Locally Recurrent and Metastatic Breast CancerPhase 2NCT00511459
Phase 2 Study of AMG 386 Plus Paclitaxel With or Without Bevacizumab as First Line Therapy in Her2-Negative Breast Cancer Patients
A Phase 2 study testing AMG 386, Bevacizumab and Paclitaxel in people with Locally Recurrent and Metastatic Breast Cancer, run by Amgen at 77 sites in 13 countries.
Trial summary
This is a phase 2, randomized, placebo controlled, multi-center study to estimate the treatment effect and evaluate the safety and tolerability of AMG 386 in combination with paclitaxel and paclitaxel/bevacizumab in the treatment of subjects with Her2-negative metastatic or locally recurrent breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Locally Recurrent and Metastatic Breast Cancer
- What is being tested?
- AMG 386, Bevacizumab and Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 228 participants
- Where
- 77 sitesin 13 countries
- Study dates
- Jul 2007to May 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects must have histologically or cytologically confirmed adenocarcinoma of the breast with locally recurrent or metastatic disease. Locally recurrent disease must not be amenable to resection with curative intent.
- Measurable or non-measurable disease per modified RECIST guidelines
- ECOG of 0 or 1 (within 14 days prior to randomization)
- Adequate organ and hematological function as evidenced by the following laboratory studies within 14 days prior to randomization:
- Cardiac function, as follows:
- Normal sinus rhythm (no significant ECG changes)
- Left ventricular ejection fraction ≥ LLN, as determined by echocardiogram or MUGA scan, according to institutional standards within 28 days prior to randomization
Who cannot join
- Inflammatory Breast Cancer
- Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 peripheral neuropathy > grade 1 at randomization
- History of arterial or venous thrombosis, including transient ischemic attack (TIA), within 1 year prior to randomization
- Adjuvant or neoadjuvant taxane treatment within 12 months of randomization. Any other adjuvant chemotherapy regimen must be discontinued at least 21 days prior to randomization
- Prior chemotherapy, vaccine, or biological therapy for locally recurrent or metastatic breast cancer (prior endocrine therapy is permitted)
- Prior radiation therapy, radiofrequency ablation, percutaneous cryotherapy or hepatic chemoembolization on all sites of disease unless disease progression was subsequently documented 14 days prior to randomization.
Show all 26Show fewer
- Overexpression of HER-2 (gene amplification by FISH or 3+ over expression by immunohistochemistry).
- Current or prior history of central nervous system metastasis
- History of bleeding diathesis or clinically significant bleeding within 6 months prior to randomization
- Major surgical procedure within 28 days prior to randomization
- Open breast biopsy within 14 days prior to randomization
- Minor surgical procedure, placement of access device, or fine needle aspiration within 7 days of first dose
- Prior malignancy (other than thyroid cancer, in situ cervical cancer, or basal cell cancer of the skin, treated with curative intent and without evidence of disease for ≥ 3 years prior to randomization)
- Clinically significant cardiac disease within 12 months prior to randomization, including myocardial infarction, unstable angina, grade 2 or greater peripheral vascular disease, cerebrovascular accident, transient ischemic attack, congestive heart failure, or arrhythmias not controlled by outpatient medication
- Non-healing wound, ulcer or fracture
- Known hypersensitivity to paclitaxel or drugs using the vehicle cremophor
- Known hypersensitivity to bacterial proteins, or any of the drugs required in this study
- Known positive test for human immunodeficiency virus (HIV), hepatitis C, or hepatitis B surface antigen
- Known active or chronic hepatitis
- Uncontrolled hypertension as defined as systolic blood pressure ≥ 150 mm Hg and diastolic blood pressure ≥ 90 mm Hg. Anti-hypertensive medications are allowed if the subject is stable on their current dose at the time of randomization
- Currently or previously treated with any VEGF or VEGFr inhibitor, including but not limited to, bevacizumab, SU11248 (sunitinib), PTK787 (vatalinib), AZD 2171, AEE-788, BAY 43-9006 (sorafenib) and AMG 706.
