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Paclitaxel, Carboplatin, and Panitumumab in Treating Patients With Metastatic Breast Cancer

A Phase II Clinical Trial of Weekly Paclitaxel and Carboplatin in Combination With Panitumumab in Metastatic Breast Cancer Patients With Triple Negative Disease

Status
Terminated
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01009983
Enrollment
14
Registered
2009-11-09
Start date
2010-03-31
Completion date
2013-12-31
Last updated
2018-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Recurrent Breast Cancer, Stage IV Breast Cancer

Keywords

triple-negative breast cancer

Brief summary

RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as panitumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Other find tumor cells and help kill them or carry tumor-killing substances to them. Giving panitumumab together with paclitaxel and carboplatin may be a better way to block tumor growth. PURPOSE: This phase II trial is studying the side effects and how well paclitaxel and carboplatin together with panitumumab works in treating patients with metastatic triple negative breast cancer.

Detailed description

PRIMARY OBJECTIVE: I. To determine the response rate to the combination of carboplatin, paclitaxel and panitumumab in women with ER-, PR- and Her-2 negative metastatic breast cancer. SECONDARY OBJECTIVES: I. To determine the tolerability and toxicities of the combination of paclitaxel, carboplatin and panitumumab. II. To determine the markers that co-occur with EGFR expression in the triple negative breast cancer. III. To assess the association between tumor biomarkers and clinical outcomes (response and survival). IV. To examine the effect this regimen has on time to progression and survival. OUTLINE: Patients receive paclitaxel IV and carboplatin IV on days 1, 8, and 15. Patients also receive panitumumab IV on days 1 and 15. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.

Interventions

BIOLOGICALpanitumumab

Given IV

DRUGpaclitaxel

Given IV

DRUGcarboplatin

Given IV

PROCEDURElaboratory biomarker analysis

Correlative study

PROCEDUREimmunohistochemistry staining method

Correlative study

Sponsors

Wake Forest University Health Sciences
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Inclusion * Pathologically confirmed invasive breast cancer with ER \< 10%, PR \< 10%, by IHC, HER2 1+ or 0 or FISH negative * Measurable (\>= 1 cm) or assessable disease detectable by imagining or physical exam * Patients with bone only disease have measurable lesions on x-ray, MRI, or CT scan * Only one or no prior therapy for metastatic or recurrent breast cancer is allowed * Prior chemotherapy or radiation therapy is permitted but at least 2 weeks should elapse prior to study enrollment * Prior therapy with bevacizumab is permitted but at least 2 weeks should elapse prior to study enrollment * Prior therapy with bevacizumab is permitted but at least 28 days should elapse from the last bevacizumab treatment prior to study enrollment * ECOG PS or 0-1 * Signed protocol specific informed consent prior to registration * Life expectancy greater than 3 months * Please contact study investigator and/or consult the protocol document for specific laboratory criteria * Tissue block available from primary breast cancer * Premenopausal women must have a negative serum or urine pregnancy test prior to starting on study treatment (post-menopausal is defined as \> 6 months of amenorrhea prior hysterectomy) Exclusion * More than or equal to 2 prior regimens for metastatic breast cancer * Leptomeningeal disease * Brain metastasis except for a solitary lesion that was resected or treated with gamma knife with no residual disease on CT or MRI or received whole brain RT and f/u MRI was normal with no residual neurologic deficit * History of interstitial lung disease (ie pneumonitis, pulmonary fibrosis) or evidence of interstitial lung disease on baseline chest computerized tomography (CT) scan * History of irreversible neuropathy * Another malignancy other than carcinoma in situ of the cervix or skin cancer * Active uncontrolled bacterial viral or fungal infection * Active pregnancy or breast feeding * Patients with pre-existing neuropathy \>= grade 2 * History of myocardial infarction, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia * Patients with previous history of CTCAE grade \>= 3 hypersensitivity to paclitaxel or Cremophor EL are not eligible

Design outcomes

Primary

MeasureTime frameDescription
Antitumor Activity as Assessed by Objective Tumor Response According to RECIST Criteriaevery 28 days for a minimum of 84 daysComplete or Partial response as defined by reduction in tumor size according to RECIST (Response Evaluation Criteria In Solid Tumors) rules.

Secondary

MeasureTime frameDescription
Time to ProgressionApproximately 7 monthsProgression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
SurvivalApproximately 7 months
Expression of EGFR and Other Protein Markersbaseline

Countries

United States

Participant flow

Participants by arm

ArmCount
Arm 1
Patients receive paclitaxel IV and carboplatin IV on days 1, 8, and 15. Patients also receive panitumumab IV on days 1 and 15. panitumumab: Given IV paclitaxel: Given IV carboplatin: Given IV laboratory biomarker analysis: Correlative study immunohistochemistry staining method: Correlative study
14
Total14

Withdrawals & dropouts

PeriodReasonFG000
Overall Studynecessary scans not completed1

Baseline characteristics

CharacteristicArm 1
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
3 Participants
Age, Categorical
Between 18 and 65 years
11 Participants
Age, Continuous54.5 years
STANDARD_DEVIATION 10.1
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
14 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
9 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
5 Participants
Region of Enrollment
United States
14 participants
Sex: Female, Male
Female
14 Participants
Sex: Female, Male
Male
0 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
14 / 14
serious
Total, serious adverse events
9 / 14

Outcome results

Primary

Antitumor Activity as Assessed by Objective Tumor Response According to RECIST Criteria

Complete or Partial response as defined by reduction in tumor size according to RECIST (Response Evaluation Criteria In Solid Tumors) rules.

Time frame: every 28 days for a minimum of 84 days

ArmMeasureValue (NUMBER)
Arm 1Antitumor Activity as Assessed by Objective Tumor Response According to RECIST Criteria6 participants
Secondary

Expression of EGFR and Other Protein Markers

Time frame: baseline

Population: Test not completed as specified in protocol that will only be completed if a full sample was accrued.

Secondary

Survival

Time frame: Approximately 7 months

ArmMeasureValue (MEDIAN)
Arm 1Survival6.8 months
Secondary

Time to Progression

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Time frame: Approximately 7 months

ArmMeasureValue (MEDIAN)
Arm 1Time to Progression5.3 months

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026