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PROACT - Pre-Operative Arimidex Compared To Tamoxifen

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00232661
First received: September 30, 2005
Last updated: February 2, 2010
Last verified: February 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Breast Cancer
 Drug: ARIMIDEX (anastrazole)
Drug: NOLVADEX (tamoxifen)
 Phase 3

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Objective tumour response [ Time Frame: Assessed at 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pathological response [ Time Frame: Assessed at 3 months ] [ Designated as safety issue: No ]
  • Extent of breast surgery [ Time Frame: Assessed at 3 months ] [ Designated as safety issue: No ]
  • Extent of axillary down-staging [ Time Frame: Assessed at 3 months ] [ Designated as safety issue: No ]
  • Clinical ultrasound response versus clinical caliper response [ Time Frame: Assessed at 3 months ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: Assessed up to 5 years + 30 days ] [ Designated as safety issue: No ]
  • Complications due to surgery [ Time Frame: Assessed up to 30 days post-surgery ] [ Designated as safety issue: No ]
  • Health economics outcomes [ Time Frame: Assessed up to 30 days post-surgery ] [ Designated as safety issue: No ]
  • Quality of Life assessments [ Time Frame: Assessed at 3 months ] [ Designated as safety issue: No ]
  • Effect of ethnicity with respect to baseline patient and tumour characteristics, safety and objective tumour response rate [ Time Frame: Assessed up to 5 years + 30 days ] [ Designated as safety issue: No ]
  • Recurrence-free survival and survival [ Time Frame: Assessed up to 5 years ] [ Designated as safety issue: No ]

Enrollment: 452
Study Start Date: August 2000
Study Completion Date: December 2007
Primary Completion Date: January 2003 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00232661

  Show 79 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca Arimidex Medical Science Director, MD AstraZeneca
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Francisco Sapunar, MD - Arimidex Medical Science Director, AstraZeneca
ClinicalTrials.gov Identifier: NCT00232661     History of Changes
Other Study ID Numbers: 1033IL/0039, D5395C00039
Study First Received: September 30, 2005
Last Updated: February 2, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Tamoxifen
Anastrozole
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
 Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Bone Density Conservation Agents
Estrogen Antagonists
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013