NCT01298713 · CITED IN SOURCE DOCUMENTS

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

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2023-09-06

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part

eligibility Criteria: 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
healthy Volunteers: false
minimum Age: 18 Years
sex: FEMALE
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Tamoxifen 20mg/d
intervention Names
Drug: Tamoxifen
label
A
type
ACTIVE_COMPARATOR
description
Tamoxifen 20mg/d + RAD001 10mg/d
intervention Names
Drug: Tamoxifen
Drug: Everolimus
label
B
type
EXPERIMENTAL

interventions

arm Group Labels
A
B
description
20mg daily (1 cap) until unbearable toxicity or progression
name
Tamoxifen
type
DRUG
arm Group Labels
B
description
10mg daily (2 caps of 5mg) until unbearable toxicity or progression
name
Everolimus
other Names
RAD001
type
DRUG

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 111
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

measure
Clinical benefit at 24 weeks
time Frame
42 months

secondary Outcomes

measure
Partial and complete response per RECIST
time Frame
42 months
measure
Qualitative and quantitative toxicities
time Frame
24 months
measure
Overall survival
time Frame
42 months

Full study description

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.

Source references

references

citation
Treilleux I, Arnedos M, Cropet C, Wang Q, Ferrero JM, Abadie-Lacourtoisie S, Levy C, Legouffe E, Lortholary A, Pujade-Lauraine E, Bourcier AV, Eymard JC, Spaeth D, Bachelot T. Translational studies within the TAMRAD randomized GINECO trial: evidence for mTORC1 activation marker as a predictive factor for everolimus efficacy in advanced breast cancer. Ann Oncol. 2015 Jan;26(1):120-125. doi: 10.1093/annonc/mdu497. Epub 2014 Oct 31.
pmid
25361980
type
DERIVED

Source notices and limitations

Discovery and provenance

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0%).</li><li>OS differences were not significant after further follow-up.[<a href="#cit/section_10.28">28</a>]</li></ul></div></li><li><a href="/clinicaltrials/NCT01298713">TAMRAD</a> (NCT01298713) was an open-label, randomized, phase II trial comparing tamoxifen with tamoxifen plus everolimus in postmenopausal women whose diseas
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es were not significant after further follow-up.[<a href="#cit/section_10.28">28</a>]</li></ul></div></li><li><a href="/clinicaltrials/NCT01298713">TAMRAD</a> (NCT01298713) was an open-label, randomized, phase II trial comparing tamoxifen with tamoxifen plus everolimus in postmenopausal women whose disease had progressed after re
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Breast Cancer Treatment (PDQ®)–Health Professional Version
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Updated: April 25, 2025
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https://www.cancer.gov/types/breast/hp/breast-treatment-pdq

Preserved source evidence · Not medical advice