Breast NeoplasmsPhase 2NCT00372996
Study Of CP-751,871 In Combination With Exemestane In Postmenopausal Women With Hormone Receptor Positive Advanced Breast Cancer
A Phase 2 study testing CP-751,871, exemestane and Fulvestrant in people with Breast Neoplasms, run by Pfizer at 62 sites in 9 countries.
Trial summary
To test the efficacy of CP-751,871 combined with exemestane in the treatment of postmenopausal patients with hormone positive advanced breast cancer Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- CP-751,871, exemestane and Fulvestrant
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 219 participants
- Where
- 62 sitesin 9 countries
- Study dates
- Feb 2007to Jun 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Postmenopausal women with a diagnosis of hormone receptor positive advanced breast cancer
- HbA1c <5.7%
Who cannot join
- Previous treatment for advanced disease
Trial locations and contacts
62 sites in 9 countries.
62 sites in 9 countries
United States33 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Bringham and Women's Hospital
Boston, Massachusetts, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Dana-Farber Cancer Institute (DFCI)
Boston, Massachusetts, 02215
Dana-Farber Cancer Institute
Boston, Massachusetts, 2215
Alamance Regional Medical Center - Cancer Center
Burlington, North Carolina, 27215-8700
Fletcher Allen Healthcare
Burlington, Vermont, 05401-1473
Fletcher Allen Health Care
Burlington, Vermont, 05401
Fletcher Allen Hospital MCHV Campus
Burlington, Vermont, 05401
Pharmacist, Investigational Drug Service
Burlington, Vermont, 05401
Fletcher Allen Healthcare
Burlington, Vermont, 05405
Fletcher Allan Health Care
Burlington, Vermont, 5401
Texas Oncology - PA Collins Building 5th Floor
Dallas, Texas, 75246-2006
Florida Cancer Research Institute
Davie, Florida, 33328
Duke University Medical Center - Morris Cancer Center Clinics
Durham, North Carolina, 27710
Duke University Medical Center- Department of Medicine Oncology
Durham, North Carolina, 27710
Duke University Medical Center-Duke Cancer Center
Durham, North Carolina, 27710
Duke University Medical Center
Durham, North Carolina, 27710
Duke University School Of Medicine
Durham, North Carolina, 27710
Baylor College Of Medicine (Bcm)
Houston, Texas, 77030
Baylor College of Medicine Breast Center
Houston, Texas, 77030
UCSD Medical Center - La Jolla
La Jolla, California, 92037
UCSD Moores Cancer Center
La Jolla, California, 92093
Central Baptist Hospital
Lexington, Kentucky, 40503
Lexington Oncology Associates
Lexington, Kentucky, 40503
Bluegrass Hematology/Oncology, PSC
Lexington, Kentucky, 40504
University of Minnesota Medical Center-Fairview, Riverside Campus
Minneapolis, Minnesota, 55454
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
University Of Minnesota Medical Center
Minneapolis, Minnesota, 55455
Florida Cancer Research Institute
Plantation, Florida, 33324
UCSD Medical Center - Hillcrest
San Diego, California, 92103
Washington Cancer Institute (WCI) at Washington Hospital Center (WHC)
Washington D.C., District of Columbia, 20010-3017
Argentina9 sites
Hospital Italiano Cordoba
Córdoba, Córdoba Province, X5004BAL
Policlinica Privada Site La Plata S.A.
La Plata, Buenos Aires, B1902 CMV
Breast Clinica de la Mama
La Plata, Buenos Aires, B1902CMV
Policlinica Privada Site
La Plata, Buenos Aires, B1902CMV
Policlinica Privada Site La Plata S. A.
La Plata, Buenos Aires
Instituto de Investigaciones Clinicas
Rosario, Santa Fe Province, S2000CVD
Centro Oncologico Rosario
Rosario, Santa Fe Province, S2000DSK
Centro Oncologico De Rosario
Rosario, Santa Fe Province, S2000KZE
Centro Oncologico
Rosario, Santa Fe Province, S2000KZE
Brazil8 sites
Jewish General Hospital
Montreal, QC, H3T 1E2
Clínica de Oncologia de porto Alegre Sociedade Simples ltda.
