Study on Olaparib with Cediranib or AZD6738 for Treating Advanced or Metastatic BRCA Mutated Breast Cancer

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04090567

Provider View

This clinical trial is testing how well the drugs Olaparib combined with either Cediranib or AZD6738 work in treating advanced or metastatic breast cancer in patients with a specific BRCA gene mutation. These drugs may help stop cancer growth by blocking certain enzymes needed for cell growth.

Patient Parameters

Program Overview

This study is exploring the effectiveness of two drug combinations—Olaparib with Cediranib and Olaparib with AZD6738—in treating advanced or metastatic breast cancer in patients with a BRCA gene mutation. The trial aims to see if these combinations can shrink tumors and how long the response lasts. It also looks at the safety of these treatments and how well patients tolerate them. Researchers will also study various biological markers to understand how the cancer responds to treatment.

Description

The main goal of this study is to see how well the drug combinations of Olaparib with Cediranib and Olaparib with AZD6738 work in shrinking tumors in patients with advanced or metastatic breast cancer who have a BRCA gene mutation and have been treated with PARP inhibitors before.

Secondary goals include assessing the safety and side effects of these drug combinations, how long the treatment response lasts, and the best response achieved. The study will also estimate how long patients live without the cancer getting worse.

Exploratory goals involve examining specific biological markers at the start and during disease progression to understand resistance and response to treatment.

Participants will be randomly assigned to one of two groups:

  • Group 1: Will take Olaparib twice daily and Cediranib once daily for 28-day cycles, repeating as long as the treatment is effective and side effects are manageable.
  • Group 2: Will take Olaparib twice daily and Ceralasertib (AZD6738) once daily for the first 7 days of each 28-day cycle, repeating as long as the treatment is effective and side effects are manageable.

After finishing the study treatment, participants will have a follow-up visit 30 days later.

Eligibility Criteria

Inclusion Criteria

  • Must provide informed consent before any study procedures.
  • Have advanced or metastatic HER2 negative, BRCA gene mutation positive breast cancer. If estrogen receptor positive, must have tried and not responded to previous hormone therapy.
  • Have adequate blood counts and organ function as determined by specific tests.
  • Be able to swallow pills and not have any digestive issues that would prevent absorption of the study drugs.
  • Be in good overall health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have a life expectancy of at least 16 weeks.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study and for one month after.
  • Must have measurable disease that can be tracked using standard criteria.
  • Willing to undergo a biopsy of a metastatic lesion at the start of the study.
  • Must have been treated with a PARP inhibitor for at least 4 months before disease progression.
  • Additional criteria for Olaparib + Cediranib group: Must have controlled blood pressure and adequate thyroid function.

Exclusion Criteria

  • Have had chemotherapy or radiation therapy within 3 weeks before starting the study drugs.
  • Have untreated or symptomatic brain metastases.
  • Have a history of allergic reactions to similar drugs.
  • Be taking medications that strongly affect liver enzymes involved in drug metabolism.
  • Have other invasive cancers within the past 5 years, except for certain skin or cervical cancers.
  • Have uncontrolled illnesses or infections.
  • Have a history of heart failure or recent heart attack.
  • Be pregnant or breastfeeding.
  • Have had major surgery within 3 weeks before starting the study treatment.
  • Additional criteria for Olaparib + Cediranib group: Cannot have bleeding disorders or be on multiple blood-thinning medications.
  • Additional criteria for Olaparib + AZD6738 group: Cannot have a diagnosis of ataxia telangiectasia.

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