Study on Turning HR+ Breast Cancer into a Personalized Vaccine

Sponsor: Weill Medical College of Cornell University

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT03804944

Provider View

This clinical trial is exploring a new approach to treat HR+HER2- breast cancer in post-menopausal women by using a combination of hormonal therapy, radiation, and immunotherapy before surgery.

Patient Parameters

Program Overview

The study is for post-menopausal women newly diagnosed with stage II-III HR+HER2- breast cancer. Participants will receive standard hormonal therapy with letrozole for four months and will be randomly assigned to one of four treatment groups. These groups will test different combinations of radiation therapy and immunotherapy to see if they can help turn the cancer into a personalized vaccine.

Description

Participants in this study will be involved for a total of five months. This includes four months of active treatment and a follow-up period after surgery. During the study, participants will be randomly assigned to one of four treatment groups:

  1. Receive the immunotherapy drug pembrolizumab (Keytruda) through an IV every three weeks.
  2. Self-administer the drug FLT3L (CDX-301) through injections for five consecutive days in the first week.
  3. All groups will receive radiation therapy to the breast tumor starting in the second week, with treatments every other day.
  4. Continue taking the hormonal therapy letrozole daily for four months until surgery, with further treatment decided by the doctor.

The goal is to see if these treatments can help the body recognize and fight the cancer more effectively.

Eligibility Criteria

Inclusion Criteria

  • Post-menopausal women aged 18 or older.
  • Must have a confirmed diagnosis of HR+HER2- breast cancer.
  • Cancer must be stage I (larger than 1.5 cm if no lymph node involvement) to stage III.
  • Must be able to understand and sign a consent form.
  • Must have adequate blood cell counts and liver function.
  • Must have good kidney function and normal blood clotting times.

Exclusion Criteria

  • Have active connective tissue disorders like lupus or scleroderma.
  • Currently using chemotherapy or other specific cancer therapies.
  • Have had breast cancer surgery or radiation on the same breast.
  • Have received certain immunotherapy treatments before.
  • Cannot provide proof of breast cancer diagnosis.
  • Have received a live vaccine within 30 days before starting the study.
  • Participating in another study or using an investigational device recently.
  • Have an immune deficiency or are on high-dose steroids.
  • Have another active cancer needing treatment in the past 3 years.
  • Have severe allergies to pembrolizumab or its ingredients.
  • Have an active autoimmune disease needing treatment in the past 2 years.
  • Have a history of lung inflammation needing steroids.
  • Have an active infection needing treatment.
  • Have a history of HIV, Hepatitis B, or active Hepatitis C.
  • Have a history of active tuberculosis.
  • Have psychiatric or substance abuse issues affecting study participation.

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