- Treatment with coumarin-type anticoagulants, (other than low dose prophylaxis for central venous catheters ≤ 1mg/day) within 7 days prior to randomization
- Currently or previously treated with angiopoietin inhibitors, or inhibitors of TIE-1 or TIE-2 including, but not limited to, AMG 386, XL880, XL820
- Treatment with immune modulators such as cyclosporine and tacrolimus within 30 days prior to randomization
- Concomitant therapy with any hormonal agent such as raloxifene, tamoxifen, or other selective estrogen receptor modulators (SERMS), given for breast cancer prevention or for osteoporosis. Subjects must have discontinued these agents 28 days prior to randomization
- Pregnant (ie, positive beta-human chorionic gonadotropin test) or is breast feeding
Trial locations and contacts
77 sites in 13 countries.
77 sites in 13 countries
United States26 sites
Research Site
Asheville, North Carolina, 28806
Research Site
Campbell, California, 95008
Research Site
Charlotte, North Carolina, 28203
Research Site
Columbia, South Carolina, 29210
Research Site
Edison, New Jersey, 08820
Research Site
Henderson, Nevada, 89052
Research Site
Hershey, Pennsylvania, 17033
Research Site
Hot Springs, Arkansas, 71913
Research Site
Lebanon, New Hampshire, 03756
Research Site
Litchfield Park, Arizona, 85340
Research Site
Little Rock, Arkansas, 72205
Research Site
Los Angeles, California, 90095
Research Site
Mountain Lakes, New Jersey, 07046
Research Site
Murrieta, California, 92562
Research Site
Nashua, New Hampshire, 03061
Research Site
New Haven, Connecticut, 06520
Research Site
Ogden, Utah, 84403
Research Site
Orlando, Florida, 32804
Research Site
Philadelphia, Pennsylvania, 19106
Research Site
Richardson, Texas, 75080
Research Site
Robbinsdale, Minnesota, 55422
Research Site
San Antonio, Texas, 78229
Research Site
Santa Maria, California, 93454
Research Site
Stamford, Connecticut, 06902
Research Site
Sugar Land, Texas, 77479
Research Site
Tucson, Arizona, 85724
France8 sites
Research Site
La Roche-sur-Yon, 85925
Research Site
Lyon, 69008
Research Site
Marseille, 13009
Research Site
Montpellier, 34298
Research Site
Paris, 75020
Research Site
Paris, 75248
Research Site
Toulouse, 31052
Research Site
Vandœuvre-lès-Nancy, 54511
India7 sites
Research Site
Bangalore, Karnataka, 560 029
Research Site
Jaipur, Rajasthan, 302 004
Research Site
Jaipur, Rajasthan, 302 013
Research Site
Miraj, Maharashtra, 416 410
Research Site
Mumbai, Maharashtra, 400 012
Research Site
Nagpur, Maharashtra, 440 012
Research Site
Pune, Maharashtra, 411 001
United Kingdom7 sites
Research Site
Guildford, GU2 7XX
Research Site
Leicester, LE1 5WW
Research Site
London, NW1 2PG
Research Site
London, W6 8RF
Research Site
Manchester, M20 4BX
Research Site
Northwood, HA6 2RN
Research Site
Nottingham, NG5 1PB
Australia6 sites
Research Site
Epping, Victoria, 3076
Research Site
Fitzroy, Victoria, 3065
Research Site
Footscray, Victoria, 3011
Research Site
Kurralta Park, South Australia, 5037
Research Site
Malvern, Victoria, 3144
Research Site
Perth, Western Australia, 6000
Poland6 sites
Research Site
Gdansk, 80-952
Research Site
Lubin, 59-300
Research Site
Poznan, 61-485
Research Site
Warsaw, 02-781
Research Site
Warsaw, 04-141
Research Site
Wroclaw, 53-413
Hungary4 sites
Research Site
Gyula, 5700
Research Site
Kaposvár, 7400
Research Site
Szombathely, 9700
Research Site
Veszprém, 8200
Spain4 sites
Research Site
Jaén, AndalucÃ-a, 23007
Research Site
Madrid, Madrid, 28033
Research Site
Sabadell, Cataluña, 08208
Research Site
Santiago de Compostela, Galicia, 15706
Austria3 sites
Research Site
Innsbruck, 6020
Research Site
Vienna, 1090
Research Site
Wels, 4600
Belgium3 sites
Research Site
Leuven, 3000
Research Site
Liège, 4000
Research Site
Wilrijk, 2610
About this study
Official title: A Randomized, 4-Arm, Placebo-Controlled Phase 2 Trial of AMG 386 in Combination With Bevacizumab and Paclitaxel or AMG 386 Plus Paclitaxel as First-Line Therapy in Subjects With Her2-Negative, Metastatic or Locally Recurrent Breast Cancer
This is a phase 2, randomized, placebo controlled, multi-center study to estimate the treatment effect and evaluate the safety and tolerability of AMG 386 in combination with paclitaxel and paclitaxel/bevacizumab in the treatment of subjects with Her2-negative metastatic or locally recurrent breast cancer.
