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Study to Compare the Effects of AZD9496 vs Fulvestrant in Breast Cancer.

NCT03236974 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2020-02-06

No results posted yet for this study

Summary

This is an open label randomised multicentre pre-surgical pharmacodynamics study to compare and assess the biological effects of AZD9496 and fulvestrant in postmenopausal women with estrogen receptor (ER) positive (ER+), human epidermal growth factor receptor 2 (HER-2) negative (HER2-) primary breast cancer.

Patients will receive AZD9496 or fulvestrant and will have an on-treatment image

-guided core biopsy after 5-14 days of commencing treatment.

Conditions

  • Postmenopausal Women With ER+ HER2- Primary Breast Cancer

Interventions

DRUG

Standard Arm - Fulvestrant

500 mg Fulvestrant administered as two consecutive 5 ml intramuscular injections on Day 1, one in each buttock

DRUG

AZD9496

Administered at 250 mg bd orally for 5-14 days commencing on Day 1, and continuing up to the day of biopsy

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-05
Primary Completion
2019-02-12
Completion
2019-02-12

Countries

  • Germany
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03236974 on ClinicalTrials.gov