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

  • STATUS
    Not Recruiting
  • End date
    Sep 27, 2022
  • participants needed
    20
  • sponsor
    MedSIR
Updated on 5 April 2022
ct scan
platelet count
measurable disease
metastasis
liver metastasis
HER2
blood transfusion
trastuzumab
tamoxifen
olaparib
ovarian suppression
herceptin
urine test

Summary

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

Description

This open-label, multicenter, single arm, two cohorts, Simon's Two-Stage minimax design, phase II clinical trial will assess the efficacy of olaparib in combination with trastuzumab in patients with HER2-positive ABC with gene alterations in HRR DNA pathway. To be included in the cohort A of the study, patients must exhibit germinal deleterious mutations in BRCA1 or BRCA2 genes.

Eligible patients will have histologically proven diagnosis of adenocarcinoma of the breast with evidence of advanced disease, and at least one measurable disease as per RECIST v.1.1. Patients will have a documented history of progression on HER2-directed therapy for the treatment of HER2-positive breast cancer with not limits on prior therapies of chemotherapy and/or trastuzumab-lapatinib in advanced scenario, and at least one regimen of chemotherapy including trastuzumab.

The accrual goal will be a total of 20 patients

Details
Condition Advanced Breast Cancer
Treatment Olaparib [Lynparza®] plus Trastuzumab [Herceptin®]
Clinical Study IdentifierNCT03931551
SponsorMedSIR
Last Modified on5 April 2022

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note