AMG 386 is a man-made medication that is designed to stop the development of blood vessels in cancer tissues. Cancer tissues rely on the development of new blood vessels, a process called angiogenesis, to obtain a supply of oxygen and nutrients to grow.
Read the detailed description
Primary Objective: To estimate the treatment effect as measured by progression free survival (PFS) of subjects receiving AMG 386 (at 2 doses) in combination with paclitaxel + bevacizumab relative to paclitaxel + bevacizumab + placebo.
Secondary Objective(s):
- To compare the treatment effect as measured by PFS of subjects receiving open-label AMG 386 in combination with paclitaxel relative to paclitaxel + bevacizumab + placebo
- To compare the treatment effect as measured by PFS of subjects receiving AMG 386 in combination with paclitaxel and bevacizumab relative to paclitaxel + AMG 386
- To evaluate the safety and tolerability of the combination and non-bevacizumab regimens
- To estimate other measures (RR, DOR, TTR, TTP) of treatment effect
- To evaluate the pharmacokinetics (PK) of AMG 386 and bevacizumab when used in combination
- To estimate the incidence of anti-AMG386 antibody formation
Exploratory Objective(s):
- To explore the pharmacodynamic (PD) response as assessed by changes in blood levels of angiogenic cytokines, tumor apoptosis, and other markers
- To explore the association of histological features and selected immunologic, biochemical, pharmacogenetic, or angiogenic markers in tumor biopsies, plasma, or serum samples with safety and/or efficacy outcomes
Study Design:
This is a phase 2, randomized, placebo controlled, multi-center study to estimate the treatment effect and evaluate the safety and tolerability of AMG 386 in combination with paclitaxel and paclitaxel/bevacizumab in the treatment of subjects with Her2-negative metastatic or locally recurrent breast cancer.
Two hundred twenty subjects will be randomized 1:1:1:1 to each of the following arms:
Arm A: Paclitaxel 90 mg/m² IV QW (3 on/1 off) + bevacizumab 10 mg/kg IV Q2W + AMG 386 10 mg/kg IV QW Arm B: Paclitaxel 90 mg/m² IV QW (3 on/1 off) + bevacizumab 10 mg/kg IV Q2W + AMG 386 3 mg/kg IV QW Arm C: Paclitaxel 90 mg/m² IV QW (3 on/1 off) + bevacizumab 10 mg/kg IV Q2W + AMG 386 placebo IV QW Arm D: Paclitaxel 90 mg/m² IV QW (3 on/1 off) + Open Label AMG 386 10 mg/kg IV QW To maintain the double-blind in arms A, B, and C, each subject will be infused weekly with a volume of investigational product equivalent to 10 mg/kg AMG 386 IV. Arm D will receive open label AMG 386 and will not receive a placebo for bevacizumab.
Subjects will be discontinued from study treatment at any time for radiographic disease progression, clinical progression, unacceptable toxicity, subject withdrawal of consent, or death.
Subjects alive at the time of discontinuation of all study medications will be followed for up to 48 months from the date of the last subject enrolled into the trial to evaluate overall survival.
Radiological imaging to assess disease status will be performed every 8 weeks ± 7 days (2 cycles) for 2 years and then every 4 months ± 1 month thereafter during the study until subjects develop radiographic disease progression per the modified RECIST criteria. In addition, any subject who discontinues study drug treatment prior to disease progression will continue to have radiological imaging performed every 8 weeks ± 7 days during the long term follow up period if the subject has not been in the study for 2 years until the subject develops radiographic disease progression or begins a new treatment. If the subject has been on study for 2 years, radiological imaging every 4 months ± 1 month will be performed during long term follow-up period until the subject develops radiographic disease progression or begins a new treatment.
