Study on Olaparib with Durvalumab, Selumetinib, Capivasertib, or Ceralasertib for Treating Metastatic Triple Negative Breast Cancer

Sponsor: OHSU Knight Cancer Institute

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT03801369

Provider View

This clinical trial is testing different combinations of the drug olaparib with other medications to see if they can effectively treat metastatic triple negative breast cancer (TNBC). The study aims to find out if these combinations can stop cancer growth and improve patient outcomes.

Patient Parameters

Program Overview

This study is exploring the effectiveness of combining the drug olaparib with other treatments like durvalumab, selumetinib, capivasertib, or using ceralasertib alone, to treat patients with metastatic triple negative breast cancer (TNBC). Olaparib works by blocking certain enzymes needed for cancer cell growth. Durvalumab helps the immune system fight cancer, while selumetinib, capivasertib, and ceralasertib block other enzymes that cancer cells need to grow. The study aims to see if these combinations can better control the cancer.

Description

The main goal of this study is to see how well the treatment works in shrinking or controlling the cancer. Researchers will also look at how long it takes for the cancer to progress, how long patients live, and how safe and tolerable the treatments are.

The study will also explore changes in patients' quality of life and how different tumor characteristics affect treatment response. Researchers will look for markers that predict how well patients respond to the treatment and understand how cancer cells might resist the therapy.

The study is open-label, meaning both doctors and patients know which treatment is being given. Patients with confirmed TNBC will first receive olaparib for two weeks, followed by a biopsy. Then, based on their tumor characteristics, they will be assigned to one of four treatment groups:

  • Group 1: Olaparib with durvalumab
  • Group 2: Olaparib with selumetinib
  • Group 3: Olaparib with capivasertib
  • Group 4: Ceralasertib alone

Each treatment cycle lasts 28 days, and patients can continue treatment for up to 12 cycles if it is beneficial and safe. After completing the study, patients will be followed up every six months for up to a year to monitor their health and cancer status. An optional biopsy may be requested if the cancer progresses.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have metastatic triple negative breast cancer (TNBC) that is hormone receptor-negative and HER2 non-amplified.
  • Can have TNBC with or without BRCA mutations.
  • Must have at least one measurable tumor that can be biopsied.
  • Can have had up to two prior chemotherapy treatments for metastatic breast cancer.
  • Must have recovered from previous treatments and have a life expectancy of at least 16 weeks.
  • Must agree to undergo biopsies before and during the study.
  • Must not have been treated with PARP inhibitors before.
  • Must have adequate blood counts and organ function.
  • Women of childbearing potential must have a negative pregnancy test and agree to use contraception during and after treatment.
  • Men must use condoms during and after treatment if their partners are of childbearing potential.

Exclusion Criteria

  • Cannot be receiving other cancer treatments at the same time.
  • Cannot have tumors with high androgen receptor levels.
  • Cannot have other cancers unless treated and disease-free for at least 5 years.
  • Cannot have certain blood disorders or active brain metastases.
  • Cannot have taken certain medications that affect the study drugs.
  • Cannot have had major surgery recently.
  • Cannot have active infections like hepatitis or HIV unless controlled.
  • Cannot have conditions that affect drug absorption.
  • Cannot have severe organ dysfunction or uncontrolled medical conditions.
  • Cannot have a history of severe allergic reactions to study drugs.
  • Cannot be pregnant or breastfeeding.
  • Must not have received live vaccines recently.
  • Must not have received certain immunotherapies before.

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