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Aromatase Inhibitor

Palbociclib + Letrozole + T-DM1 for Breast Cancer

Phase 1 & 2
Waitlist Available
Led By Lauren Nye, MD
Research Sponsored by University of Kansas Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Pathologically confirmed diagnosis of Estrogen Receptor (ER) positive and HER2 (human epidermal growth factor receptor 2) positive metastatic breast cancer based on local laboratory results
Prior treatment with a taxane (including paclitaxel, docetaxel and/or nanoparticle protein-bound paclitaxel)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial will help to determine the recommended dose of palbociclib in combination with letrozole and Ado-trastuzumab emtansine (T-DM1) to improve outcomes in advanced breast cancer patients.

Who is the study for?
This trial is for post-menopausal women with advanced breast cancer that's ER+ and HER2+. They should have had prior treatment with trastuzumab, a taxane, and be able to swallow pills. Their body must be functioning well overall. Those with allergies to similar drugs or who've used CDK 4/6 inhibitors can't join.Check my eligibility
What is being tested?
Researchers are testing different doses of Palbociclib combined with Letrozole and T-DM1 to find the safest effective dose for treating this type of breast cancer. The study starts at a low dose and increases only if patients don't experience significant toxic effects.See study design
What are the potential side effects?
Possible side effects include fatigue, nausea, blood count changes which could lead to infections or bleeding problems, liver issues, hair loss, neuropathy (nerve pain), diarrhea, mouth sores among others.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My breast cancer is positive for both ER and HER2.
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I have been treated with a taxane-based chemotherapy before.
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I have been treated with trastuzumab, with or without pertuzumab.
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My organs and bone marrow are working well.
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I can take care of myself and am up and about more than half of the day.
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I have gone through menopause.
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I can swallow pills.

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
Rate of Overall Response
Secondary outcome measures
Number of participants with a worsening Patient Reported Outcomes of Adverse Events (PRO-AE) score
Number of patients with adverse events
Peak observed plasma concentration
+4 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%
Back spasms
4%
Vaginal dryness
4%
Watering eyes
4%
Burn
4%
Flu-like symptoms
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%
Localized edema
2%
Wrist fracture
2%
Lung cancer
2%
Vaginal discharge
2%
Erythema multiforme
2%
Erythema right breast
2%
Cold sweats
2%
Puncture wound
2%
Activated partial thromboplastin time prolonged
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

4Treatment groups
Experimental Treatment
Group I: Phase 2: RP2DExperimental Treatment3 Interventions
Recommended Phase 2 dose (RP2D; determined during Phase 1 Safety Run In) Palbociclib by mouth (PO) daily Letrozole 2.5 mg PO Daily Ado-trastuzumab Emtansine (T-DM1) 3.6 milligrams per kilograms (mg/kg) intravenous (IV) Day 1
Group II: Phase 1: Palbociclib 75 mgExperimental Treatment3 Interventions
Palbociclib 75 milligrams (mg) by mouth (PO) daily Letrozole 2.5 mg PO Daily Ado-trastuzumab Emtansine (T-DM1) 3.6 milligrams per kilograms (mg/kg) intravenous (IV) Day 1
Group III: Phase 1: Palbociclib 125 mgExperimental Treatment3 Interventions
Palbociclib 125 milligrams (mg) by mouth (PO) daily Letrozole 2.5 mg PO Daily Ado-trastuzumab Emtansine (T-DM1) 3.6 milligrams per kilograms (mg/kg) intravenous (IV) Day 1
Group IV: Phase 1: Palbociclib 100 mgExperimental Treatment3 Interventions
Palbociclib 100 milligrams (mg) by mouth (PO) daily Letrozole 2.5 mg PO Daily Ado-trastuzumab Emtansine (T-DM1) 3.6 milligrams per kilograms (mg/kg) intravenous (IV) Day 1
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Letrozole
FDA approved
Palbociclib
FDA approved
Palbociclib
FDA approved
Palbociclib
FDA approved
Palbociclib
FDA approved
Trastuzumab emtansine
FDA approved

Find a Location

Who is running the clinical trial?

University of Kansas Medical CenterLead Sponsor
461 Previous Clinical Trials
169,154 Total Patients Enrolled
23 Trials studying Breast Cancer
4,510 Patients Enrolled for Breast Cancer
PfizerIndustry Sponsor
4,567 Previous Clinical Trials
10,911,871 Total Patients Enrolled
111 Trials studying Breast Cancer
36,404 Patients Enrolled for Breast Cancer
Lauren Nye, MDPrincipal InvestigatorKUCC
2 Previous Clinical Trials
111 Total Patients Enrolled
2 Trials studying Breast Cancer
111 Patients Enrolled for Breast Cancer

Media Library

Letrozole (Aromatase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03709082 — Phase 1 & 2
Breast Cancer Research Study Groups: Phase 1: Palbociclib 125 mg, Phase 2: RP2D, Phase 1: Palbociclib 75 mg, Phase 1: Palbociclib 100 mg
Breast Cancer Clinical Trial 2023: Letrozole Highlights & Side Effects. Trial Name: NCT03709082 — Phase 1 & 2
Letrozole (Aromatase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03709082 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the typical purpose of utilizing Palbociclib?

"Palbociclib is commonly used to treat polycystic ovary syndrome, but it has also been known to be effective in managing the symptoms of advanced directives, breast cancer, and carcinoma."

Answered by AI

Are there additional clinical experiments involving Palbociclib?

"The National Institutes of Health Clinical Center initiated the first studies into palbociclib in 1995, and since then 285 trials have been completed. Now there are 287 active research projects taking place with many based out of Kansas City, Kansas."

Answered by AI

Are new participants being sought for this experiment?

"No longer recruiting, this trial was first advertised on October 15th 2018 and had its last update on November 23rd 2020. For those looking for further medical studies, there are 2298 trials searching for erbb-2 receptor participants and 287 seeking Palbociclib sufferers."

Answered by AI

What is the current enrollment count for this trial?

"Unfortunately, this clinical trial is currently not in the process of recruitment. The original posting was on October 15th 2018 and it's latest update occurred two years later on November 23rd 2020. If you are searching for alternative studies, there are presently 2298 trials related to ERBB-2 receptor and 287 studies involving Palbociclib that remain open for patient enrollment."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Palbociclib in Estrogen Receptor Positive (ER+) Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Metastatic Breast Cancer
Lauren Nye 2018. "Palbociclib in Estrogen Receptor Positive (ER+) Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Metastatic Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03709082.
~0 spots leftby Apr 2025
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