18 and older, female only, with Advanced Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Overall Response Rate (ORR)Primary· Through study treatment, and average of 8 weeks
ORR is defined as the percentage of patients with a Complete Response (CR) or Partial Response (PR) out of the patients from the efficacy population. Per RECIST, CR is defined as the disappearance of all target lesions; PR is defined as an \>=30% decrease in the sum of the longest diameter of target lesions.
Tumor response will be assessed using Response Evaluation Criteria In Solid Tumors Criteria (RECIST 1.1). Efficacy population is a subset of the intend to treat population that has received at least one dose of study medication and has performed at least one tumor response assessment acco
Group
Value
95% CI
Olaparib
1
Clinical Benefit Rate (CBR)Secondary· Through study treatment, and average of 8 weeks
Tumor response was assessed using Response Evaluation Criteria In Solid Tumors Criteria (RECIST 1.1) criteria.
CBR was defined as the percentage of patients with a Complete Response (CR) or Partial Response (PR) plus stable disease (SD) ≥ 24 weeks out of the efficacy population. Per RECIST, CR is defined as the disappearance of all target lesions; PR is defined as an \>=30% decrease in the sum of the longest diameter of target lesions; SD is defined as a failure to meet criteria for CR or PR in the absence of progressive disease. Overall Response (OR) = CR + PR.
Efficacy population is a subs
Group
Value
95% CI
Olaparib
4
Response Duration (RD)Secondary· Through study treatment, up to 19 months
Tumor response was assessed using Response Evaluation Criteria In Solid Tumors Criteria (RECIST 1.1) criteria. RD was defined as the time from the first documentation of objective tumor response (complete response (CR) or partial response (PR)) to the first documented progressive disease (PD), or to death due to any cause, whichever occurs first.
Per RECIST, CR is defined as the disappearance of all target lesions; PR is defined as an \>=30% decrease in the sum of the longest diameter of target lesions; PD is defined as a 20% increase in the sum of the longest diameter of target lesions, or a
Group
Value
95% CI
Olaparib
18.4
Progression Free Survival (PFS)Secondary· Through study treatment, and average of 8 weeks
Tumor response was assessed using Response Evaluation Criteria In Solid Tumors Criteria (RECIST 1.1). PFS is defined as the time from enrollment to the first documented progression disease (PD), or death from any cause, whichever occurs first. PD is defined using RECIST, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Group
Value
95% CI
Olaparib
1.8
1.2 – 3.7
Overall Survival (OS)Secondary· Up to 14 months
Overall Survival (OS) defined as the time from the date of study enrollment to the date of death from any cause.
Group
Value
95% CI
Olaparib
8.9
1.2 – 13.7
The Number of Participants Who Experienced Adverse Events (AE) Related to Study TreatmentSecondary· Through study treatment, and average of 8 weeks
Safety assessments were performed at baseline and during the study: blood pressure, pulse, body temperature, performance status evaluation, 12-lead electrocardiogram, hemoglobin, red blod cells, platelet, mean cell volume, mean cell haemoglobin concentration, mean cell haemoglobin, white blood cells, absolute differential white cell count, absolute neutrophil count or segmented neutrophil count and band forms, activated partial thromboplastin time, international normalised ratio, sodium, potassium, calcium, magnesium, fasting glucose, creatinine, total bilirubin, gamma glutamyltransferase, alk
Group
Value
95% CI
Olaparib
8
Correlation Value Between BRCA1 Methylation Status and Efficacy Outcome DataSecondary· Through study treatment, and average of 8 weeks
To evaluate the effect of methylation status with efficacy rate parameters it will be used chi-square test if both of them are quantitative, and will be used an ANOVA analysis if one variable is quantitative and the other one is qualitative.
