PROACT - Pre-Operative Arimidex Compared To Tamoxifen

Breast Cancer Clinical Trial

Official title:

A Randomised, Double-blind, Study Comparing ARIMIDEX™ With NOLVADEX™ as Neo-adjuvant and Adjuvant Treatment in Post-menopausal Women With Large Operable (T2 (≥3cm), T3, N0-2, M0) or Potentially-operable, Locally Advanced (T4b, N0-2, M0), ER+ and/or PR+ Breast Cancer.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00232661
• Other study ID #: 1033IL/0039
• Secondary ID: D5395C00039
• Status: Completed
• Phase: Phase 3
• First received: September 30, 2005
• Last updated: February 2, 2010
• Start date: August 2000
• Est. completion date: December 2007

Study information

• Verified date: February 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare tamoxifen, versus a newer treatment, ARIMIDEX, which we already know to be well tolerated. The main objectives of this research study are to see whether using these drugs will shrink down tumours before surgery and to see if any shrinkage in the tumour affects the extent of surgery that is required.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 452
• Est. completion date: December 2007
• Est. primary completion date: January 2003
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• Operable or potentially operable breast cancer

• Invasive breast cancer proven to be hormone-sensitive (ER+/PR+)

• Patients who might benefit from endocrine treatment prior to surgery

• Postmenopausal

• Signed written informed consent

Exclusion Criteria:

• Inoperable breast cancer

• Patient unwilling to undergo surgery

• Any reason why the patient may not be able to conform to study requirements

• Any previous treatment for breast cancer

• Previous Tamoxifen use as a part of breast cancer prevention trials

• Not willing to stop taking drugs that affect sex-hormones such as HRT

• Previous history of breast cancer

• Previous history of invasive malignancy within the last 10 years

• Any other severe disease that may prevent surgery, place the patient at risk, or influence the study results

• Treatment with an experimental drug within the last 3 months

• Risk of transmitting HIV, Hepatitis B or C

Study Design

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

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Drug:
• ARIMIDEX (anastrazole)

• NOLVADEX (tamoxifen)

Locations

Country	Name	City	State
Belgium	Research Site	Antwerpen
Belgium	Research Site	Hasselt
Belgium	Research Site	Leuven
Belgium	Research Site	Liege
Brazil	Research Site	Fortaleza
Brazil	Research Site	Porto Alegre
Brazil	Research Site	Porto Alegre	RS
Brazil	Research Site	Rio de Janeiro	RJ
Brazil	Research Site	São Paulo	SP
Brazil	Research Site	Sheffield
Canada	Research Site	Chicoutimi	Quebec
Canada	Research Site	Edmonton	Alberta
Canada	Research Site	Montreal	Quebec
Canada	Research Site	Newmarket	Ontario
Canada	Research Site	Quebec
Czech Republic	Research Site	Brno
Czech Republic	Research Site	Nova Ves Pod Plesi
Czech Republic	Research Site	Olomouc
Czech Republic	Research Site	Peské Budjovice
Czech Republic	Research Site	Praha 2
Czech Republic	Research Site	Praha-5
France	Research Site	Avignon
France	Research Site	Dijon
France	Research Site	Limoges
France	Research Site	Lyon
France	Research Site	Lyon	Cedex 08
France	Research Site	Marseille
France	Research Site	Montpellier Cedex 5
France	Research Site	Nice Cedex
France	Research Site	Paris
France	Research Site	Tours Cedex
Hungary	Research Site	Budapest
Hungary	Research Site	Gyor
Hungary	Research Site	Kecskemet
Hungary	Research Site	Szeged
Hungary	Research Site	Szolnok
Italy	Research Site	Bologna	BO
Italy	Research Site	Cagliari	CA
Italy	Research Site	Firenze	FI
Italy	Research Site	Genova	GE
Italy	Research Site	Kashiwa	Chiba
Italy	Research Site	Monserrato	CA
Italy	Research Site	Palermo	PA
Italy	Research Site	Reggio Emilia	RE
Japan	Research Site	Amagasaki	Hyogo
Japan	Research Site	Chiba
Japan	Research Site	Chuo	Tokyo
Japan	Research Site	Fukuoka
Japan	Research Site	Fukuyama	Hiroshima
Japan	Research Site	Isehara	Kanagawa
Japan	Research Site	Kitaadachi	Saitama
Japan	Research Site	Kitakyusyu	Fukuoka
Japan	Research Site	Kumamoto
Japan	Research Site	Matsuyama	Ehime
Japan	Research Site	Nagoya	Aichi
Japan	Research Site	Niigata
Japan	Research Site	Oita
Japan	Research Site	Osaka
Japan	Research Site	Osakasayama	Osaka
Japan	Research Site	Ota	Gunma
Japan	Research Site	Sapporo	Hokkaido
Japan	Research Site	Suita	Osaka
Japan	Research Site	Yokohama	Kanagawa
Netherlands	Research Site	Den Haag
Netherlands	Research Site	Nijmegen
Netherlands	Research Site	Sittard
United States	Research Site	Albuquerque	New Mexico
United States	Research Site	Austin	Texas
United States	Research Site	Baton Rouge	Louisiana
United States	Research Site	Houston	Texas
United States	Research Site	Mason City	Iowa
United States	Research Site	New Britain	Connecticut
United States	Research Site	Olympia	Washington
United States	Research Site	Pittsfield	Massachusetts
United States	Research Site	Portland	Oregon
United States	Research Site	Santa Rosa	California
United States	Research Site	Springfield	Illinois
United States	Research Site	St. Louis	Missouri
United States	Research Site	Torrington	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Belgium,  Brazil,  Canada,  Czech Republic,  France,  Hungary,  Italy,  Japan,  Netherlands, 

References & Publications (1)

Cataliotti L, Buzdar AU, Noguchi S, Bines J, Takatsuka Y, Petrakova K, Dube P, de Oliveira CT. Comparison of anastrozole versus tamoxifen as preoperative therapy in postmenopausal women with hormone receptor-positive breast cancer: the Pre-Operative "Arim — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective tumour response		Assessed at 3 months	No
Secondary	Pathological response		Assessed at 3 months	No
Secondary	Extent of breast surgery		Assessed at 3 months	No
Secondary	Extent of axillary down-staging		Assessed at 3 months	No
Secondary	Clinical ultrasound response versus clinical caliper response		Assessed at 3 months	No
Secondary	Safety		Assessed up to 5 years + 30 days	No
Secondary	Complications due to surgery		Assessed up to 30 days post-surgery	No
Secondary	Health economics outcomes		Assessed up to 30 days post-surgery	No
Secondary	Quality of Life assessments		Assessed at 3 months	No
Secondary	Effect of ethnicity with respect to baseline patient and tumour characteristics, safety and objective tumour response rate		Assessed up to 5 years + 30 days	No
Secondary	Recurrence-free survival and survival		Assessed up to 5 years	No