Breast NeoplasmsPhase 2NCT00356681
A Study of AMG 706 or Bevacizumab, in Combination With Paclitaxel Chemotherapy, as Treatment for Breast Cancer
A Phase 2 study testing Bevacizumab, AMG 706 and Paclitaxel in people with Breast Neoplasms and Breast Tumors, run by Amgen.
Trial summary
To determine if treatment with paclitaxel plus AMG 706 is superior to paclitaxel plus AMG 706 placebo in subjects with HER2 negative locally recurrent or metastatic breast cancer. Also to estimate differences between treatment with paclitaxel plus AMG 706 and paclitaxel plus bevacizumab. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasms, Breast Tumors, Breast Cancer
- What is being tested?
- Bevacizumab, AMG 706 and Paclitaxel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 282 participants
- Where
- No sites listed yet
- Study dates
- Dec 2006to Aug 2012
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed adenocarcinoma of the breast with locally recurrent or metastatic disease.
- Measurable disease by RECIST guidelines.
- Tumor (primary or metastatic) must be HER2 negative.
- Adequate organ and hematologic function. Exclusion:
- Taxane treatment within 12 months prior to registration.
- Prior chemotherapy for locally recurrent or metastatic breast cancer (prior endocrine therapy is permitted).
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- Prior radiation therapy, radiofrequency ablation, percutaneous cryotherapy or hepatic chemoembolization on all sites of measurable disease.
- Current or prior history of central nervous system metastases.
- Peripheral neuropathy ≥ grade 2 (CTCAE v3.0) at registration.
- History of arterial or venous thrombosis within 1 year prior to registration.
- History of bleeding diathesis or bleeding within 14 days of registration.
- Uncontrolled hypertension (systolic >145 mmHg; diastolic >85 mmHg).
- Clinically significant cardiac disease within 12 months of registration.
- Known HIV positive, hepatitis C positive or hepatitis B surface antigen positive.
- Prior treatment with VEGFr targeted therapies.
Who cannot join
None listed.
About this study
Official title: A Randomized Phase 2 Trial of Double-Blind, Placebo Controlled AMG 706 in Combination With Paclitaxel, or Open-Label Bevacizumab in Combination With Paclitaxel, as First Line Therapy in Women With HER2 Negative Locally Recurrent or Metastatic Breast Cancer
To determine if treatment with paclitaxel plus AMG 706 is superior to paclitaxel plus AMG 706 placebo in subjects with HER2 negative locally recurrent or metastatic breast cancer. Also to estimate differences between treatment with paclitaxel plus AMG 706 and paclitaxel plus bevacizumab.
- Conditions
- Breast Neoplasms, Breast Tumors, Breast Cancer, Locally Recurrent and Metastatic Breast Cancer
- Being tested
- AMG 706 placebo, Bevacizumab, AMG 706, Paclitaxel
- Keywords
- AMG 706, Paclitaxel, Metastatic Breast Cancer, Antiangiogenic, Bevacizumab
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMG 706 placeboDrug
Blinded placebo
BevacizumabDrug
Also called Avastin
Bevacizumab is a recombinant, humanized anti-VEGF monoclonal antibody.
AMG 706Drug
Also called motesanib diphosphate
AMG 706 is a small organic molecule that has been shown in preclinical pharmacology and PK studies to be a potent, oral, multi-kinase inhibitor with anti-angiogenic and anti-tumor activity achieved by selectively targeting all known VEGF, PDGF and Kit receptors.
PaclitaxelDrug
Paclitaxel is an antineoplastic agent that acts by promoting and stabilizing the polymerization of microtubules.
| Study group | Role | What they receive |
|---|---|---|
| Arm A Placebo | Placebo comparator | Blinded AMG 706 placebo plus paclitaxel Receives: Drug: AMG 706 placebo; Drug: Paclitaxel |
| Arm B Experimental | Experimental | Blinded AMG 706 plus paclitaxel Receives: Drug: AMG 706; Drug: Paclitaxel |
| Arm C Comparator | Active comparator | Open-label bevacizumab plus paclitaxel Receives: Drug: Bevacizumab; Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate, measured radiologically and assessed by an independent review committee.
Measured: Last patient enrolled + 16 weeks of treatment
Secondary outcomes (1)
Progression free survival, duration of response, clinical benefit rate (percentage of subjects with complete response, partial response or stable disease lasting >24 weeks), overall survival and incidence of adverse events.
