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Estrogen Receptor Antagonist

Palbociclib + Hormone Therapy for Breast Cancer

Phase 2
Waitlist Available
Research Sponsored by Alliance for Clinical Trials in Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Documentation of disease: estrogen receptor positive and/or progesterone receptor (PR) positive, HER2 negative metastatic breast cancer; histologic confirmation is required
No untreated brain metastases; patients with treated brain metastases must have completed treatment with steroids to be eligible
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial is studying the side effects and effectiveness of two drugs, palbociclib and letrozole or fulvestrant, in treating older patients with breast cancer.

Who is the study for?
This trial is for patients aged 70+ with estrogen receptor positive, HER2 negative metastatic breast cancer. They must have adequate organ function, no active infections or recent malignancies (except certain skin cancers), and be able to understand English or Spanish. Prior treatment with CDK inhibitors disqualifies them, as does untreated brain metastases or known lung disease.Check my eligibility
What is being tested?
The study tests the effectiveness of palbociclib combined with letrozole or fulvestrant in older adults with advanced breast cancer. It examines how well these drugs stop tumor growth by blocking enzymes needed for cell division and spread, considering factors beyond age that may affect drug toxicity.See study design
What are the potential side effects?
Palbociclib can cause low blood cell counts leading to increased infection risk and fatigue; letrozole and fulvestrant might cause hot flashes, joint pain, weakness, nausea. The combination could potentially increase these effects but aims to better control cancer growth.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My breast cancer is estrogen or progesterone positive and HER2 negative.
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I have treated brain metastases and am not currently on steroids.
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I do not have any infections that need antibiotics.
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I can swallow and keep down pills.
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My kidneys are functioning well enough for treatment.
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I have never been treated with a CDK inhibitor.
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I do not have interstitial lung disease.
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I can care for myself and am up and about more than 50% of my waking hours.
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I can read and understand English or Spanish.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 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
Incidence of Adverse Events
Secondary outcome measures
Dose Reduction, Dose Hold, and Hospitalization Reasons
Incidence of Drug Toxicities - Measured by National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] v. 5.0
Overall Survival (OS)
+7 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%
Arthralgia
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%
Peripheral sensory neuropathy
17%
Upper respiratory infection
17%
Sinusitis
17%
Fever
17%
Anxiety
17%
Sore throat
15%
Hypoalbuminemia
13%
Urinary tract infection
13%
Hyperhidrosis
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%
Skin infection
7%
Non-cardiac chest pain
7%
Tooth infection
7%
Vertigo
7%
Breast pain
7%
Bronchitis
7%
Postnasal drip
7%
Common cold
7%
Neck pain
7%
Lymphedema
6%
Cellulitis
6%
Knee pain
6%
Death
6%
Cataract
6%
Dehydration
6%
Itchy skin
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%
Burn
4%
Vaginal dryness
4%
Flu-like symptoms
4%
Watering eyes
4%
Edema trunk
4%
Dry eye
4%
Head injury
4%
Skin bump
4%
Sinus pain
4%
Right arm numbness
4%
Nodule
4%
Hip pain
4%
Peripheral motor neuropathy
4%
Memory impairment
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%
Intrascapular pain
2%
Paronychia
2%
Puncture wound
2%
Pharyngitis
2%
Sinus tachycardia
2%
Bladder infection
2%
Urine discoloration
2%
Hemorrhoids
2%
Leg pain
2%
Wrist fracture
2%
Hypermagnesemia
2%
Erythema multiforme
2%
Erythema right breast
2%
Laryngeal inflammation
2%
Vaginal infection
2%
Sinus congestion
2%
Localized edema
2%
Yeast infection
2%
Facial nerve disorder
2%
Vaginal discharge
2%
Diverticulitis
2%
Sepsis
2%
Photophobia
2%
Blood bilirubin increased
2%
Paresthesia
2%
Urinary retention
2%
Agitation
2%
Oral fissure
2%
Eye lid pain
2%
Flank pain
2%
Cognitive disturbance
2%
Generalized weakness
2%
Rhinovirus
2%
Wound infection
2%
COPD
2%
Nail loss
2%
Fever blister
2%
Wrist pain
2%
Hoarseness
2%
Fungal toe infection
2%
Respiratory syncytial virus (RSV)
2%
Fracture
2%
Activated partial thromboplastin time prolonged
2%
Vaginal itching
2%
Lung cancer
2%
Hyperuricemia
2%
Bilateral nares sores
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%
Cold sweats
2%
Radiation recall reaction (dermatologic)
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: Treatment (palbociclib, letrozole or fulvestrant)Experimental Treatment5 Interventions
Patients receive palbociclib PO QD on days 1-21. Patients also receive letrozole PO QD on days 1-28 or fulvestrant IM on days 1 and 15 of course 1 and on day 1 of subsequent courses per MD discretion. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Palbociclib
FDA approved
Letrozole
FDA approved
Fulvestrant
FDA approved

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,717 Previous Clinical Trials
40,953,270 Total Patients Enrolled
942 Trials studying Breast Cancer
1,543,966 Patients Enrolled for Breast Cancer
Alliance for Clinical Trials in OncologyLead Sponsor
512 Previous Clinical Trials
217,533 Total Patients Enrolled
75 Trials studying Breast Cancer
40,143 Patients Enrolled for Breast Cancer
Mina Sedrak, MD, MSStudy ChairCity of Hope Comprehensive Cancer Center

Media Library

Fulvestrant (Estrogen Receptor Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT03633331 — Phase 2
Breast Cancer Research Study Groups: Treatment (palbociclib, letrozole or fulvestrant)
Breast Cancer Clinical Trial 2023: Fulvestrant Highlights & Side Effects. Trial Name: NCT03633331 — Phase 2
Fulvestrant (Estrogen Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03633331 — Phase 2
~14 spots leftby May 2025
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