PROACT - Pre-Operative Arimidex Compared To Tamoxifen

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00232661
Recruitment Status : Completed
First Posted : October 5, 2005
Last Update Posted : February 3, 2010
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: ARIMIDEX (anastrazole) Drug: NOLVADEX (tamoxifen) Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 452 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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.
Study Start Date : August 2000
Actual Primary Completion Date : January 2003
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Objective tumour response [ Time Frame: Assessed at 3 months ]

Secondary Outcome Measures :
  1. Pathological response [ Time Frame: Assessed at 3 months ]
  2. Extent of breast surgery [ Time Frame: Assessed at 3 months ]
  3. Extent of axillary down-staging [ Time Frame: Assessed at 3 months ]
  4. Clinical ultrasound response versus clinical caliper response [ Time Frame: Assessed at 3 months ]
  5. Safety [ Time Frame: Assessed up to 5 years + 30 days ]
  6. Complications due to surgery [ Time Frame: Assessed up to 30 days post-surgery ]
  7. Health economics outcomes [ Time Frame: Assessed up to 30 days post-surgery ]
  8. Quality of Life assessments [ Time Frame: Assessed at 3 months ]
  9. 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 ]
  10. Recurrence-free survival and survival [ Time Frame: Assessed up to 5 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00232661

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

Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Francisco Sapunar, MD - Arimidex Medical Science Director, AstraZeneca Identifier: NCT00232661     History of Changes
Other Study ID Numbers: 1033IL/0039
First Posted: October 5, 2005    Key Record Dates
Last Update Posted: February 3, 2010
Last Verified: February 2010

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