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Phase II Study to Evaluate the Efficacy and Tolerability of Fulvestrant 250mg, 250mg Plus 250mg Loading Regimen and 500mg in Postmenopausal Women With ER +ve Advanced Breast Cancer Progressing or Relapsing After Previous Endocrine Therapy


Phase 2
N/A
N/A
Open (Enrolling)
Female
Advanced Breast Cancer, Metastatic Breast Cancer

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Trial Information

Phase II Study to Evaluate the Efficacy and Tolerability of Fulvestrant 250mg, 250mg Plus 250mg Loading Regimen and 500mg in Postmenopausal Women With ER +ve Advanced Breast Cancer Progressing or Relapsing After Previous Endocrine Therapy


Inclusion Criteria:



- 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.

- Postmenopausal women (woman who has stopped having menstrual periods)

Exclusion Criteria:

- Treatment with more than one previous regimen of systemic anticancer therapy other
than endocrine therapy for advanced BC.

- Treatment with more than one previous regimen of endocrine therapy for advanced BC.

- An existing condition that prevents compliance.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Objective Response (OR)

Outcome Description:

Number of participants who were objective responders over the number of participants evaluable for response x100. An objective responder = a patient whose best response is either CR (disappearance of all lesions) or PR (>= 30% shrinkage in the sum of the longest diameters of the measurable lesions + no new lesions + no progression of non-measurable lesions)

Outcome Time Frame:

RECIST scans were performed every 12 weeks (+/- 2 weeks) from randomisation to until data cut off on 13th June 2008

Safety Issue:

No

Principal Investigator

AstraZeneca Breast Cancer Established Brands Team Medical Science Director, MD

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca

Authority:

Belgium: Federal Agency for Medicines and Health Products, FAMHP

Study ID:

D6997C00006

NCT ID:

NCT00313170

Start Date:

May 2006

Completion Date:

December 2012

Related Keywords:

  • Advanced Breast Cancer
  • Metastatic Breast Cancer
  • oncology
  • cancer
  • breast cancer
  • Breast Neoplasms

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