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Alkylating agents

Temozolomide + Olaparib for Breast Cancer

Phase 2

Waitlist Available

Led By Don Morris, MD, PhD

Research Sponsored by AHS Cancer Control Alberta

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

At least one line of chemotherapy in the context of metastatic disease.

ECOG performance status 0 or 1 (Appendix A).

Must not have

Patients who have received chemotherapy within 4 weeks or radiotherapy to a non-target site within 2 weeks prior to entering the study or who have not recovered from adverse events from prior anti-cancer therapy (residual toxicities > Grade 1) with the exception of alopecia.

Patients with HIV, Hepatitis B, or Hepatitis C infection.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the date of first study drug dosing to the date of death, assessed up to 5 years.

Awards & highlights

No Placebo-Only Group

Summary

This trial studies if a combination of drugs can better treat triple-negative breast cancer with an MGMT gene. Patients randomly get either 1 drug or a combo of 2.

Who is the study for?

This trial is for adults with a specific type of breast cancer called triple-negative that hasn't spread to the bone. They must have had at least one chemotherapy treatment, be able to use effective birth control, and not be pregnant or breastfeeding. People can't join if they're allergic to the drugs being tested, have certain infections like HIV or Hepatitis B/C, or have been treated with these drugs before.

What is being tested?

The study is testing Temozolomide alone versus Temozolomide combined with Olaparib in patients whose tumors are MGMT-methylated. It's a phase II trial where participants are randomly placed into two groups to compare how well each treatment controls the disease.

What are the potential side effects?

Temozolomide may cause nausea, fatigue, constipation, headache and low blood counts leading to infection risk. Olaparib could add side effects like anemia, loss of appetite, taste changes and dizziness. Each person might experience side effects differently.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have received chemotherapy for cancer that has spread.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My breast cancer is triple negative as confirmed by tests.

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I have a tumor that can be seen on a CT scan or felt by a doctor, but it's not just in my bones.

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I am 18 years old or older.

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I have been treated with anthracyclines and taxanes before.

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My cancer has a specific genetic feature known as MGMT promoter methylation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't had chemotherapy in the last 4 weeks or radiotherapy in the last 2 weeks, and I've recovered from previous cancer treatment side effects.

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I have HIV, Hepatitis B, or Hepatitis C.

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I have a known BRCA1 or BRCA2 gene mutation.

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My cancer has spread to the bones only.

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I am not allergic to Olaparib, temozolomide, or dacarbazine.

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I have been treated with Temozolomide or Olaparib.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the date of first study drug dosing to the date of death, assessed up to 5 years.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the date of first study drug dosing to the date of death, assessed up to 5 years.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the date of first study drug dosing to the date of death, assessed up to 5 years. for reporting.