The overall study design is described by a study schema immediately following this synopsis. Amgen Global Safety (AGS) will charter a data review team (DRT) that is independent of the team conducting the study and will review unblinded safety data after 20, 40, and 80 subjects have been randomized and have had the opportunity to receive at least 1 cycle (4 weeks) of study treatment.
- Being tested
- AMG 386 Placebo, AMG 386, Bevacizumab, Paclitaxel
- Keywords
- Randomized, 4-Arm, Placebo controlled, Phase 2 Trial, AMG 386, Paclitaxel, Bevacizumab, First-line Therapy, Her-2 Negative, Metastatic or Locally Recurrent Breast Cancer
- 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 386 PlaceboDrug
AMG 386 Placebo [blinded]
AMG 386Drug
AMG 386 3mg/kg IV QW [blinded]
BevacizumabDrug
Bevacizumab 10mg/kg IV Q2W
AMG 386Drug
AMG 386 10mg/kg IV QW [Open-Label]
AMG 386Drug
AMG 386 10mg/kg IV QW [blinded]
PaclitaxelDrug
Paclitaxel 90mg/m2 IV QW (3 on/1 0ff)
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Paclitaxel 90 mg/m² IV QW (3 on/1 off) + bevacizumab 10 mg/kg IV Q2W + AMG 386 10 mg/kg IV QW Receives: Drug: Bevacizumab; Drug: AMG 386; Drug: Paclitaxel |
| D | Experimental | Paclitaxel 90 mg/m² IV QW (3 on/1 off) + Open Label AMG 386 10 mg/kg IV QW Receives: Drug: AMG 386; Drug: Paclitaxel |
| B | Experimental | Paclitaxel 90 mg/m² IV QW (3 on/1 off) + bevacizumab 10 mg/kg IV Q2W + AMG 386 3 mg/kg IV QW Receives: Drug: AMG 386; Drug: Bevacizumab; Drug: Paclitaxel |
| C | Active comparator | Paclitaxel 90 mg/m² IV QW (3 on/1 off) + bevacizumab 10 mg/kg IV Q2W + AMG 386 placebo IV QW Receives: Drug: AMG 386 Placebo; Drug: Bevacizumab; Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
Measured: 3 YEARS
Secondary outcomes (8)
Objective Response (OR)
Measured: 3 YEARS
Duration of Response (DOR)
Measured: 3 YEARS
Time to response
Measured: 3 YEARS
Overall Survival
Measured: 3 YEARS
Time to progression (TTP)
Measured: 3 YEARS
Incidence of AEs and significant laboratory changes
Measured: 3 YEARS
AMG 386 Pharmakokinetic parameters
Measured: 3 YEARS
Incidence of the occurrence of anti-AMG 386 antibody formation
Measured: 3 YEARS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2007 (estimated)
- Study startJul 2007
- Primary completionAug 2010
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Locally Recurrent and Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by AmgenThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 228 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00511459
- Sponsor's protocol ID
- 20060341
- Status last verified
- Oct 2015
- First submitted
- 2 Aug 2007
- Last updated
- 29 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Dieras V, Wildiers H, Jassem J, Dirix LY, Guastalla JP, Bono P, Hurvitz SA, Goncalves A, Romieu G, Limentani SA, Jerusalem G, Lakshmaiah KC, Roche H, Sanchez-Rovira P, Pienkowski T, Segui Palmer MA, Li A, Sun YN, Pickett CA, Slamon DJ. Trebananib (AMG 386) plus weekly paclitaxel with or without bevacizumab as first-line therapy for HER2-negative locally recurrent or metastatic breast cancer: A phase 2 randomized study. Breast. 2015 Jun;24(3):182-90. doi: 10.1016/j.breast.2014.11.003. Epub 2015 Mar 5.
PubMed 25747197
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, 4-Arm, Placebo-Controlled Phase 2 Trial of AMG 386 in Combination With Bevacizumab and Paclitaxel or AMG 386 Plus Paclitaxel as First-Line Therapy in Subjects With Her2-Negative, Metastatic or Locally Recurrent Breast Cancer
- ClinicalTrials.gov ID
- NCT00511459
- Acronym / sponsor ID
- 20060341
- Keywords
- Randomized, 4-Arm, Placebo controlled, Phase 2 Trial, AMG 386, Paclitaxel, Bevacizumab, First-line Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 228 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Aug 2010 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 3 Aug 2007 (estimated)
- Results
- Not posted in the source record
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 phase 2, randomized, placebo controlled, multi-center study to estimate the treatment effect and evaluate the safety and tolerability of AMG 386 in combination with paclitaxel and paclitaxel/bevacizumab in the treatment of subjects with Her2-negative metastatic or locally recurrent breast cancer.
