4%
Sinus pain
4%
Head injury
4%
Memory impairment
4%
Skin bump
4%
Right arm numbness
4%
Nodule
4%
Hip pain
4%
Peripheral motor neuropathy
4%
Hypothyroidism
4%
Broken tooth
4%
Abdominal pain
4%
Dry lips
4%
Toothache
4%
Tick bite
4%
Extremity infection
4%
Hypomagnesemia
4%
Generalized muscle weakness
4%
Pleural effusion
4%
Sleep apnea
4%
Right thumb bump
4%
Osteonecrosis of jaw
4%
Chest pain - cardiac
4%
Acute kidney injury
4%
Muscle cramp
4%
Muscle spasm
4%
Gastroesophageal reflux disease
4%
Bruising
4%
Burn - left hand
4%
Brittle nail
2%
Hemorrhoids
2%
Intrascapular pain
2%
Erythema right breast
2%
Pharyngitis
2%
Radiation recall reaction (dermatologic)
2%
Hypermagnesemia
2%
Vaginal discharge
2%
Leg pain
2%
Wrist fracture
2%
Lung cancer
2%
Erythema multiforme
2%
Cold sweats
2%
Puncture wound
2%
Paronychia
2%
Vaginal infection
2%
Sinus congestion
2%
Localized edema
2%
Yeast infection
2%
Sinus tachycardia
2%
Diverticulitis
2%
Sepsis
2%
Photophobia
2%
Blood bilirubin increased
2%
Facial nerve disorder
2%
Paresthesia
2%
Urinary retention
2%
Hyperuricemia
2%
Agitation
2%
Oral fissure
2%
Eye lid pain
2%
Flank pain
2%
Cognitive disturbance
2%
Generalized weakness
2%
Rhinovirus
2%
Wound infection
2%
Activated partial thromboplastin time prolonged
2%
COPD
2%
Fracture
2%
Vaginal itching
2%
Fever blister
2%
Wrist pain
2%
Hoarseness
2%
Laryngeal inflammation
2%
Bladder infection
2%
Fungal toe infection
2%
Respiratory syncytial virus (RSV)
2%
Urine discoloration
2%
Nail loss
2%
Shoulder nodule
2%
Bilateral nares sores
2%
Peeling lips
2%
Vaginal itch
2%
Head injury - upper left occipital swelling
2%
Acoustic neuroma
2%
Eye lid pain/soreness
2%
Open cutaneous area left breast
2%
Peeling skin palms of hands
2%
Mole pain
2%
Itchy scalp
2%
Spinal fracture
2%
Asthma
2%
Hand cramps
2%
Left hand puncture wound
2%
C. difficile
2%
Gait disturbance
2%
Myocardial infarction
2%
Red eye
2%
Groin pain
2%
Superficial thrombophlebitis
2%
Paronychia - infection right middle
2%
Snake bite
2%
Hemoglobin increased
2%
Muscle weakness lower limb
2%
Right arm pain
2%
Mitral valve disease
2%
Tinnitus
2%
Vestibular schwannoma
2%
Dry mouth
2%
Oral dysesthesia
2%
Oral pain
2%
Stomach pain
2%
Ulcerative colitis
2%
Acute bronchitis
2%
Otitis media
2%
INR increased
2%
Lymphocyte count increased
2%
Bilateral leg pain
2%
Chest wall pain
2%
Left sided flank pain
2%
Sternum pain
2%
ADHD
2%
Confusion
2%
Sacroliac joint pain
2%
Shoulder pain
2%
Hallucinations
2%
Mood swings
2%
Nasal dryness
2%
Productive cough
2%
Voice alteration
2%
Hypotension
2%
Cold sensitivity
2%
Sciatic pain
2%
Nasal drainage
2%
Heart failure
2%
Skin bumps
2%
Skin hypopigmentation
2%
Leg stiffness
2%
Asystole
2%
Failure to thrive
2%
Intracranial hemorrhage
2%
Gastric ulcer
2%
Gingival pain
2%
Hematochezia
2%
Hemorrhoidal hemorrhage
2%
Dilation of appendix with periappendiceal fat stranding seen on CT
2%
Edema face
2%
Yeast infection under right breast
2%
Weight gain
2%
Spasticity
2%
Syncope
2%
Blister
2%
Sores bilateral nares
2%
Stomach rash
2%
Tender nail bed
100%
80%
60%
40%
20%
0%
Study treatment Arm
Palbociclib + Letrozole or + Fulvestrant
WI223281 Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Group AExperimental Treatment1 Intervention
Patients enrolled to Group A will receive a 12-day course of Palbociclib before surgery. They will receive Palbociclib 100mg PO daily x 12 days.
Group II: Group BActive Control1 Intervention
These patients will receive no pre-operative treatment. Core biopsies from diagnosis and material from definitive surgery will be collected for translational studies and tissue banking. They will also provide blood samples at screening and prior to definitive surgery.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Palbociclib
2017
Completed Phase 3
~3760
Find a Location
Who is running the clinical trial?
Georgetown UniversityLead Sponsor
343 Previous Clinical Trials
136,485 Total Patients Enrolled
PfizerIndustry Sponsor
4,570 Previous Clinical Trials
10,916,009 Total Patients Enrolled
Candace Mainor, MDPrincipal InvestigatorGeorgetown University
3 Previous Clinical Trials
104 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Women who are still having their periods (premenopausal) or have already stopped having their periods (postmenopausal), and men can participate.You have taken any CDK inhibitor medication within the last 3 months.You are willing to give a tissue sample from your surgery for research purposes.
Research Study Groups:
This trial has the following groups:- Group 1: Group A
- Group 2: Group B
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 any current openings for subjects in this research?
"Last updated on April 5th, 2022, this clinical trial is still recruiting patients according to information found on clinicaltrials.gov. The study was originally posted on October 8th, 2018."
Answered by AI
What are the risks associated with Palbociclib?
"Palbociclib has undergone some clinical testing, so it received a score of 2 in regards to safety."
Answered by AI
What conditions does Palbociclib help alleviate?
"Palbociclib is indicated for the treatment of breast cancer. Additionally, it can be used to palliate malignant neoplasms, postmenopause symptoms, and as part of advance directives."
Answered by AI
Are there other instances where Palbociclib has been used in medical research?
"As of now, there are 139 clinical trials involving Palbociclib that are still ongoing. Out of these, 17 have reached Phase 3. Additionally, while many of the studies for Palbociclib are based in Burgas and New jersey, there are 6640 locations worldwide where research is being conducted on this medication."
Answered by AI
How many individuals are included in this research project?
"That is correct. The information available on clinicaltrials.gov affirms that this trial, which was first advertised on October 8th 2018, is still actively looking for participants. In total, they need 24 patients from a single location."
Answered by AI
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