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A Randomised, Double Blind Trial Comparing Arimidex Alone With Nolvadex Alone With Arimidex and Nolvadex in Combination, as Adjuvant Treatment in Post-Menopausal Women With Breast Cancer


Phase 3
45 Years
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

A Randomised, Double Blind Trial Comparing Arimidex Alone With Nolvadex Alone With Arimidex and Nolvadex in Combination, as Adjuvant Treatment in Post-Menopausal Women With Breast Cancer


Inclusion Criteria:



- Patients with histologically proven operable invasive breast cancer

- Patients who have completed all primary surgery and chemotherapy (if given), and are
candidates to receive hormonal adjuvant therapy

- Women defined as post-menopausal

Exclusion Criteria:

- Patients in whom there is any clinical evidence of metastatic disease

- Patients who, for whatever reason (e.g. confusion, infirmity, alcoholism), are
unlikely to comply with trial requirements

- Patients whose chemotherapy was started more than 8 weeks (ie 56 days) after
completion of primary surgery or whose chemotherapy was completed more than 8 weeks
(ie 56 days) before starting randomised treatment

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Time to recurrence of breast cancer

Outcome Time Frame:

Earliest of local or distant recurrence, new primary breast cancer, or death

Safety Issue:

No

Authority:

Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Study ID:

1033IL/0029

NCT ID:

NCT00849030

Start Date:

July 1996

Completion Date:

April 2010

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

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