Know Cancer

or
forgot password

A Randomized Double-Blind Phase-2 Study of Anastrozole Plus Lonafarnib (SCH 66336) or Anastrozole Plus Placebo for the Treatment of Subjects With Advanced Breast Cancer


Phase 2
N/A
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

A Randomized Double-Blind Phase-2 Study of Anastrozole Plus Lonafarnib (SCH 66336) or Anastrozole Plus Placebo for the Treatment of Subjects With Advanced Breast Cancer


Inclusion Criteria:



- Postmenopausal women who have histologically-confirmed breast cancer with the
following characteristics:

- estrogen and/or progesterone receptor positive,

- locally advanced disease

- distant metastatic disease, stage 4

- Subjects eligible for single-agent treatment with aromatase inhibitors for current
disease.

- Subjects taking biophosphonates are allowed if they begin bisphosphonate therapy AT
LEAST two weeks prior to randomization.

- Measurable disease (masses with clearly defined margins on radiological images and at
least one diameter >=20 mm[>=10 mm if spiral CT]) or evaluable disease (masses with
margins not clearly defined on radiological images or with no diameter >= 20 mm).
Subjects with bone disease only are permitted if disease is evaluable.

- ECOG Performance Status of 0 or 1.

- Sufficient bone marrow reserve.

- Adequate hepatic and renal function: laboratory values within protocol requirements.

Exclusion Criteria:

- Subjects who have received more than one regimen of cytotoxic chemotherapy for
advanced disease.

- Subjects with with CLINICALLY APPARENT brain metastases or extensive visceral
disease, including extensive hepatic involvement or pulmonary lymphangitic spread of
tumor.

- Subjects with prior treatments with FTIs.

- Subjects with a known or suspected hypersensitivity to any excipients in the
lonafarnib formulation (Providone, Poloxamer 188, croscarmellose sodium, silicon
dioxide, and magnesium stearate).

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Progression-free survival (PFS)

Outcome Time Frame:

When approximately 70 subjects have progressed

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

P03480

NCT ID:

NCT00081510

Start Date:

December 2003

Completion Date:

May 2009

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

Name

Location