Breast Cancer, Recurrent Breast Cancer, Stage IV Breast Cancer
Conditions
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
Given IV
Given IV
Given IV
Correlative study
Correlative study
Sponsors
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Antitumor Activity as Assessed by Objective Tumor Response According to RECIST Criteria | every 28 days for a minimum of 84 days | Complete or Partial response as defined by reduction in tumor size according to RECIST (Response Evaluation Criteria In Solid Tumors) rules. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Progression | Approximately 7 months | 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. |
| Survival | Approximately 7 months | — |
| Expression of EGFR and Other Protein Markers | baseline | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 |
| Total | 14 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | necessary scans not completed | 1 |
Baseline characteristics
| Characteristic | Arm 1 |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 3 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants |
| Age, Continuous | 54.5 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 type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 14 / 14 |
| serious Total, serious adverse events | 9 / 14 |
Outcome results
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1 | Antitumor Activity as Assessed by Objective Tumor Response According to RECIST Criteria | 6 participants |
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.
Survival
Time frame: Approximately 7 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm 1 | Survival | 6.8 months |
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm 1 | Time to Progression | 5.3 months |