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Anastozole

Phase 3

Breast Cancer | Small molecule | Oncology |AstraZeneca PLC|Trials Updated: Jun 6, 2012

Anastozole target and mechanism

ModalitySmall molecule

Also known as Anastozole (Arimidex)

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment9,358

FDA Designations

No designations recorded

Anastozole clinical trials

Anastozole · 1 trial · 1 indication

Phase 3 1
NCT00849030ATAC - Arimidex, Tamoxifen Alone or in CombinationBreast Cancer
COMPLETED9,358 Analytics
PHASE3COMPLETED
ATAC - Arimidex, Tamoxifen Alone or in Combination
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Study Endpoints

Primary Endpoints

Time to recurrence of breast cancer
Earliest of local or distant recurrence, new primary breast cancer, or death
Safety and side effects
Earliest of local or distant recurrence, new primary breast cancer, or death

Secondary Endpoints

Time to distant recurrence
Earliest of local or distant recurrence, new primary breast cancer, or death
Survival
Earliest of local or distant recurrence, new primary breast cancer, or death
New breast primaries
Earliest of local or distant recurrence, new primary breast cancer, or death
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1ACTIVE_COMPARATORArimidex 1mg + Nolvadex placebo
2ACTIVE_COMPARATORArimidex placebo + Nolvadex 20mg
3ACTIVE_COMPARATORArimidex 1mg + Nolvadex 20mg

Interventions

NameTypeDescription
Anastozole (Arimidex)DRUG1mg, orally, once daily
Tamoxifen (Nolvadex)DRUG20mg, orally, once daily
Anastozole (Arimidex) placeboDRUG1mg, orally, once daily
Tamoxifen (Nolvadex) placeboDRUG20mg, orally, once daily
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Eligibility Criteria

Age Range45 Years to N/A
SexFEMALE
Healthy VolunteersNo

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 who...

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Competitive Landscape -Breast Cancer 609 trials

Frequently asked questions about Anastozole

What is Anastozole used for?

Anastozole is used for the treatment of breast cancer. It is a small molecule therapy studied in a Phase 3 clinical program in this indication. The pivotal trial enrolled postmenopausal women aged 45 years and older with breast cancer.

Who makes Anastozole?

Anastozole is developed by AstraZeneca PLC, which trades under the ticker AZN. The company sponsored the Phase 3 ATAC trial evaluating the drug in breast cancer.

What phase is Anastozole in?

Anastozole is in Phase 3 development for breast cancer. The Phase 3 ATAC trial, NCT00849030, has been completed. Anastozole is an investigational agent in this program rather than a newly approved product.

What clinical trials is Anastozole in?

Anastozole was evaluated in the Phase 3 ATAC trial, registered as NCT00849030, titled Arimidex, Tamoxifen Alone or in Combination. The trial enrolled 9,358 female participants aged 45 years and older with breast cancer and is now completed.

How was the ATAC trial for Anastozole designed?

The ATAC trial was a Phase 3, randomized, double-blind study with an active control comparator. It enrolled 9,358 female breast cancer patients aged 45 years and older and did not use biomarker selection for enrollment. The trial is listed as completed.

Is Anastozole the same as Arimidex?

Anastozole is also known as Arimidex. The name Arimidex appears in the title of the Phase 3 ATAC trial, which stands for Arimidex, Tamoxifen Alone or in Combination. Both names refer to the same AstraZeneca small molecule developed for breast cancer.