Study of Neoadjuvant Olaparib Monotherapy and Olaparib and Durvalumab Combination in HER2 Negative BRCAm Breast Cancer (NCT05498155)
A Phase II, Multicentre, Open-Label Study to Assess the Efficacy and Safety of Olaparib Monotherapy and Olaparib Plus Durvalumab Combination as Neoadjuvant Therapy in Patients With BRCA Mutations and Early Stage HER2-Negative Breast Cancer
🩺 Plain-English Summary (8th-Grade Level)
This study to learn more about olaparib and olaparib plus durvalumab combination therapy and also to better understand the studied disease, breast cancer, and associated health problems. Olaparib is a type of drug called a PARP (poly \[adenosine diphosphate-ribose\] polymerase) inhibitor. PARP inhibitors can destroy cancer cells that are not good at repairing DNA damage. Olaparib is also approved by US Food and Drug Administration (FDA), European Medicines Agency (EMA) and in other countries for treating women with BRCA-mutated, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer. Durvalumab is a type of anticancer drug called immunotherapy that targets cancer cells by blocking the signal that prevents the immune system from seeing the cancer cell. Your immune system can then attack and kill the cancer cells. Durvalumab is approved by the FDA and the EMA for the treatment of patients with locally advanced non-small cell lung cancer after receiving chemoradiation therapy and extensive-stage small cell lung cancer in combination with chemotherapy . Some parts of this study are experimental, which means that durvalumab and the combination of olaparib and durvalumab are still in the development stage for the treatment of breast cancer, and they are not approved for treatment of breast cancer, except for use in research studies like this.
Who can join: Review the eligibility criteria below.
Location: Research Site — Greeley, Colorado
Age range: 18 Years to 130 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (37 Sites)
Showing the first 25 of 37 sites.
- Research Site — Greeley, Colorado
- Research Site — Loveland, Colorado
- Research Site — Boston, Massachusetts
- Research Site — Portland, Oregon
- Research Site — Philadelphia, Pennsylvania
- Research Site — Melbourne,
- Research Site — Rankweil,
- Research Site — Salzburg,
- Research Site — Brussels,
- Research Site — Liège,
- Research Site — Augsburg, by,
- Research Site — Cologne,
- Research Site — Essen,
- Research Site — Hamburg,
- Research Site — Hanover,
- Research Site — Heidelberg,
- Research Site — München,
- Research Site — Jerusalem,
- Research Site — Kfar Saba,
- Research Site — Ramat Gan,
- Research Site — Rehovot,
- Research Site — Bologna,
- Research Site — Meldola,
- Research Site — Modena,
- Research Site — Roma,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Breast Cancer
- S0221 Adjuvant Doxorubicin, Cyclophosphamide, and Paclitaxel in Treating Patients With Breast Cancer — Anniston, Alabama
- [177Lu]Lu-NeoB in Combination With Ribociclib and Fulvestrant in Participants With ER+, HER2- and GRPR+ Advanced Breast Cancer — Los Angeles, California
- Evaluation And Risk Assessment For Persistent Postsurgical Pain After Breast Surgery — Durham, North Carolina
- TACTIVE-U: A Study to Learn About the Study Medicine (Vepdegestrant) When Given With Other Medicines in People With Advanced or Metastatic Breast Cancer (Sub-Study B) — Palo Alto, California
- A Multi Modality Surveillance Program for Women At High Risk for Breast Cancer — Chicago, Illinois
- ATOP TRIAL: T-DM1 in HER2 Positive Breast Cancer — Duarte, California
Explore by condition: All Breast Cancer clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.