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Endocrine Therapy
Palbociclib + Endocrine Therapy for Breast Cancer (PALLAS Trial)
Phase 3
Waitlist Available
Led By Suzanne George, MD
Research Sponsored by Alliance Foundation Trials, LLC.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have sufficient resolution of any surgical side effects (no active wound healing complications).
Serum creatinine below the upper limit of the institutional normal range (ULN) or creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with serum creatinine levels above institutional ULN.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights
PALLAS Trial Summary
This trial will compare the addition of 2 years of palbociclib to standard adjuvant endocrine therapy to endocrine therapy alone in patients with HR+ / HER2- early breast cancer.
Who is the study for?
This trial is for adults over 18 with HR+/HER2- early breast cancer (Stage II or III), who have had surgery, can take oral meds, and are on or starting hormone treatment. They must not be pregnant, have normal organ function tests, no history of other cancers, and no severe illnesses that could affect participation.Check my eligibility
What is being tested?
The study is testing if adding palbociclib to standard endocrine therapy after breast cancer surgery improves patient outcomes compared to endocrine therapy alone. It's a Phase III trial where patients are randomly assigned to two groups in an open-label setting.See study design
What are the potential side effects?
Palbociclib may cause low white blood cell counts which can lead to infection risk, fatigue, nausea, hair thinning or loss, nosebleeds and other bleeding issues. Side effects vary from person to person.
PALLAS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have healed from surgery without any ongoing wound issues.
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My kidney function, measured by creatinine levels, is within the normal range.
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I have had surgery to remove my breast cancer.
Select...
I am starting or already on hormone therapy after cancer surgery.
Select...
I have Stage II or III early invasive breast cancer.
Select...
I can swallow and keep down pills.
Select...
I have Stage II or III early invasive breast cancer.
Select...
My breast cancer is ER+ or PR+, and not HER2+.
Select...
I am fully active or can carry out light work.
PALLAS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Invasive Disease Free Survival (iDFS)
Secondary outcome measures
Distant Recurrence-free Survival (DRFS)
Invasive Disease Free Survival (iDFS) Excluding Second Primary Invasive Cancers of Non-breast Origin.
Locoregional Recurrences-free Survival (LRRFS)
+1 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%
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%
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%
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%
Itchy skin
6%
Death
6%
Cellulitis
6%
Cataract
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%
Paronychia
2%
Fever blister
2%
Cold sweats
2%
Vaginal itching
2%
Intrascapular pain
2%
Vaginal infection
2%
Hoarseness
2%
COPD
2%
Sinus congestion
2%
Sinus tachycardia
2%
Diverticulitis
2%
Sepsis
2%
Fracture
2%
Yeast infection
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%
Hemorrhoids
2%
Generalized weakness
2%
Rhinovirus
2%
Wound infection
2%
Wrist pain
2%
Leg pain
2%
Localized edema
2%
Bladder infection
2%
Fungal toe infection
2%
Respiratory syncytial virus (RSV)
2%
Wrist fracture
2%
Activated partial thromboplastin time prolonged
2%
Hypermagnesemia
2%
Lung cancer
2%
Urine discoloration
2%
Vaginal discharge
2%
Laryngeal inflammation
2%
Erythema multiforme
2%
Erythema right breast
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
PALLAS Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm BExperimental Treatment1 Intervention
Standard adjuvant endocrine therapy for a duration of at least 5 years.
Group II: Arm AExperimental Treatment2 Interventions
Palbociclib at a dose of 125 mg orally once daily, Day 1 to Day 21 followed by 7 days off treatment in a 28-day cycle for a total duration of 2 years, in addition to standard adjuvant endocrine therapy for a duration of at least 5 years.
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?
Alliance Foundation Trials, LLC.Lead Sponsor
23 Previous Clinical Trials
19,236 Total Patients Enrolled
1 Trials studying Breast Cancer
3 Patients Enrolled for Breast Cancer
Austrian Breast & Colorectal Cancer Study GroupNETWORK
21 Previous Clinical Trials
13,063 Total Patients Enrolled
6 Trials studying Breast Cancer
5,208 Patients Enrolled for Breast Cancer
NSABP Foundation IncNETWORK
86 Previous Clinical Trials
131,192 Total Patients Enrolled
44 Trials studying Breast Cancer
94,734 Patients Enrolled for Breast Cancer
Media Library
Research Study Groups:
This trial has the following groups:- Group 1: Arm A
- Group 2: Arm B
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are some of the past research projects that have looked at Standard Adjuvant Endocrine Therapy?
"As of now, there are 139 clinical studies investigating Standard Adjuvant Endocrine Therapy. Out of these, 17 are in Phase 3. Although many of the research trials for Standard Adjuvant Endocrine Therapy take place in Burgas, New jersey, there are a total 6640 locations running similar investigations."
Answered by AI
For what purposes is Standard Adjuvant Endocrine Therapy most often employed?
"Standard Adjuvant Endocrine Therapy is a course of treatment with breast cancer patients as the primary focus, but it can also be prescribed to men and women post-menopause that have neoplasms."
Answered by AI
How many participants are allowed in this trial?
"Unfortunately, this study is not currently enrolling patients. The listing was initially posted on 8/1/2015 and updated as recently as 3/21/2022. However, there are 2695 studies actively recruiting breast cancer patients and 139 Standard Adjuvant Endocrine Therapy studies seeking participants."
Answered by AI
Are we still taking volunteers for this experiment?
"The clinical trial in question is not recruiting patients at this time. This can be found on clinicaltrials.gov, where the trial was first posted on 8/1/2015 and last edited on 3/21/2022. However, there are 2834 other trials that are currently looking for participants."
Answered by AI
At how many different locations is this experiment being conducted today?
"100 institutions are participating in this research project, some of which include Mayo Clinic-Rochester, Mayo Clinic in Pittsburgh, and Allegheny General Hospital."
Answered by AI
Has the FDA sanctioned Standard Adjuvant Endocrine Therapy?
"Standard Adjuvant Endocrine Therapy is backed by both efficacy data and multiple rounds of safety testing, giving it a score of 3."
Answered by AI
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