Patients with no Response: BRCA1 methylated
Group
Value
95% CI
Olaparib
5
Patients with no Response: BRCA1 no methylated
Group
Value
95% CI
Olaparib
2
Patients with Partial Response or Stable: BRCA1 methylated
Group
Value
95% CI
Olaparib
4
Patients with Partial Response or Stable: BRCA1 no methylated
Group
Value
95% CI
Olaparib
0
Correlation Value Between BRCA2 Methylation Status and Efficacy Outcome DataSecondary· Through study treatment, and average of 8 weeks
To evaluate the effect of methylation status with efficacy rate parameters it will be used chi-square test if both of them are quantitative, and will be used an ANOVA analysis if one variable is quantitative and the other one is qualitative.
Patients with Partial Response or Stable : BRCA2 methylated
Group
Value
95% CI
Olaparib
1
Patients with Partial Response or Stable : BRCA2 no methylated
Group
Value
95% CI
Olaparib
3
Patients with no Response : BRCA2 methylated
Group
Value
95% CI
Olaparib
3
Patients with no Response : BRCA2 no methylated
Group
Value
95% CI
Olaparib
4
Adverse events — posted to ClinicalTrials.gov
Time frame: AEs have been recorded through study treatment, an average of 8 weeks. Deaths were assessed up to 14 months..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This is a multicenter single-arm phase II clinical trial to evaluate the efficacy and safety of olaparib in patients diagnosed of advanced triple negative breast cancer (TNBC) with methylation of BRCA1 and/or BRCA2 promoters assessed in DNA from metastatic lesions and absence of BRCA1 and 2 germline mutations.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT05522491 — Olaparib in the Treatment of BRCA1/2 Unmutated and BRCA1 Promoter Methylated Recurrent and Metastatic Triple-negative Br
· Phase 2
· not yet recruiting
NCT05128734 — Temozolomide Monotherapy or in Combination With Olaparib in Patients With Triple Negative Breast Cancer (TNBC)
· Phase 2
· not yet recruiting
NCT07382544 — Phase 1b Trial of BMS-986504 in Combination With Olaparib in Patients With MTAP Loss
· Phase 1
· recruiting
NCT07407452 — Iparomlimab and Tuvonralimab (QL1706) Combined With Standard Chemotherapy or Combined With Intraperitoneal Perfusion Che
· Phase 2
· not yet recruiting
NCT06915025 — Phase 3 Trial Evaluating the Safety & Efficacy of IMNN-001 Administered in Combination w/ Standard NACT & Adjuvant Chemo
· Phase 3
· recruiting
Other recruiting trials for Advanced Breast Cancer
Currently open trials in the same condition.
NCT07408089 — Study of the Kinesin Oral Molecular Degrader BBI-940 in Subjects With Advanced or Metastatic Breast Cancer
· Phase 1
· recruiting
NCT07318805 — A Study to Learn About the Study Medicine Called PF-08032562 in People With Advanced or Metastatic Solid Tumors
· Phase 1
· recruiting
NCT07259226 — Optimal Methods to Characterize ADC Resistance in Solid Tumors and Identify Clinically Useful Biomarkers
· Phase 2
· recruiting
NCT06982521 — Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PI
· Phase 3
· recruiting
NCT07428655 — Acceptability and Feasibility of PSC Model of Serious Illness Communication
· NA
· active not recruiting
Other Spanish Breast Cancer Research Group trials
Trials by the same sponsor.
NCT07478939 — Study on the Level of Physical Activity in Patients Diagnosed With Breast Cancer in Spain
· completed
NCT05744375 — Trastuzumab Deruxtecan in First-line HER2-positive Locally Advanced/MBC Patients Resistant to Trastuzumab+Pertuzumab
· Phase 2
· terminated
NCT05583110 — Efficacy and Safety of the Combination of Trastuzumab Plus TUCAtinib Plus viNorelbine in Patients With HER2-positive Non
· Phase 2
· terminated
NCT04293393 — Neoadjuvant Study Chemotherapy vs Letrozole + Abemaciclib in HR+/HER2- High/Intermediate Risk Breast Cancer Patients
· Phase 2
· active not recruiting
NCT03800355 — Study on the Progress of Breast Cancer Cases in Males and the Assessment of Relapse Risk
· completed
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Spanish Breast Cancer Research Group
Last refreshed: 18 October 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03205761.