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ATAC - Arimidex, Tamoxifen Alone or in Combination

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ClinicalTrials.gov Identifier: NCT00849030
Recruitment Status : Completed
First Posted : February 23, 2009
Last Update Posted : June 6, 2012
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
The aim of this study is to test whether Arimidex alone or in combination with Tamoxifen is beneficial in the treatment of breast cancer.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Anastozole (Arimidex) Drug: Tamoxifen (Nolvadex) Drug: Anastozole (Arimidex) placebo Drug: Tamoxifen (Nolvadex) placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9358 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : July 1996
Actual Primary Completion Date : June 2001
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Active Comparator: 1
Arimidex 1mg + Nolvadex placebo
Drug: Anastozole (Arimidex)
1mg, orally, once daily
Other Name: Arimidex

Drug: Tamoxifen (Nolvadex) placebo
20mg, orally, once daily

Active Comparator: 2
Arimidex placebo + Nolvadex 20mg
Drug: Tamoxifen (Nolvadex)
20mg, orally, once daily
Other Name: Nolvadex

Drug: Anastozole (Arimidex) placebo
1mg, orally, once daily

Active Comparator: 3
Arimidex 1mg + Nolvadex 20mg
Drug: Anastozole (Arimidex)
1mg, orally, once daily
Other Name: Arimidex

Drug: Tamoxifen (Nolvadex)
20mg, orally, once daily
Other Name: Nolvadex




Primary Outcome Measures :
  1. Time to recurrence of breast cancer [ Time Frame: Earliest of local or distant recurrence, new primary breast cancer, or death ]
  2. Safety and side effects [ Time Frame: Earliest of local or distant recurrence, new primary breast cancer, or death ]

Secondary Outcome Measures :
  1. Time to distant recurrence [ Time Frame: Earliest of local or distant recurrence, new primary breast cancer, or death ]
  2. Survival [ Time Frame: Earliest of local or distant recurrence, new primary breast cancer, or death ]
  3. New breast primaries [ Time Frame: Earliest of local or distant recurrence, new primary breast cancer, or death ]


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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00849030     History of Changes
Other Study ID Numbers: 1033IL/0029
D5392C00029
First Posted: February 23, 2009    Key Record Dates
Last Update Posted: June 6, 2012
Last Verified: June 2012

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Tamoxifen
Anastrozole
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