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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00793546




Registration number
NCT00793546
Ethics application status
Date submitted
29/10/2008
Date registered
19/11/2008
Date last updated
5/11/2012

Titles & IDs
Public title
Study Evaluating Bosutinib-Exemestane Combination Vs Exemestane Alone in Post Menopausal Women With Breast Cancer
Scientific title
A Phase 2, Randomized, Open-Label Study Of Bosutinib Administered In Combination With Exemestane Versus Exemestane Alone As Second Line Therapy In Postmenopausal Women With Locally Advanced Or Metastatic ER+/PgR+/ErbB2- Breast Cancer
Secondary ID [1] 0 0
B1871009
Secondary ID [2] 0 0
3160A6-2206
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Bosutinib
Treatment: Drugs - exemestane
Treatment: Drugs - Exemestane

Experimental: 1 - combination of bosutinib and exemestane

Active Comparator: 2 - exemestane


Treatment: Drugs: Bosutinib
300 mg =(3x100mg) tablets once daily during the active phase of treatment until disease progression, unacceptable toxicity or withdrawal of consent occurs

Treatment: Drugs: exemestane
25 mg tablet once daily

Treatment: Drugs: Exemestane
25 mg - 1 tablet per day- once daily daily during the active phase of treatment until disease progression, unacceptable toxicity or withdrawal of consent occurs

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival (PFS) Based on Independent Radiologist - Time in weeks from randomization to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of randomization plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was "Death").
Timepoint [1] 0 0
Part 2 Baseline, every 8 weeks up to 2 to 6 weeks after last dose
Secondary outcome [1] 0 0
Percentage of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs) - An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.
Timepoint [1] 0 0
Baseline up to 28 days after the last dose
Secondary outcome [2] 0 0
Progression Free Survival (PFS) Based on Investigator - Time in weeks from randomization to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of randomization plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was "Death").
Timepoint [2] 0 0
Part 2 Baseline, every 8 weeks up to 2 to 6 weeks after last dose
Secondary outcome [3] 0 0
Percentage of Participants With Objective Response - Percentage of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as greater than or equal to >=30 percent (%) decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study >=4 weeks after initial documentation of response.
Timepoint [3] 0 0
Part 2 Baseline, every 8 weeks up to 2 to 6 weeks after last dose
Secondary outcome [4] 0 0
Overall Survival (OS) - Time in weeks from randomization to date of death due to any cause. OS was calculated as (the death date minus the date of randomization plus 1) divided by 7. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).
Timepoint [4] 0 0
Part 2 Baseline until death or up to 24 months
Secondary outcome [5] 0 0
Duration of Response (DR) - Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7. DR was calculated for the subgroup of participants with a confirmed objective tumor response.
Timepoint [5] 0 0
Part 2 Baseline, every 8 weeks up to 2 to 6 weeks after last dose
Secondary outcome [6] 0 0
Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B) - FACT-B is used for assessment of health-related quality of life (QoL) in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and additional concerns on breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures ranges from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
Timepoint [6] 0 0
Part 2 Baseline, Week 12, 2 to 6 weeks after last dose
Secondary outcome [7] 0 0
Euro Quality of Life (EQ-5D)- Health State Profile Utility Score - EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Timepoint [7] 0 0
Part 2 Baseline, Week 12, 2 to 6 weeks after last dose
Secondary outcome [8] 0 0
Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) - EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 millimeter (mm) = worst imaginable health state to 100 mm =best imaginable health state; higher scores indicate a better health state.
Timepoint [8] 0 0
Part 2 Baseline, Week 12, 2 to 6 weeks after last dose
Secondary outcome [9] 0 0
Maximum Observed Plasma Concentration (Cmax)
Timepoint [9] 0 0
0 hour (pre-dose) on Day 1, 1, 2, 3, 4, 6, 8, 24 hours post-dose on Day 29
Secondary outcome [10] 0 0
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Timepoint [10] 0 0
0 hour (pre-dose) on Day 1, 1, 2, 3, 4, 6, 8, 24 hours post-dose on Day 29
Secondary outcome [11] 0 0
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-24)] - AUC (0-24)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-24).
Timepoint [11] 0 0
0 hour (pre-dose) on Day 1, 1, 2, 3, 4, 6, 8, 24 hours post-dose on Day 29

Eligibility
Key inclusion criteria
- Woman aged 18 years or older.

- Confirmed pathologic diagnosis of breast cancer.

- Locally advanced, metastatic, or locoregional recurrent breast cancer not amenable to
curative treatment with surgery or radiotherapy.

- Surgically sterile or postmenopausal woman.

- Documented ER+ and/or PgR+ and erbB2- tumor.

- Progression of locally advanced or metastatic disease during treatment with a
nonsteroidal AI or tamoxifen, or progression during treatment with (or within 6 months
of discontinuation of) an adjuvant nonsteroidal AI.
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- Prior exemestane, prior bosutinib, or any other prior anti-Src therapy.

- More than 1 prior endocrine treatment for locally advanced or MBC.

- More than 1 prior cytotoxic chemotherapy regimen in metastatic setting.

- Bone or skin as the only site of disease.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Pfizer Investigational Site - South Brisbane
Recruitment postcode(s) [1] 0 0
4101 - South Brisbane
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Illinois
Country [3] 0 0
United States of America
State/province [3] 0 0
Massachusetts
Country [4] 0 0
United States of America
State/province [4] 0 0
Michigan
Country [5] 0 0
United States of America
State/province [5] 0 0
New Jersey
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
Pennsylvania
Country [8] 0 0
United States of America
State/province [8] 0 0
Washington
Country [9] 0 0
Belgium
State/province [9] 0 0
Brussels
Country [10] 0 0
Belgium
State/province [10] 0 0
Leuven
Country [11] 0 0
Belgium
State/province [11] 0 0
Liege
Country [12] 0 0
Belgium
State/province [12] 0 0
Wilrijk
Country [13] 0 0
Canada
State/province [13] 0 0
British Columbia
Country [14] 0 0
China
State/province [14] 0 0
Beijing
Country [15] 0 0
Hong Kong
State/province [15] 0 0
Hong Kong
Country [16] 0 0
Hungary
State/province [16] 0 0
Budapest
Country [17] 0 0
India
State/province [17] 0 0
Maharashtra
Country [18] 0 0
Poland
State/province [18] 0 0
Olsztyn
Country [19] 0 0
South Africa
State/province [19] 0 0
Gauteng
Country [20] 0 0
Spain
State/province [20] 0 0
Barcelona
Country [21] 0 0
Spain
State/province [21] 0 0
Madrid
Country [22] 0 0
Spain
State/province [22] 0 0
Valencia
Country [23] 0 0
State/province [23] 0 0

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a phase 2, open-label, multicenter, 2-arm study of bosutinib administered in
combination with exemestane versus exemestane alone. This is a 2-part study consisting of a
safety lead-in phase and randomized phase 2 portion. Subjects in part 1 will receive
bosutinib and exemestane daily, and will be closely monitored for 28 days. If no safety
concerns arise, then future eligible subjects will be randomly assigned to the main phase of
the study. They will either receive bosutinib daily combined with daily exemestane, or daily
exemestane alone for a specified period of time. Subjects will be followed up for survival
after treatment discontinuation.
Trial website
https://clinicaltrials.gov/show/NCT00793546
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT00793546