Adding an Immunotherapy Drug, Durvalumab, to the Usual Chemotherapy for Stage II-III Breast Cancer

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06058377

Provider View

This study is testing whether adding the immunotherapy drug durvalumab to the usual chemotherapy can help treat patients with a specific type of stage II-III breast cancer. The goal is to see if this combination can prevent the cancer from coming back.

Patient Parameters

Program Overview

This phase III trial is exploring if adding an immunotherapy drug called durvalumab to the standard chemotherapy treatment can improve outcomes for patients with a specific type of stage II-III breast cancer. The study focuses on patients with hormone receptor positive, HER2 negative breast cancer who have a high risk of cancer returning. The trial will compare the effectiveness of the usual chemotherapy drugs (paclitaxel, doxorubicin, and cyclophosphamide) alone versus the same chemotherapy combined with durvalumab. Researchers hope that this combination will help the immune system attack the cancer and prevent it from growing and spreading.

Description

The main goal of this study is to see if adding durvalumab to the usual chemotherapy can improve breast cancer event-free survival, meaning the time patients remain free from cancer events. The study will also look at other outcomes, such as how well the cancer responds to treatment, the distribution of any remaining cancer, and overall survival rates. Additionally, the study will assess the side effects and quality of life for patients receiving the combination treatment compared to those receiving chemotherapy alone.

Participants will be divided into two groups. One group will receive the standard chemotherapy treatment, while the other group will receive the same chemotherapy along with durvalumab. The chemotherapy drugs will be given in cycles, with paclitaxel administered first, followed by doxorubicin and cyclophosphamide. Durvalumab will be given every other cycle.

Patients will undergo various tests and procedures, including mammography and blood sample collection, to monitor their health and the treatment's effects. The study will follow participants for up to 10 years to track their progress and any long-term effects of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of hormone receptor positive, HER2 negative breast cancer.
  • Must have stage II or III breast cancer.
  • Must not have metastatic or locally recurrent breast cancer.
  • Must have a MammaPrint Ultrahigh (MP2) score or provide tissue for testing.
  • Must not have received any prior treatment for the current breast cancer.
  • Must be 18 years or older.
  • Must have a complete medical history and physical exam.
  • Must weigh more than 30 kg.
  • Must have a performance status score of 0-2, indicating good overall health.
  • Must not have medical conditions that prevent receiving immunotherapy.
  • Must agree to informed consent and understand the study's investigational nature.
  • Must not have received live vaccines recently.
  • Must not plan to receive other cancer treatments during the study.
  • Must have adequate blood counts and organ function.
  • Must not have uncontrolled diabetes or active infections.
  • Must not be pregnant or nursing and must agree to use effective contraception.
  • Must be willing to participate in specimen banking and quality of life assessments if eligible.

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