NCT03544125

Olaparib and Durvalumab in Treating Participants With Metastatic Triple Negative Breast Cancer

Completed Phase 1 Last updated 20 November 2020

What this trial tests

Phase 1 trial testing Durvalumab in Anatomic Stage IV Breast Cancer AJCC v8 in 3 participants. Completed in 18 November 2020.

Timeline

3 May 2018

Primary endpoint
7 August 2018

18 November 2020

Quick facts

Lead sponsor	OHSU Knight Cancer Institute
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	3
Start date	3 May 2018
Primary completion	7 August 2018
Estimated completion	18 November 2020
Sites	1 location across United States

Drugs / interventions tested

• Durvalumab — full drug profile →
• Olaparib (olaparib) — full drug profile →

Conditions studied

• Anatomic Stage IV Breast Cancer AJCC v8 — all drugs for Anatomic Stage IV Breast Cancer AJCC v8 →
• Estrogen Receptor Negative — all drugs for Estrogen Receptor Negative →
• HER2/Neu Negative — all drugs for HER2/Neu Negative →
• Progesterone Receptor Negative — all drugs for Progesterone Receptor Negative →

Sponsor

OHSU Knight Cancer Institute

Who can join

18 and older, any sex, with Anatomic Stage IV Breast Cancer AJCC v8 or Estrogen Receptor Negative. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This pilot phase I trial studies whether it is feasible to conduct a detailed molecular profile of triple negative breast cancer as part of a treatment strategy that asks whether or not we can lower the chance of breast cancer growing or spreading, by treating with a combination of PARP inhibitor how well (olaparib) and immune therapy (durvalumab). Olaparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving olaparib and durvalumab may work better in treating participants with metastatic triple negative breast cancer.

Publications & conference data

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

1. Alterations of DNA damage response pathway: Biomarker and therapeutic strategy for cancer immunotherapy.
   Jiang M, Jia K, Wang L, Li W, et al · · 2021 · cited 236× · PMID 34729299 · DOI 10.1016/j.apsb.2021.01.003
2. Recent advances in targeted strategies for triple-negative breast cancer.
   Zhu S, Wu Y, Song B, Yi M, et al · · 2023 · cited 200× · PMID 37641116 · DOI 10.1186/s13045-023-01497-3
3. Advances in immunotherapy for triple-negative breast cancer.
   Liu Y, Hu Y, Xue J, Li J, et al · · 2023 · cited 198× · PMID 37660039 · DOI 10.1186/s12943-023-01850-7
4. Racial Disparity and Triple-Negative Breast Cancer in African-American Women: A Multifaceted Affair between Obesity, Biology, and Socioeconomic Determinants.
   Siddharth S, Sharma D. · · 2018 · cited 170× · PMID 30558195 · DOI 10.3390/cancers10120514
5. Triple-Negative Breast Cancer: Current Understanding and Future Therapeutic Breakthrough Targeting Cancer Stemness.
   Lee KL, Kuo YC, Ho YS, Huang YH. · · 2019 · cited 164× · PMID 31505803 · DOI 10.3390/cancers11091334
6. Combined PARP Inhibition and Immune Checkpoint Therapy in Solid Tumors.
   Peyraud F, Italiano A. · · 2020 · cited 163× · PMID 32526888 · DOI 10.3390/cancers12061502
7. Therapeutic Potential of Combining PARP Inhibitor and Immunotherapy in Solid Tumors.
   Vikas P, Borcherding N, Chennamadhavuni A, Garje R. · · 2020 · cited 130× · PMID 32457830 · DOI 10.3389/fonc.2020.00570
8. Targeting PD-1/PD-L1 in cancer immunotherapy: An effective strategy for treatment of triple-negative breast cancer (TNBC) patients.
   Kumar S, Chatterjee M, Ghosh P, Ganguly KK, et al · · 2023 · cited 72× · PMID 37397537 · DOI 10.1016/j.gendis.2022.07.024