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CDK4/6 Inhibitor
Palbociclib for Breast Cancer
Phase 2
Waitlist Available
Led By Cynthia X Ma, M.D., Ph.D.
Research Sponsored by Washington University School of Medicine
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 1 year
Awards & highlights
Study Summary
This trial is testing an alternative dosing schedule for a cancer drug, to see if it is more tolerable and effective.
Eligible Conditions
- Breast Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Adverse Event Profile of Palbociclib
Clinical Benefit Rate (Complete Response + Partial Response + Stable Disease) for at Least 6 Months)
Kaplan-Meier Estimate of Progression-free Survival (PFS)
+5 moreSide 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%
Arthralgia
35%
Anorexia
35%
Hyponatremia
35%
Cough
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%
Upper respiratory infection
17%
Peripheral sensory neuropathy
17%
Sinusitis
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%
Epistaxis
9%
Hypophosphatemia
9%
COVID-19
9%
Dysphagia
7%
Non-cardiac chest pain
7%
Tooth infection
7%
Skin infection
7%
Blurred vision
7%
Vertigo
7%
Breast pain
7%
Bronchitis
7%
Postnasal drip
7%
Common cold
7%
Neck pain
7%
Lymphedema
6%
Itchy skin
6%
Death
6%
Dehydration
6%
Cellulitis
6%
Knee pain
6%
Cataract
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%
Memory impairment
4%
Vaginal dryness
4%
Flu-like symptoms
4%
Edema trunk
4%
Sinus pain
4%
Back spasms
4%
Watering eyes
4%
Dry eye
4%
Head injury
4%
Burn
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%
Lung cancer
2%
Hoarseness
2%
Urine discoloration
2%
COPD
2%
Oral fissure
2%
Cold sweats
2%
Intrascapular pain
2%
Eye lid pain
2%
Paronychia
2%
Vaginal itching
2%
Sinus congestion
2%
Pharyngitis
2%
Yeast infection
2%
Puncture wound
2%
Vaginal infection
2%
Activated partial thromboplastin time prolonged
2%
Shoulder nodule
2%
Blood bilirubin increased
2%
Hypermagnesemia
2%
Bladder infection
2%
Diverticulitis
2%
Flank pain
2%
Paresthesia
2%
Cognitive disturbance
2%
Sinus tachycardia
2%
Localized edema
2%
Wrist pain
2%
Fever blister
2%
Radiation recall reaction (dermatologic)
2%
Facial nerve disorder
2%
Agitation
2%
Fungal toe infection
2%
Respiratory syncytial virus (RSV)
2%
Photophobia
2%
Hemorrhoids
2%
Sepsis
2%
Fracture
2%
Vaginal discharge
2%
Generalized weakness
2%
Leg pain
2%
Wrist fracture
2%
Bilateral nares sores
2%
Rhinovirus
2%
Laryngeal inflammation
2%
Erythema right breast
2%
Wound infection
2%
Hyperuricemia
2%
Urinary retention
2%
Erythema multiforme
2%
Nail loss
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
Trial Design
1Treatment groups
Experimental Treatment
Group I: Palbociclib + letrozole or + fulvestrantExperimental Treatment8 Interventions
Palbociclib should be taken by mouth with food on a 5 days on/2 days off schedule (meaning: on Days 1-5, 8-12, 15-19, and 22-26 of each 28-day cycle).
Patients who are receiving letrozole will take it daily by mouth, every day of each 28-day cycle.
Patients who are receiving fulvestrant will receive it as two intramuscular injections (one into each buttock) on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter.
Goserelin is given as a subcutaneous injection every 28 days. It is preferred to be given on Day 1 of each cycle, but it may be administered on any day of the treatment cycle to accommodate its specific Q28-day cycle. It will be given to pre- or peri-menopausal women only.
Optional research biopsy at baseline and progression
Blood for research at baseline, cycle 1 day 15, cycle 2 day 1, every 2-3 months (to coincide with imaging studies), and time of progression
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tumor biopsy (optional)
2017
Completed Phase 2
~60
Optional research biopsy
2017
Completed Phase 2
~60
Palbociclib
2017
Completed Phase 3
~3760
Letrozole
2002
Completed Phase 4
~3240
Fulvestrant
2011
Completed Phase 3
~3690
Goserelin
2008
Completed Phase 3
~7100
Circulating tumor cell blood draw
2017
Completed Phase 2
~60
Research blood draw
2022
Completed Phase 2
~240
Find a Location
Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,930 Previous Clinical Trials
2,298,912 Total Patients Enrolled
46 Trials studying Breast Cancer
5,113 Patients Enrolled for Breast Cancer
PfizerIndustry Sponsor
4,567 Previous Clinical Trials
10,907,833 Total Patients Enrolled
110 Trials studying Breast Cancer
36,349 Patients Enrolled for Breast Cancer
Cynthia X Ma, M.D., Ph.D.Principal InvestigatorWashington University School of Medicine
2 Previous Clinical Trials
84 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the top applications for Palbociclib?
"Palbociclib, while often used in radiation therapy, has also been effective at treating conditions like endometrial thinning and t2b carcinoma of the prostate."
Answered by AI
Does Palbociclib have a history of research?
"There are currently 398 clinical trials ongoing that involve Palbociclib. Out of these, 99 are classified as Phase 3 trials. Additionally, although many of these studies take place in Shanghai, there are 24860 total locations for these trials."
Answered by AI
Are there any documented dangers of Palbociclib?
"Palbociclib's safety was given a score of 2 because, while there is evidence that it does not pose serious risks, its efficacy has yet to be proven."
Answered by AI
What is the projected or estimated enrollment for this clinical trial?
"This study is not recruiting at this moment. It was first posted on June 15th, 2017 and has since been edited July 20th, 2022. If you are interested in other trials, 5002 studies involving breast cancer patients are actively enrolling participants and 398 clinical trials testing Palbociclib are also looking for volunteers."
Answered by AI
Are people still able to sign up for this experiment?
"This clinical study is not enrolling patients at the present moment. The trial was first posted on June 15th, 2017 and updated most recently on July 20th, 2022. If you are interested in other medical trials, there are 5002 active studies for breast cancer and 398 for Palbociclib that are actively recruiting patients."
Answered by AI
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