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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).
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

Study 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.Check my eligibility
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.See study design
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.

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.
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.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Disease Control Rate (DCR)
Secondary outcome measures
Duration of Response (DoR)
Number of adverse events in participants treated with Temozolomide ± Olaparib as assessed by CTCAE version 5.0.
Overall Survival (OS)
+1 more
Other outcome measures
Correlative Analyses
Disease control rate in patients with BRCAness phenotype
Duration of Response in patients with BRCAness phenotype
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Temozolomide+Olaparib ArmExperimental Treatment2 Interventions
Temozolomide 75 mg/m2 day 1 to day 7 with Olaparib 200 mg BID, oral, day 1 to day 7 in cycles of 21 days
Group II: Temozolomide ArmExperimental Treatment1 Intervention
Temozolomide: 50 mg/m2 daily in cycles of 21 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Temozolomide
2010
Completed Phase 3
~1930
Olaparib
2007
Completed Phase 4
~2140

Find a Location

Who is running the clinical trial?

AHS Cancer Control AlbertaLead Sponsor
182 Previous Clinical Trials
36,172 Total Patients Enrolled
13 Trials studying Breast Cancer
1,337 Patients Enrolled for Breast Cancer
Don Morris, MD, PhDPrincipal InvestigatorAlberta Health services

Media Library

Temozolomide (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT05128734 — Phase 2
Breast Cancer Research Study Groups: Temozolomide Arm, Temozolomide+Olaparib Arm
Breast Cancer Clinical Trial 2023: Temozolomide Highlights & Side Effects. Trial Name: NCT05128734 — Phase 2
Temozolomide (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05128734 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What risks are associated with utilizing Temozolomide Arm as a treatment option?

"The safety of the Temozolomide Arm was judged to be a 2. This is because there is evidence confirming its security, however it has yet to receive support for effectiveness from Phase 2 trials."

Answered by AI

Has research been conducted on Temozolomide Arm prior to now?

"Currently, there are 350 Temozolomide Arm studies in progress and 47 of them have reached the third phase. While many trials are operating out of Rochester, Minnesota, 14246 different sites across the globe are actively running trials for this medication."

Answered by AI

What has been the primary application of Temozolomide Arm treatments?

"Patients with advance directives, history of chemotherapy, and disease progression can be treated through the Temozolomide Arm."

Answered by AI

Is recruitment for this research endeavor currently underway?

"This clinical trial is no longer taking new patients; it was originally posted on December 1st 2023 and last modified on July 19th of the same year. For other applicable studies, 2447 trials are presently recruiting participants with breast cancer while 350 investigations are actively seeking volunteers for Temozolomide Arm."

Answered by AI

What is the total number of candidates enrolled in this research project?

"This investigation is no longer recruiting patients. It was first shared on December 1st of 2023, with the last update occurring July 19th of 2023. If you're interested in additional studies, there are 2447 trials actively seeking subjects afflicted by breast cancer and 350 investigations that focus on Temozolomide Arm enrollees."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Temozolomide Monotherapy or in Combination With Olaparib in Patients With Triple Negative Breast Cancer (TNBC)
2024. "Temozolomide Monotherapy or in Combination With Olaparib in Patients With Triple Negative Breast Cancer (TNBC)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05128734.
~27 spots leftby Jul 2027
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