A Phase 2 Study of Neratinib with or without Fulvestrant in HER2-Positive ER-Positive Metastatic Breast Cancer

Study on Investigational Medication for Advanced Breast Cancer

Recruiting
18 years - 100 years
Female
Phase N/A
1 Location

Brief description of study.

The purpose of this research study is to determine how well neratinib, by itself or together with Fulvestrant, works in treating breast cancer that has spread to other parts of the body. We will also be looking at the side effects associated with this combination of drugs.

Detailed description of study

This is a Phase II study to determine how well neratinib, alone or together with Fulvestrant (FDA approved), works in treating breast cancer that has spread to other parts of the body.
Participants will not be paid for their participation.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: HER2,metastatic breast cancer,metastatic,breast cancer,cancer,oncology
  • Age: 18 years - 100 years
  • Gender: Female

Inclusion Criteria
In order to be eligible to take part in this trial, patients must meet the following criteria:

  • Females 18 years or older
  • Inoperable locally advanced or metastatic ER+ breast cancer.

For a full list of participation criteria, please visit clinicaltrials.gov.

Updated on 19 Feb 2024. Study ID: 1803730353 (17-318)

This study investigates the effectiveness of an investigational medication, alone or in combination with another treatment, in treating breast cancer that has spread to other parts of the body. Breast cancer can be described as a disease where cells in the breast grow out of control, and when it spreads, it is known as metastatic breast cancer. The purpose of this study is to determine how well these treatments work and to observe any side effects that may occur.

Participants in this study will receive either the investigational medication alone or with another treatment. The study will monitor the effects of these treatments on breast cancer and assess any side effects. This will help researchers understand how the treatment impacts the disease.

  • Who can participate: Females aged 18 years or older with inoperable locally advanced or metastatic ER+ breast cancer are eligible to participate.
  • Study details: Participants will receive either the investigational medication alone or with another treatment. A placebo, an inactive substance that looks like the investigational medicine but does not contain any medicine, will not be used in this study.

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