Breast CancerPhase 2NCT00392392
Preoperative Bevacizumab and Trastuzumab With ABI-007 and Carboplatin in HER2+ Breast Cancer
A Phase 2 study testing nab-paclitaxel, Bevacizumab and Trastuzumab in people with Breast Cancer, run by SCRI Development Innovations, LLC at 6 sites in United States.
Trial summary
This trial combines trastuzumab and bevacizumab monoclonal antibodies, with ABI-007 and carboplatin, as neoadjuvant therapy in previously untreated locally advanced breast cancers demonstrating HER2 gene amplification. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- nab-paclitaxel, Bevacizumab and Trastuzumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 6 sitesUnited States
- Study dates
- Oct 2006to Dec 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
- Female patients with histologically confirmed adenocarcinoma of the breast or inflammatory breast cancer
- Clinical stage T 1-4, N 0-3, M0
- FISH+ HER2 gene amplified breast cancer
- 18 years or older
- Normal cardiac function
- Performance status 0-2
Show all 12Show fewer
- Cannot have received any prior chemotherapy for this disease or cannot have received chemotherapy for any other cancer in the past 5 years.
- Previous diagnosis of noninvasive breast cancer is OK.
- Must have adequate bone marrow, renal and liver function.
- Pregnant or lactating females not allowed.
- Preexisting peripheral neuropathy must be equal to or less than grade 1
- Must have archived tumor tissue for tissue testing.
Who cannot join
- You cannot be in this study if you any of the following:
- History of cardiac disease, with New York Heart Association Class II or greater with congestive heart failure
- Any heart attack, stroke or TIAs within the last 6 months or serious arrhythmias needing medication; no bleeding diathesis or coagulopathy.
- No prior investigational drug within the last 30 days
- No prior trastuzumab or bevacizumab therapy
- There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Chattanooga Oncology Hematology Associates
Chattanooga, Tennessee, 37404
Florida Cancer Specialists
Fort Myers, Florida, 33901
Northeast Georgia Medical Center
Gainesville, Georgia, 30501
Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, 49503
Tennessee Oncology, PLLC
Nashville, Tennessee, 37023
Florida Hospital Cancer Institute
Orlando, Florida, 32804
About this study
Official title: Phase II Study of Preoperative Bevacizumab and Trastuzumab Administered With ABI-007 and Carboplatin in HER2 Overexpressing Breast Cancer
This trial combines trastuzumab and bevacizumab monoclonal antibodies, with ABI-007 and carboplatin, as neoadjuvant therapy in previously untreated locally advanced breast cancers demonstrating HER2 gene amplification. It is hoped that this novel combination will result in increased pathologic response rates that will translate into long term outcome improvements in HER2 positive patients with locally advanced breast cancer.
Read the detailed description
All eligible patients will receive induction chemotherapy prior to consideration of primary surgical intervention. If surgical intervention is deemed not to be in the best interest of the patient, patient will go off study at the time of evaluation for surgery. Upon completion of chemotherapy and surgery, all ER + and/or PR + patients will be placed on Tamoxifen 20 mg/qd or an aromatase inhibitor.
Induction preoperative therapy:
- Bevacizumab
- Trastuzumab
- ABI-007
- Carboplatin
Postoperative Adjuvant Therapy:
- Bevacizumab
- Trastuzumab
- Conditions
- Breast Cancer
- Being tested
- nab-paclitaxel, Bevacizumab, Trastuzumab
- Keywords
- Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nab-paclitaxelDrug
Also called Abraxane, ABI-007
ABI-007
BevacizumabDrug
Also called Avastin
Bevacizumab
TrastuzumabDrug
Also called Herceptin
Trastuzumab
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Patients received treatment with nab-paclitaxel (100 mg/m2 IV days 1, 8, 15) and carboplatin (AUC 6 IV day 1) every 28 days for 6 cycles. Trastuzumab (4 mg/kg loading dose, followed by 2 mg/kg) and bevacizumab (5 mg/kg IV) were administered weekly for 23 weeks, beginning concurrently with chemotherapy. Patients then underwent either mastectomy or breast conserving surgery and pathologic treatment responses were assessed. After surgery, trastuzumab 6 mg/kg and bevacizumab 15 mg/kg were administered at 3 week intervals for a total of 52 weeks. Receives: Drug: nab-paclitaxel; Drug: Bevacizumab; Drug: Trastuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic Complete Response Rate (PCRR), the Percentage of Patients Who Have No Evidence of Cancer in the Breast or Lymph Nodes Following Surgery
Pathologic complete response was defined as the absence of residual invasive cancer in the breast (pT0) and axillary lymph nodes (pN0).
