Kyoto Palbo : Neoadjuvant hormonal therapy plus Palbociclib in operable, hormone sensitive and HER2-negative primary breast cancer

Female<br/>OnlyGender Female
Only

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 comparing the effectiveness between using a targeted therapy (Palbociclib) in conjunction with endocrine therapy and endocrine therapy alone to treat patients with HR+, HER2 negative breast cancer .
 

This trial is treating patients with Breast Cancer.

This is a systemic therapy.

You may be able to join this trial if:

  • You are able to swallow medication by mouth.
  • You have been diagnosed with cancer, but have not received any treatment.
  • 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

Neoadjuvant hormonal therapy plus Palbociclib in operable, hormone sensitive and HER2-negative primary breast cancer

Cooperative Group

Kyoto Breast Cancer Research Network

Commercial Sponsor

Pfizer

Summary

Eligible patients who are pre- or peri-menopausal will receive 16 weeks of endocrine therapy in the form of either leuprorelin alone every 28 days or goserelin every 28 days with daily doses of tamoxifen. Eligible patients who are post-menopausal will receive 16 weeks of daily doses of Letrozole. All patients will receive either single doses of Palbocicib or placebo taken daily for the first 21 days of a 28-day cycle.

Recruiting Hospitals Read MoreRead more

Monash Health, Medical Oncology
Clayton
Breast and Gynaecology Research Study Coordinator
breastgynae.oncresearch@monashhealth.org
0491299561

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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