Breast CancerPhase 2NCT00626106
QUILT-2.015: A Study of AMG 479 With Exemestane or Fulvestrant in Postmenopausal Women With Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer
A Phase 2 study testing AMG 479 in people with Breast Cancer and Breast Tumors, run by NantCell, Inc. at 60 sites in 9 countries.
Trial summary
This is a randomized, double-blind, placebo-controlled, phase 2 study. Subjects will include postmenopausal women with confirmed HR-positive, locally advanced or metastatic breast cancer, who have disease progression during or within 12 months after completing prior adjuvant endocrine therapy or during the first prior… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Breast Tumors, Metastatic Cancer
- What is being tested?
- AMG 479
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 156 participants
- Where
- 60 sitesin 9 countries
- Study dates
- 27 Mar 2008to 23 Sep 2011
- 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
- Histologically or cytologically confirmed carcinoma of the breast with locally advanced or metastatic disease
- Confirmation of hormone receptor (HR) positive disease status
- Amenable to receive endocrine therapy
- Disease progression while receiving prior endocrine therapy for locally advanced or metastatic breast cancer
- Postmenopausal woman ≥ 18 years old
Who cannot join
- HR-unknown or HR-negative disease
- Not amenable to endocrine therapy
- Central nervous system metastasis
Trial locations and contacts
60 sites in 9 countries.
60 sites in 9 countries
United States25 sites
Research Site
American Fork, Utah, 84003
Research Site
Anaheim, California, 92801
Research Site
Atlanta, Georgia, 30309
Research Site
Beverly Hills, California, 90211
Research Site
Boca Raton, Florida, 33428
Research Site
Boynton Beach, Florida, 33435
Research Site
Chandler, Arizona, 85224
Research Site
Chicago, Illinois, 60637
Research Site
Concord, California, 94520
Research Site
Coral Springs, Florida, 33065
Research Site
Denville, New Jersey, 07834
Research Site
Duarte, California, 91010
Research Site
Gainesville, Florida, 32605
Research Site
Hershey, Pennsylvania, 17033
Research Site
High Point, North Carolina, 27262
Research Site
Lake Worth, Florida, 33467
Research Site
Lebanon, New Hampshire, 03756
Research Site
Marietta, Georgia, 30060
Research Site
Memphis, Tennessee, 38120
Research Site
Montebello, California, 90640
Research Site
Pittsburgh, Pennsylvania, 15213
Research Site
San Francisco, California, 94115
Research Site
Stamford, Connecticut, 06902
Research Site
Sylmar, California, 91342
Research Site
Tacoma, Washington, 98405
France8 sites
Research Site
Dijon, 21079
Research Site
Le Mans, 72000
Research Site
Lyon, 69008
Research Site
Montpellier, 34298
Research Site
Nice, 06182
Research Site
Paris, 75248
Research Site
Reims, 51056
Research Site
Saint-Herblain, 44800
Australia5 sites
Research Site
Footscray, Victoria, 3011
Research Site
Geelong, Victoria, 3220
Research Site
Malvern, Victoria, 3144
Research Site
Waratah, New South Wales, 2298
Research Site
Woodville South, South Australia, 5011
Canada5 sites
Research Site
Montreal, Quebec, H1T 2M4
Research Site
Ottawa, Ontario, K1H 8L6
Research Site
Sault Ste. Marie, Ontario, P6B 0A8
Research Site
Toronto, Ontario, M5G 2M9
Research Site
Vancouver, British Columbia, V5Z 4E6
Germany4 sites
Research Site
Frankfurt, 60590
Research Site
Frankfurt, 65929
Research Site
Hanover, 30177
Research Site
Munich, 80637
Spain4 sites
Research Site
Barcelona, Cataluña, 08003
Research Site
L'Hospitalet de Llobregat, Cataluña, 08907
Research Site
Madrid, 28040
Research Site
Sabadell, Cataluña, 08208
United Kingdom4 sites
Research Site
Derby, DE22 3DT
Research Site
London, W6 8RF
Research Site
Manchester, M20 4BX
Research Site
Peterborough, PE3 9GZ
Switzerland3 sites
Research Site
Chur, 7000
Research Site
Lucerne, 6000
Research Site
Zurich, 8032
About this study
Official title: An International, Randomized, Double-blind, Placebo-controlled, Phase 2 Study of AMG 479 With Exemestane or Fulvestrant in Postmenopausal Women With Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer
This is a randomized, double-blind, placebo-controlled, phase 2 study. Subjects will include postmenopausal women with confirmed HR-positive, locally advanced or metastatic breast cancer, who have disease progression during or within 12 months after completing prior adjuvant endocrine therapy or during the first prior endocrine therapy for metastatic disease.
