KEYNOTE-756 : A Randomized, Double-Blind, Phase III Study of Pembrolizumab Versus Placebo in Combination With Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy for the Treatment of High-Risk Early-Stage Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2-) Breast Cancer

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 an immunotherapy in combination with pre-treatment (neoadjuvant) chemotherapy and post-treatment (adjuvant) hormone therapy for the treatment of ER+/HER2- breast cancer.
 

This trial is treating patients with ER+/HER2- breast cancer.

This is a systemic therapy trial.

You may be able to join this trial if:

  • Your cancer has not 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

A Randomized, Double-Blind, Phase III Study of Pembrolizumab Versus Placebo in Combination With Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy for the Treatment of High-Risk Early-Stage Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2-) Breast Cancer

Commercial Sponsor

Merck

Summary

This is a randomised trial, in which patients will receive either pembrolizumab or a placebo via intravenous (IV) infusion once every 3 weeks (Q3W) + paclitaxel (X) 80 mg/m^2 via IV infusion once weekly (QW) for 4 cycles (Treatment 1). This will be followed by followed by pembrolizumab or placebo via IV infusion + doxorubicin or epirubicin (A or E; 60 mg/m^2 or 100 mg/m^2) via IV infusion Q3W + cyclophosphamide (C) 600 mg/m^2 via IV infusion Q3W for 4 cycles (Treatment 2). At 3 to 6 weeks after last cycle of neoadjuvant treatment, participants will undergo definitive surgery for their breast cancer. After surgery, participants will begin adjuvant study treatment. In the adjuvant setting, participants receive pembrolizumab or placebo via IV infusion Q3W for 9 cycles + variable endocrine therapy for up to 10 years. Each cycle is 21 days long.

Recruiting Hospitals Read MoreRead more

PCCTU (Parkville Cancer Clinical Trials Unit) *
Parkville
Ms Marian Lieschke
marian.lieschke@petermac.org
03 8559 7140

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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