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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by ARCAGY/ GINECO GROUP.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Novartis
Information provided by:
ARCAGY/ GINECO GROUP
ClinicalTrials.gov Identifier:
NCT01298713
First received: February 16, 2011
Last updated: NA
Last verified: February 2011
History: No changes posted
  Purpose

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 Intervention Phase
Breast Neoplasms
mTor Protein
Drug: Tamoxifen
Drug: Everolimus
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by ARCAGY/ GINECO GROUP:

Primary Outcome Measures:
  • Clinical benefit at 24 weeks [ Time Frame: 42 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Partial and complete response per RECIST [ Time Frame: 42 months ] [ Designated as safety issue: No ]
  • Qualitative and quantitative toxicities [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Overall survival [ Time Frame: 42 months ] [ Designated as safety issue: No ]

Enrollment: 111
Study Start Date: March 2008
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01298713

Locations
France
Hopital Hotel Dieu
Paris, France, 75004
Sponsors and Collaborators
ARCAGY/ GINECO GROUP
Novartis
Investigators
Principal Investigator: Thomas Bachelot, MD ARCAGY-GINECO
  More Information

No publications provided

Responsible Party: Dr Thomas Bachelot, ARCAGY-GINECO
ClinicalTrials.gov Identifier: NCT01298713     History of Changes
Other Study ID Numbers: TAMRAD, EUDRACT 2006-004332-79
Study First Received: February 16, 2011
Last Updated: February 16, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by ARCAGY/ GINECO GROUP:
Hormonoresistance
tamoxifen
Previously received anti-aromatase treatment
mTor inhibitor

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasm Metastasis
Neoplasms by Site
Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes
Tamoxifen
Sirolimus
Everolimus
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Selective Estrogen Receptor Modulators
Bone Density Conservation Agents
Immunosuppressive Agents
Immunologic Factors
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents

ClinicalTrials.gov processed this record on August 28, 2014