BreastVAX: Enhancing Immunotherapy with Radiation Boost for Early Breast Cancer

Sponsor: Abramson Cancer Center at Penn Medicine

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04454528

Provider View

This study is exploring whether adding a single dose of radiation to the immunotherapy drug pembrolizumab can help treat early-stage breast cancer. Researchers will also look at how the treatment affects the immune system and tumor size.

Patient Parameters

Program Overview

The main goal of this study is to see if combining the immunotherapy drug pembrolizumab with a single dose of radiation is possible and effective for patients with early-stage breast cancer. Researchers will also evaluate how the treatment affects the cancer by using clinical exams, imaging, and tissue samples. They will track changes in specific immune cells in the blood and tumor tissue. A significant response is considered if the tumor shrinks by more than 30% after the treatment.

Description

The study has four groups:

  • Groups 1 and 2 differ in the order of receiving radiation and pembrolizumab.
  • Group 3 will receive only pembrolizumab.
  • Group 4 is the control group, where patients will receive standard care but will provide blood and tissue samples for research.

Initially, at least 6 patients will be enrolled to ensure safety. The second phase will include more participants, with an estimated 27 people in Group 3. Enrollment in Groups 1 and 2 will depend on funding. Group 4 participants will follow a separate protocol for sample collection.

Eligibility Criteria

Inclusion Criteria

  • Men and women aged 18 and older.
  • Able to provide written consent.
  • Good overall health (ECOG status 0-1).
  • Newly diagnosed breast cancer with a tumor size less than 5 cm, not eligible for certain other trials, or not recommended for standard chemotherapy, with specific cancer features:
    • Triple negative breast cancer (TNBC) with certain characteristics.
    • Hormone receptor-positive (HR+) and HER2-negative breast cancer, with specific age and tumor size criteria.
    • HER2-positive breast cancer with a tumor size less than 2.5 cm.
    • Ductal carcinoma in situ (DCIS) with microinvasion.
  • Locally recurrent breast cancer of any type, with no prior radiation and expecting surgery.
  • Female participants must not be pregnant or breastfeeding and must agree to use effective birth control during the study and for 120 days after the last treatment.
  • Able to undergo radiation therapy.
  • Have adequate blood, kidney, liver, thyroid, and bone marrow function.

Exclusion Criteria

  • Positive pregnancy test within 72 hours before starting the study.
  • Previous radiation to the same breast or chest area that prevents further radiation.
  • Previous treatment with certain immune therapies.
  • Recent cancer treatment within the last 4 weeks.
  • Not fully recovered from major surgery or have ongoing complications.
  • Another progressing cancer requiring treatment, except for certain skin or cervical cancers.
  • Active autoimmune disease needing treatment in the past 2 years, except for certain conditions.
  • History of lung disease requiring steroids or current lung disease.
  • Active infection needing treatment.
  • Any condition or treatment that could interfere with the study.
  • Psychiatric or substance abuse issues affecting participation.
  • Pregnant, breastfeeding, or planning to conceive during the study.
  • History of HIV or active Hepatitis B or C infection.
  • Recent live vaccine within 30 days before starting the study.
  • Severe allergy to pembrolizumab or its ingredients.
  • Previous organ transplant.

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