Measured: >24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2006 (estimated)
- Study startDec 2006
- Primary completionFeb 2009
- Study completionAug 2012
Why it stopped: Sponsor decision to close study
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 Breast NeoplasmsStudies 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
- 282 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
- NCT00356681
- Sponsor's protocol ID
- 20050225
- Other IDs
- CIRG/TORI 010
- Status last verified
- Sep 2015
- First submitted
- 24 Jul 2006
- Last updated
- 15 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Martin M, Roche H, Pinter T, Crown J, Kennedy MJ, Provencher L, Priou F, Eiermann W, Adrover E, Lang I, Ramos M, Latreille J, Jagiello-Gruszfeld A, Pienkowski T, Alba E, Snyder R, Almel S, Rolski J, Munoz M, Moroose R, Hurvitz S, Banos A, Adewoye H, Hei YJ, Lindsay MA, Rupin M, Cabaribere D, Lemmerick Y, Mackey JR; TRIO 010 investigators. Motesanib, or open-label bevacizumab, in combination with paclitaxel, as first-line treatment for HER2-negative locally recurrent or metastatic breast cancer: a phase 2, randomised, double-blind, placebo-controlled study. Lancet Oncol. 2011 Apr;12(4):369-76. doi: 10.1016/S1470-2045(11)70037-7. Epub 2011 Mar 21.
PubMed 21429799
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase 2 Trial of Double-Blind, Placebo Controlled AMG 706 in Combination With Paclitaxel, or Open-Label Bevacizumab in Combination With Paclitaxel, as First Line Therapy in Women With HER2 Negative Locally Recurrent or Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00356681
- Acronym / sponsor ID
- 20050225
- Conditions
- Breast Neoplasms, Breast Tumors, Breast Cancer, Locally Recurrent and Metastatic Breast Cancer
- Keywords
- AMG 706, Paclitaxel, Metastatic Breast Cancer, Antiangiogenic, Bevacizumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision to close study
- Enrolment
- 282 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Feb 2009 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 26 Jul 2006 (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.
To determine if treatment with paclitaxel plus AMG 706 is superior to paclitaxel plus AMG 706 placebo in subjects with HER2 negative locally recurrent or metastatic breast cancer. Also to estimate differences between treatment with paclitaxel plus AMG 706 and paclitaxel plus bevacizumab.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A Placebo | Placebo comparator | Drug: AMG 706 placebo, Drug: PaclitaxelBlinded AMG 706 placebo plus paclitaxel |
| Arm B Experimental | Experimental | Drug: AMG 706, Drug: PaclitaxelBlinded AMG 706 plus paclitaxel |
| Arm C Comparator | Active comparator | Drug: Bevacizumab, Drug: PaclitaxelOpen-label bevacizumab plus paclitaxel |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Histologically or cytologically confirmed adenocarcinoma of the breast with locally recurrent or metastatic disease.
- Measurable disease by RECIST guidelines.
- Tumor (primary or metastatic) must be HER2 negative.
- Adequate organ and hematologic function. Exclusion:
- Taxane treatment within 12 months prior to registration.
Key exclusion criteria (0 listed)
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 706 placeboBlinded placebo | Drug | Arm A Placebo |
| BevacizumabAlso: AvastinBevacizumab is a recombinant, humanized anti-VEGF monoclonal antibody. | Drug | Arm C Comparator |
| AMG 706Also: motesanib diphosphateAMG 706 is a small organic molecule that has been shown in preclinical pharmacology and PK studies to be a potent, oral, multi-kinase inhibitor with anti-angiogenic and anti-tumor activity achieved by selectively targeting all known VEGF, PDGF and Kit receptors. | Drug | Arm B Experimental |
| PaclitaxelPaclitaxel is an antineoplastic agent that acts by promoting and stabilizing the polymerization of microtubules. | Drug | Arm A Placebo, Arm B Experimental, Arm C Comparator |
Primary outcome
Objective response rate, measured radiologically and assessed by an independent review committee.
Time frame: Last patient enrolled + 16 weeks of treatment
1 secondary outcome
Progression free survival, duration of response, clinical benefit rate (percentage of subjects with complete response, partial response or stable disease lasting >24 weeks), overall survival and incidence of adverse events.
Time frame: >24 weeks
Results and safety
The study was stopped early (reason given: Sponsor decision to close study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2015.
- Derived from this study: PubMed 21429799Martin M, Roche H, Pinter T, Crown J, Kennedy MJ, Provencher L, Priou F, Eiermann W, Adrover E, Lang I, Ramos M, Latreille J, Jagiello-Gruszfeld A, Pienkowski T, Alba E, Snyder R, Almel S, Rolski J, Munoz M, Moroose R, Hurvitz S, Banos A, Adewoye H, Hei YJ, Lindsay MA, Rupin M, Cabaribere D, Lemmerick Y, Mackey JR; TRIO 010 investigators. Motesanib, or open-label bevacizumab, in combination with paclitaxel, as first-line treatment for HER2-negative locally recurrent or metastatic breast cancer: a phase 2, randomised, double-blind, placebo-controlled study. Lancet Oncol. 2011 Apr;12(4):369-76. doi: 10.1016/S1470-2045(11)70037-7. Epub 2011 Mar 21.
- 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
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bevacizumab, AMG 706 and Paclitaxel in people with Breast Neoplasms and Breast Tumors, run by Amgen.
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 15 inclusion and 0 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 15 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was stopped early (reason given: Sponsor decision to close study). Results are not available in the source record.
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?
Objective response rate, measured radiologically and assessed by an independent review committee. (time frame: Last patient enrolled + 16 weeks of treatment). 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 NCT00356681, 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 15 Oct 2015.