Trial Outcomes & Findings for Saracatinib in Treating Patients With Metastatic or Locally Advanced Breast Cancer That Cannot Be Removed By Surgery (NCT NCT00559507)

Results Overview

DCR defined as complete response (CR), partial response (PR), stable disease (SD) \> 24 weeks. Simon's two-stage optimal design was used to estimate the DCR of AZD0530 after 24 weeks of therapy since this design allowed for early termination of the study. Response and progression was evaluated in this study using the Response Evaluation Criteria in Solid Tumors (RECIST) Target lesions: Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD Progressive Disease (PD): At least a 20% increase in the sum of the 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 Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

12 participants

Primary outcome timeframe

After 24 weeks of study therapy

Results posted on

2014-04-30

Participant Flow

Protocol Open to Accrual 10/25/2007 Primary Compeltion Date 02/22/2011 Recruitment Location is medical clinic

Participant milestones

Participant milestones
Measure	Treatment (Enzyme Inhibitor Therapy) Patients receive saracatinib 175 mg PO on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Study STARTED	12
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (Enzyme Inhibitor Therapy) Patients receive saracatinib 175 mg PO on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Study Not treated, patient ineligible	3

Baseline Characteristics

Saracatinib in Treating Patients With Metastatic or Locally Advanced Breast Cancer That Cannot Be Removed By Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Saracatinib) n=12 Participants Patients will receive AZD0530 175mg orally daily for 4 weeks.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=93 Participants
Age, Categorical >=65 years	3 Participants n=93 Participants
Age, Continuous	57 years STANDARD_DEVIATION 38.18376618 • n=93 Participants
Sex: Female, Male Female	12 Participants n=93 Participants
Sex: Female, Male Male	0 Participants n=93 Participants
Region of Enrollment United States	12 participants n=93 Participants

PRIMARY outcome

Timeframe: After 24 weeks of study therapy

DCR defined as complete response (CR), partial response (PR), stable disease (SD) \> 24 weeks. Simon's two-stage optimal design was used to estimate the DCR of AZD0530 after 24 weeks of therapy since this design allowed for early termination of the study. Response and progression was evaluated in this study using the Response Evaluation Criteria in Solid Tumors (RECIST) Target lesions: Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD Progressive Disease (PD): At least a 20% increase in the sum of the 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 Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started

Outcome measures

Outcome measures
Measure	Treatment (Enzyme Inhibitor Therapy) n=9 Participants Patients receive saracatinib PO on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Disease Control Rate (DCR)	0 participants

SECONDARY outcome

Timeframe: From start of treatment to 24 weeks after completion of study treatment

Overall Response rate is defined as the sum of the complete response rate and partial response rate. Response and progression was evaluated in this study using the Response Evaluation Criteria in Solid Tumors (RECIST) Target lesions: Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD Progressive Disease (PD): At least a 20% increase in the sum of the 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 Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started

Outcome measures

Outcome measures
Measure	Treatment (Enzyme Inhibitor Therapy) n=9 Participants Patients receive saracatinib PO on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Response Rate (CR and PR) Stable Disease	3 participants
Overall Response Rate (CR and PR) Progression of Disease	6 participants

SECONDARY outcome

Timeframe: From the start of treatment up to 4 weeks after completion of study treatment

Outcome measures

Outcome measures
Measure	Treatment (Enzyme Inhibitor Therapy) n=9 Participants Patients receive saracatinib PO on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Median Time to Treatment Failure	82 Days Interval 12.0 to 109.0

Adverse Events

Treatment (Enzyme Inhibitor Therapy)

Serious events: 3 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Enzyme Inhibitor Therapy) n=9 participants at risk Patients receive saracatinib PO on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Blood and lymphatic system disorders Hypoxia	11.1% 1/9 • Number of events 1
General disorders Fatigue (asthenia, lethargy, malaise)	11.1% 1/9 • Number of events 1
General disorders Adrenal insufficiency	11.1% 1/9 • Number of events 1
General disorders Sodium, low (hyponatremia)	11.1% 1/9 • Number of events 1
Hepatobiliary disorders Elevated liver enzymes	11.1% 1/9 • Number of events 1

Other adverse events

Other adverse events
Measure	Treatment (Enzyme Inhibitor Therapy) n=9 participants at risk Patients receive saracatinib PO on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Blood and lymphatic system disorders AST, SGOT	22.2% 2/9 • Number of events 2
Metabolism and nutrition disorders Fatigue	11.1% 1/9 • Number of events 1
Blood and lymphatic system disorders Neutrophils/granulocytes (ANC/AGC)	11.1% 1/9 • Number of events 1
Blood and lymphatic system disorders Hemoglobin	11.1% 1/9 • Number of events 1
General disorders Glucose, high (hyperglycemia)	11.1% 1/9 • Number of events 1
General disorders Potassium, low (hypokalemia)	11.1% 1/9 • Number of events 1
General disorders Phosphate, low (hypophosphatemia)	22.2% 2/9 • Number of events 2
General disorders Bilirubin	11.1% 1/9 • Number of events 1
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	11.1% 1/9 • Number of events 1

Additional Information

Clifford Hudis, MD

Memorial Sloan-Kettering Cancer Center

Phone: 646-888-4551

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60