Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00696072
Other study ID # CA180-185
Secondary ID USOR 06-185
Status Completed
Phase Phase 2
First received June 10, 2008
Last updated May 6, 2015
Start date August 2008
Est. completion date June 2014

Study information

Verified date May 2015
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to find out what effect the combination of letrozole (brand name: Femara) and dasatinib (brand name: Sprycel) has on metastatic breast cancer compared to letrozole alone


Recruitment information / eligibility

Status Completed
Enrollment 108
Est. completion date June 2014
Est. primary completion date June 2014
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

- Has histologic or cytologic diagnosis of breast cancer; evidence of unresectable locally recurrent or metastatic disease

- Has measurable or evaluable-only disease

- Is female, =18 yrs of age, post menopausal or surgically sterile

- HER2 negative, HR+, ER+ and/or PgR+ breast cancer

- 0-1 prior chemotherapy regimen for metastatic disease.

- Prior adjuvant or neoadjuvant chemotherapy completed at least 1 month prior

- Prior tamoxifen therapy is allowed

- No AI therapy for >1 year without recurrence

Exclusion Criteria:

- Pregnant or breast feeding

- Prior hormonal therapy for metastatic or locally recurrent disease

- >1 chemotherapy regimen for metastatic disease

- Pleural or pericardial effusion

- Serious cardiac condition

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Dasatinib + Letrozole
Tablets, Oral, once daily, up to 2 years Dasatinib 100 mg + Letrozole 2.5 mg
Letrozole
Tablets, Oral, 2.5 mg, once daily, up to 2 years

Locations

Country Name City State
United States Texas Oncology-Central Austin Cancer Center Austin Texas
United States Texas Oncology Bedord Texas
United States Central Indiana Cancer Centers Carmel Indiana
United States Texas Cancer Center At Medical City Dallas Texas
United States Texas Oncology Dallas Texas
United States Texas Oncology Sammons Cancer Center Dallas Texas
United States Rocky Mountain Cancer Centers Denver Colorado
United States El Paso Cancer Treatment Ctr - East El Paso Texas
United States Willamette Valley Cancer Center Eugene Oregon
United States Texas Oncology Fort Worth Texas
United States Texas Oncology Garland Texas
United States Texas Oncology Houston Texas
United States Florida Cancer Institute - New Hope Hudson Florida
United States Dayton Oncology And Hematology Kettering Ohio
United States Medical Oncology Associates Kingston Pennsylvania
United States Virginia Oncology Associates Norfolk Virginia
United States Texas Oncology-Plano East Plano Texas
United States Northwest Cancer Specialists, Pc Portland Oregon
United States Oncology & Hematology Associates Of Southwest Virginia, Inc. Salem Virginia
United States Cancer Care Centers Of South Texas San Antonio Texas
United States Northern Arizona Hematology & Oncology Associates Sedona Arizona
United States Texas Oncology Cancer Center - Sugar Land Sugar Land Texas
United States New York Oncology Hematology, Pc Troy New York
United States Arizona Oncology Associates D.B.A. Hematology Oncology Tucson Arizona
United States Tyler Cancer Center Tyler Texas
United States Texas Oncology Cancer Care And Research Center Waco Texas
United States Yakima Valley Memorial Hospital/North Star Lodge Yakima Washington

Sponsors (2)

