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Triple Drug Therapy for HER2 Positive Breast Cancer
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I am on medication for seizures.You have a history of having a longer than normal QT interval in your heart.I cannot swallow pills or have a stomach condition that affects medication absorption.My kidney function, measured by creatinine clearance, is adequate.I haven't had major surgery or a serious injury in the last 28 days.I may receive blood transfusions, G-CSF, and hydration as part of the study.Your calcium levels in your blood are normal or can be adjusted to normal before starting the trial.Your platelet count needs to be at least 100,000 per cubic millimeter within a week before you join the study.I have a wound or ulcer that is not healing.Your heart function is strong, with a good percentage of blood being pumped out with each heartbeat.I haven't taken strong CYP3A4 or CYP2C8 drugs recently.My liver enzyme (ALT) levels are within the required range for the study.My liver enzyme AST levels are within the required range for my condition.Your potassium levels are normal or have been adjusted to normal before starting the treatment.Your magnesium levels are normal before starting the study.My high blood pressure is not controlled, even with medication.I do not have uncontrolled heart disease or abnormal heart rhythms.I am currently taking medication for osteoporosis or to prevent breast cancer.There is too much protein in your urine, based on a urine test.My menstrual status is pre, peri, or post-menopausal.Your white blood cell count must be at least 1500 per cubic millimeter within a week before joining the study.I have an autoimmune disease other than Hashimoto's with normal TSH.Your hemoglobin level is at least 9.0 grams per deciliter within the week before joining the study.I am willing and able to follow the study's schedule and procedures.My bilirubin levels are within the normal range, or I have Gilbert's syndrome with acceptable bilirubin levels.I have tissue samples available for further HER2 testing.I am not pregnant or have had a hysterectomy, and I agree to use effective birth control during and after the study.Your blood has enough albumin, a type of protein, at a level of 2.5 grams per deciliter or higher within the past week.I have not had any cancer except for skin cancer or cervical pre-cancer in the last 5 years.I use oxygen therapy regularly.I am over 18 years old.You are currently receiving any other cancer treatment not included in this study.I have not had a heart attack or unstable chest pain in the last 6 months.My heart condition does not severely limit my daily activities.I am not on high doses of steroids (more than 15 mg of prednisone or equivalent).I have an active hepatitis B, hepatitis C, or HIV infection.I do not have a serious or uncontrolled infection.You are allergic to the study drugs or their ingredients.I have had a bone marrow or organ transplant from another person.I haven't had a stroke, deep vein thrombosis, or lung clot in the last 3 months.Your blood clotting tests should be within a normal range before joining the study.
- Group 1: Phase II,Arm B(docetaxel,carboplatin,trastuzumab,pertuzumab)
- Group 2: Phase II,Arm A(ribociclib,tucatinib, trastuzumab, fulvestrant)
- Group 3: Phase Ib (ribociclib, tucatinib, trastuzumab)
- Group 4: Phase II, Arm C (ribociclib, tucatinib, trastuzumab)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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