Study on Alisertib With or Without Fulvestrant for Treating Advanced Breast Cancer Resistant to Hormone Therapy

Sponsor: Mayo Clinic

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT02860000

Provider View

This clinical trial is exploring whether the drug alisertib, alone or combined with fulvestrant, can effectively treat breast cancer that has spread and is resistant to hormone therapy. Alisertib may stop cancer cell growth by blocking certain enzymes, while fulvestrant may help by blocking or reducing estrogen, which some breast cancers need to grow.

Patient Parameters

Program Overview

The purpose of this study is to see if alisertib, with or without the hormone therapy drug fulvestrant, can help control breast cancer that has spread and is resistant to hormone treatments. Alisertib works by blocking enzymes that help cancer cells grow, and fulvestrant works by blocking estrogen, which some breast cancers need to grow. The study aims to find out if this combination is more effective than alisertib alone.

Description

This study is divided into two groups. In one group, patients will take alisertib pills on specific days each month. If their cancer progresses, they may switch to the second group. In the second group, patients will receive fulvestrant injections along with alisertib pills. The study will monitor how well the treatments work, their safety, and how long patients remain free from cancer progression. Researchers will also study changes in certain proteins and genes in the cancer cells to understand how the treatments work. Patients will be followed up every six months for up to five years after completing the study treatment.

Eligibility Criteria

Inclusion Criteria

  • Must be post-menopausal, either naturally or through surgery.
  • Have advanced or metastatic breast cancer that cannot be surgically removed.
  • Cancer must be estrogen receptor-positive and HER2-negative.
  • Have received no more than two chemotherapy treatments for metastatic cancer.
  • Must have previously been treated with fulvestrant, unless the cancer was estrogen receptor-negative.
  • Must have measurable cancer that can be tracked with scans.
  • No history of cancer affecting the spinal cord or heart.
  • Must be in good overall health with an ECOG performance status of 0, 1, or 2.
  • Must not be taking certain medications like proton pump inhibitors or H2 antagonists.
  • Must be willing to limit alcohol intake.
  • Must not have uncontrolled illnesses like infections or heart conditions.
  • Must not have other active cancers within the last five years, except for certain skin or cervical cancers.
  • Must be able to swallow pills and not have gastrointestinal issues that affect absorption.
  • Must be willing to provide a tumor sample for research purposes.

Exclusion Criteria

  • Have received chemotherapy, immunotherapy, or biologic therapy within 21 days before joining the study.
  • Have received hormonal therapy or monoclonal antibodies within 14 days before joining the study.
  • Have received radiation therapy within 14 days before joining the study.
  • Have received certain medications like enzyme inducers or corticosteroids within 14 days before joining the study.
  • Have a systemic infection requiring IV antibiotics within 14 days before joining the study.

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