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Estrogen Receptor Antagonist

Palbociclib for Breast Cancer

Phase 3
Waitlist Available
Research Sponsored by Pfizer
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 from randomization until death (up to 4.5 years)
Awards & highlights

Study Summary

This trial is testing whether a new combination drug therapy is better than the current standard of care for women with metastatic breast cancer.

Eligible Conditions
  • Breast Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization until death (up to 4.5 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization until death (up to 4.5 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 (PFS) as Assessed by the Investigator
Secondary outcome measures
Change From Baseline Between Treatment Comparison in EORTC QLQ BR23 Symptom Scale Scores
Change From Baseline Between Treatment Comparison in EORTC QLQ-C30 Symptom Scale Scores
Change From Baseline Between Treatment Comparison in EQ-5D Visual Analog Scale (VAS) Scores Scale
+16 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%
Hypophosphatemia
9%
Epistaxis
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%
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%
Bilateral nares sores
2%
Wrist fracture
2%
Lung cancer
2%
Vaginal discharge
2%
Erythema multiforme
2%
Erythema right breast
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%
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%
Activated partial thromboplastin time prolonged
2%
COPD
2%
Fracture
2%
Vaginal itching
2%
Fever blister
2%
Hemorrhoids
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

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm AExperimental Treatment2 Interventions
Given until objective progression, symptomatic deterioration, unacceptable toxicity, death, or withdrawal of consent, whichever occurs first.
Group II: Arm BActive Control2 Interventions
Given until objective progression, symptomatic deterioration, unacceptable toxicity, death, or withdrawal of consent, whichever occurs first.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Palbociclib
2017
Completed Phase 3
~3760
Fulvestrant
2011
Completed Phase 3
~3690

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor
4,570 Previous Clinical Trials
10,909,919 Total Patients Enrolled
111 Trials studying Breast Cancer
36,404 Patients Enrolled for Breast Cancer
AstraZenecaIndustry Sponsor
4,265 Previous Clinical Trials
288,604,761 Total Patients Enrolled
174 Trials studying Breast Cancer
1,246,339 Patients Enrolled for Breast Cancer
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,475 Previous Clinical Trials
8,091,033 Total Patients Enrolled
43 Trials studying Breast Cancer
12,808 Patients Enrolled for Breast Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
Journal of Clinical OncologyJournal
US Food and Drug Administration Pooled Analysis to Assess the Impact of Bone-only Metastatic Breast Cancer on Clinical Trial Outcomes and Radiographic Assessments
Wedam, Suparna B., Julia A. Beaver, Laleh Amiri-Kordestani, Erik Bloomquist, Shenghui Tang, Kirsten B. Goldberg, Rajeshwari Sridhara, et al.. 2018. “US Food and Drug Administration Pooled Analysis to Assess the Impact of Bone-only Metastatic Breast Cancer on Clinical Trial Outcomes and Radiographic Assessments”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.2017.74.6917.
The OncologistJournal
Evaluation of the Association of Polymorphisms with Palbociclib-induced Neutropenia: Pharmacogenetic Analysis of PALOMA-2/-3
Iwata, Hiroji, Yoshiko Umeyama, Yuan Liu, Zhe Zhang, Patrick Schnell, Yuko Mori, Olivia Fletcher, et al.. 2021. “Evaluation of the Association of Polymorphisms with Palbociclib-induced Neutropenia: Pharmacogenetic Analysis of PALOMA-2/-3”. The Oncologist. Oxford University Press (OUP). doi:10.1002/onco.13811.
Breast Cancer Research and TreatmentJournal
Treatment Effect of Palbociclib Plus Endocrine Therapy by Prognostic and Intrinsic Subtype and Biomarker Analysis in Patients with Bone-only Disease: A Joint Analysis of PALOMA-2 and PALOMA-3 Clinical Trials
Finn, Richard S., Massimo Cristofanilli, Johannes Ettl, Karen A. Gelmon, Marco Colleoni, Carla Giorgetti, Eric Gauthier, et al.. 2020. “Treatment Effect of Palbociclib Plus Endocrine Therapy by Prognostic and Intrinsic Subtype and Biomarker Analysis in Patients with Bone-only Disease: A Joint Analysis of PALOMA-2 and PALOMA-3 Clinical Trials”. Breast Cancer Research and Treatment. Springer Science and Business Media LLC. doi:10.1007/s10549-020-05782-4.
Journal of Clinical OncologyJournal
Cyclin E1 Expression and Palbociclib Efficacy in Previously Treated Hormone Receptor–positive Metastatic Breast Cancer
Turner, Nicholas C., Yuan Liu, Zhou Zhu, Sherene Loi, Marco Colleoni, Sibylle Loibl, Angela DeMichele, et al.. 2019. “Cyclin E1 Expression and Palbociclib Efficacy in Previously Treated Hormone Receptor–positive Metastatic Breast Cancer”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.18.00925.
~45 spots leftby Apr 2025
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