Trastuzumab and Oxaliplatin in Patients With Metastatic Breast Cancer

Completed · Phase 2

Conditions studied: Breast Cancer

In brief

This is a phase II study of the combination of oxaliplatin and trastuzumab as first or second line therapy in patients with stage IV, metastatic breast cancer

Key facts

Study ID

NCT00297596

Run by

SCRI Development Innovations, LLC

People needed

25

Starts

2006-02-01

Expected to finish

2010-10-01

Last updated by the study team

2021-10-28

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Females ≥ 18 years of age
• Histologically confirmed breast cancer that is HER2/neu positive (3+ by IHC or FISH +) and evidence of metastatic disease. Tumor may be of any estrogen and progesterone receptor type
• Measurable disease by RECIST and an ECOG ≤ 2
• Patients with known evidence of brain metastases are eligible if they are asymptomatic and have completed all therapy (surgery, radiotherapy, and/or steroids)
• Baseline LVEF value within the institutional normal range
• Any number of prior hormonal therapy treatments in the adjuvant setting or for metastatic disease. A subject must have progressed on hormonal therapy and all hormonal therapy (including birth control pills) must be discontinued at study entry.
• Prior chemotherapy in the adjuvant setting and up to one prior chemotherapy regimen for metastatic disease is allowed.
• Patients may have received one prior trastuzumab/chemotherapy containing regimen or prior single agent trastuzumab.
• Prior radiation therapy in the adjuvant setting or for metastatic disease, provided it was not to the only site of evaluable disease.
• All prior chemotherapy, trastuzumab and radiation therapy should be completed > 2 weeks before enrollment.
• Patients receiving bisphosphonate therapy are eligible. However, if bisphosphonate were started within < 2 months prior to enrollment, the bone lesions will not be evaluated for response and the patient must have another site of metastatic disease that is either measurable or evaluable for response.
• Patients must have recovered from toxicities due to prior therapy.
• Lab values in accordance with the protocol
• Patients must be nonpregnant and nonlactating. Patients of childbearing potential must implement an effective method of contraception during the study (birth control pills are not allowed).

You may not qualify if…

• Bone only disease are ineligible
• Patients who received more than 1 prior chemotherapy regimen for metastatic disease are ineligible.
• Patients with a history of other cancers except curatively-treated carcinoma of the cervix in situ or non-melanomatous skin cancer.
• Active serious infection or other underlying medical condition that would impair their ability to receive protocol treatment.
• Uncontrolled nervous system metastases
• Dementia or significantly altered mental status that would interfere with proper consenting.
• Receiving other investigational therapy.

Where it is running

• Graves-Gilbert Clinic — Bowling Green, Kentucky, United States
• Hematology Oncology Life Center — Alexandria, Louisiana, United States
• Baton Rouge General Medical Center — Baton Rouge, Louisiana, United States
• Oncology Hematology Care — Cincinnati, Ohio, United States
• Spartanburg Regional Medical Center — Spartanburg, South Carolina, United States
• Chattanooga Oncology and Hematology Associates — Chattanooga, Tennessee, United States
• Tennessee Oncology, PLLC — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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