Porto Alegre, Rio Grande do Sul, 90430-090
Hospital Sao Lucas da PUCRS
Porto Alegre, Rio Grande do Sul, 90610-000
Centro de Pesquisa em Oncologia - CPO
Porto Alegre, 90610-000
Instituto Nacional DO Cancer - INCA
Rio de Janeiro, Rio de Janeiro, 20560-120
Instituto Nacional do Cancer
Rio de Janeiro, RJ 20230 - 130
Instituto Nacional de Cancer - HCII
Santo Cristo, Rio de Janeiro, RJ 20220-410
Hospital Das Clinicas Da Faculdade De Medicina Da Universidade De Sao Paulo Instituto Central
São Paulo, São Paulo, 05403-900
Belgium3 sites
UZ Gasthuisberg, Medische Oncologie
Leuven, 3000
UZ Gasthuisberg
Leuven, 3000
Oncologisch Centrum GZA
Wilrijk, 2610
Italy3 sites
Dipartimento di Medicina, Divisione di Oncologia Medica, Istituto Europeo di Oncologia
Milan, 20141
Divisione di Oncologia
Naples, 80131
Uo Oncologia Medica 2 Regione Del Veneto Istituto Oncologico Veneto IRCCS Ospedale Busonera
Padova, 35128
Canada2 sites
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Sir Mortimer B. Davis - Jewish General Hospital
Montreal, Quebec, H3T 1E2
United Kingdom2 sites
St Mary's Hospital NHS Trust
London, W2 1NY
Imperial College Healthcare NHS Trust - Charing Cross Hospital
London, W6 8RF
About this study
Official title: A Two-arm Randomized Open Label Phase 2 Study Of Cp-751,871 In Combination With Exemestane Versus Exemestane Alone As First Line Treatment For Postmenopausal Patients With Hormone Receptor Positive Advanced Breast Cancer
To test the efficacy of CP-751,871 combined with exemestane in the treatment of postmenopausal patients with hormone positive advanced breast cancer
- Conditions
- Breast Neoplasms
- Being tested
- CP-751,871, exemestane, Fulvestrant
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CP-751,871Drug
CP-751,871 given at 20 mg/kg IV on day 1 of each 21 day cycle.
exemestaneDrug
Exemestane given at 25 mg orally once a day.
exemestaneDrug
Exemestane given at 25 mg orally once a day. Treatment until progression or toxicity
FulvestrantDrug
Used for salvage therapy and administered according to the local label and standard clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | CP-751,871 + exemestane Treatment until progression or toxicity Receives: Drug: CP-751,871; Drug: exemestane; Drug: Fulvestrant |
| 2 | Active comparator | Not described Receives: Drug: exemestane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
PFS was calculated from the time of randomization to either progression of disease, death, or treatment discontinuation because of unsatisfactory therapy results (such as global deterioration of health status). Disease progression was defined as 1 or more of the following: radiographic progression (20 percent [%] increase in measurable lesions, appearance of new lesions or unequivocal progression of evaluable lesions as defined by Response Evaluation Criteria in Solid Tumors [RECIST]); occurrence of new pleural/pericardial effusions or ascites confirmed by positive cytology; persistent hypercalcemia requiring more than 2 IV treatments with bisphosphonates; intervention for any cancer-related events (radiations, surgery) or new symptoms related to tumor growth requiring participant discontinuation; development of brain metastasis; or death for any cause. Median PFS was estimated from the Kaplan-Meier curve. 95% confidence interval (CI) is based on the Brookmeyer and Crowley method.
Measured: Baseline, Day 1 of Cycles 2 and 4 and then Day 1 of every 3rd cycle starting at Cycle 7 up to 60 months
PFS in Participants With Hemoglobin A1c (HbA1c) Less Than (<) 5.7% at Baseline
PFS was calculated from the time of randomization to either progression of disease, death, or treatment discontinuation because of unsatisfactory therapy results (such as global deterioration of health status). Disease progression was defined as 1 or more of the following: radiographic progression (20% increase in measurable lesions, appearance of new lesions or unequivocal progression of evaluable lesions as defined by RECIST); occurrence of new pleural/pericardial effusions or ascites confirmed by positive cytology; persistent hypercalcemia requiring more than 2 IV treatments with bisphosphonates; intervention for any cancer-related events (radiations, surgery) or new symptoms related to tumor growth requiring participant discontinuation; development of brain metastasis; or death for any cause. Median PFS was estimated from the Kaplan-Meier curve. 95% CI is based on the Brookmeyer and Crowley method.
Measured: Baseline, Day 1 of Cycles 2 and 4 and then Day 1 of every 3rd cycle starting at Cycle 7 up to 60 months
Secondary outcomes (9)
Percentage of Participants Achieving Complete Response (CR), Partial Response (PR), or Stable Disease (SD) Maintained for at Least 6 Months
Objective responses were defined using RECIST as CR: disappearance of all target and nontarget lesions. PR: at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as a reference the baseline sum LD. Nontarget lesions may persist provided there is no unequivocal progression in these lesions. SD: measurements demonstrating neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify as progressive disease (PD) during the first 6 weeks after the start of treatment taking as reference the smallest sum LD since the treatment started. During this time, nontarget lesions may persist provided there is no unequivocal progression in these lesions.
