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


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer, Recurrent Breast Cancer, Stage IV Breast Cancer

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Trial Information

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


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.

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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Antitumor activity as assessed by objective tumor response according to RECIST criteria

Outcome Time Frame:

monthly

Safety Issue:

No

Principal Investigator

Julia Lawrence

Investigator Role:

Principal Investigator

Investigator Affiliation:

Wake Forest University

Authority:

United States: Institutional Review Board

Study ID:

CCCWFU74108

NCT ID:

NCT01009983

Start Date:

March 2010

Completion Date:

March 2016

Related Keywords:

  • Breast Cancer
  • Recurrent Breast Cancer
  • Stage IV Breast Cancer
  • triple-negative breast cancer
  • Breast Neoplasms

Name

Location

Ochsner Clinic FoundationNew Orleans, Louisiana  70121
Wake Forest University Health SciencesWinston-Salem, North Carolina  27157