Metastatic Breast Cancer Clinical Trial
Official title:
Randomized Phase II Trial of Letrozole With or Without Dasatinib as First and Second-line Treatment for Hormone Receptor-positive, HER2-negative Post-menopausal Breast Cancer That is Unresectable, Locally Recurrent or Metastatic
| 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 |
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
| 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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb | US Oncology Research |
United States,
| 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 |
| 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 |