Randomized Trial of Fulvestrant With or Without Dasatinib in Men and Postmenopausal Women Who Have Hormone Receptor-positive Advanced Breast Cancer Previously Treated With an Aromatase Inhibitor

Advanced Breast Cancer Clinical Trial

Official title:

Phase II Randomized Trial of Fulvestrant With or Without Dasatinib in Men and Postmenopausal Women Who Have Hormone Receptor-positive Advanced Breast Cancer Previously Treated With an Aromatase Inhibitor

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00754325
• Other study ID #: CA180-158
• Secondary ID: USOR 06-030
• Status: Completed
• Phase: Phase 2
• First received: August 29, 2008
• Last updated: May 25, 2016
• Start date: September 2008
• Est. completion date: January 2014

Study information

• Verified date: May 2016
• 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 fulvestrant (Faslodex) and dasatinib (Sprycel) has on advanced breast cancer compared to fulvestrant alone.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 2014
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

For more information regarding Bristol-Myers Squibb (BMS) clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

• Histologically confirmed hormone receptor positive (HR+) [(estrogen receptor (ER+) and/or progesterone receptors(PgR+)] breast cancer according to immunohistochemistry (IHC)

• Measureable or evaluable-only disease

• human epidermal growth factor receptor 2+ (HER2+) or HER2- breast cancer

• Males and females =18 years of age

• Females are post menopausal or surgically sterile

• Recurrent or progressive advanced breast cancer (locally-advanced or metastatic), that has progressed: (a) during or within 12 months after completion of adjuvant Aromatase Inhibitor (AI) treatment OR (b) during AI treatment in advanced setting (metastatic therapy)

Exclusion Criteria:

• Pregnant or breast feeding

• >1 chemotherapy regimen for advanced 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

• Advanced Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Dasatinib
Tablets, Oral, 100 mg, once daily (QD), upto 2 years
• Fulvestrant
Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1. In subsequent cycles, 500 mg IM administered on Day 1. IM day 1 and 15 first cycle then IM Day 1 for all other cycles for 2 years

Locations

Country	Name	City	State
United States	Texas Oncology-Central Austin Cancer Center	Austin	Texas
United States	Texas Oncology, P.A.	Bedford	Texas
United States	Central Indiana Cancer Centers	Carmel	Indiana
United States	Missouri Cancer Associates	Columbia	Missouri
United States	Texas Oncology	Dallas	Texas
United States	Texas Oncology Sammons Cancer Center	Dallas	Texas
United States	Texas Oncology, P.A.	Dallas	Texas
United States	Texas Cancer Center	Denton	Texas
United States	El Paso Cancer Treatment Ctr - West	El Paso	Texas
United States	Willamette Valley Cancer Center	Eugene	Oregon
United States	Quest Diagnostic Clinical Laboratories Inc	Houston	Texas
United States	Us Oncology Research, Inc.	Houston	Texas
United States	Florida Cancer Institute - New Hope	Hudson	Florida
United States	Minnesota Oncology Hematology, P.A.	Minneapolis	Minnesota
United States	Virginia Oncology Associates	Norfolk	Virginia
United States	Cancer Centers Of Florida, P.A	Ocoee	Florida
United States	Kansas City Cancer Center, Llc.	Overland Park	Kansas
United States	Northwest Cancer Specialists, P.C.	Portland	Oregon
United States	Raleigh Hematology Oncology Associates	Raleigh	North Carolina
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	New York Oncology Hematology, Pc	Troy	New York
United States	Arizona Oncol Assoc Dba (Hem Onc Physicians&Extenders) Hope	Tucson	Arizona
United States	Tyler Cancer Center	Tyler	Texas
United States	Texas Oncology Cancer Care And Research Center	Waco	Texas
United States	Texas Oncology, P.A.	Webster	Texas
United States	Virginia Center Specialists, Pc	Woodbridge	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Disease Progression (PD) or Death	This endpoint evaluated the progression free survival (PFS) of participants amongst the total evaluable population. Progression free survival (PFS) was defined as the time from randomization to either the date the subject was first recorded as having PD (even if the subject went off treatment because of toxicity), or the date of death if the subject died due to any causes before progression. Participants with no recorded post-baseline tumor assessment had PFS censored at the day of randomization. Participants lost to follow-up were censored at the last date of contact. Participants that had not progressed or died had PFS censored at the date of last follow-up.	Date of randomization to date of initial disease progression, or date of death (whichever occurs first), up to January 2014 (approximately 5 years)	No
Secondary	Median Time of Progression-free Survival (PFS)	Progression free survival (PFS) was defined as the time in months from randomization to either the date the subject was first recorded as having PD (even if the subject went off treatment because of toxicity), or the date of death if the subject died due to any causes before progression. Progression=At least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.	Date of randomization to date of initial disease progression, or date of death (whichever occurs first), up to January 2014 (approximately 5 years)	No
Secondary	Percentage of Participants With Progression Free Survival (PFS) at 6 Months	PFS rate was defined as the percentage of participants experiencing no disease progression or death from any cause at 6 months after randomization. Progression free survival (PFS) was defined as the time from randomization to either the date the subject was first recorded as having PD (even if the subject went off treatment because of toxicity), or the date of death if the subject died due to any causes before progression. Progression=At least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Kaplan Meier assessments were used to estimate the percentages.	at 6 months	No
Secondary	Percentage of Participants With Clinical Benefit for At Least 6 Months	Clinical benefit rate (CBR) was defined as the percentage of participants that had Stable Disease (SD), complete response (CR), or partial response (PR) for greater than or equal to 6 months if there was no evidence of progression at or before assessment performed on or after Study Day 161. CR= Disappearance of all target lesions. No new lesions. PR= At least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. SD= Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) taking as reference the smallest sum LD since the treatment started. Physical examination, radiological assessment, and bone scans (if applicable) were used to assess outcome.	Date of randomization to date of initial disease progression, or date of death (whichever occurs first), up to January 2014 (approximately 5 years)	No
Secondary	Number of Participants With Complete Response (CR) , Partial Response (PR), Stable Disease (SD), and Disease Progression (PD)	Table represents the best response achieved over this time frame. CR = Disappearance of all target lesions. No new lesions. PR = At least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. SD = Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) taking as reference the smallest sum LD since the treatment started. Progression (PD): At least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.	Date of randomization to date of initial disease progression, or date of death (whichever occurs first), up to January 2014 (approximately 5 years)	No
Secondary	Number of Participants With Best Overall Response	Best overall response rate (ORR) = number of participants with measurable lesions by Response Evaluation Criteria in Solid Tumors (RECIST) having a best response of complete response (CR) or partial response (PR) divided by number of randomized participants. RECIST 1.1 response criteria applies. To be recorded as best response, CR or PR had to be confirmed at = 4 weeks interval. An unconfirmed CR was recorded as PR.	Date of randomization to date of initial disease progression, or date of death (whichever occurs first), up to January 2014 (approximately 5 years)	No
Secondary	Number of Participants With Serious Adverse Events, Death, and Discontinuation Due to Adverse Events	Adverse event (AE) defined: any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Serious adverse event (SAE) defined: a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.	Date of randomization to date of initial disease progression, or date of death (whichever occurs first), up to January 2014 (approximately 5 years)	Yes

External Links

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