NCT03931551 (OPHELIA) is a Phase 2 clinical trial of Olaparib [Lynparza®] plus Trastuzumab [Herceptin®] in Advanced Breast Cancer, sponsored by MedSIR.

Who is sponsoring NCT03931551?

NCT03931551 is sponsored by MedSIR.

What drugs are being tested in NCT03931551?

Interventions in NCT03931551: Olaparib [Lynparza®] plus Trastuzumab [Herceptin®].

What condition does NCT03931551 study?

NCT03931551 studies Advanced Breast Cancer.

Is NCT03931551 still recruiting?

NCT03931551 is currently terminated. Last updated 22 February 2023.

Last reviewed 2023-02-22 · How we verify

NCT03931551: OPHELIA

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Olaparib+Trastuzumab in HER2[+],Breast Cancer Susceptibility Gene (BRCA) Mutated Advanced Breast Cancer

Terminated Phase 2 Last updated 22 February 2023

What this trial tests

Phase 2 trial testing Olaparib [Lynparza®] plus Trastuzumab [Herceptin®] in Advanced Breast Cancer in 5 participants. Terminated before completion.

Timeline

30 April 2019

Primary endpoint
2 March 2022

2 March 2022

Quick facts

Lead sponsor	MedSIR
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	5
Start date	30 April 2019
Primary completion	2 March 2022
Estimated completion	2 March 2022
Sites	4 locations across Spain

Drugs / interventions tested

Olaparib [Lynparza®] plus Trastuzumab [Herceptin®] — full drug profile →

Conditions studied

Advanced Breast Cancer — all drugs for Advanced Breast Cancer →

Sponsor

MedSIR — full company profile →

Who can join

18 and older, any sex, with Advanced Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a multicenter, open-label, single-arm, phase II clinical trial, phase II trial will evaluate the efficacy and safety of olaparib plus trastuzumab in patients with HER2\[+\], BRCA-mutated advanced breast cancer

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

An Overview of PARP Inhibitors for the Treatment of Breast Cancer.
Cortesi L, Rugo HS, Jackisch C. · · 2021 · cited 263× · PMID 33710534 · DOI 10.1007/s11523-021-00796-4
BRCA1 and Breast Cancer: Molecular Mechanisms and Therapeutic Strategies.
Fu X, Tan W, Song Q, Pei H, et al · · 2022 · cited 77× · PMID 35300412 · DOI 10.3389/fcell.2022.813457
Characterization of the HER2 status in BRCA-mutated breast cancer: a single institutional series and systematic review with pooled analysis.
Tomasello G, Gambini D, Petrelli F, Azzollini J, et al · · 2022 · cited 17× · PMID 35810556 · DOI 10.1016/j.esmoop.2022.100531
Beyond PARP Inhibitors in Advanced Breast Cancer Patients with Germline <i>BRCA1/2</i> Mutations: Focus on CDK4/6-Inhibitors and Data Review on Other Biological Therapies.
Nerone M, Rossi L, Condorelli R, Ratti V, et al · · 2023 · cited 5× · PMID 37444415 · DOI 10.3390/cancers15133305
Perspectives on PARP inhibitors as pharmacotherapeutic strategies for breast cancer.
Oh SY, Rahman S, Sparano JA. · · 2021 · cited 4× · PMID 33646064 · DOI 10.1080/14656566.2021.1876662
Real-world data in patients with <i>BRCA</i> mutated breast cancer treated with poly (ADP-ribose) polymerase inhibitors.
Beas-Lozano EL, Verduzco-Aguirre HC, Gonzalez-Salazar R, Chavarri-Guerra Y. · · 2023 · cited 2× · PMID 38414963 · DOI 10.3332/ecancer.2023.1633
Multi-task learning for predicting synergistic drug combinations based on auto-encoding multi-relational graphs.
Shan W, Shen C, Luo L, Ding P. · · 2023 · cited 2× · PMID 37854693 · DOI 10.1016/j.isci.2023.108020
Real-World Evidence on Prescribing Patterns and Clinical Outcomes of Metastatic Breast Cancer Patients Treated with PARP Inhibitors: The Mayo Clinic Experience.
Jahan N, Taraba J, Boddicker NJ, Giridhar KV, et al · · 2025 · cited 1× · PMID 39516069 · DOI 10.1016/j.clbc.2024.10.006

Verify or expand the search:

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 MedSIR trials

Trials by the same sponsor.

NCT07494448 — Phase Ib/II Study of Zanidatamab Plus Tucatinib and Chemotherapy in HER2-Positive Advanced Breast Cancer · Phase 1, PHASE2 · not yet recruiting
NCT07178938 — Platform Trial Assessing Uptake, Safety and Efficacy of Theranostic Agents in Solid Tumors With Active Brain Metastases · Phase 2 · not yet recruiting
NCT05708235 — A PoC Study to Evaluate Treatments' Efficacy by Monitoring MRD Using ctDNA in HR-positive/HER2-negative EBC Population · Phase 2 · recruiting
NCT05659563 — Preoperative Window Opportunity Study With Giredestrant or Tamoxifen in Premenopausal Women With ER+/HER2[-] & Ki67≥10% · Phase 2 · completed
NCT05520723 — Preventive stRategy for IMMU132-relatED AEs in TNBC or Luminal Breast Cancer- PRIMED · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03931551 (US National Library of Medicine, public domain)
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 MedSIR
Last refreshed: 22 February 2023

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/NCT03931551.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing