NCT00466102

Brief Summary

The purpose of this study is to determine wether RAD001 can inhibit growth of tumour cells and/or stop the formation and activity of bone degrading osteoclasts.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
130

participants targeted

Target at P75+ for phase_2 breast-cancer

Timeline
Completed

Started Dec 2006

Typical duration for phase_2 breast-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 27, 2007

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

August 30, 2012

Status Verified

August 1, 2012

Enrollment Period

4 years

First QC Date

April 25, 2007

Last Update Submit

August 29, 2012

Conditions

Breast Cancer

Keywords

Breast CancerBone metastases as only metastatic siteBreast cancer, HER2 negativeBone metastasis as only metastatic sitePretreated with endocrine therapyUp to one previous chemotherapyPrevious treatment with bisphosphonates allowed

Outcome Measures

Primary Outcomes (1)

  • To determine the time to progression (TTP) in patients with no change in bone metastases after an 8 week run in treatment with RAD001 compared to placebo

    40 weeks

Secondary Outcomes (6)

  • To determine the objective response rate after 8 weeks of RAD001

    8 weeks

  • To determine the TTP in patients with a response after 8 weeks of RAD001

    8 weeks

  • To determine the overall clinical benefit defined as CR, PR or stable disease > 24 weeks for patients continuing RAD001 after the 8 week run in phase

    40 weeks

  • To evaluate the safety and toxicity of RAD001

    40 weeks

  • To assess the frequency of bone related events

    40 weeks

  • +1 more secondary outcomes

Study Arms (2)

1

ACTIVE COMPARATOR

Patients with stable disease after 8 week run in randomized to RAD001 (blinded)

Drug: RAD001

2

PLACEBO COMPARATOR

Patients with stable disease after 8 week run in receive placebo (blinded)

Drug: Placebo

Interventions

RAD001DRUG

Tablet of 5 mg, 2 tablets (10 mg) are taken once daily during study therapy

1
PlaceboDRUG

2 tablets are taken once daily during study therapy

2

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Written informed consent prior to beginning specific protocol procedures, including expected cooperation of the patients for the treatment and follow-up, must be obtained and documented according to the local regulatory requirements.
  • Histologically confirmed invasive adenocarcinoma of the breast.
  • Primary tumour or metastasis negative or positive (≥ 10% positive stained cells) for oestrogen and/or progesterone receptor detected by immunohistochemistry.
  • Single or multiple bone metastasis (x-ray, CT or MRI) as only metastatic site.
  • Postmenopausal hormone receptor positive patients should have received an aromatase inhibitor in any given previous breast cancer therapy. Concurrent endocrine treatment for metastatic bone disease is obligatory. Previous treatment with bisphosphonates is allowed.
  • Up to one previous chemotherapy for metastatic disease is allowed.
  • Patients must have either measurable or non-measurable target lesions according to the WHO criteria.
  • At least 1 target lesion must be completely outside the radiation portal or there must be pathologic proof of progressive disease.
  • At least 2 weeks since major surgery with full recovery.
  • Complete staging within 4 weeks prior to registration.
  • Karnofsky performance status evaluation \> 60%.
  • Age \>18 years.
  • Absolute neutrophil count \>1,500 cells/µl, platelet count \>100,000 cells/µl.
  • Bilirubin \>1.5x the upper normal limit for the institution (UNL); elevation of transaminases, alkaline phosphatase \< 2.5x UNL and serum albumin \< 30g/l. Normal renal function (creatinine \>1.5x upper normal limit)
  • If of childbearing potential, negative pregnancy test. In addition the patient has to agree to use an effective method to avoid pregnancy for the duration of the study.

You may not qualify if:

  • Known hypersensitivity reaction to the compounds or incorporated substances (e.g. everolimus or sirolimus \[rapamycin\] or lactose).
  • Concurrent immunotherapy or hormone replacement therapy and use of hormonal contraceptives.
  • Need for chemotherapy or irradiation of bone metastasis during study treatment
  • HER2 positive primary tumour and/or lesion
  • Evidence of metastasis in other organs
  • Uncompensated diabetes mellitus; fasting value of blood sugar of \>120 (mg/dl)
  • Corrected (adjusted for serum albumin) serum calcium concentration \< 8.0 mg/dl (2.00 mmol/l) or \> 12.0 mg/dl (3.00 mmol/l)
  • Abnormal renal function as evidenced by a calculated creatinine clearance \< 30 ml/minute
  • Life expectancy of less than 3 months
  • Serious intercurrent medical or psychiatric illness that may interfere with the planned treatment (including AIDS and serious active infection).
  • History of other malignancy within the last 5 years which could affect the diagnosis or assessment of metastatic breast cancer
  • Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational not marketed drug within 30 days prior to study entry.
  • Patients being treated with drugs recognized as being strong inhibitors or inducers of the isoenzyme CYP3A (e.g. rifabutin, rifampicin, clarithromycin, ketoconazole, itraconazole, ritonavir, telithromycin, erythromycin, verapamil, dilitazem) within the last 5 days or the expected need for these treatments during study participation.
  • Pregnant or nursing women.
  • The patient is not accessible for treatment and follow-up. Patients registered on this trial must be treated and followed at the participating centre which could be the Principal or Co-Investigator's site.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. med. Christoph Mundhenke

Kiel, Schleswig-Holstein, 24105, Germany

Location

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Everolimus

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

SirolimusMacrolidesLactonesOrganic Chemicals

Study Officials

  • Nicolai Maass, MD, Prof.

    Universitätsfrauenklinik Aachen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2007

First Posted

April 27, 2007

Study Start

December 1, 2006

Primary Completion

December 1, 2010

Study Completion

December 1, 2012

Last Updated

August 30, 2012

Record last verified: 2012-08

Locations

DE(1)