Measured: Baseline, Day 1 of Cycles 2 and 4 and then Day 1 of every 3rd cycle starting at Cycle 7 up to 60 months
Maximum Plasma Concentration of CP-751,871
Measured: Predose on Day 1 at Cycles 1, 2, 4, and 5 and 150 days post last dose of CP-751,871 and for salvage therapy, at Day 1 and 150 days post last dose of CP-751,871
Minimum Plasma Concentration of CP-751,871
Measured: Predose on Day 1 at Cycles 1, 2, 4, and 5 and 150 days post last dose of CP-751,871 and for salvage therapy, at Day 1 and 150 days post last dose of CP-751,871
Area Under the Concentration Time Curve From Time 0 to the Last Time Point With Quantifiable Concentration
Measured: Predose on Day 1 at Cycles 1, 2, 4, and 5 and 150 days post last dose of CP-751,871 and for salvage therapy, at Day 1 and 150 days post last dose of CP-751,871
Number of Participants With Negative Human Anti-Human Antibodies (HAHAs)
Negative human anti-human antibodies were defined as <6.64
Measured: Predose on Day 1 of Cycle 1 and at 150 days post last CP-751,871 infusion
Percentage of Participants With Circulating Tumor Cells Expressing Insulin-Like Growth Factor 1 Receptor (IGF-IR)
Measured: Predose on Day 1 of Cycle 1
Percentage of Participants With Serum Markers Relevant to the IGF-1R Pathway
Measured: Predose on Day 1 of Cycles 1 and 4 and at end of treatment prior to beginning salvage therapy
European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 (QLQ-C30) Scores
EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4 point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score equals (=) better level of functioning or greater degree of symptoms.
Measured: Predose on Day 1 of each cycle, at the end of treatment and at follow-up, up to 60 months
EORTC QLQ Breast Cancer Module (BR23) Scores
EORTC-QLQ-BR23: included functional scales (body image, sexual functioning, sexual enjoyment, and future perspective) and single item symptoms scales (systemic therapy side effects, breast symptoms, arm symptoms, and upset by hair loss). Questions used 4-point Likert scale (1 ‘Not at All’ to 4 ‘Very Much’). Scores averaged and transformed to 0-100 scale. High score for functional scale=high/healthy level of functioning. High score for single item=high level of symptomatology/problems. Change from baseline=Cycle/Day score minus baseline score.
Measured: Predose on Day 1, at end of treatment, and at Follow-up, up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2006 (estimated)
- Study startFeb 2007
- Primary completionSep 2012
- Study completionJun 2014
Why it stopped: This study was closed to enrollment as of 13 May 2011 due to business reasons. Premature closure was not prompted by any safety or efficacy concerns.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 219 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00372996
- Sponsor's protocol ID
- A4021004
- Other IDs
- 2006-005573-21
- Status last verified
- Oct 2015
- First submitted
- 5 Sep 2006
- Last updated
- 28 Oct 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-arm Randomized Open Label Phase 2 Study Of Cp-751,871 In Combination With Exemestane Versus Exemestane Alone As First Line Treatment For Postmenopausal Patients With Hormone Receptor Positive Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT00372996
- Acronym / sponsor ID
- A4021004
- Conditions
- Breast Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study was closed to enrollment as of 13 May 2011 due to business reasons. Premature closure was not prompted by any safety or efficacy concerns.