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2006 (estimated)
- Study startOct 2006
- Primary completionApr 2008
- Study completionDec 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- SCRI Development Innovations, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene Corporation, Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Denise Yardley, MD, Principal investigator, SCRI Development Innovations, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00392392
- Sponsor's protocol ID
- SCRI BRE 83
- Status last verified
- Sep 2013
- First submitted
- 25 Oct 2006
- Last updated
- 20 Sep 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Yardley DA, Raefsky E, Castillo R, Lahiry A, Locicero R, Thompson D, Shastry M, Burris HA 3rd, Hainsworth JD. Phase II study of neoadjuvant weekly nab-paclitaxel and carboplatin, with bevacizumab and trastuzumab, as treatment for women with locally advanced HER2+ breast cancer. Clin Breast Cancer. 2011 Oct;11(5):297-305. doi: 10.1016/j.clbc.2011.04.002. Epub 2011 May 5.
PubMed 21729666
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Preoperative Bevacizumab and Trastuzumab Administered With ABI-007 and Carboplatin in HER2 Overexpressing Breast Cancer
- ClinicalTrials.gov ID
- NCT00392392
- Acronym / sponsor ID
- SCRI BRE 83
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- SCRI Development Innovations, LLCUniversity, hospital or other
- Collaborators
- Celgene Corporation, Genentech, Inc.
- Study start
- Oct 2006
- Primary completion
- Apr 2008 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 26 Oct 2006 (estimated)
- Results
- Posted 13 Feb 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial combines trastuzumab and bevacizumab monoclonal antibodies, with ABI-007 and carboplatin, as neoadjuvant therapy in previously untreated locally advanced breast cancers demonstrating HER2 gene amplification. It is hoped that this novel combination will result in increased pathologic response rates that will translate into long term outcome improvements in HER2 positive patients with locally advanced breast cancer.
Detailed description
All eligible patients will receive induction chemotherapy prior to consideration of primary surgical intervention. If surgical intervention is deemed not to be in the best interest of the patient, patient will go off study at the time of evaluation for surgery. Upon completion of chemotherapy and surgery, all ER + and/or PR + patients will be placed on Tamoxifen 20 mg/qd or an aromatase inhibitor.
Induction preoperative therapy:
- Bevacizumab
- Trastuzumab
- ABI-007
- Carboplatin
Postoperative Adjuvant Therapy:
- Bevacizumab
- Trastuzumab
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: nab-paclitaxel, Drug: Bevacizumab, Drug: TrastuzumabPatients received treatment with nab-paclitaxel (100 mg/m2 IV days 1, 8, 15) and carboplatin (AUC 6 IV day 1) every 28 days for 6 cycles. Trastuzumab (4 mg/kg loading dose, followed by 2 mg/kg) and bevacizumab (5 mg/kg IV) were administered weekly for 23 weeks, beginning concurrently with chemotherapy. Patients then underwent either mastectomy or breast conserving surgery and pathologic treatment responses were assessed. After surgery, trastuzumab 6 mg/kg and bevacizumab 15 mg/kg were administered at 3 week intervals for a total of 52 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Female patients with histologically confirmed adenocarcinoma of the breast or inflammatory breast cancer
- Clinical stage T 1-4, N 0-3, M0
- FISH+ HER2 gene amplified breast cancer
- 18 years or older
- Normal cardiac function
Key exclusion criteria (6 listed)
- History of cardiac disease, with New York Heart Association Class II or greater with congestive heart failure
- Any heart attack, stroke or TIAs within the last 6 months or serious arrhythmias needing medication; no bleeding diathesis or coagulopathy.
- No prior investigational drug within the last 30 days
- No prior trastuzumab or bevacizumab therapy
- There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons.
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 |
|---|---|---|
| nab-paclitaxelAlso: Abraxane, ABI-007ABI-007 | Drug | Intervention |
| BevacizumabAlso: AvastinBevacizumab | Drug | Intervention |
| TrastuzumabAlso: HerceptinTrastuzumab | Drug | Intervention |
Primary outcome
Pathologic Complete Response Rate (PCRR), the Percentage of Patients Who Have No Evidence of Cancer in the Breast or Lymph Nodes Following Surgery
Time frame: 18 months
Pathologic complete response was defined as the absence of residual invasive cancer in the breast (pT0) and axillary lymph nodes (pN0).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21729666Yardley DA, Raefsky E, Castillo R, Lahiry A, Locicero R, Thompson D, Shastry M, Burris HA 3rd, Hainsworth JD. Phase II study of neoadjuvant weekly nab-paclitaxel and carboplatin, with bevacizumab and trastuzumab, as treatment for women with locally advanced HER2+ breast cancer. Clin Breast Cancer. 2011 Oct;11(5):297-305. doi: 10.1016/j.clbc.2011.04.002. Epub 2011 May 5.
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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.
Denise Yardley, MD principal investigator
SCRI Development Innovations, LLC
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing nab-paclitaxel, Bevacizumab and Trastuzumab in people with Breast Cancer, run by SCRI Development Innovations, LLC at 6 sites in United States.
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 12 inclusion and 6 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 20 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. 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 13 Feb 2013). 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?
Pathologic Complete Response Rate (PCRR), the Percentage of Patients Who Have No Evidence of Cancer in the Breast or Lymph Nodes Following Surgery (time frame: 18 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 NCT00392392, 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 20 Sep 2013.