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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

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

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080220266
Enrollment
Unknown
Registered
2006-06-30
Start date
2006-06-30
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Interventions

investigational material(s) Generic name etc : ARIMIDEX (anastrazole)|NOLVADEX (tamoxifen) INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and Administ

Sponsors

AstraZeneca
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Efficacy Primary Outcomes: Objective tumour response at 3 months Secondary Outcomes: Pathological response at 3 months; Extent of breast surgery at 3 months; Extent of axillary down-staging at 3 months; Clinical ultrasound response versus clinical caliper response at 3 months; Safety up to 5 years +30 days; Complications due to surgery up to 30 days post-surgery; Health economics outcomes up to 30 days post-surgery; Quality of Life assessments at 3 months; Effect of ethnicity with respect to baseline patient and tumour characteristics, safety and objective tumour response rate, up to 5 years +30 days; Recurrence-free survival and survival up to 5 years—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026