Solid TumorPhase 2NCT05522491

Olaparib in the Treatment of BRCA1/2 Unmutated and BRCA1 Promoter Methylated Recurrent and Metastatic Triple-negative Breast Cancer

A Phase 2 study testing Olaparib in people with Solid Tumor, run by Hebei Medical University Fourth Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record

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Trial summary

This is an open-label, single-arm, single-center,exploratory clinical study. Read more about this study

Who is it for?: Ages 18 to 70 years, women only
Conditions the study is for: Solid Tumor
What is being tested?: Olaparib
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: No sites listed yet
Study dates: 1 Sep 2026to 1 Sep 2031
Phase: Phase 2
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

1. Age 18-70 years old, female; 2. Histologically confirmed recurrent and metastatic TNBC patients without BRCA1/2 mutation and BRCA1 promoter methylation.
Note: Triple-negative breast cancer is defined as estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor (HER2) negative. ER and PR negative were defined as: ER<1% positive, PR<1% positive. HER2 negativity was defined as: HER2 (-) or (1+) or HER2 (2+) FISH negative by immunohistochemistry.
3. The number of treatment lines at the stage of recurrence and metastasis should not exceed 2 lines.
4. According to RECIST1.1 criteria, there is at least one evaluable lesion; 5. ECOG physical condition score ≤ 1 point; 6. Expected survival period ≥ 3 months;

Who cannot join

1. Pregnant, breastfeeding women, or those who are fertile and unwilling to take effective contraceptive measures; 2. Patients who have received chemotherapy, radiotherapy, targeted therapy and other anti-tumor treatments within 4 weeks before enrollment; 3. Previous use of PARP inhibitors, including olaparib and other PARP inhibitors; 4. Known serious cardiovascular disease, myocardial infarction, or arterial thrombosis, or unstable angina pectoris, or known heart failure in the past 6 months, QT interval>450ms; 5. The toxicity of the previous treatment regimen has not recovered before enrollment, and there are still toxic reactions of grade 1 or above (except for alopecia); 6. Clinically obvious gastrointestinal abnormalities that may affect the intake, transport or absorption of drugs (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.) or patients with total gastrectomy; 7. Patients with known or suspected brain metastases, including central nervous system and spinal cord compression or meningeal metastases; 8. History of severe central nervous system disease (including epilepsy patients); 9. In the past 5 years, suffering from a second primary malignant tumor other than breast cancer and receiving related treatment; 10. Known congenital or acquired immunodeficiency, active hepatitis, active tuberculosis and other active infections; 11. Patients who are allergic to this test drug or similar drugs; 12. Those who have participated in clinical trials of other drugs within 28 days before screening, or plan to participate in any other clinical trials during this study; 13. Any other disease or condition of clinical significance (such as active or uncontrolled infection, etc.) that the investigator believes may affect compliance with the protocol or affect the patient's signing of ICF

About this study

Official title: An Open-label, Single-arm, Single-center Exploratory Clinical Study of Olaparib in the Treatment of BRCA1/2 Unmutated and BRCA1 Promoter Methylated Recurrent and Metastatic Triple-negative Breast Cancer

This is an open-label, single-arm, single-center,exploratory clinical study.

Read the detailed description

This is an open-label, single-arm, single-center,exploratory clinical study initiated by the investigator to evaluate the efficacy of olaparib in recurrent and metastatic TNBC without BRCA1/2 mutation and methylated BRCA1 promoter.

Conditions: Solid Tumor
Being tested: Olaparib

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OlaparibDrug
All subjects enrolled will receive olaparib.Subjects continued to take medication until disease progression, unacceptable toxicity, withdrawal of informed consent, or discontinuation of medication at the discretion of the investigator.

Study groups in NCT05522491
Study group	Role	What they receive
Olapalib	Experimental	Olaparib Oral 300mg 2/day; 4 weeks (28 days) as a treatment cycle. Receives: Drug: Olaparib

What is being measured

The primary outcome is the main question the study is designed to answer.

