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Aromatase Inhibitor

Tucatinib in Combination with Palbociclib and Letrozole for Breast Cancer

Phase 1 & 2
Waitlist Available
Led By Elena Shagisultanova, MD, PhD
Research Sponsored by University of Colorado, Denver
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 4 years
Awards & highlights

Study Summary

This trial is testing a new combination drug treatment for metastatic hormone receptor positive and HER2-positive breast cancer.

Eligible Conditions
  • Breast Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 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
Phase II : Median Progression-free Survival (mPFS)
Phase Ib : Proportion of Patients Who Experienced DLTs Attributable to Palbociclib, Tucatinib, or Both
Secondary outcome measures
Phase II : Clinical Benefit Rate (CBR)
Phase II : Median Duration of Response (mDOR)
Phase II : Overall Response Rate (ORR)
+2 more

Side effects data

From 2023 Phase 1 & 2 trial • 42 Patients • NCT03054363
85%
Neutrophil Count, Decreased
65%
Fatigue
60%
Infection
60%
Pain
55%
Nausea
55%
White Blood Cell Count Decreased
55%
Diarrhea
50%
Vomiting
45%
Mucositis
35%
Anemia
35%
Epistaxis
35%
Headache
30%
Platelet Count Decreased
30%
Hypokalemia
25%
Dizziness
25%
Weight Loss
25%
Abdominal Pain
25%
Constipation
25%
Alopecia
20%
Edema
20%
Chills
20%
Cough
20%
Pruritis
20%
fever
15%
Arthralgias
15%
Flu like symptoms
15%
Thrombocytopenia
15%
Hypoalbuminemia
15%
Lymphocyte Count Decreased
15%
Myalgia
15%
Urinary Retention
15%
Insomnia
15%
Aspartate Aminotransferase Increased
15%
Alanine aminotransferase increased
10%
Hyperkalemia
10%
Vaginal dryness
10%
Bloating
10%
Increased INR
10%
Numbness
10%
Parethesias
10%
Acne (acneform rash)
10%
Hot Flashes
10%
Hypocalcemia
10%
Sepsis
10%
maculopapular rash
10%
Activated Partial Thromboplastin Time Prolonged
10%
Dry Eyes
10%
Anorexia
10%
Dyspnea
10%
Weakness
10%
Hoarseness
10%
Bilirubin, Increased
10%
Alkaline Phosphatase increased
5%
Skin Laceration
5%
Sore Throat
5%
Skin Infection
5%
Fall
5%
hypophosphatemia
5%
Respiratory Failure
5%
Abdominal Distension
5%
ALT Increase
5%
Lung Infection (Pneumonia)
5%
Migraine
5%
Urinary Tract Infection
5%
Adenopathy
5%
Pneumonia, Atypical
5%
Cystitis noninfective
5%
Dysuria
5%
Hyponatremia
5%
Neuropathy
5%
Tremors, Bilateral hands
5%
Thromboembolic Event, Pulmonary Embolism
5%
Hyperglycemia
5%
Dysgeusia
5%
AST Increase
5%
Memory Impairment
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase Ib
Phase II

Trial Design

2Treatment groups
Experimental Treatment
Group I: Phase IIExperimental Treatment1 Intervention
Tucatinib 300 mg BID; palbociclib 75 mg PO daily 21 days on, 7 days off; letrozole 2.5 mg PO daily.
Group II: Phase 1bExperimental Treatment1 Intervention
Tucatinib 300 mg PO BID, palbociclib 125 mg PO daily 21 days on and 7 days off, and letrozole 2.5 mg PO daily on a 28 day cycle length.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tucatinib in Combination with Palbociclib and Letrozole
2017
Completed Phase 2
~50

Find a Location

Who is running the clinical trial?

Criterium, Inc.Industry Sponsor
16 Previous Clinical Trials
732 Total Patients Enrolled
3 Trials studying Breast Cancer
174 Patients Enrolled for Breast Cancer
University of Colorado, DenverLead Sponsor
1,732 Previous Clinical Trials
2,143,541 Total Patients Enrolled
26 Trials studying Breast Cancer
6,471 Patients Enrolled for Breast Cancer
PfizerIndustry Sponsor
4,567 Previous Clinical Trials
10,911,832 Total Patients Enrolled
110 Trials studying Breast Cancer
36,362 Patients Enrolled for Breast Cancer

Media Library

Letrozole (Aromatase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03054363 — Phase 1 & 2
Breast Cancer Research Study Groups: Phase 1b, Phase II
Breast Cancer Clinical Trial 2023: Letrozole Highlights & Side Effects. Trial Name: NCT03054363 — Phase 1 & 2
Letrozole (Aromatase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03054363 — Phase 1 & 2

Frequently Asked Questions

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

Are adults aged 20 and above eligible for this experiment?

"According to the qualifications laid out for this trial, participants must be aged 18 or over and no older than 100."

