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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in United States

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.

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 groups in NCT00894504
Study groupRoleWhat they receive
Panitumumab/Gemcitabine/CarboplatinExperimentalSystemic 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.

  1. 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)

  1. 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

  2. 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

  3. 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.

  1. First posted7 May 2009 (estimated)
  2. Study startFeb 2010
  3. Primary completionSep 2014
  4. Study completionSep 2014

Resources

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)
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
Data monitoring committee
No

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?

On the ClinicalTrials.gov record for NCT00894504.

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; AzTrials last refreshed its copy on 8 Nov 2026.

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