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

Breast Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01298713
• Other study ID #: TAMRAD
• Secondary ID: EUDRACT 2006-004
• Status: Completed
• Phase: Phase 2
• Start date: March 2008
• Est. completion date: September 12, 2018

Study information

• Verified date: September 2023
• Source: ARCAGY/ GINECO GROUP
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: September 12, 2018
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• mTor Protein
• Neoplasm Metastasis

Intervention

Drug:
• Tamoxifen
20mg daily (1 cap) until unbearable toxicity or progression
• Everolimus
10mg daily (2 caps of 5mg) until unbearable toxicity or progression

Locations

Country	Name	City	State
France	Hopital Hotel Dieu	Paris

Sponsors (2)

Lead Sponsor	Collaborator
ARCAGY/ GINECO GROUP	Novartis

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical benefit at 24 weeks		42 months
Secondary	Partial and complete response per RECIST		42 months
Secondary	Qualitative and quantitative toxicities		24 months
Secondary	Overall survival		42 months