- Conditions
- Breast Cancer, Breast Tumors, Metastatic Cancer
- Being tested
- AMG 479, Placebo
- Keywords
- postmenopausal, hormone receptor positive, locally advanced, metastatic
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMG 479Drug
AMG 479 administered with exemestane or fulvestrant
PlaceboDrug
Placebo administered with either exemestane or fulvestrant
| Study group | Role | What they receive |
|---|---|---|
| Arm A: AMG 479 12 mg/kg IV Q2W + Endocrine Therapy | Active comparator | Not described Receives: Drug: AMG 479 |
| Arm B: placebo IV Q2W + Endocrine Therapy | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
PFS was defined as the time from randomization to the first observation of disease progression (as classified by modified RECIST), symptomatic deterioration or death due to any cause, whichever occurs first. Disease progression per RECIST is defined as at least a 20% increase in the sum of diameters of target lesions in reference to the smallest sum on study and an absolute increase of at least 5 mm; the appearance of any new lesions is also considered progression.
Measured: Subject completing study will be contacted by the study staff by telephone or at routine clinic visits approximately every 3 months, up to approximately 3 years and 6 months.
Secondary outcomes (6)
Number of Participants With Adverse Events
Graded Using the National Cancer Institute(NCI) Common Terminology Criteria for Adverse Events(CTCAE) Version 3.0
Measured: 30 days after the last dose of study treatment, up to 109 weeks
Cmax of AMG 479
Serum AMG 479 Concentrations After IV Administration of 12 mg/kg AMG 479 in combination with Exemestane, and in combination with Fulvestrant (Cmax).
Measured: Subject completing study will be contacted by the study staff by telephone or at routine clinic visits approximately every 3 months, up to approximately 3 years and 6 months.
Clinical Benefit and Objective Response Rate
Clinical benefit was defined as complete/partial response, or stable disease≥24 weeks per modified RECIST/local review.
Objective response rate was defined as complete/partial response per modified RECIST/local review.
Per Response Evaluation Criteria in Solid Tumors [RECIST]: a complete response is the disappearance of all target lesions; a partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable disease is disease that is not complete, partial or progressive (PD = at least a 20% increase in the sum of diameters of target lesions in reference to the smallest sum on study)
Measured: Subject completing study will be contacted by the study staff by telephone or at routine clinic visits approximately every 3 months, up to approximately 3 years and 6 months.
Duration of Response and Time-to-response
Duration of response was defined as time from the date of first confirmed response to the date of first disease progression or death due to any cause in a subset of subjects with confirmed response.
Time to response was defined as the interval in days from randomization to the first assessment of objective response (CR or PR).
A complete response is the disappearance of all target lesions; a partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive disease is at least a 20% increase in the sum of diameters of target lesions in reference to the smallest sum on study.
Measured: Subject completing study will be contacted by the study staff by telephone or at routine clinic visits approximately every 3 months, up to approximately 3 years and 6 months.
Time To Progression, Time-to-treatment Failure, Overall Survival
Time to progression was defined as the time from date of randomization to the date of first occurrence of disease progression or death due to disease progression
Time to treatment failure was defined as the time from date of randomization to the earliest date of disease progression, death, or end of cycle [last dose date + 1 cycle time: 14 days] for the last dose of ganitumab or placebo regardless of the reason of discontinuation
Overall survival was defined as the time from randomization to death.
Progressive disease is at least a 20% increase in the sum of diameters of target lesions in reference to the smallest sum on study.
Measured: Subject completing study will be contacted by the study staff by telephone or at routine clinic visits approximately every 3 months, up to approximately 3 years and 6 months.
Global Health Status Time-Adjusted AUC
Based on the European Organization Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C-30) v3, a 30-item questionnaire comprised of 5 functional scales, 3 symptom scales, and 6 single item scales, all with scores ranging from 1=not at all to 4=very much, along with the Health-Related Quality of Life scale with scores ranging from 1=very poor to 7=excellent; and 2 questions from the Dermatology Life Quality Index (DLQI; scores ranged from 1=not at all to 4=very much). Summing of all these questions and standardizing yielded a total score ranging from 0-100; higher total scores = better quality of life.
AUC of the change from baseline of the mean total score over time were calculated using the linear trapezoidal rule. The time-adjusted AUC was calculated by dividing the AUC by the time interval between baseline and the last scheduled assessment, the difference was analyzed using analysis of covariance with baseline score and stratification factors as covariates.
Measured: From start of study, on Day 1 of cycles 2, 3, and 4 and Day 1 every 3rd cycle thereafter, up to cycle 25 (Cycle = 28 days), approximately 700 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2008 (estimated)
- Study start27 Mar 2008
- Primary completion5 May 2010
- Study completion23 Sep 2011
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- NantCell, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00626106
- Sponsor's protocol ID
- 20060362
- Other IDs
- QUILT-2.015
- Status last verified
- Oct 2016
- First submitted
- 21 Feb 2008
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Robertson JF, Ferrero JM, Bourgeois H, Kennecke H, de Boer RH, Jacot W, McGreivy J, Suzuki S, Zhu M, McCaffery I, Loh E, Gansert JL, Kaufman PA. Ganitumab with either exemestane or fulvestrant for postmenopausal women with advanced, hormone-receptor-positive breast cancer: a randomised, controlled, double-blind, phase 2 trial. Lancet Oncol. 2013 Mar;14(3):228-35. doi: 10.1016/S1470-2045(13)70026-3. Epub 2013 Feb 13.
