NCT03598257

Radiation Therapy With or Without Olaparib in Treating Patients With Inflammatory Breast Cancer

Active, enrolled Phase 2 Last updated 13 April 2026

What this trial tests

Phase 2 trial testing Biospecimen Collection in Breast Inflammatory Carcinoma in 300 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

18 January 2019

Primary endpoint
1 June 2027

1 June 2027

Quick facts

Lead sponsor	National Cancer Institute (NCI)
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	300
Start date	18 January 2019
Primary completion	1 June 2027
Estimated completion	1 June 2027
Sites	220 locations across Canada, United States, Puerto Rico

Drugs / interventions tested

• Biospecimen Collection — full drug profile →
• Olaparib (olaparib) — full drug profile →
• Radiation Therapy — full drug profile →
• Survey Administration

Conditions studied

• Breast Inflammatory Carcinoma — all drugs for Breast Inflammatory Carcinoma →

Sponsor

National Cancer Institute (NCI)

Who can join

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

Sponsor's own description

This phase II trial studies how well radiation therapy with or without olaparib works in treating patients with inflammatory breast cancer. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Olaparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep cancer cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. It is not yet known whether radiation therapy with or without olaparib may work better in treating patients with inflammatory breast cancer.

Publications & conference data

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

1. Targeting DNA repair pathway in cancer: Mechanisms and clinical application.
   Wang M, Chen S, Ao D. · · 2021 · cited 84× · PMID 34977872 · DOI 10.1002/mco2.103
2. PARP1 Inhibition Radiosensitizes Models of Inflammatory Breast Cancer to Ionizing Radiation.
   Michmerhuizen AR, Pesch AM, Moubadder L, Chandler BC, et al · · 2019 · cited 43× · PMID 31413177 · DOI 10.1158/1535-7163.mct-19-0520
3. Optimizing Radiation Therapy to Boost Systemic Immune Responses in Breast Cancer: A Critical Review for Breast Radiation Oncologists.
   Ho AY, Wright JL, Blitzblau RC, Mutter RW, et al · · 2020 · cited 32× · PMID 32417409 · DOI 10.1016/j.ijrobp.2020.05.011
4. Update on systemic treatment for newly diagnosed inflammatory breast cancer.
   Chainitikun S, Saleem S, Lim B, Valero V, et al · · 2021 · cited 31× · PMID 33842000 · DOI 10.1016/j.jare.2020.08.014
5. NOTCH and DNA repair pathways are more frequently targeted by genomic alterations in inflammatory than in non-inflammatory breast cancers.
   Bertucci F, Rypens C, Finetti P, Guille A, et al · · 2020 · cited 31× · PMID 31854063 · DOI 10.1002/1878-0261.12621
6. Enhancing anti-tumour innate immunity by targeting the DNA damage response and pattern recognition receptors in combination with radiotherapy.
   Chan Wah Hak CML, Rullan A, Patin EC, Pedersen M, et al · · 2022 · cited 27× · PMID 36106115 · DOI 10.3389/fonc.2022.971959
7. PARP Inhibitors in the Treatment of Early Breast Cancer: The Step Beyond?
   Gonçalves A, Bertucci A, Bertucci F. · · 2020 · cited 26× · PMID 32471249 · DOI 10.3390/cancers12061378
8. Clinical and Preclinical Outcomes of Combining Targeted Therapy With Radiotherapy.
   Elbanna M, Chowdhury NN, Rhome R, Fishel ML. · · 2021 · cited 25× · PMID 34733787 · DOI 10.3389/fonc.2021.749496