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OpenTrials
Completed

NCT Number: NCT00426530

Safety of Everolimus in Combination Therapy, in Patients With HER2-overexpressing Metastatic Breast Cancer

This study will look at different dose levels and regimens of everolimus combined with weekly trastuzumab and vinorelbine therapy in patients with HER-2 overexpressing metastatic breast cancer.

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Key information

Conditions

Breast Neoplasms Breast Diseases Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Novartis Investigative Site, Brussels, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female or male patients ≥18 years with WHO performance status ≤ 1
  • HER-2 overexpressing metastatic breast cancer cells confirmed by histology
  • Progressive disease on prior trastuzumab alone/or in combination with other anticancer agents, or relapsed any time after completion of this therapy
  • Patients neurologically stable with adequate bone marrow, liver and renal function

Exclusion criteria

  • Patients receiving endocrine therapy for breast cancer ≤ 2 weeks prior to study treatment start
  • Patients currently receiving chemotherapy, immunotherapy or radiotherapy or who have received these ≤ 4 weeks prior to study treatment start or patients who have received lapatinib ≤ 2 weeks prior to study treatment start
  • Patients who have previously received vinorelbine or mTOR inhibitors

Other protocol-defined inclusion/exclusion criteria may apply

Treatment and study plan

Everolimus (RAD001)

Drug

Primary outcomes

  1. To establish the feasible dose levels/regimens based on End-of-cycle-1 dose limiting toxicity (DLT)

    Time frame: after ever DLT within the first cycle, at least 21 days on treatment, every 2 months from first date of enrollment in a particular regimen

Secondary outcomes

  1. To assess the ability to deliver the trastuzumab and vinorelbine therapy

    Time frame: After LPLV

  2. To assess everolimus, trastuzumab and vinorelbine blood levels in this combination

    Time frame: After LPLV

  3. To evaluate the overall tumor response

    Time frame: every 9 weeks/minus 1 week

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A Phase Ib Study Investigating the Combination of Everolimus With Trastuzumab and Vinorelbine in Patients With HER2-overexpressing Metastatic Breast Cancer

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Jan 24, 2007
Registry last updated
Dec 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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