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Olaparib

Phase 2

Breast Cancer Triple Negative | Small molecule | Oncology |Avalon GloboCare Corp.|Last Updated: Dec 15, 2025

Target and mechanism

Molecular targetPARP1, PARP3, PARP2
Target classInhibitor
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

Clinical trial landscape

Olaparib · 1 trial · 1 indication

Phase 2 1
NCT05128734Temozolomide Monotherapy or in Combination With Olaparib in Patients With Triple Negative Breast Cancer (TNBC)Breast Cancer Triple Negative
NOT YET_RECRUITING40 Analytics
PHASE2NOT YET_RECRUITING
Temozolomide Monotherapy or in Combination With Olaparib in Patients With Triple Negative Breast Cancer (TNBC)
Breast Cancer Triple NegativeUnlock trial analytics

Study Endpoints

Primary Endpoints

Disease Control Rate (DCR)
From the date of first study drug dosing to the date of first documented complete response or partial response or stable disease, whichever came first, assessed up to 5 years.

To determine DCR by assessing complete/partial response or stable disease, as per RECIST 1.1 in patients with mMGMT TNBC treated with Temozolomide ± Olaparib.

Secondary Endpoints

Progression Free Survival (PFS)
From the date of first study drug dosing to the date of first documented disease progression, assessed up to 5 years.
Overall Survival (OS)
From the date of first study drug dosing to the date of death, assessed up to 5 years.
Number of adverse events in participants treated with Temozolomide ± Olaparib as assessed by CTCAE version 5.0.
From the date of first study drug dosing until the last date of study drug dosing, assessed up to 5 years.
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Temozolomide ArmEXPERIMENTALTemozolomide: 50 mg/m2 daily in cycles of 21 days
Temozolomide+Olaparib ArmEXPERIMENTALTemozolomide 75 mg/m2 day 1 to day 7 with Olaparib 200 mg BID, oral, day 1 to day 7 in cycles of 21 days

Interventions

NameTypeDescription
TemozolomideDRUGTemozolomidewill be administered orally for 7 days (D) every 21 days until progression of the disease in both arms.
OlaparibDRUGOlaparib will be administered orally twice daily in treatment arm 2.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Female or male patients with triple negative breast cancer confirmed by pathology of the primary tumour or metastatic biopsy sample. Estrogen receptor (ER) and progesterone receptor (PgR) must be ≤2 Allred score by Immunohistochemistry (IHC); human epidermal growth factor rece...

Countries:Canada
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Frequently asked questions about Olaparib

What is Olaparib used for in breast cancer triple negative?

Olaparib is being studied for the treatment of triple negative breast cancer (TNBC). It is an investigational small molecule in Phase 2 clinical development for this indication. The drug is being evaluated in a clinical trial in Canada.

What does Olaparib target?

Olaparib targets PARP, a class of enzymes involved in DNA repair. By inhibiting PARP, the drug is intended to exploit vulnerabilities in cancer cells. It is being studied in biomarker-selected patients with triple negative breast cancer.

Who is developing Olaparib?

Olaparib is being developed by Avalon GloboCare Corp., a biopharmaceutical company. The company's ticker symbol is ALBT. The drug is currently in Phase 2 clinical development for triple negative breast cancer.

What phase is Olaparib in?

Olaparib is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied in a Phase 2 trial for triple negative breast cancer.

What clinical trials is Olaparib in?

Olaparib is being evaluated in clinical trial NCT05128734, titled "Temozolomide Monotherapy or in Combination With Olaparib in Patients With Triple Negative Breast Cancer (TNBC)". This Phase 2 trial is not yet recruiting and plans to enroll 40 participants in Canada.

Is Olaparib the same as any other drug?

Olaparib is also known by its generic name and is sometimes referred to as a PARP inhibitor. No alternative brand names have been established for this investigational drug in the context of this development program.