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Research & Clinical Trials > Study Search Tool > A Study in Advanced Breast Cancer Patients with BRCA 1/2 Mutations Evaluating Olaparib alone or in Combination with Atezolizumab

A Study in Advanced Breast Cancer Patients with BRCA 1/2 Mutations Evaluating Olaparib alone or in Combination with Atezolizumab

This study is open to:

Women or men who are have been diagnosed with Stage III/IV, unresectable locally advanced or metastatic, HER2-negative breast cancer with a known BRCA 1/2 mutation present, who 

  • Are at least 18 years of age
  • Have tumors determined to be accessible for biopsy and must be willing to have serial biopsies (with a third biopsy upon evidence of disease progression) 
This study is not open to:

Patients will be excluded if: 

  • they have received prior treatment with any PARP inhibitor or any anti-PD1/anti-PD-L1 antibody •
  • they do not have adequate tissue available for analysis 
  • their breast cancer is HER2-positive 
  • they have symptomatic central nervous system or brain metastasi
A Study in Advanced Breast Cancer Patients with BRCA 1/2 Mutations Evaluating Olaparib alone or in Combination with Atezolizumab

PARP Inhibitor Alone or Plus Immunotherapy for Advanced BRCA-Associated Breast Cancer

Clinicaltrials.gov identifier:
NCT02849496

Treatment:
Breast

Study Contact Information

For additional information, please contact: Jamison Langguth by phone at: 203-4647261 or by email.

About the Study 

This is a study for women or men who have been diagnosed with advanced breast cancer with a BRCA 1/2 mutation. The goal of this study is to look at whether giving the DNA damage repair inhibitor (PARP inhibitorolaparib (Lynparza) in combination with the immunotherapy atezolizumab (Tecentriq) improves outcomes for patients compared to olaparib alone.  

Type of Study 

This is a Phase 2, randomized, open-label, 2-arm study evaluating olaparib with or without atezolizumab in patients with a known BRCA1 or BRCA2 mutation who have been diagnosed with metastatic or locally advanced, HER2-negative breast cancer. Any number of prior therapies is allowed.   

  • This is a randomized study, which means that participants will be placed into one of the two treatment groups by chance. Neither patients nor the research doctor will choose the group participants are placed in. 
  • The study is open-label. All participating patients will receive the assigned study agent(s) and will know which group they will be assigned to.
  • The study has two arms. This means that patients in the study are placed in one of two different groups. 
    • Group 1 will receive the study drug olaparib by mouth, twice daily. Should any patient on Group 1 experience a worsening or progression of their cancer while on study, and if they remain eligible, they may choose to receive the combination therapy (crossover study).
    • Group 2 will receive both study drugs, olaparib and atezolizumab, in combination. Atezolizumab will be given by vein, once every 3 weeks at the treating center.   

What the Study Entails 

  • Patients will be randomized to one of the two arms and receive treatment according to the arm they are assigned to.  
  • For those assigned to atezolizumab, the IV dose of atezolizumab will be administered on Day 1 of each 21-day cycle until disease progression or treatment discontinuation for any other reason.
  • For both arms, the oral dose of olaparib will be continued twice daily until disease progression or treatment discontinuation for other reason.
  • In all subjects, tumor tissue will be obtained via image-guided core biopsy at study entry and 6 weeks after commencing treatment. If the cancer gets worse or progresses while on the study, a third biopsy will be required.
  • Patients will be treated according to their assigned arm until progressive disease. Patients in the olaparib-only arm (Group 1) who experience progression may be eligible to cross-over to the combination therapy arm. 
  • In order to participate, patients must undergo mandatory tumor core biopsies and mandatory whole blood samplings for biomarkers research and molecular (genetic) testing. 

Study Sites 

This study is open nationwide at several sites participating in the National Cancer Institute Experimental Therapeutics Clinical Trials Network (ETCTN). View a full list of sites here

