Metastatic Breast CancerPhase 2NCT00894504
Panitumumab, Gemcitabine and Carboplatin in Triple-Negative Metastatic Breast Cancer
A Phase 2 study testing Panitumumab, Carboplatin and Gemcitabine in people with Metastatic Breast Cancer, run by SCRI Development Innovations, LLC at 17 sites in United States.
Trial summary
In this Phase II trial, the investigators will evaluate the combination of gemcitabine, carboplatin, and panitumumab in the treatment of patients with metastatic triple-negative breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Panitumumab, Carboplatin and Gemcitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 17 sitesUnited States
- Study dates
- Feb 2010to Sep 2014
- 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 >=18 years of age.
- Histologically or cytologically confirmed diagnosis of unresectable locally advanced or stage IV breast cancer.
- No more than 1 prior treatment regimen for metastatic breast cancer.
- Estrogen receptor and progesterone receptor negative (defined as <10% staining by IHC).
- Paraffin-embedded tumor tissue (from the primary tumor or metastasis) for biomarker testing. (In the absence of paraffinembedded tissue, unstained paraffin-embedded tumor slides are acceptable).
- Measurable disease, as defined by the Response Evaluation Criteria in Solid Tumors (RECIST version 1.1) guidelines
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- HER2 negative tumors. HER2 negativity must be confirmed by one of the following:
- FISH-negative (FISH ratio <2.2), or
- IHC 0-1+, or
- IHC 2-3+ AND FISH-negative (FISH ratio <2.2)
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-1.
- Absolute neutrophil count (ANC) >=1.5 × 109/L; platelet count >=100 × 109/L; hemoglobin >=9.0 g/dL.
- Creatinine <=1.5 mg/dL, or creatinine clearance >=40 mL/min (as calculated by the Cockcroft-Gault method, as follows: Female creatinine clearance = (140 - age) × (weight in kg) × 0.85 (serum creatinine × 72)
- Adequate hepatic function, defined as follows: total bilirubin <=1.5 x ULN; aspartate aminotransferase (AST) <=3 × ULN (or <= 5 x ULN if liver metastases); alanine aminotransferase (ALT) <=3 x ULN (or <=5 x ULN if liver metastases).
- Magnesium level >= the institutional lower limit of normal (LLN).
- Women of childbearing potential must agree to use adequate contraception (per institutional standard of care) during treatment and until 6 months after the last administration of investigational products.
Who cannot join
- Patients with brain metastases are not eligible.
- History of another primary cancer, with the exception of the following:
- Curatively treated in situ cervical cancer;
- Curatively resected non-melanoma skin cancer;
- Other primary solid tumor curatively treated with no known active disease present and no treatment administered for >=5 years prior to study enrollment.
- History of interstitial lung disease (e.g., pneumonitis, pulmonary fibrosis), or any evidence of interstitial lung disease on the CT scan of the chest performed at the baseline visit.
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- Prior anti-EGFR antibody therapy (e.g., cetuximab), or treatment with small-molecule EGFR inhibitors (e.g., gefitinib, erlotinib, lapatinib).
- Radiotherapy <=14 days prior to study enrollment. Any acute effects of radiotherapy must be resolved prior to the administration of study drugs.
- Systemic chemotherapy, hormonal therapy, immunotherapy, or experimental or approved proteins/antibodies (e.g., bevacizumab) <=21 days prior to study enrollment.
- Prior therapy with gemcitabine or carboplatin in the metastatic setting is not permitted. Patients who received gemcitabine or carboplatin as part of adjuvant therapy are eligible, as long as recurrence was first documented >12 months after the last exposure to the drug(s).
- Major surgery within 28 days or minor surgery within 14 days of study enrollment.
- Requirement of chronic use of immunosuppressive agents (e.g., methotrexate, cyclosporine).
- Any investigational agent or therapy <=30 days prior to study enrollment.
- Uncontrolled or intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
- History of any medical or psychiatric condition or laboratory abnormality that, in the opinion of the investigator, may increase the risks associated with the study participation or administration of the investigational products, or that may interfere with the interpretation of the results.
- Unwillingness or inability to comply with study requirements.
- Women who are pregnant or breastfeeding.