Answered by AI

Are there several locations conducting this research endeavor within the city?

"The clinical trial is operating in 6 different places, including the University of Arizona at Tucson, University of Texas Health Science Center San Antonio and Stony Brook University. Several other locations are also involved with this project."

Answered by AI

Could you provide a summary of any previous research for the combination of Tucatinib, Palbociclib and Letrozole?

"Presently, there are 272 active clinical trials investigating the efficacy of Tucatinib in combination with Palbociclib and Letrozole. Out of these, 52 have reached phase 3 with most occurring in Melbourne, Victoria. Across 16858 locations around the world studies involving this drug cocktail are taking place."

Answered by AI

Are there vacancies for prospective participants in this research project?

"At this time, recruitment for the clinical trial has been filled and is no longer accepting new participants. This medical study was first posted on November 27th 2017 and underwent its most recent update on March 8th 2022. However, there are currently 2,600 trials seeking patients with breast cancer as well as 272 studies involving Tucatinib in conjunction with Palbociclib and Letrozole that remain open to enrolment."

Answered by AI

How many participants have registered for this investigation?

"This study is no longer enlisting patients, as the trial was first posted on November 27th 2017 and last updated on March 8th 2022. Alternatively, if you are looking for other clinical trials related to breast cancer there are currently 2600 available with 272 of those specifically recruiting participants for Tucatinib in combination with Palbociclib and Letrozole."

Answered by AI

Is it feasible for me to join this clinical experiment?

"This clinical trial is open to participants who are between 18 and 100 years old, have breast cancer, and meet other criteria. The research team seeks 42 individuals for their study."

Answered by AI

What medical condition is the drug combination of Tucatinib, Palbociclib and Letrozole typically prescribed for?

"Tucatinib in Combination with Palbociclib and Letrozole is a recommended treatment for tamoxifen, postmenopause, advanced directives and carcinoma."

Answered by AI
Recent research and studies
Breast Cancer ResearchJournal
PD 0332991, a Selective Cyclin D Kinase 4/6 Inhibitor, Preferentially Inhibits Proliferation of Luminal Estrogen Receptor-positive Human Breast Cancer Cell Lines in Vitro
Finn, Richard S, Judy Dering, Dylan Conklin, Ondrej Kalous, David J Cohen, Amrita J Desai, Charles Ginther, et al.. 2009. “PD 0332991, a Selective Cyclin D Kinase 4/6 Inhibitor, Preferentially Inhibits Proliferation of Luminal Estrogen Receptor-positive Human Breast Cancer Cell Lines in Vitro”. Breast Cancer Research. Springer Science and Business Media LLC. doi:10.1186/bcr2419.
The Lancet OncologyJournal
The Cyclin-dependent Kinase 4/6 Inhibitor Palbociclib in Combination with Letrozole Versus Letrozole Alone as First-line Treatment of Oestrogen Receptor-positive, Her2-negative, Advanced Breast Cancer (PALOMA-1/TRIO-18): A Randomised Phase 2 Study
Finn, Richard S, John P Crown, Istvan Lang, Katalin Boer, Igor M Bondarenko, Sergey O Kulyk, Johannes Ettl, et al.. 2015. “The Cyclin-dependent Kinase 4/6 Inhibitor Palbociclib in Combination with Letrozole Versus Letrozole Alone as First-line Treatment of Oestrogen Receptor-positive, Her2-negative, Advanced Breast Cancer (PALOMA-1/TRIO-18): A Randomised Phase 2 Study”. The Lancet Oncology. Elsevier BV. doi:10.1016/s1470-2045(14)71159-3.
European Journal of CancerJournal
New Response Evaluation Criteria in Solid Tumours: Revised RECIST Guideline (version 1.1)
Eisenhauer, E.A., P. Therasse, J. Bogaerts, L.H. Schwartz, D. Sargent, R. Ford, J. Dancey, et al.. 2009. “New Response Evaluation Criteria in Solid Tumours: Revised RECIST Guideline (version 1.1)”. European Journal of Cancer. Elsevier BV. doi:10.1016/j.ejca.2008.10.026.
European Journal of CancerJournal
A Phase Two Randomised Trial of Neratinib Monotherapy Versus Lapatinib Plus Capecitabine Combination Therapy in Patients with HER2+ Advanced Breast Cancer
Martin, Miguel, Jacques Bonneterre, Charles E. Geyer Jr., Yoshinori Ito, Jungsil Ro, Istvan Lang, Sung-Bae Kim, et al.. 2013. “A Phase Two Randomised Trial of Neratinib Monotherapy Versus Lapatinib Plus Capecitabine Combination Therapy in Patients with HER2+ Advanced Breast Cancer”. European Journal of Cancer. Elsevier BV. doi:10.1016/j.ejca.2013.07.142.
~6 spots leftby Apr 2025
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