NCT00210028

Brief Summary

The purpose of this study is to evaluate the objective response rate when ZARNESTRA is added to treatment with tamoxifen

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2003

Longer than P75 for phase_2

Geographic Reach
1 country

3 active sites

Status
terminated

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

August 1, 2003

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

November 14, 2006

Status Verified

November 1, 2006

First QC Date

September 13, 2005

Last Update Submit

November 10, 2006

Conditions

Breast Neoplasms

Keywords

Breast NeoplasmsZarnestraTamoxifenestrogen receptorprogesterone receptor

Outcome Measures

Primary Outcomes (1)

  • To evaluate the objective response rate when ZARNESTRA is added to administration of tamoxifen in patients suffering from metastatic or advanced inoperable breast cancer, who are progressing on tamoxifen treatment

Secondary Outcomes (5)

  • To evaluate the time to progression

  • To evaluate the clinical benefit (response + stable disease at 6 months)

  • To evaluate the safety of the combination ZARNESTRA and tamoxifen

  • To evaluate a possible pharmacokinetic interaction between ZARNESTRA and tamoxifen

  • To evaluate the biological predictive and prognostic factors of a response

Interventions

TamoxifenDRUG
ZarnestraDRUG

Eligibility Criteria

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

You may qualify if:

  • Histologically proven, metastatic or locally advanced inoperable breast cancer
  • Tumor considered potentially hormone-sensitive, i.e. presence by IHC of hormone receptors for estrogens (ER+ for more than 10% of cells) and/or progesterone (Pg+ for more than 10% of cells) or both. This expression may have been detected on the primary tumor or at a metastatic site. The method used will be reassessed by IHC if it involves a radioligand technique whenever it is possible to obtain histological material.
  • Progressing on treatment with tamoxifen, given either as adjuvant treatment or for advanced/metastatic breast cancer. Any previous treatment with a steroidal or nonsteroidal antiaromatase in a neo-adjuvant, adjuvant or metastatic situation is permitted. Likewise, any previous treatment with chemotherapy and/or herceptin in a nonmetastatic situation is permitted.
  • Post-menopausal patients
  • Age \> 18 years
  • At least one measurable lesion according to the Response Evaluation Criteria for Solid Tumors (RECIST) criteria; for patients who only have bone metastases, an evaluable non-irradiated lytic lesion is required
  • Performance Status (WHO): PS ≤ 2 (Appendix 1).
  • Laboratory tests in accordance with the following criteria:
  • Neutrophils ≥ 2x109/l,Platelets ≥ 100x109/l,Hemoglobin ≥ 10 g/dl, ASAT, ALAT ≤ 2.5 N , or \< 5 N when liver metastasis,bilirubin ≤ 1.5 N creatinin ≤ 1.5 N
  • Signed, written consent before any study-related procedure

You may not qualify if:

  • Men
  • Pre-menopausal patients who are not receiving concurrent LHRH agonist therapy
  • ER- and PR-negative patients
  • Contraindication to antiestrogens (thromboembolic risk) or ZARNESTRA
  • Non metastatic tumor susceptible to management by radiotherapeutic and/or surgical means
  • T4d inflammatory tumor (PEV 2 or 3).
  • Short-term, life-threatening lesions: hepatic invasion \> 1/3 of liver volume, pulmonary lymphangitis, uncontrolled cerebral metastases, carcinomatous meningitis
  • Sensory neuropathy \> or = grade 1 (WHO)
  • Previous history of uncontrolled cancers or controlled for less than 5 years, except basal cell skin cancers and in situ cancers of the cervix.
  • Chronic diseases (somatic or psychiatric) with a poor prognosis
  • subjects with enzyme-inducing anti-convulsants (e.g., phenytoin, phenobarbital, carbamazepine) : this treatment is not permitted while taking ZARNESTRA
  • Patients who, for family, social, geographic or psychological reasons, could not be followed up correctly.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Institut Bergonie

Bordeaux, France

Location

Institut Val d'Aurelle_ Paul Lamarque

Montpellier, France

Location

Institut Claudius Regaud

Toulouse, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Tamoxifentipifarnib

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

StilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Henri Roché, Pr

    Institut Claudius Regaud

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

August 1, 2003

Study Completion

August 1, 2008

Last Updated

November 14, 2006

Record last verified: 2006-11

Locations

FR(3)