- Enrolment
- 219 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Feb 2007
- Primary completion
- Sep 2012 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 7 Sep 2006 (estimated)
- Results
- Posted 28 Jul 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To test the efficacy of CP-751,871 combined with exemestane in the treatment of postmenopausal patients with hormone positive advanced breast cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: CP-751,871, Drug: exemestane, Drug: FulvestrantCP-751,871 + exemestane Treatment until progression or toxicity |
| 2 | Active comparator | Drug: exemestane |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Postmenopausal women with a diagnosis of hormone receptor positive advanced breast cancer
- HbA1c <5.7%
Key exclusion criteria (1 listed)
- Previous treatment for advanced disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CP-751,871CP-751,871 given at 20 mg/kg IV on day 1 of each 21 day cycle. | Drug | 1 |
| exemestaneExemestane given at 25 mg orally once a day. | Drug | 1 |
| exemestaneExemestane given at 25 mg orally once a day. Treatment until progression or toxicity | Drug | 2 |
| FulvestrantUsed for salvage therapy and administered according to the local label and standard clinical practice. | Drug | 1 |
Primary outcome
Progression-Free Survival (PFS)
Time frame: Baseline, Day 1 of Cycles 2 and 4 and then Day 1 of every 3rd cycle starting at Cycle 7 up to 60 months
PFS was calculated from the time of randomization to either progression of disease, death, or treatment discontinuation because of unsatisfactory therapy results (such as global deterioration of health status). Disease progression was defined as 1 or more of the following: radiographic progression (20 percent [%] increase in measurable lesions, appearance of new lesions or unequivocal progression of evaluable lesions as defined by Response Evaluation Criteria in Solid Tumors [RECIST]); occurrence of new pleural/pericardial effusions or ascites confirmed by positive cytology; persistent hypercalcemia requiring more than 2 IV treatments with bisphosphonates; intervention for any cancer-related events (radiations, surgery) or new symptoms related to tumor growth requiring participant discontinuation; development of brain metastasis; or death for any cause. Median PFS was estimated from the Kaplan-Meier curve. 95% confidence interval (CI) is based on the Brookmeyer and Crowley method.
PFS in Participants With Hemoglobin A1c (HbA1c) Less Than (<) 5.7% at Baseline
Time frame: Baseline, Day 1 of Cycles 2 and 4 and then Day 1 of every 3rd cycle starting at Cycle 7 up to 60 months
PFS was calculated from the time of randomization to either progression of disease, death, or treatment discontinuation because of unsatisfactory therapy results (such as global deterioration of health status). Disease progression was defined as 1 or more of the following: radiographic progression (20% increase in measurable lesions, appearance of new lesions or unequivocal progression of evaluable lesions as defined by RECIST); occurrence of new pleural/pericardial effusions or ascites confirmed by positive cytology; persistent hypercalcemia requiring more than 2 IV treatments with bisphosphonates; intervention for any cancer-related events (radiations, surgery) or new symptoms related to tumor growth requiring participant discontinuation; development of brain metastasis; or death for any cause. Median PFS was estimated from the Kaplan-Meier curve. 95% CI is based on the Brookmeyer and Crowley method.
9 secondary outcomes
Percentage of Participants Achieving Complete Response (CR), Partial Response (PR), or Stable Disease (SD) Maintained for at Least 6 Months
Time frame: Baseline, Day 1 of Cycles 2 and 4 and then Day 1 of every 3rd cycle starting at Cycle 7 up to 60 months
Maximum Plasma Concentration of CP-751,871
Time frame: Predose on Day 1 at Cycles 1, 2, 4, and 5 and 150 days post last dose of CP-751,871 and for salvage therapy, at Day 1 and 150 days post last dose of CP-751,871
Minimum Plasma Concentration of CP-751,871
Time frame: Predose on Day 1 at Cycles 1, 2, 4, and 5 and 150 days post last dose of CP-751,871 and for salvage therapy, at Day 1 and 150 days post last dose of CP-751,871
Area Under the Concentration Time Curve From Time 0 to the Last Time Point With Quantifiable Concentration
Time frame: Predose on Day 1 at Cycles 1, 2, 4, and 5 and 150 days post last dose of CP-751,871 and for salvage therapy, at Day 1 and 150 days post last dose of CP-751,871
Number of Participants With Negative Human Anti-Human Antibodies (HAHAs)
Time frame: Predose on Day 1 of Cycle 1 and at 150 days post last CP-751,871 infusion
Percentage of Participants With Circulating Tumor Cells Expressing Insulin-Like Growth Factor 1 Receptor (IGF-IR)
Time frame: Predose on Day 1 of Cycle 1
Percentage of Participants With Serum Markers Relevant to the IGF-1R Pathway
Time frame: Predose on Day 1 of Cycles 1 and 4 and at end of treatment prior to beginning salvage therapy
European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 (QLQ-C30) Scores
Time frame: Predose on Day 1 of each cycle, at the end of treatment and at follow-up, up to 60 months
EORTC QLQ Breast Cancer Module (BR23) Scores
Time frame: Predose on Day 1, at end of treatment, and at Follow-up, up to 60 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
62 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CP-751,871, exemestane and Fulvestrant in people with Breast Neoplasms, run by Pfizer at 62 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 62 sites in United States, Argentina, Brazil, Belgium, Italy and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jul 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: Baseline, Day 1 of Cycles 2 and 4 and then Day 1 of every 3rd cycle starting at Cycle 7 up to 60 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2015.