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
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Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
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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 Genetics related topics:
Breast cancer
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 :
- Time to recurrence of breast cancer [ Time Frame: Earliest of local or distant recurrence, new primary breast cancer, or death ]
- Safety and side effects [ Time Frame: Earliest of local or distant recurrence, new primary breast cancer, or death ]
Secondary Outcome Measures :
- Time to distant recurrence [ Time Frame: Earliest of local or distant recurrence, new primary breast cancer, or death ]
- Survival [ Time Frame: Earliest of local or distant recurrence, new primary breast cancer, or death ]
- 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
No Contacts or Locations Provided
Responsible Party: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00849030 |
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 |