Clinical trial NCT00232661: PROACT - Pre-Operative Arimidex Compared To Tamoxifen
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-10-05
Enrollment: 452
Sex: FEMALE
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Objective tumour response
timeFrame: Assessed at 3 months
Secondary outcomes:
measure: Pathological response
timeFrame: Assessed at 3 months
measure: Extent of breast surgery
timeFrame: Assessed at 3 months
measure: Extent of axillary down-staging
timeFrame: Assessed at 3 months
measure: Clinical ultrasound response versus clinical caliper response
timeFrame: Assessed at 3 months
measure: Safety
timeFrame: Assessed up to 5 years + 30 days
measure: Complications due to surgery
timeFrame: Assessed up to 30 days post-surgery
measure: Health economics outcomes
timeFrame: Assessed up to 30 days post-surgery
measure: Quality of Life assessments
timeFrame: Assessed at 3 months
measure: Effect of ethnicity with respect to baseline patient and tumour characteristics, safety and objective tumour response rate
timeFrame: Assessed up to 5 years + 30 days
measure: Recurrence-free survival and survival
timeFrame: Assessed up to 5 years
Other outcomes:
Locations:
city: Santa Rosa
country: United States
facility: Research Site
state: California
city: New Britain
country: United States
facility: Research Site
state: Connecticut
city: Torrington
country: United States
facility: Research Site
state: Connecticut
city: Springfield
country: United States
facility: Research Site
state: Illinois
city: Mason City
country: United States
facility: Research Site
state: Iowa
city: Baton Rouge
country: United States
facility: Research Site
state: Louisiana
city: Pittsfield
country: United States
facility: Research Site
state: Massachusetts
city: St. Louis
country: United States
facility: Research Site
state: Missouri
city: Albuquerque
country: United States
facility: Research Site
state: New Mexico
city: Portland
country: United States
facility: Research Site
state: Oregon
city: Austin
country: United States
facility: Research Site
state: Texas
city: Houston
country: United States
facility: Research Site
state: Texas
city: Olympia
country: United States
facility: Research Site
state: Washington
city: Antwerpen
country: Belgium
facility: Research Site
city: Hasselt
country: Belgium
facility: Research Site
city: Leuven
country: Belgium
facility: Research Site
city: Liege
country: Belgium
facility: Research Site
city: Rio de Janeiro
country: Brazil
facility: Research Site
state: RJ
city: Porto Alegre
country: Brazil
facility: Research Site
state: RS
city: São Paulo
country: Brazil
facility: Research Site
state: SP
city: Fortaleza
country: Brazil
facility: Research Site
city: Porto Alegre
country: Brazil
facility: Research Site
city: Sheffield
country: Brazil
facility: Research Site
city: Edmonton
country: Canada
facility: Research Site
state: Alberta
city: Newmarket
country: Canada
facility: Research Site
state: Ontario
city: Chicoutimi
country: Canada
facility: Research Site
state: Quebec
city: Montreal
country: Canada
facility: Research Site
state: Quebec
city: Quebec
country: Canada
facility: Research Site
city: Brno
country: Czech Republic
facility: Research Site
city: Nova Ves Pod Plesi
country: Czech Republic
facility: Research Site
city: Olomouc
country: Czech Republic
facility: Research Site
city: Peské Budjovice
country: Czech Republic
facility: Research Site
city: Praha 2
country: Czech Republic
facility: Research Site
city: Praha-5
country: Czech Republic
facility: Research Site
city: Lyon
country: France
facility: Research Site
state: Cedex 08
city: Avignon
country: France
facility: Research Site
city: Dijon
country: France
facility: Research Site
city: Limoges
country: France
facility: Research Site
city: Lyon
country: France
facility: Research Site
city: Marseille
country: France
facility: Research Site
city: Montpellier Cedex 5
country: France
facility: Research Site
city: Nice Cedex
country: France
facility: Research Site
city: Paris
country: France
facility: Research Site
city: Tours Cedex
country: France
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Gyor
country: Hungary
facility: Research Site
city: Kecskemet
country: Hungary
facility: Research Site
city: Szeged
country: Hungary
facility: Research Site
city: Szolnok
country: Hungary
facility: Research Site
city: Bologna
country: Italy
facility: Research Site
state: BO
city: Cagliari
country: Italy
facility: Research Site
state: CA
city: Monserrato
country: Italy
facility: Research Site
state: CA
city: Kashiwa
country: Italy
facility: Research Site
state: Chiba
city: Firenze
country: Italy
facility: Research Site
state: FI
city: Genova
country: Italy
facility: Research Site
state: GE
city: Palermo
country: Italy
facility: Research Site
state: PA
city: Reggio Emilia
country: Italy
facility: Research Site
state: RE
city: Nagoya
country: Japan
facility: Research Site
state: Aichi
city: Matsuyama
country: Japan
facility: Research Site
state: Ehime
city: Kitakyusyu
country: Japan
facility: Research Site
state: Fukuoka
city: Ota
country: Japan
facility: Research Site
state: Gunma
city: Fukuyama
country: Japan
facility: Research Site
state: Hiroshima
city: Sapporo
country: Japan
facility: Research Site
state: Hokkaido
city: Amagasaki
country: Japan
facility: Research Site
state: Hyogo
city: Isehara
country: Japan
facility: Research Site
state: Kanagawa
city: Yokohama
country: Japan
facility: Research Site
state: Kanagawa
city: Osakasayama
country: Japan
facility: Research Site
state: Osaka
city: Suita
country: Japan
facility: Research Site
state: Osaka
city: Kitaadachi
country: Japan
facility: Research Site
state: Saitama
city: Chuo
country: Japan
facility: Research Site
state: Tokyo
city: Chiba
country: Japan
facility: Research Site
city: Fukuoka
country: Japan
facility: Research Site
city: Kumamoto
country: Japan
facility: Research Site
city: Niigata
country: Japan
facility: Research Site
city: Oita
country: Japan
facility: Research Site
city: Osaka
country: Japan
facility: Research Site
city: Den Haag
country: Netherlands
facility: Research Site
city: Nijmegen
country: Netherlands
facility: Research Site
city: Sittard
country: Netherlands
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Arimidex Medical Science Director, MD
role: STUDY_DIRECTOR
References:
citation: 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 "Arimidex" Compared to Tamoxifen (PROACT) trial. Cancer. 2006 May 15;106(10):2095-103. doi: 10.1002/cncr.21872.
citation: Fujiwara Y, Takatsuka Y, Imoto S, Inaji H, Ikeda T, Akiyama F, Tamura M, Miyoshi K, Iwata H, Mitsuyama S, Noguchi S. Outcomes of Japanese breast cancer patients treated with pre-operative and post-operative anastrozole or tamoxifen. Cancer Sci. 2012 Mar;103(3):491-6. doi: 10.1111/j.1349-7006.2011.02171.x. Epub 2012 Jan 13.