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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

Phase 3
Conditions
Breast Cancer
Registration Number
JPRN-jRCT2080220266
Lead Sponsor
AstraZeneca
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Sex
Female
Target Recruitment
Not specified
Inclusion Criteria

Ages Eligible for Study: 60 Years and above, Genders Eligible for Study: Female
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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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