ORR ORR
Objective response rate
Measured: 24 month

Secondary outcomes (1)

PFS
Progression-free survival
Measured: 24 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 20261 Sep 2031

First posted31 Aug 2022
Study start1 Sep 2026 (estimated)
Primary completion1 Sep 2030 (estimated)
Study completion1 Sep 2031 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Solid TumorStudies of the same condition, open and under way.
More trials run by Hebei Medical University Fourth HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 30 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05522491
Sponsor's protocol ID: 2021157
Status last verified: Aug 2025
First submitted: 28 Aug 2022
Last updated: 11 Dec 2025
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm

All Solid Tumor trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Single-arm, Single-center Exploratory Clinical Study of Olaparib in the Treatment of BRCA1/2 Unmutated and BRCA1 Promoter Methylated Recurrent and Metastatic Triple-negative Breast Cancer
ClinicalTrials.gov ID: NCT05522491
Acronym / sponsor ID: 2021157
Conditions: Solid Tumor
Phase: Phase 2
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 30 participants (estimated)
Lead sponsor: Hebei Medical University Fourth HospitalUniversity, hospital or other
Study start: 1 Sep 2026 (estimated)
Primary completion: 1 Sep 2030 (estimated)
Study completion: 1 Sep 2031 (estimated)
First posted: 31 Aug 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This is an open-label, single-arm, single-center,exploratory clinical study.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Olapalib	Experimental	Drug: OlaparibOlaparib Oral 300mg 2/day; 4 weeks (28 days) as a treatment cycle.

Who may qualify

Ages: 18 to 70 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

1. Age 18-70 years old, female; 2. Histologically confirmed recurrent and metastatic TNBC patients without BRCA1/2 mutation and BRCA1 promoter methylation.
Note: Triple-negative breast cancer is defined as estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor (HER2) negative. ER and PR negative were defined as: ER<1% positive, PR<1% positive. HER2 negativity was defined as: HER2 (-) or (1+) or HER2 (2+) FISH negative by immunohistochemistry.
3. The number of treatment lines at the stage of recurrence and metastasis should not exceed 2 lines.
4. According to RECIST1.1 criteria, there is at least one evaluable lesion; 5. ECOG physical condition score ≤ 1 point; 6. Expected survival period ≥ 3 months;

Key exclusion criteria (1 listed)

1. Pregnant, breastfeeding women, or those who are fertile and unwilling to take effective contraceptive measures; 2. Patients who have received chemotherapy, radiotherapy, targeted therapy and other anti-tumor treatments within 4 weeks before enrollment; 3. Previous use of PARP inhibitors, including olaparib and other PARP inhibitors; 4. Known serious cardiovascular disease, myocardial infarction, or arterial thrombosis, or unstable angina pectoris, or known heart failure in the past 6 months, QT interval>450ms; 5. The toxicity of the previous treatment regimen has not recovered before enrollment, and there are still toxic reactions of grade 1 or above (except for alopecia); 6. Clinically obvious gastrointestinal abnormalities that may affect the intake, transport or absorption of drugs (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.) or patients with total gastrectomy; 7. Patients with known or suspected brain metastases, including central nervous system and spinal cord compression or meningeal metastases; 8. History of severe central nervous system disease (including epilepsy patients); 9. In the past 5 years, suffering from a second primary malignant tumor other than breast cancer and receiving related treatment; 10. Known congenital or acquired immunodeficiency, active hepatitis, active tuberculosis and other active infections; 11. Patients who are allergic to this test drug or similar drugs; 12. Those who have participated in clinical trials of other drugs within 28 days before screening, or plan to participate in any other clinical trials during this study; 13. Any other disease or condition of clinical significance (such as active or uncontrolled infection, etc.) that the investigator believes may affect compliance with the protocol or affect the patient's signing of ICF

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
OlaparibAll subjects enrolled will receive olaparib.Subjects continued to take medication until disease progression, unacceptable toxicity, withdrawal of informed consent, or discontinuation of medication at the discretion of the investigator.	Drug	Olapalib

Primary outcome

ORR ORR
Time frame: 24 month
Objective response rate

1 secondary outcome

PFS
Time frame: 24 month

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
Individual participant dataSharing planned: No

Related trials for Solid Tumor

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Olaparib in people with Solid Tumor, run by Hebei Medical University Fourth Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR ORR (time frame: 24 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05522491.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2025.