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Triple Drug Therapy for HER2 Positive Breast Cancer

Phase 1 & 2
Recruiting
Led By Nicholas P McAndrew
Research Sponsored by Jonsson Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Creatinine clearance >= 30 mL/min as calculated using the Cockcroft-Gault equation or Serum creatinine =< 1.5 × upper limit of normal (ULN) (within 7 days before enrollment)
Red blood cell transfusion, filgrastim (G-CSF), and hydration allowed at the discretion of the investigator for Phase Ib only
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-infusion and 1, 2, 3, and 6 hours after the start of the infusion
Awards & highlights

Study Summary

This trial is studying the side effects and best dose of two drugs, ribociclib and tucatinib, when used with the drug trastuzumab to treat patients with HER2 positive breast cancer. The trial will also compare the effect of the combination of these three drugs with or without the drug fulvestrant to the standard of care for the treatment of patients with early stage breast cancer before surgery.

Who is the study for?
Adults with HER2 positive metastatic breast cancer or early stage breast cancer pre-surgery can join. They need a normal heart function, blood counts within specific ranges, and proper liver and kidney function. Pregnant women can't participate; others must use effective contraception. Excluded are those with recent other cancers, uncontrolled conditions like hypertension, major surgery within the last month, certain drug therapies, infections or heart issues.Check my eligibility
What is being tested?
The trial is testing ribociclib and tucatinib's effectiveness in stopping tumor growth when combined with trastuzumab for metastatic cases. It also compares this combo to standard chemotherapy before surgery in early-stage cases. The study will determine the best dose of these drugs and their impact on tumor size reduction.See study design
What are the potential side effects?
Potential side effects include reactions related to blocking enzymes needed for cell growth which may affect organ functions, as well as typical chemotherapy effects such as fatigue, nausea, hair loss and increased risk of infection due to immune system interference.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My kidney function, measured by creatinine clearance, is adequate.
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I may receive blood transfusions, G-CSF, and hydration as part of the study.
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My liver enzyme (ALT) levels are within the required range for the study.
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My liver enzyme AST levels are within the required range for my condition.
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My menstrual status is pre, peri, or post-menopausal.
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I am willing and able to follow the study's schedule and procedures.
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My bilirubin levels are within the normal range, or I have Gilbert's syndrome with acceptable bilirubin levels.
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I have tissue samples available for further HER2 testing.
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I am not pregnant or have had a hysterectomy, and I agree to use effective birth control during and after the study.
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I am over 18 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-infusion and 1, 2, 3, and 6 hours after the start of the infusion
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-infusion and 1, 2, 3, and 6 hours after the start of the infusion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum tolerated dose (MTD) (Phase Ib)
Pathologic complete response (pCR) (Phase II)
Secondary outcome measures
Clinical objective response rate (ORR) (Phase IB and II)
Evaluate the pharmacokinetics of ribociclib and tucatinib when given in combination with tucatinib and trastuzumab. (Phase 1b): Area Under Curve (AUC)
Evaluate the pharmacokinetics of ribociclib and tucatinib when given in combination with tucatinib and trastuzumab. (Phase 1b): Average plasma concentration at steady state (Cavg)
+6 more

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Phase Ib (ribociclib, tucatinib, trastuzumab)Experimental Treatment4 Interventions
Patients receive ribociclib PO QD on days 1-21, tucatinib PO BID on days 1-28, and trastuzumab IV over 30-90 minutes every 7 days. Cycles repeat every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
Group II: Phase II,Arm A(ribociclib,tucatinib, trastuzumab, fulvestrant)Experimental Treatment4 Interventions
Patients receive ribociclib PO QD on days 1-21, tucatinib BID on days 1-28, trastuzumab IV over 30-90 minutes every 7 days and fulvestrant subcutaneously (SC) on days 1 and 15 of cycle 1 and day 1 of every subsequent cycle. Cycles repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Group III: Phase II, Arm C (ribociclib, tucatinib, trastuzumab)Experimental Treatment4 Interventions
Patients receive ribociclib PO QD on days 1-21, tucatinib BID on days 1-28, and trastuzumab IV over 30-90 minutes every 7 days. Cycles repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Group IV: Phase II,Arm B(docetaxel,carboplatin,trastuzumab,pertuzumab)Active Control5 Interventions
Patients receive docetaxel IV over 1 hour on day 1, carboplatin IV on day 1, trastuzumab IV over 30-90 minutes on day 1, and pertuzumab IV over 1 hour on day 1. Cycles repeat every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trastuzumab
2014
Completed Phase 4
~5190
Ribociclib
2018
Completed Phase 3
~2330
Fulvestrant
2011
Completed Phase 3
~3700
Tucatinib
2017
Completed Phase 2
~520

Find a Location

Who is running the clinical trial?

Jonsson Comprehensive Cancer CenterLead Sponsor
358 Previous Clinical Trials
26,058 Total Patients Enrolled
24 Trials studying Breast Cancer
1,758 Patients Enrolled for Breast Cancer
Seagen Inc.Industry Sponsor
206 Previous Clinical Trials
69,321 Total Patients Enrolled
6 Trials studying Breast Cancer
3,308 Patients Enrolled for Breast Cancer
NovartisIndustry Sponsor
1,609 Previous Clinical Trials
2,717,908 Total Patients Enrolled
57 Trials studying Breast Cancer
21,188 Patients Enrolled for Breast Cancer

Media Library

Ribociclib Clinical Trial Eligibility Overview. Trial Name: NCT05319873 — Phase 1 & 2
Breast Cancer Research Study Groups: Phase II,Arm B(docetaxel,carboplatin,trastuzumab,pertuzumab), Phase II,Arm A(ribociclib,tucatinib, trastuzumab, fulvestrant), Phase Ib (ribociclib, tucatinib, trastuzumab), Phase II, Arm C (ribociclib, tucatinib, trastuzumab)
Breast Cancer Clinical Trial 2023: Ribociclib Highlights & Side Effects. Trial Name: NCT05319873 — Phase 1 & 2
Ribociclib 2023 Treatment Timeline for Medical Study. Trial Name: NCT05319873 — Phase 1 & 2

Frequently Asked Questions

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

How many people are enrolled in this experiment at most?

"The listing on clinicaltrials.gov verifies that this trial is still open and recruiting patients. This study was first advertised on April 7th, 2022 with the most recent update being May 11th,2022. A total of 18 individuals are needed for the research, which will be conducted across a single site."

Answered by AI

Are new participants currently being recruited for this experiment?

"Yes, this information is accurate according to the listing on clinicaltrials.gov. The trial was posted on April 7th, 2022 and updated May 11th, 2022."

Answered by AI

What are researchers hoping to discover or achieve with this experiment?

"The primary objective of this study is to assess Pathologic complete response (pCR) during the first treatment cycle (1 cycle = 28 days). Secondary objectives include evaluating the pharmacokinetics of ribociclib and tucatinib when given in combination with tucatinib and trastuzumab, determining the minimum plasma concentration for ribociclib and tucatinib, and assessing the maximum plasma concentration for ribociclib and tucatinib."

Answered by AI
~0 spots leftby Apr 2024