Study on Ribociclib, Tucatinib, and Trastuzumab for Treating HER2 Positive Breast Cancer

Sponsor: Jonsson Comprehensive Cancer Center

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05319873

Provider View

This clinical trial is testing the safety and best dose of a new combination of drugs, ribociclib, tucatinib, and trastuzumab, for treating HER2 positive breast cancer that has spread. It also compares this combination with standard treatments for early-stage breast cancer before surgery.

Patient Parameters

Program Overview

The study aims to find out if a combination of ribociclib, tucatinib, and trastuzumab can effectively treat HER2 positive breast cancer that has spread to other parts of the body. It also compares this new combination with standard chemotherapy and immunotherapy treatments for early-stage breast cancer before surgery. Ribociclib and tucatinib work by blocking enzymes that help cancer cells grow, while trastuzumab targets specific molecules on cancer cells to stop their growth. The study will also explore if adding fulvestrant, which blocks estrogen, can improve treatment outcomes.

Description

The study is divided into two phases: Phase Ib and Phase II.

Phase Ib:

  • The goal is to determine the safest and most effective dose of ribociclib when combined with tucatinib and trastuzumab for patients with metastatic HER2 positive breast cancer.
  • Patients will take ribociclib daily, tucatinib twice daily, and receive trastuzumab intravenously every week for up to 4 cycles, each lasting 28 days.

Phase II:

  • Patients with hormone receptor positive status will be randomly assigned to either Arm A or Arm B, while those with hormone receptor negative status will be assigned to Arm B or Arm C.

Arm A:

  • Patients receive ribociclib, tucatinib, trastuzumab, and fulvestrant. Treatment cycles repeat every 28 days for up to 6 cycles.

Arm B:

  • Patients receive docetaxel, carboplatin, trastuzumab, and pertuzumab. Treatment cycles repeat every 21 days for up to 6 cycles.

Arm C:

  • Patients receive ribociclib, tucatinib, and trastuzumab. Treatment cycles repeat every 28 days for up to 6 cycles.

After completing the study treatment, patients will have follow-up visits within 7 and 30 days to monitor their health and treatment effects.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Must have available tissue samples for HER2 testing.
  • Heart function must be adequate, with a left ventricular ejection fraction of 50% or higher.
  • Must have a platelet count of at least 100,000/mm³.
  • Hemoglobin level must be 9.0 g/dL or higher.
  • Absolute neutrophil count must be 1500/mm³ or higher.
  • Kidney function must be adequate, with creatinine clearance of 30 mL/min or higher.
  • Liver enzymes must be within specified limits.
  • Must have normal levels of potassium, magnesium, and calcium.
  • Must be willing to comply with study visits and procedures.
  • Can be premenopausal, perimenopausal, or postmenopausal.
  • Must agree to use effective contraception during and after the study.
  • For Phase Ib: Must have advanced or metastatic HER2 positive breast cancer and have received prior HER2 therapy.
  • For Phase II: Must have operable HER2 positive breast cancer and no prior systemic therapy for the current diagnosis.

Exclusion Criteria

  • Cannot be receiving other cancer treatments not part of the study.
  • Cannot have had another cancer within the past 5 years, except for certain skin or cervical cancers.
  • Cannot have uncontrolled high blood pressure or active infections.
  • Cannot have significant heart disease or abnormal heart rhythms.
  • Cannot have a history of severe allergic reactions to study drugs.
  • Cannot be on certain medications that affect the heart.
  • Cannot have had major surgery or significant injury recently.
  • Cannot have conditions that affect the ability to swallow pills.
  • Cannot be on high-dose corticosteroids.
  • Cannot have received a bone marrow or organ transplant.
  • Cannot be on certain medications that affect drug metabolism.
  • For Phase Ib: Cannot have untreated brain metastases larger than 2 cm.
  • For Phase II: Cannot have metastatic breast cancer or be on certain hormone therapies.

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