AMG 386 is a man-made medication that is designed to stop the development of blood vessels in cancer tissues. Cancer tissues rely on the development of new blood vessels, a process called angiogenesis, to obtain a supply of oxygen and nutrients to grow.
Detailed description
Primary Objective: To estimate the treatment effect as measured by progression free survival (PFS) of subjects receiving AMG 386 (at 2 doses) in combination with paclitaxel + bevacizumab relative to paclitaxel + bevacizumab + placebo.
Secondary Objective(s):
- To compare the treatment effect as measured by PFS of subjects receiving open-label AMG 386 in combination with paclitaxel relative to paclitaxel + bevacizumab + placebo
- To compare the treatment effect as measured by PFS of subjects receiving AMG 386 in combination with paclitaxel and bevacizumab relative to paclitaxel + AMG 386
- To evaluate the safety and tolerability of the combination and non-bevacizumab regimens
- To estimate other measures (RR, DOR, TTR, TTP) of treatment effect
- To evaluate the pharmacokinetics (PK) of AMG 386 and bevacizumab when used in combination
- To estimate the incidence of anti-AMG386 antibody formation
Exploratory Objective(s):
- To explore the pharmacodynamic (PD) response as assessed by changes in blood levels of angiogenic cytokines, tumor apoptosis, and other markers
- To explore the association of histological features and selected immunologic, biochemical, pharmacogenetic, or angiogenic markers in tumor biopsies, plasma, or serum samples with safety and/or efficacy outcomes
Study Design:
This is a phase 2, randomized, placebo controlled, multi-center study to estimate the treatment effect and evaluate the safety and tolerability of AMG 386 in combination with paclitaxel and paclitaxel/bevacizumab in the treatment of subjects with Her2-negative metastatic or locally recurrent breast cancer.
Two hundred twenty subjects will be randomized 1:1:1:1 to each of the following arms:
Arm A: Paclitaxel 90 mg/m² IV QW (3 on/1 off) + bevacizumab 10 mg/kg IV Q2W + AMG 386 10 mg/kg IV QW Arm B: Paclitaxel 90 mg/m² IV QW (3 on/1 off) + bevacizumab 10 mg/kg IV Q2W + AMG 386 3 mg/kg IV QW Arm C: Paclitaxel 90 mg/m² IV QW (3 on/1 off) + bevacizumab 10 mg/kg IV Q2W + AMG 386 placebo IV QW Arm D: Paclitaxel 90 mg/m² IV QW (3 on/1 off) + Open Label AMG 386 10 mg/kg IV QW To maintain the double-blind in arms A, B, and C, each subject will be infused weekly with a volume of investigational product equivalent to 10 mg/kg AMG 386 IV. Arm D will receive open label AMG 386 and will not receive a placebo for bevacizumab.
Subjects will be discontinued from study treatment at any time for radiographic disease progression, clinical progression, unacceptable toxicity, subject withdrawal of consent, or death.
Subjects alive at the time of discontinuation of all study medications will be followed for up to 48 months from the date of the last subject enrolled into the trial to evaluate overall survival.
Radiological imaging to assess disease status will be performed every 8 weeks ± 7 days (2 cycles) for 2 years and then every 4 months ± 1 month thereafter during the study until subjects develop radiographic disease progression per the modified RECIST criteria. In addition, any subject who discontinues study drug treatment prior to disease progression will continue to have radiological imaging performed every 8 weeks ± 7 days during the long term follow up period if the subject has not been in the study for 2 years until the subject develops radiographic disease progression or begins a new treatment. If the subject has been on study for 2 years, radiological imaging every 4 months ± 1 month will be performed during long term follow-up period until the subject develops radiographic disease progression or begins a new treatment.