- Patients with known human immunodeficiency virus (HIV), hepatitis C virus, and/or acute or chronic hepatitis B virus infection.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Aventura Hospital and Medical Center
Aventura, Florida, 33180
Center for Cancer and Blood Disorders
Bethesda, Maryland, 20817
National Capital Clinical Research Consortium
Bethesda, Maryland, 20817
Chattanooga Oncology Hematology Associates
Chattanooga, Tennessee, 37404
St. Louis Cancer Care
Chesterfield, Missouri, 63017
Oncology Hematology Care
Cincinnati, Ohio, 45242
Family Cancer Center
Collierville, Tennessee, 38119
Texas Health Physician Group
Dallas, Texas, 76011
Florida Cancer Specialists
Fort Myers, Florida
Research Medical Center
Kansas City, Missouri, 64132
Norton Cancer Institute
Louisville, Kentucky, 40207
Atlantic Health System
Morristown, New Jersey, 07960
Tennessee Oncology
Nashville, Tennessee, 37203
Peninsula Cancer Institute
Newport News, Virginia, 23601
Nebraska Methodist Cancer Center
Omaha, Nebraska, 68114
Providence Medical Group
Terre Haute, Indiana, 47802
Los Robles
Thousand Oaks, California, 91360
About this study
Official title: A Phase II Trial of Panitumumab, Gemcitabine, and Carboplatin in Triple-Negative Metastatic Breast Cancer
In this Phase II trial, the investigators will evaluate the combination of gemcitabine, carboplatin, and panitumumab in the treatment of patients with metastatic triple-negative breast cancer. In addition, to assess the efficacy of this combination, tumor tissue will be examined for the presence of various markers, including K-ras and PI3K-activating mutations, EGFR, PTEN, and p53. Correlation of tumor response with marker expression may define a patient subset that is particularly responsive to treatment with a panitumumab-containing combination.
Read the detailed description
All patients will receive a pre-emptive skin care regimen during panitumumab therapy to reduce skin toxicity. Treatment cycles will be repeated every 14 days (2 weeks). During each treatment, panitumumab will be administered first, then carboplatin, then gemcitabine. All drugs will be administered according to standard guidelines. Patients will be re-evaluated for response after completion of 3 cycles (6 weeks) of treatment. Patients with objective response or stable disease will continue treatment. Subsequent re-evaluations will occur every 6 weeks. Patients will continue treatment with all three drugs until tumor progression, or until unacceptable toxicity occurs. If patients experience toxicity caused by gemcitabine/carboplatin and are continuing to benefit from treatment, panitumumab can be continued as a single agent (at the same dose and schedule), at the discretion of the investigator, until disease progression occurs.
- Conditions
- Metastatic Breast Cancer
- Being tested
- Panitumumab, Carboplatin, Gemcitabine
- Keywords
- Metastatic Breast Cancer, Triple Negative, Panitumumab, Vectibix, Gemcitabine, Gemzar, Carboplatin
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PanitumumabDrug
Also called Systemic Therapy, Vectibix
6 mg/kg IV on Day 1 of each 2-week treatment cycle for 3 cycles (6 weeks)
CarboplatinDrug
Also called Systemic Therapy, Paraplatin
AUC=2.5 IV, Day 1 of each 2-week treatment cycle for 3 cycles (6 weeks)
GemcitabineDrug
Also called Systemic Therapy, Gemzar
1500 mg/m2 IV, Day 1 of each 2-week treatment cycle for 3 cycles (6 weeks)
| Study group | Role | What they receive |
|---|---|---|
| Panitumumab/Gemcitabine/Carboplatin | Experimental | Systemic therapy Receives: Drug: Panitumumab; Drug: Carboplatin; Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival (PFS)
Measured from Day 1 of study drug administration to disease progression - defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as a 20% increase in the sum of the longest diameter of target lesions and/or appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Measured: every 6 weeks until treatment discontinuation
Secondary outcomes (3)
Objective Response Rate and Clinical Benefit Rate
Estimated as the proportion of subjects who meet the criteria for complete or partial response (CR or PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1 - for target lesions assessed by MRI: Complete Response (CR) is defined as disappearance of all target lesions; Partial Response (PR) is defined as >=30% decrease in the sum of the longest diameter of target lesions.
Measured: every 6 weeks until treatment discontinuation
Number of Treatment-related Toxicities Occurring in ≥10% of Patients as a Measure of Tolerability and Toxicity
Assessments made through analysis of treatment-related adverse events and serious adverse events
Measured: every 6 weeks until discontinuation of treatment, expected average of 18 months
Correlation of Biomarker Expressions of EGFR, K-ras, p53, PTEN Expression, and PI3K in Triple-negative Breast Cancer With Response to Treatment With the Combination of Gemcitabine, Carboplatin, and Panitumumab
Median PFS (95% CI), months, reported by biomarker expression/mutation status for: EGFR, p53, PTEN, PIK3CA, KRAS
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 posted7 May 2009 (estimated)
- Study startFeb 2010
- Primary completionSep 2014
- Study completionSep 2014
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.
