The EMBRACE study : Phase II clinical trial of the PARP inhibitor, olaparib, in HR-deficient metastatic breast and relapsed ovarian cancer in patients without germline mutations in BRCA1 and BRCA2

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

TwoPhase Two

18+Age Over 18

Advanced CancersCancer LocationMulti-Cancer
Trial

Systemic therapy | Breast,Female reproductive organsBreast,Ovary

Trial Overview Read MoreRead more

This Phase II trial is evaluating an oral drug (Olaparib) in the treatment of HR-deficient metastatic breast cancer and relapsed ovarian cancer without BRCA1 and BRCA2 mutations.
 

This trial is treating patients with triple negative breast or ovarian cancers that don't have the BRCA1 or BRCA2 mutation.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • Your cancer has spread to other parts of the body.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific Title

Phase II clinical trial of the PARP inhibitor, olaparib, in HR-deficient metastatic breast and relapsed ovarian cancer in patients without germline mutations in BRCA1 and BRCA2

Cooperative Group

Australia New Zealand Gynaecological Oncology Group (ANZGOG)

Other Non-Commercial Sponsor

Cancer Australia

Summary

Olaparib is the study intervention in this trial. Olaparib (LynparzaTM) is a poly(ADP-ribose) polymerase (PARP) inhibitor. The inactive ingredients are copovidone, colloidal silicon dioxide, mannitol, sodium stearyl fumarate, hydroxypropyl methylcellulose (hypromellose), macrogol 400 (polyethylene glycol 400), titanium dioxide, iron oxide yellow and iron oxide black. It is provided as tablets each containing 100mg or 150mg olaparib for oral administration. administered as 300 mg orally twice daily until disease progression or unacceptable toxicity. Each bottle contains 32 tablets. Patients will be asked to return unused drug and empty drug containers at each return visit for adherence. Olaparib should be commenced within 7 days after registration and will be continued until disease progression or unacceptable toxicity.

Recruiting Hospitals Read MoreRead more

Border Medical Oncology
Albury
Ms Nyree Sarakis
Nsarkis@bordermedonc.com.au
02 6064 1493

PCCTU (Parkville Cancer Clinical Trials Unit) *
Parkville
Enquiries Line Coordinator
clinicaltrials.enquiries@petermac.org
03 8559 7456 (9am-2pm, Mon-Fri)

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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