Anastrozole Monotherapy Versus Maximal Oestrogen Blockade With Anastrozole and Fulvestrant Combination Therapy

NCT00256698 | Completed Phase 3 Results

• 3 other identifiers: D6997L000029238SW/0001FACT
• Study Type: interventional
• Target: 514
• Locations: 12 countries
• Sites: 85

Brief Summary

The purpose of this study is to determine the efficacy of anastrozole monotherapy versus maximal oestrogen blockade with combinated therapy of fulvestrant and anastrozole compared with in treatment of hormone receptor positive women with first relapse of breast cancer.

Conditions

Breast Cancer

Keywords

Hormone; receptor; positive; breast; cancer; first; relapse

Outcome Measures

Primary Outcomes (1)

• Time to Progression (TTP)

  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.

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

Secondary Outcomes (6)

• Percentage of Evaluable Participants With Objective Response Rate (ORR)

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

• Percentage of Clinical Benefit Rate (CBR) Responders

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

• Duration of Response (DoR)

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

• Duration of Clinical Benefit (DoCB)

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

• Time to Treatment Failure (TTF)

  From randomisation until data cut-off on 30th April 2009

Study Arms (2)

1

ACTIVE COMPARATOR

Anastrozole

Drug: Anastrozole

2

EXPERIMENTAL

Anastrozole + Fulvestrant

Drug: Fulvestrant; Drug: Anastrozole

Interventions

Fulvestrant DRUG

intramuscular injection 250 mg loading dose (LD) regimen

Also known as: Faslodex, ZD9238

2

Anastrozole DRUG

1 mg oral tablet

Also known as: Arimidex, ZD1033

1; 2

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Previous systemic endocrine therapy for advanced or recurrent disease; prior fulvestrant therapy
• Premenopausal women

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (85)

Research Site

Brampton, Canada

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Halifax, Canada

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Kingston, Canada

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Ontario, Canada

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Toronto, Canada

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San José, Costa Rica

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Hämeenlinna, Finland

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Turku, Finland

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Avignon, France

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Caen, France

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Créteil, France

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Grenoble, France

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La Chaussée-Saint-Victor, France

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Perpignan, France

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Périgueux, France

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Saint Cyr Sur Louire, France

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Toulouse, France

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Augsburg, Germany

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Cologne, Germany

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Düsseldorf, Germany

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Erlangen, Germany

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Frankfurt, Germany

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Gifhorn, Germany

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Großhadern, Germany

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Halle, Germany

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Hamburg, Germany

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Hanover, Germany

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Heidelberg, Germany

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Ingolstadt, Germany

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Kassel, Germany

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Kiel, Germany

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Leipzig, Germany

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Leverkusen, Germany

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Magdeburg, Germany

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Mannheim, Germany

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Marburg, Germany

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München, Germany

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Rostock, Germany

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Trier, Germany

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Ulm, Germany

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Ziwicken, Germany

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Guatemala City, Guatemala

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Reykjavik, Iceland

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Como, Italy

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Fabriano, Italy

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Ferrara, Italy

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Florence, Italy

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Lugo, Italy

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Milan, Italy

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Taormina, Italy

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Treviglio, Italy

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Vicenza, Italy

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Drammen, Norway

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Ilesund, Norway

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Oslo, Norway

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Porsgrunn, Norway

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Stavanger, Norway

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Troms, Norway

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Trondheim, Norway

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Cascais, Portugal

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Coimbra, Portugal

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Lisbon, Portugal

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Santa Maria da Feira, Portugal

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Halmstad, Sweden

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Helsingborg, Sweden

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Kalmar, Sweden

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Karlskrona, Sweden

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Kristianstad, Sweden

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Link'ping, Sweden

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M'lndal, Sweden

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Malm, Sweden

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Norrk'ping, Sweden

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Skellefteå, Sweden

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Skövde, Sweden

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Södra Sunderbyn, Sweden

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Stockholm, Sweden

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Sundsvall, Sweden

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Umeå, Sweden

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V'rnamo, Sweden

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V'stervik, Sweden

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Varberg, Sweden

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Ankara, Turkey (Türkiye)

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Edirne, Turkey (Türkiye)

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Gaziantep, Turkey (Türkiye)

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Istanbul, Turkey (Türkiye)

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MeSH Terms

Conditions

Breast Neoplasms; Neoplasms; Recurrence

Interventions

Fulvestrant; Anastrozole

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Gerard Lynch
• Organization: AstraZeneca

aztrial_results_posting@astrazeneca.com

Study Officials

• Roger Henriksson, MD

  AstraZeneca

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2005
• First Posted: November 22, 2005
• Study Start: January 1, 2004
• Primary Completion: April 1, 2009
• Study Completion: February 1, 2012
• Last Updated: August 1, 2012
• Results First Posted: February 9, 2011

Record last verified: 2012-07

Locations

CA (5); FR (9); CO (1); IT (9); PT (4); DE (24); NO (7); IC (1); SE (18); FI (2); TU (4); GU (1)