Phase III Study on Dato-DXd and Durvalumab for Pre- and Post-Surgery Treatment of Certain Types of Breast Cancer

Sponsor: AstraZeneca

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06112379

Provider View

This clinical trial is comparing two treatment plans for patients with specific types of breast cancer. It aims to find out if a combination of Dato-DXd and durvalumab, given before and after surgery, is more effective than the current standard treatment with pembrolizumab and chemotherapy.

Patient Parameters

Program Overview

The study is testing whether a new treatment combination of Dato-DXd and durvalumab, given before and after surgery, can better treat patients with triple-negative or hormone receptor-low/HER2-negative breast cancer compared to the standard treatment of pembrolizumab and chemotherapy. The trial will look at how well the cancer responds to these treatments and how long patients remain free of cancer progression.

Description

This Phase III study is designed to evaluate the effectiveness and safety of a new treatment approach for patients with specific types of breast cancer. The trial involves two groups: one group will receive Dato-DXd and durvalumab before surgery, followed by durvalumab with or without chemotherapy after surgery. The other group will receive the standard treatment of pembrolizumab and chemotherapy before surgery, followed by pembrolizumab with or without chemotherapy after surgery. The main goal is to see if the new treatment can better eliminate cancer cells and improve patient outcomes compared to the standard approach. Researchers will assess the cancer's response to treatment and track the time patients remain free from cancer progression.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of Stage II or III triple-negative or hormone receptor-low/HER2-negative breast cancer.
  • Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Provide a tumor sample for testing.
  • Have adequate bone marrow and organ function.
  • Use contraception as required by local regulations during the study.

Exclusion Criteria

  • Have had another cancer within the last 3 years, unless it was treated and is not expected to return.
  • Have cancer that has spread to distant parts of the body.
  • Have significant eye disease affecting the cornea.
  • Have active or uncontrolled hepatitis B or C infection.
  • Have HIV that is not well controlled.
  • Have an uncontrolled infection requiring intravenous treatment.
  • Have active tuberculosis.
  • Have significant heart problems or abnormal ECG results.
  • Have a history of lung inflammation or pneumonitis.
  • Have had previous treatment for the specific breast cancer being studied.
  • Women who are pregnant, breastfeeding, or planning to become pregnant during the study.
  • Women should not breastfeed during the study and for at least 7 months after the last treatment dose.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.