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Tamoxifen-RAD001 Versus Tamoxifen Alone in Patients With Anti-aromatase Resistant Breast Metastatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01298713
Recruitment Status : Completed
First Posted : February 18, 2011
Last Update Posted : November 8, 2018
Information provided by (Responsible Party):

Brief Summary:
Tamoxifen is a classical treatment for breast metastatic cancer after 3rd generation anti-aromatase hormonotherapy in adjuvant or in metastatic line. The Tamoxifen efficacy is lowered by the hormonoresistance mechanisms due to the primary use of the anti-aromatases. The Pi3K-AKT-mTor pathway is frequently associated to the hormonoresistance mechanisms. This study is aimed to check if the inhibition of this signal transduction pathway by a synthetic mTor inhibitor (Everolimus) could improve the efficacy of the Tamoxifen.

Condition or disease Intervention/treatment Phase
Breast Neoplasms mTor Protein Drug: Tamoxifen Drug: Everolimus Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 111 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Study Assessing the Tolerance and Efficacy of Tamoxifen Alone Versus the Association Tamoxifen-RAD001 (Everolimus) in Patients With Anti-aromatase Resistant Breast Metastatic Cancer
Actual Study Start Date : March 2008
Actual Primary Completion Date : June 2011
Actual Study Completion Date : September 12, 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: A
Tamoxifen 20mg/d
Drug: Tamoxifen
20mg daily (1 cap) until unbearable toxicity or progression

Experimental: B
Tamoxifen 20mg/d + RAD001 10mg/d
Drug: Tamoxifen
20mg daily (1 cap) until unbearable toxicity or progression

Drug: Everolimus
10mg daily (2 caps of 5mg) until unbearable toxicity or progression
Other Name: RAD001

Primary Outcome Measures :
  1. Clinical benefit at 24 weeks [ Time Frame: 42 months ]

Secondary Outcome Measures :
  1. Partial and complete response per RECIST [ Time Frame: 42 months ]
  2. Qualitative and quantitative toxicities [ Time Frame: 24 months ]
  3. Overall survival [ Time Frame: 42 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Menopausal female patient aged > 18 years
  • Histologically proven breast adenocarcinoma
  • ER and/or PR positive receptors and HER2 negative
  • previously received first or second line of hormonotherapy for metastatic disease
  • previously treated with anti-aromatase in adjuvant and/or in metastatic line
  • presence of one or several mesurable or evaluable metastatic lesion(s)
  • presence of at least one target lesion not previously irradiated
  • ECOG Performance status < 2
  • adequate biological values
  • patient who has clearly given her consent by signing on informed consent form prior to participation

Exclusion Criteria:

  • patient with only local metastatic disease that can be treted by surgery
  • uncotrolled brain metastases, pulmonary carcinomatosal lymphangitis, hepatic metastases
  • Previous treatment by Tamoxifen unless in adjuvant and terminated more than a year before metastatic relapse
  • Patient with a tumor surexpressing HER2 that should be treated by trastuzumab
  • Patient that need an immediate local antalgic radiotherapy
  • Thrombo-embolism disease
  • serious concomitant pathology or uncontrolled that is susceptible to compromise the participation in the study
  • history of another malignancy within past 5 years that could confound diagnosis or staging of breast cancer (with the exception of in situ cacinoma of the cervix or adequately treated basel cell carcinoma of the skin) and cancers cured for at least for 5 years
  • patient with an history of significant cardiovascular impairment (congestive heart failure> NYHA grade II, unstable angina or myocardial infraction within the past six months or serious cardiac arrhythmia)
  • patient with any medical or psychiatric condition that, in the opinion of the Principal Investigator, would preclude her from participating in this study
  • patient with a known allergy to one or several of the study compounds
  • patients who may not be regularly available due to geographical, social or family reasons
  • history of renal, hepatic or metabolic pathology that could preclude with metabolism or elimination of the study product
  • deficiencies of the upper intestinal tract, malabsorption syndrome
  • patient who is pregnant, breast-feeding or using inadequate contraception
  • Treatment with experimental drugs (mTor inhibitor or tyrosin kinase inhibitor)
  • Patient treated with molecules that interfer with isoenzyme CYP3A

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01298713

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Hopital Hotel Dieu
Paris, France, 75004
Sponsors and Collaborators
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Principal Investigator: Thomas Bachelot, MD ARCAGY-GINECO
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: ARCAGY/ GINECO GROUP
ClinicalTrials.gov Identifier: NCT01298713    
Other Study ID Numbers: TAMRAD
EUDRACT 2006-004332-79
First Posted: February 18, 2011    Key Record Dates
Last Update Posted: November 8, 2018
Last Verified: November 2018
Keywords provided by ARCAGY/ GINECO GROUP:
Previously received anti-aromatase treatment
mTor inhibitor
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasm Metastasis
Neoplasms by Site
Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes
MTOR Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents