NCT03846583

Tucatinib + Abemaciclib + Herceptin for HER2+ MBC

Phase Ib Trial of Tucatinib in Combination With Abemaciclib and Trastuzumab for Patients With HER2-Positive Metastatic Breast Cancer

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research study is studying a combination of drugs as a possible treatment for HER2-Postive Metastatic Breast Cancer. The interventions involved in this study are: * Tucatinib * Abemaciclib (VerzenioTM) * Trastuzumab (Herceptin®) * Endocrine Therapy: Exemestane (Aromasin®), Letrozole (Femara®), or Anastrozole (Arimidex®)

Detailed description

This research study is a Phase Ib clinical trial, which tests the safety of an investigational intervention and also tries to define the appropriate dose of the investigational intervention to use for further studies. "Investigational" means that the intervention is being studied. The U.S. Food and Drug Administration (FDA) has not approved the combination of Tucatinib, Abemaciclib, and Trastuzumab as a treatment for any disease. In this research study, the investigators are: * Studying the combination of Tucatinib, Abemaciclib, Trastuzumab, and hormonal therapy. * Tucatinib is a drug that inhibits human epidermal growth factor receptor 2 (HER-2) protein, which is a protein expressed in the cancer cells. By inhibiting this protein, tucatinib may help stop or reduce the growth of the tumor. The U.S. Food and Drug Administration (FDA) has not approved Tucatinib as a treatment for any disease, but it has been used in a research setting with humans for many years. * Abemaciclib is a cyclin-dependent kinase (CDK) inhibitor. CDK inhibitors work to stop cell growth. The FDA has not approved Abemaciclib for this specific disease, but it has been approved for other uses. * Trastuzumab is called a "targeted therapy" because it works by attaching itself to specific receptors on the surface of breast cancer cells, known as HER2 receptors. When Trastuzumab attaches to HER2 receptors, the signals that tell the cells to grow are blocked and the cancer cell may be marked for destruction by your immune system. This process allows trastuzumab to help slow or stop the growth of the breast cancer. The FDA has approved Trastuzumab as a treatment for this disease. * Exemestane, Letrozole, and Anastrozole belong to a class of drugs called aromatase inhibitors. the participant and the physician will choose the most appropriate aromatase inhibitor for them. These drugs act by lowering the amount of estrogen produced by the body by blocking an enzyme called aromatase. Each of these drugs have been approved by the FDA for this cancer and have been used in the treatment of metastatic ER-positive breast cancer for many years. * In this part of the research study the investigators are looking for the safest doses of these drugs to give to participants at the same time. * The overall goal of this study is to evaluate the safety and effectiveness of Tucatinib in combination with Abemaciclib, Trastuzumab, and hormonal therapy for hormone receptor-positive, HER2-positive Metastatic Breast Cancer

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Tucatinib	Tucatinib is a drug that inhibits human epidermal growth factor receptor 2 (HER-2) protein, which is a protein expressed in the cancer cells. By inhibiting this protein, tucatinib may help stop or reduce the growth of the tumor
DRUG	Abemaciclib	Abemaciclib is a cyclin-dependent kinase (CDK) inhibitor. CDK inhibitors work to stop cell growth.
DRUG	Trastuzumab	• Trastuzumab is called a "targeted therapy" because it works by attaching itself to specific receptors on the surface of breast cancer cells, known as HER2 receptors. When Trastuzumab attaches to HER2 receptors, the signals that tell the cells to grow are blocked and the cancer cell may be marked for destruction by the immune system.
DRUG	Aromatase Inhibitor	These drugs act by lowering the amount of estrogen produced by the body by blocking an enzyme called aromatase

Timeline

• Start date: 2020-06-28
• Primary completion: 2020-09-22
• Completion: 2020-09-22
• First posted: 2019-02-19
• Last updated: 2020-10-23

Regulatory

• FDA-regulated drug study