Efficacy and Safety of BMS-690514 in Combination With Letrozole to Treat Metastatic Breast Cancer

Part of paid clinical trials in Abilene, Texas.

Sponsor
Bristol-Myers Squibb
Study ID
NCT01068704
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BMS-690514 — DRUG
    Tablets, Oral, 200 mg, once daily, \~ 12 months depending on response
  • Lapatinib — DRUG
    Tablets, Oral, 1500 mg, once daily, \~ 12 months depending on response
  • Letrozole — DRUG
    Tablets, Oral, 2.5 mg, once daily, \~ 12 months depending on response

Study Details

The purpose of this study is to determine if BMS-690514 + letrozole will be more effective than lapatinib + letrozole in patients who have metastatic hormone receptor positive breast cancer after developing progressive disease immediately following adjuvant antiendocrine therapy

Key Dates

Start date
Jun 30, 2010
Status verified
Sep 2015
Primary completion
Dec 31, 2010
Completion
Dec 31, 2010

Study Design

Enrollment
4 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: BMS-690514 + Letrozole
  • Active Comparator: Lapatinib + Letrozole

Primary Outcome Measure

Clinical Benefit Rate defined as percentage of subjects with a complete response, partial response, or stable disease for at least 6 months [ Time Frame: Every 8 weeks according to CT scan ]

Locations (4)

FacilityCityStateZIPSite coordinators
Texas Oncology-AbileneAbileneTexas79606-
Texas Oncology-BeaumontBeaumontTexas77702-
Us Oncology Central PharmacyFort WorthTexas76177-
Yakima Valley Memorial Hospital/North Star LodgeYakimaWashington98902-

Find similar trials in Abilene, TX

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Texas Oncology-Abilene· Abilene, TXTexas Oncology-Beaumont· Beaumont, TXUs Oncology Central Pharmacy· Fort Worth, TXYakima Valley Memorial Hospital/North Star Lodge· Yakima, WA

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