GDC-9545 in postmenopausal women with ER+ breast cancer - Clinical trial • Breast Cancer Foundation NZ

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GDC-9545 in postmenopausal women with ER+ breast cancer

Early Breast Cancer clinical trials for ER+

Recruiting
Updated: July 6, 2020

This study will evaluate the pharmacodynamics, pharmacokinetics, safety, and biologic activity of GDC-9545 in participants with Stage I-III operable ER+, HER2- untreated breast cancer.

This study will evaluate the pharmacodynamics, pharmacokinetics, safety, and biologic activity of GDC-9545 in participants with Stage I-III operable ER+, HER2- untreated breast cancer.

Who is it for?

You may be eligible for this study if you meet the below criteria:

  • Ability to comply with the study protocol, in the investigator's judgment.
  • Histologically confirmed invasive breast carcinoma, with all of the following characteristics: Primary tumor greater than or equal to (≥)1.5 centimeters (cm) in largest diameter by ultrasound; Stage I-III operable breast cancer; Documentation confirming the absence of distant metastasis (M0) as determined by institutional practice.
  • ER-positive tumor and HER2-negative breast cancer as per local laboratory testing.
  • Postmenopausal status.
  • Breast cancer eligible for primary surgery.
  • Submission of a representative tumor tissue specimen.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to (≤)1.
  • Adequate organ function.

Study details

Participants will receive varying dosages of GDC-9545 once daily, starting on Day 1 up to and including the day of surgery (if allowed per local process) on Day 15.

For full trial information

Australia

St Vincent's Hospital Sydney, Darlinghurst
Peter MacCallum Cancer Centre, Melbourne
Fiona Stanley Hospital, Murdoch

If you think you might be a candidate for this trial, use the contact details supplied, or talk to your doctor.

Want to access a trial that's not in your area? It's not always possible, but if you're interested, email us at intouch@bcf.org.nz

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