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FACT: Anastrozole Monotherapy Versus Maximal Oestrogen Blockade With Anastrozole and Fulvestrant Combination Therapy; an Open Randomized, Comparative, Phase III Multicentre Study in Postmenopausal Women With Hormone Receptor Positive Breast Cancer in First Relapse After Primary Treatment of Localized Tumor.


Phase 3
N/A
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

FACT: Anastrozole Monotherapy Versus Maximal Oestrogen Blockade With Anastrozole and Fulvestrant Combination Therapy; an Open Randomized, Comparative, Phase III Multicentre Study in Postmenopausal Women With Hormone Receptor Positive Breast Cancer in First Relapse After Primary Treatment of Localized Tumor.


Inclusion Criteria:



- Signed informed consent, postmenopausal females, histological or cytological
confirmed oestrogene and/or progesterone (PgR) receptor positive breast cancer, local
recurrence or metastasis

Exclusion Criteria:

- Previous systemic endocrine therapy for advanced or recurrent disease; prior
fulvestrant therapy

- Premenopausal women

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to Progression (TTP)

Outcome Description:

RECIST (Response Evaluation Criteria in Solid Tumours) assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009. TTP, time in months to worsen 'progression' according to RECIST criteria. (RECIST is a set of published rules that define when cancer patients improve "respond", stay the same "stable"or worsen "progression" during treatments.

Outcome Time Frame:

RECIST assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009

Safety Issue:

No

Principal Investigator

Roger Henriksson, MD

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

D6997L00002

NCT ID:

NCT00256698

Start Date:

January 2004

Completion Date:

February 2012

Related Keywords:

  • Breast Cancer
  • Hormone
  • receptor
  • positive
  • breast
  • cancer
  • first
  • relapse
  • Breast Neoplasms

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