Clinical trials are an important way to improve treatment for people with cancer. While most are continuing during the COVID-19 pandemic, the period of time that clinical trials are available and recruiting may change quickly. If you would like to get involved in a clinical trial, speak to your treatment team or the health service where the clinical trial is being undertaken, to confirm it is open and appropriate for you. For cancer information and support, call Cancer Council's experienced cancer nurses on 13 11 20 Monday to Friday from 9am-5pm.

Astefania : A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Adjuvant Atezolizumab or Placebo and Trastuzumab Emtansine for HER2-Positive Breast Cancer at High Risk of Recurrence Following Preoperative Therapy

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

ThreePhase Three

18+Age Over 18

Breast<br/>CancersCancer LocationBreast
Cancers

Systemic therapy | BreastBreast

Trial Overview Read MoreRead more

This Phase III trial is evaluating how safe and effective immunotherapy (Atezolizumab) is compared with a placebo, when combined with targeted therapy (Trastuzumab Emtansine) in people with HER2-positive breast cancer.
 

This trial is treating patients with HER2-positive breast cancer.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You have had a certain type of treatment or surgical procedure.

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.

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

A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Adjuvant Atezolizumab or Placebo and Trastuzumab Emtansine for HER2-Positive Breast Cancer at High Risk of Recurrence Following Preoperative Therapy

Commercial Sponsor

Hoffmann-La Roche

Summary

This is a randomised, double-blind trial for people with HER2-positive primary breast cancer who have received preoperative chemotherapy and HER2-directed therapy, followed by surgery, with a finding of residual invasive disease in the breast and/or axillary lymph nodes. There is one Active Comparator Arm and one Experimental Arm. Participants in the Active Comparator arm will receive Placebo + Trastuzumab Emtansine. The placebo will be administered via intravenous (IV) infusion at a dose of 1200mg Q3W for 14 cycles. Participants will then receive Trastuzumab Emtansine (vi IV infusion) at a dose of 3.6 mg/kg for 14 weeks. Participants in the Experimental Arm will receive Atezolizumab + Trastuzumab Emtansine. Atezolizumab will be administered via IV infusion at a dose of 1200mg Q3W for 14 weeks. Participants will then receive Trastuzumab Emtansine (via IV infusion) at a dose of 3.6 mg/kg Q3W for 14 weeks. For both cohorts, Trastuzumab will be used to complete 14 cycles of study treatment if trastuzumab emtansine is discontinued for toxicity not considered to be related to the trastuzumab component of the drug.

Recruiting Hospitals Read MoreRead more

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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