Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow accrual
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Recurrent Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IV Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carboplatin | Drug | Carboplatin | ALIAS |
| immunohistochemistry staining method | Procedure | — | UNRESOLVED |
| laboratory biomarker analysis | Procedure | — | UNRESOLVED |
| paclitaxel | Drug | Paclitaxel | ALIAS |
| panitumumab | Biological | Panitumumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm 1
- description
- Patients receive paclitaxel IV and carboplatin IV on days 1, 8, and 15. Patients also receive panitumumab IV on days 1 and 15.
- interventionNames
- Biological: panitumumab
- Drug: paclitaxel
- Drug: carboplatin
- Procedure: laboratory biomarker analysis
- Procedure: immunohistochemistry staining method
Primary outcomes (1)
- measure
- Antitumor Activity as Assessed by Objective Tumor Response According to RECIST Criteria
- timeFrame
- every 28 days for a minimum of 84 days
- description
- Complete or Partial response as defined by reduction in tumor size according to RECIST (Response Evaluation Criteria In Solid Tumors) rules.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available