Lead Sponsor Collaborator
Bristol-Myers Squibb US Oncology Research

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Determine the clinical benefit rate with letrozole or with letrozole plus dasatinib (CBR equal to CR+PR+SD =6 months) No
Secondary Overall response rate in patients who receive letrozole plus dasatinib or single-agent letrozole at 2 years No
Secondary Median PFS in patients in both Arms at 6 and 12 months No
Secondary Overall response rate & CBR in patients who crossover to either Arm 1b or Arm 2b at 2 years No
Secondary PFS for both treatment arms at 6- and 12-months No
Secondary Time to treatment failure (TTF) at 6 months and 1 year No
Secondary Changes in bone markers at 6 months and 1 year No
Secondary Toxicity at each clinic visit Yes
Secondary Effect on bone pain at each clinic visit No
Secondary Bone Mineral Density changes between baseline and 6 months No
See also
  Status Clinical Trial Phase
Withdrawn NCT04872608 - A Study of Letrozole, Palbociclib, and Onapristone ER in People With Metastatic Breast Cancer Phase 1
Terminated NCT02202746 - A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer Phase 2
Completed NCT02506556 - Phosphatidylinositol 3-kinase (PI3K) Alpha iNhibition In Advanced Breast Cancer Phase 2
Recruiting NCT05534438 - A Study on Adding Precisely Targeted Radiation Therapy (Stereotactic Body Radiation Therapy) to the Usual Treatment Approach (Drug Therapy) in People With Breast Cancer Phase 2
Recruiting NCT03368729 - Niraparib in Combination With Trastuzumab in Metastatic HER2+ Breast Cancer Phase 1/Phase 2
Completed NCT04103853 - Safety, Tolerability, and Pharmacokinetics of Proxalutamide Therapy in Women With Metastatic Breast Cancer Phase 1
Terminated NCT01847599 - Educational Intervention to Adherence of Patients Treated by Capecitabine +/- Lapatinib N/A
Active, not recruiting NCT03147287 - Palbociclib After CDK and Endocrine Therapy (PACE) Phase 2
Not yet recruiting NCT06062498 - Elacestrant vs Elacestrant Plus a CDK4/6 Inhibitor in Patients With ERpositive/HER2-negative Advanced or Metastatic Breast Cancer Phase 2
Recruiting NCT05383196 - Onvansertib + Paclitaxel In TNBC Phase 1/Phase 2
Recruiting NCT04095390 - A Phase Ⅱ Trial of Pyrotinib Combination With CDK4/6 Inhibitor SHR6390 in Patients Prior Trastuzumab-treated Advanced HER2-Positive Breast Cancer Phase 2
Active, not recruiting NCT04432454 - Evaluation of Lasofoxifene Combined With Abemaciclib in Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation Phase 2
Recruiting NCT03323346 - Phase II Trial of Disulfiram With Copper in Metastatic Breast Cancer Phase 2
Recruiting NCT05744375 - Trastuzumab Deruxtecan in First-line HER2-positive Locally Advanced/MBC Patients Resistant to Trastuzumab+Pertuzumab Phase 2
Completed NCT02924883 - A Study to Evaluate the Efficacy and Safety of Trastuzumab Emtansine in Combination With Atezolizumab or Atezolizumab-Placebo in Participants With Human Epidermal Growth Factor-2 (HER2) Positive Locally Advanced or Metastatic Breast Cancer (BC) Who Received Prior Trastuzumab and Taxane Based Therapy Phase 2
Completed NCT01942135 - Palbociclib (PD-0332991) Combined With Fulvestrant In Hormone Receptor+ HER2-Negative Metastatic Breast Cancer After Endocrine Failure (PALOMA-3) Phase 3
Completed NCT01881230 - Evaluate Risk/Benefit of Nab Paclitaxel in Combination With Gemcitabine and Carboplatin Compared to Gemcitabine and Carboplatin in Triple Negative Metastatic Breast Cancer (or Metastatic Triple Negative Breast Cancer) Phase 2/Phase 3
Active, not recruiting NCT04448886 - Sacituzumab Govitecan +/- Pembrolizumab In HR+ / HER2 - MBC Phase 2
Completed NCT01401959 - Trial of Eribulin in Patients Who Do Not Achieve Pathologic Complete Response (pCR) Following Neoadjuvant Chemotherapy Phase 2
Terminated NCT04720664 - Oral SM-88 in Patients With Metastatic HR+/HER2- Breast Cancer Phase 2