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Tucatinib + Abemaciclib + Herceptin for HER2+ MBC

NCT03846583 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2020-10-23

No results posted yet for this study

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®)

Conditions

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Jose Pablo Leone, MD · Dana-Farber Cancer Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-28
Primary Completion
2020-09-22
Completion
2020-09-22
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03846583 on ClinicalTrials.gov