The overall study design is described by a study schema immediately following this synopsis. Amgen Global Safety (AGS) will charter a data review team (DRT) that is independent of the team conducting the study and will review unblinded safety data after 20, 40, and 80 subjects have been randomized and have had the opportunity to receive at least 1 cycle (4 weeks) of study treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Bevacizumab, Drug: AMG 386, Drug: PaclitaxelPaclitaxel 90 mg/m² IV QW (3 on/1 off) + bevacizumab 10 mg/kg IV Q2W + AMG 386 10 mg/kg IV QW |
| D | Experimental | Drug: AMG 386, Drug: PaclitaxelPaclitaxel 90 mg/m² IV QW (3 on/1 off) + Open Label AMG 386 10 mg/kg IV QW |
| B | Experimental | Drug: AMG 386, Drug: Bevacizumab, Drug: PaclitaxelPaclitaxel 90 mg/m² IV QW (3 on/1 off) + bevacizumab 10 mg/kg IV Q2W + AMG 386 3 mg/kg IV QW |
| C | Active comparator | Drug: AMG 386 Placebo, Drug: Bevacizumab, Drug: PaclitaxelPaclitaxel 90 mg/m² IV QW (3 on/1 off) + bevacizumab 10 mg/kg IV Q2W + AMG 386 placebo IV QW |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects must have histologically or cytologically confirmed adenocarcinoma of the breast with locally recurrent or metastatic disease. Locally recurrent disease must not be amenable to resection with curative intent.
- Measurable or non-measurable disease per modified RECIST guidelines
- ECOG of 0 or 1 (within 14 days prior to randomization)
- Adequate organ and hematological function as evidenced by the following laboratory studies within 14 days prior to randomization:
- Normal sinus rhythm (no significant ECG changes)
Key exclusion criteria (26 listed)
- Inflammatory Breast Cancer
- Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 peripheral neuropathy > grade 1 at randomization
- History of arterial or venous thrombosis, including transient ischemic attack (TIA), within 1 year prior to randomization
- Adjuvant or neoadjuvant taxane treatment within 12 months of randomization. Any other adjuvant chemotherapy regimen must be discontinued at least 21 days prior to randomization
- Prior chemotherapy, vaccine, or biological therapy for locally recurrent or metastatic breast cancer (prior endocrine therapy is permitted)
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 386 PlaceboAMG 386 Placebo [blinded] | Drug | C |
| AMG 386AMG 386 3mg/kg IV QW [blinded] | Drug | B |
| BevacizumabBevacizumab 10mg/kg IV Q2W | Drug | A, B, C |
| AMG 386AMG 386 10mg/kg IV QW [Open-Label] | Drug | D |
| AMG 386AMG 386 10mg/kg IV QW [blinded] | Drug | A |
| PaclitaxelPaclitaxel 90mg/m2 IV QW (3 on/1 0ff) | Drug | A, B, C, D |
Primary outcome
Progression-free survival (PFS)
Time frame: 3 YEARS
8 secondary outcomes
Objective Response (OR)
Time frame: 3 YEARS
Duration of Response (DOR)
Time frame: 3 YEARS
Time to response
Time frame: 3 YEARS
Overall Survival
Time frame: 3 YEARS
Time to progression (TTP)
Time frame: 3 YEARS
Incidence of AEs and significant laboratory changes
Time frame: 3 YEARS
AMG 386 Pharmakokinetic parameters
Time frame: 3 YEARS
Incidence of the occurrence of anti-AMG 386 antibody formation
Time frame: 3 YEARS
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2015.
- Derived from this study: PubMed 25747197Dieras V, Wildiers H, Jassem J, Dirix LY, Guastalla JP, Bono P, Hurvitz SA, Goncalves A, Romieu G, Limentani SA, Jerusalem G, Lakshmaiah KC, Roche H, Sanchez-Rovira P, Pienkowski T, Segui Palmer MA, Li A, Sun YN, Pickett CA, Slamon DJ. Trebananib (AMG 386) plus weekly paclitaxel with or without bevacizumab as first-line therapy for HER2-negative locally recurrent or metastatic breast cancer: A phase 2 randomized study. Breast. 2015 Jun;24(3):182-90. doi: 10.1016/j.breast.2014.11.003. Epub 2015 Mar 5.
- 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
77 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AMG 386, Bevacizumab and Paclitaxel in people with Locally Recurrent and Metastatic Breast Cancer, run by Amgen at 77 sites in 13 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 7 inclusion and 26 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 29 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 77 sites in United States, France, India, United Kingdom, Australia and 8 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: 3 YEARS). 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 NCT00511459, 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 29 Oct 2015.