Metastatic Breast CancerPhase 2NCT00517361
Phase II Study of Carboplatin and Bevacizumab (Avastin) for ER Neg, PR Neg, and HER2/Neu Neg Metastatic Breast Cancer
A Phase 2 study testing carboplatin and bevacizumab in people with Metastatic Breast Cancer, run by University of Chicago at 2 sites in United States.
Trial summary
The purpose of this study is to determine the progression free survival (PFS) of metastatic ER, PR and HER2/neu negative breast cancers to the combination of carboplatin and bevacizumab (Avastin®) therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- carboplatin and bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2007to Apr 2012
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have pathologically confirmed ER, PR and HER2/neu negative (FISH ratio of <2.0 or IHC <1+) metastatic breast cancer. Locally advanced or recurrent disease is also eligible.
- Patients must have measurable disease
- Patients must not have received prior chemotherapy for metastatic breast cancer (not including adjuvant therapy). Patients should be > 4 weeks from their most recent chemotherapy or radiation therapy treatment.
- Age >18 years
- ECOG performance status <1 (Karnofsky >80%).
- Patients must have normal organ and marrow function as defined below:
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- absolute neutrophil count >1,500/uL
- platelets >100,000/uL
- total bilirubin within normal institutional limits
- AST(SGOT)/ALT(SGPT) <2.5X institutional upper limit of normal
- creatinine within normal institutional limits OR creatinine clearance>60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
- PT INR < 1.5 (Unless patient is on anticoagulation)
- urine protein <1+
- Tissue from the primary tumor must be available for correlative studies
- Women of child-bearing potential must agree to use adequate contraception
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Patients who have had prior therapy with platinum agents or a VEGF inhibitor are not eligible.
- Patients may not be receiving any other investigational agents.
- Patients with known brain metastases will be excluded
- Patients may have had prior radiation therapy, provided the patient has measurable disease and there has been clear progression since the completion of radiation therapy. Patients who have had radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to therapy administered more than 4 weeks earlier will be excluded.
- Patients with significant cardiac dysfunction will be excluded
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
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- Pregnant women are excluded from this study, breastfeeding should be discontinued.
- HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with carboplatin or the other agents administered during the study.
- Patients with evidence of bleeding diathesis or coagulopathy.
- Patients with inadequately controlled hypertension will be excluded
- Patients who have had a stroke or TIA within 6 months of registration will be excluded.
- Patients with a history of hypertensive crisis or hypertensive encephalopathy will be excluded.
- Patients with a history of abdominal fistula, GI perforation, or intra-abdominal abscess within 6 months of registration.
- Patient with history of serious non-healing wound, ulcer or bone fracture.
- Patients with major surgery, open biopsy, or significant traumatic injury within 28 days of registration or anticipated need for surgery during course of study treatment.
- Patients with a history core biopsy or other minor surgery, excluding venous access device (VAD) placement, within 7 days of registration.
- Patients with active second malignancy.
- Known hypersensitivity to any component of bevacizumab (Avastin®).
- Peripheral neuropathy > Grade 1.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Chicago
Chicago, Illinois, 60637
Oncology Specialists
Park Ridge, Illinois, 60068
About this study
Official title: A Phase II Study of Carboplatin and Bevacizumab (Avastin) Combination Therapy for ER Negative, PR Negative, and HER2/Neu Negative Metastatic Breast Cancer
The purpose of this study is to determine the progression free survival (PFS) of metastatic ER, PR and HER2/neu negative breast cancers to the combination of carboplatin and bevacizumab (Avastin®) therapy.
- Conditions
- Metastatic Breast Cancer
- Being tested
- carboplatin, 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.
carboplatinDrug
AUC 6 in 250mL saline IV over 30 minutes
bevacizumabDrug
Also called Avastin
15mg/kg in 100mL saline IV over 60 - 90 minutes
| Study group | Role | What they receive |
|---|---|---|
| Carboplatin + Avastin | Experimental | Not described Receives: Drug: carboplatin; Drug: bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
Progression is defined using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee [JNCI 92(3):205-216, 2000], as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions, or appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
Measured: Up to 5 years
Secondary outcomes (3)
Response Rate
Response is defined using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee [JNCI 92(3):205-216, 2000]: Complete Response (CR), Disappearance of all target lesions or disappearance of all non-target lesions and normalization of tumor marker level; Partial Response (PR), At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum LD since the treatment started, or persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits.
Measured: Up to 5 years
Duration of Response
Measured: Up to 5 years
Correlation of Response to BRCA1 Methylation Status
The methylation status of the tumor is defined using Methylation Specific polymerase chain reaction and/or pyrosequencing.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2007 (estimated)
- Study startAug 2007
- Primary completionApr 2011
- Study completionApr 2012
Why it stopped: This study has been terminated due to poor accrual
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 Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Rita Nanda, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00517361
- Sponsor's protocol ID
- 15578A
- Status last verified
- Mar 2014
- First submitted
- 14 Aug 2007
- Last updated
- 15 Apr 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Carboplatin and Bevacizumab (Avastin) Combination Therapy for ER Negative, PR Negative, and HER2/Neu Negative Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00517361
- Acronym / sponsor ID
- 15578A
- Conditions
- Metastatic Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study has been terminated due to poor accrual
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Aug 2007
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 16 Aug 2007 (estimated)
- Results
- Posted 15 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the progression free survival (PFS) of metastatic ER, PR and HER2/neu negative breast cancers to the combination of carboplatin and bevacizumab (Avastin®) therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Carboplatin + Avastin | Experimental | Drug: carboplatin, Drug: bevacizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Patients must have pathologically confirmed ER, PR and HER2/neu negative (FISH ratio of <2.0 or IHC <1+) metastatic breast cancer. Locally advanced or recurrent disease is also eligible.
- Patients must have measurable disease
- Patients must not have received prior chemotherapy for metastatic breast cancer (not including adjuvant therapy). Patients should be > 4 weeks from their most recent chemotherapy or radiation therapy treatment.
- Age >18 years
- ECOG performance status <1 (Karnofsky >80%).
Key exclusion criteria (19 listed)
- Patients who have had prior therapy with platinum agents or a VEGF inhibitor are not eligible.
- Patients may not be receiving any other investigational agents.
- Patients with known brain metastases will be excluded
- Patients may have had prior radiation therapy, provided the patient has measurable disease and there has been clear progression since the completion of radiation therapy. Patients who have had radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to therapy administered more than 4 weeks earlier will be excluded.
- Patients with significant cardiac dysfunction will be excluded
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 |
|---|---|---|
| carboplatinAUC 6 in 250mL saline IV over 30 minutes | Drug | Carboplatin + Avastin |
| bevacizumabAlso: Avastin15mg/kg in 100mL saline IV over 60 - 90 minutes | Drug | Carboplatin + Avastin |
Primary outcome
Progression Free Survival
Time frame: Up to 5 years
Progression is defined using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee [JNCI 92(3):205-216, 2000], as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions, or appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
3 secondary outcomes
Response Rate
Time frame: Up to 5 years
Duration of Response
Time frame: Up to 5 years
Correlation of Response to BRCA1 Methylation Status
Time frame: Up to 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Rita Nanda, MD principal investigator
University of Chicago
2 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 carboplatin and bevacizumab in people with Metastatic Breast Cancer, run by University of Chicago at 2 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 16 inclusion and 19 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 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 15 Apr 2014). 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 (time frame: Up to 5 years). 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 15 Apr 2014.