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CDK4/6 Inhibitor

Palbociclib for Breast Cancer

Phase 2
Waitlist Available
Research Sponsored by Oana Danciu, MD
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 3 years
Awards & highlights

Study Summary

This trial is testing a new cancer drug in women with a certain type of breast cancer.

Eligible Conditions
  • Breast Cancer
  • Tumors

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression Free Survival
Secondary outcome measures
Assess Adverse Events
Clinical Benefit Rate (CBR)
Overall Survival (OS)
+1 more

Side effects data

From 2023 Phase 2 trial • 55 Patients • NCT03007979
96%
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%
Peripheral sensory neuropathy
17%
Sinusitis
17%
Upper respiratory infection
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%
Blurred vision
7%
Tooth infection
7%
Non-cardiac chest pain
7%
Skin infection
7%
Vertigo
7%
Breast pain
7%
Bronchitis
7%
Postnasal drip
7%
Common cold
7%
Neck pain
7%
Lymphedema
6%
Death
6%
Cellulitis
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%
Vaginal dryness
4%
Watering eyes
4%
Burn
4%
Flu-like symptoms
4%
Edema trunk
4%
Back spasms
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%
Bilateral nares sores
2%
Puncture wound
2%
Cold sweats
2%
Localized edema
2%
Wrist fracture
2%
Activated partial thromboplastin time prolonged
2%
Lung cancer
2%
Vaginal discharge
2%
Erythema multiforme
2%
Erythema right breast
2%
Paronychia
2%
Vaginal infection
2%
COPD
2%
Sinus congestion
2%
Sinus tachycardia
2%
Diverticulitis
2%
Sepsis
2%
Hyperuricemia
2%
Facial nerve disorder
2%
Paresthesia
2%
Agitation
2%
Urinary retention
2%
Oral fissure
2%
Eye lid pain
2%
Pharyngitis
2%
Blood bilirubin increased
2%
Flank pain
2%
Cognitive disturbance
2%
Radiation recall reaction (dermatologic)
2%
Photophobia
2%
Generalized weakness
2%
Rhinovirus
2%
Wound infection
2%
Fracture
2%
Vaginal itching
2%
Fever blister
2%
Hemorrhoids
2%
Yeast infection
2%
Intrascapular pain
2%
Wrist pain
2%
Hoarseness
2%
Laryngeal inflammation
2%
Leg pain
2%
Bladder infection
2%
Fungal toe infection
2%
Respiratory syncytial virus (RSV)
2%
Hypermagnesemia
2%
Urine discoloration
2%
Nail loss
2%
Shoulder nodule
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: Investigational TreatmentExperimental Treatment2 Interventions
71 subjects will be enrolled to determine progression-free survival (PFS) in subjects with HR(+)/HER2(-) advanced breast cancer who have not received prior systemic anti-cancer therapies. Palbociclib 125 mg will be administered orally once daily on days D1-D21 of each 28-day cycle. Subjects will not take palbociclib on D22-D28. Tamoxifen 20 mg will be administered orally once daily for every day of the 28-day cycle (i.e., continuously).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Palbociclib
FDA approved
Tamoxifen
FDA approved

Find a Location

Who is running the clinical trial?

Oana Danciu, MDLead Sponsor
PfizerIndustry Sponsor
4,567 Previous Clinical Trials
10,911,825 Total Patients Enrolled
111 Trials studying Breast Cancer
36,404 Patients Enrolled for Breast Cancer
Big Ten Cancer Research ConsortiumOTHER
10 Previous Clinical Trials
425 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 medical condition is Palbociclib typically prescribed for?

"Palbociclib is the primary drug of choice for treating malignant neoplasms. It may also be used in other medical scenarios, including those involving ovarian cancer, ovulation induction therapy and high-risk patients."

Answered by AI

How many medical facilities have adopted this trial to their research agenda?

"Patients can enrol in this trial at University of Wisconsin-Madison, Pennsylvania's Penn State Cancer Institute in Hershey, the University of Illinois Cancer Center located in Chicago and 7 other sites situated throughout the US."

Answered by AI

How many patients have been selected to partake in this trial?

"This particular investigation is not presently enrolling participants. It was originally advertised on June 30th, 2016 and last edited on August 29th 2022. If you are looking for alternative studies, there are 4,533 trials that seek cancer patients and 192 studies searching for Palbociclib candidates."

Answered by AI

Are there any previous experiments that have utilized Palbociclib?

"Currently, 192 Palbociclib studies are being conducted with 38 of those in the final phase. Of these trials, a majority are situated in Burgas, New jersey; however there exist 13808 total sites running clinical observations for this medication."

Answered by AI

What are the core aims of this experiment?

"The primary objective of this three-year clinical trial is to assess response rates in subjects with HR(+)/HER2(-) advanced breast cancer who have yet to receive systemic anti-cancer treatments. Additionally, the study will evaluate adverse events and toxicity along with progression free survival and clinical benefit rate through RECIST 1.1 or MDA criteria for those with bone only disease."

Answered by AI

To what extent could Palbociclib be detrimental to a person's health?

"There is limited clinical data available to support the safety of Palbociclib, thus Power assigned it a score of 2 on its scale."

Answered by AI

Is this research endeavor actively seeking participants at present?

"The clinicaltrials.gov database has revealed that this experiment is currently not recruiting patients, despite being initially posted on June 30th 2016 and last edited on August 29th 2022. Nonetheless, there are 4,725 other medical trials actively searching for participants as of now."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Palbociclib in Combination With Tamoxifen as First Line Therapy for Metastatic Hormone Receptor Positive Breast Cancer
Oana Danciu, MD 2016. "Palbociclib in Combination With Tamoxifen as First Line Therapy for Metastatic Hormone Receptor Positive Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02668666.
All > Acth
~6 spots leftby Apr 2025
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