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A Randomised, Double-Blind, Parallel-Group, Multicentre Study Comparing the Efficacy and Tolerability of Fulvestrant 500 mg Versus 250 mg in Postmenopausal Women With ER+ Advanced Breast Cancer Progressing or Relapsing After Previous Endocrine Therapy


Phase 3
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

Thank you

Trial Information

A Randomised, Double-Blind, Parallel-Group, Multicentre Study Comparing the Efficacy and Tolerability of Fulvestrant 500 mg Versus 250 mg in Postmenopausal Women With ER+ Advanced Breast Cancer Progressing or Relapsing After Previous Endocrine Therapy


Inclusion Criteria:



- Postmenopausal women defined as a woman who has stopped having menstrual periods

- Breast Cancer has continued to grow after having received treatment with an
anti-estrogen hormonal treatment such as tamoxifen or an aromatase inhibitor

- Requiring hormonal treatment

- Oestrogen-receptor positive tumour

- Written informed consent to participate in the trial

Exclusion Criteria:

- Treatment with an investigational or non-approved drug within one month

- An existing serious disease, illness, or condition that will prevent participation or
compliance with study procedures

- A history of allergies to any active or inactive ingredients of fulvestrant (i.e.
castor oil)

- Treatment with more than one regimen of chemotherapy for advanced breast cancer

- Treatment with more than one regimen of hormonal treatment for advanced breast cancer

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Progression-free survival (Response Evaluation Criteria in Solid Tumors) (RECIST 1.1)

Outcome Time Frame:

RECIST 1.1 tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation until disease progression

Safety Issue:

No

Principal Investigator

Zefei Jiang

Investigator Role:

Principal Investigator

Investigator Affiliation:

307 Hospital of PLA

Authority:

China: Food and Drug Administration

Study ID:

D6997L00021

NCT ID:

NCT01300351

Start Date:

March 2011

Completion Date:

March 2014

Related Keywords:

  • Breast Cancer
  • Advanced breast cancer
  • metastatic breast cancer
  • Breast Neoplasms

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