  • ​Arizona
    • Phoenix: Mayo Clinic Hospital
      • Principal Investigator: Ciara O'Sullivan
      • Contact: 855-776-0015
    • Scottsdale: Mayo Clinic 
      •  Principal Investigator: Ciara O'Sullivan
      • Contact: 855-776-001
  • California
    • San Diego: UC San Diego Moores Cancer Center
      • Principal Investigator: Erin Roesch, MD 
      • Contact: 858-822-5354 or by email
    • Sacramento: UC Davis Comprehensive Cancer Center
      • Principal Investigator: Helen Chew, MD 
      • Contact: 916-734-3089
  • Colorado
    • Aurora: University of Colorado Hospital 
      • Principal Investigator: Anosheh Afghahi 
      • Contact: 720-848-0650
  • Connecticut
    • Derby: Smilow Cancer Hospital-Derby Care Center 
      • Principal Investigator: Patricia M. LoRusso, DO
      • Contact: 203-785-5702 or by email    
    • Fairfield: Smilow Cancer Hospital-Fairfield Care Center
      • Principal Investigator: Patricia M. LoRusso, DO
      • Contact: 203-785-5702 or by email  
    • Guilford: Yale - New Haven Shoreline Medical Center
      • Principal Investigator: Patricia M. LoRusso, DO
      • Contact: 203-785-5702 or by email    
    • Hartford: Smilow Cancer Hospital Care Center at Saint Francis
      • Principal Investigator: Patricia M. LoRusso, DO
      • Contact: 203-785-5702 or by email
    • New Haven: Smilow Cancer Center/Yale-New Haven Hospital
      • Principal Investigator: Patricia M. LoRusso, DO
      • Contact: 203-785-5702 or by email
    • Orange: Smilow Cancer Hospital-Orange Care Center
      • Principal Investigator: Patricia M. LoRusso, DO
      • Contact: 203-785-5702 or by email
    • Torrington: Smilow Cancer Hospital-Torrington Care Center
      • Principal Investigator: Patricia M. LoRusso, DO
      • Contact: 203-785-5702 or by email
    • Trumbull: Smilow Cancer Hospital Care Center-Trumbull
      • Principal Investigator: Patricia M. LoRusso, DO
      • Contact: 203-785-5702 or by email
    • Waterbury: Smilow Cancer Hospital Care Center-Waterbury
      • Principal Investigator: Patricia M. LoRusso, DO
      • Contact: 203-785-5702 or by email
  • Florida
    • Jacksonville: Mayo Clinic in Florida
      • Principal Investigator: Ciara C. O'Sullivan
      • Contact: 855-776-0015
    • Tampa: Moffitt Cancer Center
      • Principal Investigator: Hyo S. Han, MD
      • Contact:  800-456-7121 or by email 
  • Illinois
    • Chicago: University of Chicago Comprehensive Cancer Center
      • Principal Investigator: Rita Nanda, MD
      • Contact: 773-702-8222 or by email  
    • New Lenox: UC Comprehensive Cancer Center at Silver Cross
      • Principal Investigator: Rita Nanda, MD
      • Contact: 773-702-8222 or by email
    • Oakland Park: University of Chicago Medicine-Orland Park
      • Principal Investigator: Rita Nanda, MD
      • Contact: 773-702-8222 or by email
  • Kansas 
    • Fairway: University of Kansas Clinical Research Center
      • Principal Investigator: Qamar J. Khan, MD
      • Contact: 913-945-7552 or by email 
  •  Maryland
    • Baltimore: Johns Hopkins University/Sidney Kimmel Cancer Center 
      • Principal Investigator: Roisin M. Connolly, MD
      • Contact: 410-955-8804 or by email    
  • Massachusetts
    • Boston: Massachusetts General Hospital Cancer Center 
      • Principal Investigator: Gerburg M. Wulf
      • Contact: 877-726-5130
    • Boston: Brigham and Women's Hospital 
      • Principal Investigator: Gerburg M. Wulf
      • Contact: 888-823-5923 or by email 
    • Boston: Beth Israel Deaconess Medical Center Recruiting 
      • Principal Investigator: Gerburg M. Wulf
      • Contact: 617-667-9925
    • Boston: Dana-Farber Cancer Institute
      • Principal Investigator: Gerburg M. Wulf
      • Contact: 877-442-3324
  • Michigan
    • Detroit: Wayne State University/Karmanos Cancer Institute
      • Principal Investigator: Hadeel Assad
      • Contact: 313-576-9790 or by email 
    • Farmington Hills: Weisberg Cancer Treatment Center Recruiting
      • Principal Investigator: Hadeel Assad 
      • Contact: 313-576-9790 or by email      
  • Minnesota
    • Rochester: Mayo Clinic     
      • Principal Investigator: Ciara C. O'Sullivan
      • Contact: 855-776-0015         
  • Missouri
    • Creve Coeur: Siteman Cancer Center at West County Hospital
      • Principal Investigator: Haeseong Park
      • Contact: 800-600-3606 or by email   
    • Saint Louis: Washington University School of Medicine
      • Principal Investigator: Haeseong Park
      • Contact: 800-600-3606 or by email 
    • Saint Peters: Siteman Cancer Center at Saint Peters Hospital 
      • Contact: 800-600-3606 or by email      
  • Nebraska
    • Bellevue: Nebraska Medicine-Bellevue 
      • Principal Investigator: Pavankumar Tandra
      • Contact: 402-559-6941 or by email 
    • Omaha: Nebraska Medicine-Village Pointe
      • Principal Investigator: Pavankumar Tandra
      • Contact: 402-559-5600 
    • Omaha: University of Nebraska Medical Center
      • Principal Investigator: Pavankumar Tandra
      • Contact: 402-559-6941 or by email      
  • New York
    • Bronx: Montefiore Medical Center-Einstein Campus, Weiler Hospital and Moses Campus
      • Principal Investigator: Jesus D. Anampa Mesias
      • Contact: 718-379-6866 or by email   
    • New York: Columbia University/Herbert Irving Cancer Center
      • Principal Investigator: Meghna S. Trivedi, MD
      • Contact: 212-305-6361 or by email
  • ​​North Carolina
    • Chapel Hill: UNC Lineberger Comprehensive Cancer Center 
      • Principal Investigator: Elizabeth C. Dees, MD
      • Contact: 877-668-0683 or by email
    • Durham: Duke University Medical Center 
      • Principal Investigator: James L. Abbruzzese
      • Contact: 888-275-3853   
  • Ohio
    • Columbus: Ohio State University Comprehensive Cancer Center 
      • Principal Investigator: Anne M. Noonan, MD
      • Contact: 800-293-5066 or by email     
  • Pennsylvania
    • Pittsburgh: University of Pittsburgh Cancer Institute (UPCI)
      •  Principal Investigator: Adam M. Brufsky, MD
      • Contact: 412-647-8073      
  • Tennessee
    • Nashville: Vanderbilt University/Ingram Cancer Center
    • Principal Investigator: Vandana G. Abramson, MD
    • Contact: 800-811-8480      
  • Texas 
    • Dallas: UT Southwestern/Simmons Cancer Center-Dallas
      • Principal Investigator: Barbara Jean B. Haley, MD
      • Contact: 214-648-7097 or by email      
  • Utah 
    • Salt Lake City: Huntsman Cancer Institute/University of Utah
    • Principal Investigator: Norah L. Henry
    • Contact: 888-424-2100 or by email   

Study Lead Investigator

Patricia LoRusso, DO
Yale University Cancer Center
For additional information, please contact: Jamison Langguth by phone at: 203-4647261 or by email.      

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