NCT03584009 : A Phase II, Multicenter, Randomized Study To Compare The Efficacy Of Venetoclax Plus Fulvestrant Versus Fulvestrant In Women With Estrogen Receptor-Positive, Her2-Negative Locally Advanced Or Metastatic Breast Cancer Who Experienced Disease Recurrence Or Progression During Or After CDK4/6 Inhibitor Therapy

Female<br/>OnlyGender Female
Only

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

TwoPhase Two

18+Age Over 18

Breast<br/>CancersCancer LocationBreast
Cancers

Systemic therapy | BreastBreast

Trial Overview Read MoreRead more

This phase II trial is trying to determine whether it is more effective to give a type of hormonal treatment (Fulvestrant) alone or in combination with an oral chemotherapy drug (Venetoclax) in the treatment of ER+, HER2 negative locally advanced or metastatic breast cancer that has come back or gotten worse after treatment.
 

This trial is treating patients with breast cancer (ER+, HER2 negative).

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.
  • You have had treatment, but your cancer has come back.
  • 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

A Phase II, Multicenter, Randomized Study To Compare The Efficacy Of Venetoclax Plus Fulvestrant Versus Fulvestrant In Women With Estrogen Receptor-Positive, Her2-Negative Locally Advanced Or Metastatic Breast Cancer Who Experienced Disease Recurrence Or Progression During Or After CDK4/6 Inhibitor Therapy

Commercial Sponsor

Hoffmann-La Roche

Summary

Participants in this study will be randomised into one of two treatment arms. Participants in the venetoclax arm will receive venetoclax, taken orally and fulvestrant administered as IM injections until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined end of the study (2 years after the last patient is enrolled) which ever occur first. Participants will in the fulvestrant arm will receive fulvestrant via IM (intramuscular) injections. No crossover to the venetoclax arm is permitted. Study treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined end of the study (2 years after the last patient is enrolled) which ever occur first.

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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