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Completed

NCT Number: NCT00232661

PROACT - Pre-Operative Arimidex Compared To Tamoxifen

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

60 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Antwerp, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ARIMIDEX (anastrazole)

Drug

NOLVADEX (tamoxifen)

Drug

Primary outcomes

  1. Objective tumour response

    Time frame: Assessed at 3 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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.

Important dates

Study start
2000
Primary completion
2003
Study completion
2007
First posted
Oct 5, 2005
Registry last updated
Feb 3, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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