- 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
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- SCRI Development Innovations, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen, Eli Lilly and Company
- Responsible party
- Sponsor
- Investigators
- Denise A Yardley, M.D., Study chair, SCRI Development Innovations, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00894504
- Sponsor's protocol ID
- SCRI BRE 126
- Status last verified
- Apr 2015
- First submitted
- 5 May 2009
- Last updated
- 15 May 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Panitumumab, Gemcitabine, and Carboplatin in Triple-Negative Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00894504
- Acronym / sponsor ID
- SCRI BRE 126
- Conditions
- Metastatic Breast Cancer
- Keywords
- Metastatic Breast Cancer, Triple Negative, Panitumumab, Vectibix, Gemcitabine, Gemzar, Carboplatin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- SCRI Development Innovations, LLCUniversity, hospital or other
- Collaborators
- Amgen, Eli Lilly and Company
- Study start
- Feb 2010
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 7 May 2009 (estimated)
- Results
- Posted 15 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this Phase II trial, the investigators will evaluate the combination of gemcitabine, carboplatin, and panitumumab in the treatment of patients with metastatic triple-negative breast cancer. In addition, to assess the efficacy of this combination, tumor tissue will be examined for the presence of various markers, including K-ras and PI3K-activating mutations, EGFR, PTEN, and p53. Correlation of tumor response with marker expression may define a patient subset that is particularly responsive to treatment with a panitumumab-containing combination.
Detailed description
All patients will receive a pre-emptive skin care regimen during panitumumab therapy to reduce skin toxicity. Treatment cycles will be repeated every 14 days (2 weeks). During each treatment, panitumumab will be administered first, then carboplatin, then gemcitabine. All drugs will be administered according to standard guidelines. Patients will be re-evaluated for response after completion of 3 cycles (6 weeks) of treatment. Patients with objective response or stable disease will continue treatment. Subsequent re-evaluations will occur every 6 weeks. Patients will continue treatment with all three drugs until tumor progression, or until unacceptable toxicity occurs. If patients experience toxicity caused by gemcitabine/carboplatin and are continuing to benefit from treatment, panitumumab can be continued as a single agent (at the same dose and schedule), at the discretion of the investigator, until disease progression occurs.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Panitumumab/Gemcitabine/Carboplatin | Experimental | Drug: Panitumumab, Drug: Carboplatin, Drug: GemcitabineSystemic therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Female patients >=18 years of age.
- Histologically or cytologically confirmed diagnosis of unresectable locally advanced or stage IV breast cancer.
- No more than 1 prior treatment regimen for metastatic breast cancer.
- Estrogen receptor and progesterone receptor negative (defined as <10% staining by IHC).
- Paraffin-embedded tumor tissue (from the primary tumor or metastasis) for biomarker testing. (In the absence of paraffinembedded tissue, unstained paraffin-embedded tumor slides are acceptable).
Key exclusion criteria (18 listed)
- Patients with brain metastases are not eligible.
- History of another primary cancer, with the exception of the following:
- History of interstitial lung disease (e.g., pneumonitis, pulmonary fibrosis), or any evidence of interstitial lung disease on the CT scan of the chest performed at the baseline visit.
- Prior anti-EGFR antibody therapy (e.g., cetuximab), or treatment with small-molecule EGFR inhibitors (e.g., gefitinib, erlotinib, lapatinib).
- Radiotherapy <=14 days prior to study enrollment. Any acute effects of radiotherapy must be resolved prior to the administration of study drugs.
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 |
|---|---|---|
| PanitumumabAlso: Systemic Therapy, Vectibix6 mg/kg IV on Day 1 of each 2-week treatment cycle for 3 cycles (6 weeks) | Drug | Panitumumab/Gemcitabine/Carboplatin |
| CarboplatinAlso: Systemic Therapy, ParaplatinAUC=2.5 IV, Day 1 of each 2-week treatment cycle for 3 cycles (6 weeks) | Drug | Panitumumab/Gemcitabine/Carboplatin |
| GemcitabineAlso: Systemic Therapy, Gemzar1500 mg/m2 IV, Day 1 of each 2-week treatment cycle for 3 cycles (6 weeks) | Drug | Panitumumab/Gemcitabine/Carboplatin |
Primary outcome
Progression-free Survival (PFS)
Time frame: every 6 weeks until treatment discontinuation
Measured from Day 1 of study drug administration to disease progression - defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as a 20% increase in the sum of the longest diameter of target lesions and/or appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
3 secondary outcomes
Objective Response Rate and Clinical Benefit Rate
Time frame: every 6 weeks until treatment discontinuation
Number of Treatment-related Toxicities Occurring in ≥10% of Patients as a Measure of Tolerability and Toxicity
Time frame: every 6 weeks until discontinuation of treatment, expected average of 18 months
Correlation of Biomarker Expressions of EGFR, K-ras, p53, PTEN Expression, and PI3K in Triple-negative Breast Cancer With Response to Treatment With the Combination of Gemcitabine, Carboplatin, and Panitumumab
Time frame: 18 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2015.
- 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.
Denise A Yardley, M.D. study chair
SCRI Development Innovations, LLC
17 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 Panitumumab, Carboplatin and Gemcitabine in people with Metastatic Breast Cancer, run by SCRI Development Innovations, LLC at 17 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 18 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 15 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 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 Dec 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 (PFS) (time frame: every 6 weeks until treatment discontinuation). 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 May 2015.