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

Bristol-Myers Squibb120 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

120

Conditions

Metastatic Breast Cancer

Interventions

DasatinibDRUG

Tablets, Oral, 100 mg once daily, up to 2 years

LetrozoleDRUG

Tablets, Oral, 2.5 mg, once daily, up to 2 years

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (27)

Outcomes

Primary Outcomes

Number of Participants With Clinical Benefit (CBR) and Number of Participants With CBR Having a Disease Free Interval (DFI) Greater Than 2 Years - Evaluable Population

CBR=participants with complete response (CR) + participants with partial response (PR) + participants with stable disease (SD) for a length of time greater than, equal to 6 months. 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.

Time frame: First dose of study drug to last dose plus 7 days, up to study completion (approximately 6 years)

Secondary Outcomes

Number of Participants With Complete Response, Partial Response, Stable Disease, and Disease Progression

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.

Time frame: First dose of study drug to last dose plus 7 days, up to study completion (approximately 6 years)

Median Progression Free Survival (PFS) - Intent to Treat (ITT) Population

PFS was measured in months. 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. Study initiated 2008 and completed 2014.

Time frame: Day 1 to Study Completion (approximately 6 years)

Data from ClinicalTrials.gov

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Northern Arizona Hematology & Oncology Associates

Sedona, Arizona, United States

Arizona Oncology Associates D.B.A. Hematology Oncology

Tucson, Arizona, United States

Rocky Mountain Cancer Centers

Denver, Colorado, United States

Florida Cancer Institute - New Hope

Hudson, Florida, United States

Central Indiana Cancer Centers

Carmel, Indiana, United States

New York Oncology Hematology, Pc

Troy, New York, United States

Dayton Oncology And Hematology

Kettering, Ohio, United States

Willamette Valley Cancer Center

Eugene, Oregon, United States

Northwest Cancer Specialists, Pc

Portland, Oregon, United States

Medical Oncology Associates

Kingston, Pennsylvania, United States

...and 17 more locations

Percentage of Participants Best Overall Response After Change From Letrozole to Letrozole Plus Dasatinib

Participants in single-agent letrozole treatment arm who developed progressive disease, could continue letrozole, and add dasatinib to their treatment regimen. CBR=participants with CR + participants with partial response (PR) + participants with SD for a length of time ≥6 months divided by the total number of participants (%). 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. 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.

Time frame: First dose of study drug to last dose plus 7 days, up to study completion (approximately 6 years)

Percentage of Participants With PFS At 6 Months and At 12 Months - ITT Population

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. ITT population: from time of first enrollment to first PD for all ITT participants.

Time frame: At 6 months and at 12 months

Median Time to Treatment Failure (TTF) - ITT Population

Time to TTF was measured in months. The number of participants with events (PD or off treatment due to any reason) was evaluated. The first PD was defined as the event for cross over participants in the single- agent letrozole treatment arm to add dasatinib to their regimen.

Time frame: First dose of study drug to last dose plus 7 days, up to study completion (approximately 6 years)

Number of Participants With Adverse Events (AEs) Leading to Discontinuation, Serious Adverse Events (SAEs), and Deaths

AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=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.

Time frame: First dose of study drug to last dose plus 30 days, up to study completion (approximately 6 years)