Study on 177Lu-DOTATATE for Treating Stage IV or Recurrent Breast Cancer

Sponsor: OHSU Knight Cancer Institute

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT04529044

Provider View

This clinical trial is exploring how well a treatment called 177Lu-DOTATATE works for patients with advanced or returning breast cancer. The treatment targets cancer cells with a specific marker, aiming to shrink or destroy them.

Patient Parameters

Program Overview

This phase II study is testing the effectiveness of 177Lu-DOTATATE in patients with stage IV or recurrent breast cancer. The treatment uses a targeted approach, where a compound called DOTATATE, linked to a radioactive substance (177Lu), attaches to cancer cells with a marker called SSTR2. This allows the radioactive agent to directly attack and kill the cancer cells. The goal is to reduce the size and number of tumors and circulating cancer stem cells in the blood of patients whose cancer shows the SSTR2 marker.

Description

The main goal of this study is to see how well the treatment 177Lu-DOTATATE works in shrinking tumors in patients. Researchers will also look at how long the treatment keeps the cancer under control, how long the response lasts, and how safe and tolerable the treatment is for patients.

Patients will receive 177Lu-DOTATATE through an IV over 30-40 minutes during weeks 1, 8, 16, and 24, as long as the cancer does not progress or cause unacceptable side effects. They will also undergo scans and provide blood samples throughout the study to monitor the treatment's effects.

After finishing the treatment, patients will have follow-up visits every 3 months for up to 5 years to check on their health and the cancer's status.

Eligibility Criteria

Inclusion Criteria

  • Life expectancy of more than 6 months
  • Ability to understand and sign a consent form
  • Aged 18 to 100 years old
  • Confirmed diagnosis of metastatic breast cancer
  • Stage IV or recurrent cancer with distant spread
  • Both female and male patients can participate
  • Cancer must have progressed after at least two standard treatments or one chemotherapy line
  • Must have at least one measurable tumor that can be biopsied
  • Cancer must show the SSTR2 marker in more than 50% of lesions
  • Must have recovered from previous treatments to a certain level
  • ECOG performance status of 2 or less
  • Must agree to a pre-treatment biopsy
  • Meet specific blood count and organ function requirements
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during and after treatment

Exclusion Criteria

  • Currently in another study or received an investigational treatment within 4 weeks
  • Prior extensive radiation to the bone marrow
  • Other cancers unless treated and disease-free for 5 years
  • Untreated or unstable brain metastases
  • Previous peptide receptor radionuclide therapy
  • Allergies to treatment components
  • Uncontrolled infections or illnesses
  • Uncontrolled diabetes or heart conditions
  • Cannot interrupt certain medications before treatment
  • Recent surgery or radiation affecting more than 25% of bone marrow
  • Recent chemotherapy or targeted therapy
  • Urinary incontinence preventing safe treatment
  • Psychiatric conditions affecting consent
  • Pregnant or breastfeeding, or planning to conceive during the study

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