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RAD001, Letrozole

Phase 2

Breast Neoplasm | Small molecule | Oncology |Novartis AG|Last Updated: Mar 4, 2013

Target and mechanism

Molecular targetmTOR
Target classProtein
ModalitySmall molecule

Also known as RAD001

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment267

FDA Designations

No designations recorded

Clinical trial landscape

RAD001, Letrozole · 1 trial · 1 indication

Phase 2 1
NCT00107016Everolimus and Letrozole as Preoperative Therapy of Primary Breast Cancer in Post-menopausal WomenBreast Neoplasm
COMPLETED267 Analytics
PHASE2COMPLETED
Everolimus and Letrozole as Preoperative Therapy of Primary Breast Cancer in Post-menopausal Women
Breast NeoplasmUnlock trial analytics

Study Endpoints

Primary Endpoints

To assess the added efficacy obtained by combining RAD001 and letrozole as preoperative therapy for four months in hormone-receptor positive breast cancer in postmenopausal women

Secondary Endpoints

To assess the four month treatment as being predictive of clinical tumor response
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
RAD001 + letrozole 2.5mgEXPERIMENTAL -
Letrozole 2.5mgACTIVE_COMPARATOR -

Interventions

NameTypeDescription
RAD001, Letrozole 2.5mgDRUG -
Letrozole 2.5mgDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexFEMALE
Healthy VolunteersNo
Study Sites46

Inclusion Criteria: * Histologically-confirmed diagnosis of invasive breast cancer, previously untreated * Patients must be postmenopausal * Candidates for mastectomy or breast-conserving surgery * Primary tumor of above 2 cm diameter, measured by imaging * Clinical Stage M0 * WHO performance statu...

Countries:United StatesAustriaBelgiumCanadaFranceGermanyItalyRussiaSpainUnited Kingdom
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Frequently asked questions about RAD001, Letrozole

What is RAD001 used for?

RAD001 is an investigational small molecule being studied in oncology for gastrointestinal stromal tumors, renal cell carcinoma, breast cancer, prostate cancer, carcinoma, and non-small-cell lung carcinoma. It is also being evaluated in other conditions such as tuberous sclerosis complex and prevention of acute rejection in pediatric renal transplant recipients.

What does RAD001 target?

RAD001 targets mTOR, a protein that regulates cell growth and proliferation. By inhibiting mTOR, RAD001 is being studied as a potential treatment for various cancers and other conditions.

Who makes RAD001?

RAD001 is being developed by Novartis AG, which trades under the ticker NVS. The drug is currently in Phase 1 clinical development for oncology indications.

What phase is RAD001 in?

RAD001 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials are ongoing to evaluate its safety and efficacy.

What clinical trials is RAD001 in?

RAD001 has been studied in several clinical trials, including NCT01122199 (RAD001 plus AMG479 for advanced solid tumors), NCT01275222 (everolimus with imatinib for gastrointestinal stromal tumors), NCT01289912 (RAD001 and neurocognition in tuberous sclerosis complex), and NCT01544491 (everolimus in pediatric renal transplant recipients).

Is RAD001 the same as everolimus?

Yes, RAD001 is also known as everolimus. Clinical trials listed under the name everolimus, such as NCT01275222 and NCT01544491, are studying the same drug compound.