PubMed 23414585
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An International, Randomized, Double-blind, Placebo-controlled, Phase 2 Study of AMG 479 With Exemestane or Fulvestrant in Postmenopausal Women With Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00626106
- Acronym / sponsor ID
- 20060362
- Conditions
- Breast Cancer, Breast Tumors, Metastatic Cancer
- Keywords
- postmenopausal, hormone receptor positive, locally advanced, metastatic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- NantCell, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Mar 2008 (actual)
- Primary completion
- 5 May 2010 (actual)
- Study completion
- 23 Sep 2011 (actual)
- First posted
- 29 Feb 2008 (estimated)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, double-blind, placebo-controlled, phase 2 study. Subjects will include postmenopausal women with confirmed HR-positive, locally advanced or metastatic breast cancer, who have disease progression during or within 12 months after completing prior adjuvant endocrine therapy or during the first prior endocrine therapy for metastatic disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: AMG 479 12 mg/kg IV Q2W + Endocrine Therapy | Active comparator | Drug: AMG 479 |
| Arm B: placebo IV Q2W + Endocrine Therapy | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically or cytologically confirmed carcinoma of the breast with locally advanced or metastatic disease
- Confirmation of hormone receptor (HR) positive disease status
- Amenable to receive endocrine therapy
- Disease progression while receiving prior endocrine therapy for locally advanced or metastatic breast cancer
- Postmenopausal woman ≥ 18 years old
Key exclusion criteria (3 listed)
- HR-unknown or HR-negative disease
- Not amenable to endocrine therapy
- Central nervous system metastasis
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 |
|---|---|---|
| AMG 479AMG 479 administered with exemestane or fulvestrant | Drug | Arm A: AMG 479 12 mg/kg IV Q2W + Endocrine Therapy |
| PlaceboPlacebo administered with either exemestane or fulvestrant | Drug | Arm B: placebo IV Q2W + Endocrine Therapy |
Primary outcome
Progression Free Survival (PFS)
Time frame: Subject completing study will be contacted by the study staff by telephone or at routine clinic visits approximately every 3 months, up to approximately 3 years and 6 months.
PFS was defined as the time from randomization to the first observation of disease progression (as classified by modified RECIST), symptomatic deterioration or death due to any cause, whichever occurs first. Disease progression per RECIST is defined as at least a 20% increase in the sum of diameters of target lesions in reference to the smallest sum on study and an absolute increase of at least 5 mm; the appearance of any new lesions is also considered progression.
6 secondary outcomes
Number of Participants With Adverse Events
Time frame: 30 days after the last dose of study treatment, up to 109 weeks
Cmax of AMG 479
Time frame: Subject completing study will be contacted by the study staff by telephone or at routine clinic visits approximately every 3 months, up to approximately 3 years and 6 months.
Clinical Benefit and Objective Response Rate
Time frame: Subject completing study will be contacted by the study staff by telephone or at routine clinic visits approximately every 3 months, up to approximately 3 years and 6 months.
Duration of Response and Time-to-response
Time frame: Subject completing study will be contacted by the study staff by telephone or at routine clinic visits approximately every 3 months, up to approximately 3 years and 6 months.
Time To Progression, Time-to-treatment Failure, Overall Survival
Time frame: Subject completing study will be contacted by the study staff by telephone or at routine clinic visits approximately every 3 months, up to approximately 3 years and 6 months.
Global Health Status Time-Adjusted AUC
Time frame: From start of study, on Day 1 of cycles 2, 3, and 4 and Day 1 every 3rd cycle thereafter, up to cycle 25 (Cycle = 28 days), approximately 700 days.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23414585Robertson JF, Ferrero JM, Bourgeois H, Kennecke H, de Boer RH, Jacot W, McGreivy J, Suzuki S, Zhu M, McCaffery I, Loh E, Gansert JL, Kaufman PA. Ganitumab with either exemestane or fulvestrant for postmenopausal women with advanced, hormone-receptor-positive breast cancer: a randomised, controlled, double-blind, phase 2 trial. Lancet Oncol. 2013 Mar;14(3):228-35. doi: 10.1016/S1470-2045(13)70026-3. Epub 2013 Feb 13.
- AmgenTrials clinical trials websiteLink 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.
MD study director
Amgen
60 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 AMG 479 in people with Breast Cancer and Breast Tumors, run by NantCell, Inc. at 60 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 5 inclusion and 3 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: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 60 sites in United States, France, Australia, Canada, Germany 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. Some participants in this study may receive a placebo. 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 19 Sep 2024). 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: Subject completing study will be contacted by the study staff by telephone or at routine clinic visits approximately every 3 months, up to approximately 3 years and 6 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00626106, which also lists 1 linked publication.
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 19 Sep 2024.