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A Phase II Trial of Trastuzumab and Oxaliplatin in Patients With Metastatic Breast Cancer

Phase 2
18 Years
Not Enrolling
Breast Cancer

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Trial Information

A Phase II Trial of Trastuzumab and Oxaliplatin in Patients With Metastatic Breast Cancer

Eligible patients will receive a minimum of six cycles of combination therapy. If a patient
is still responding to the oxaliplatin at 6 cycles, the oxaliplatin may be continued with
the trastuzumab up to 10 cycles at the investigator's discretion. After discontinuing the
oxaliplatin/trastuzumab combination, patients should continue with single agent trastuzumab
until disease progression.

Trastuzumab will be administered as an 8 mg/kg loading dose by intravenous (IV) infusion
over 90 minutes on day 1 of cycle 1. Subsequent doses will be administered as a 6 mg/kg IV
dose over 30 minutes. Oxaliplatin will be administered at a dose of 130 mg/ m2 over 120
minutes on day 1 of each cycle, following standard antiemetic premedications. 21 day

For the first cycle, trastuzumab will be administered before oxaliplatin; however for
subsequent cycles, oxaliplatin will be infused prior to trastuzumab

Inclusion Criteria:

- 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).

Exclusion Criteria:

- 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

- Receiving other investigational therapy.

Type of Study:


Study Design:

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

Outcome Measure:

Objective Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment

Outcome Description:

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."

Outcome Time Frame:

18 months

Safety Issue:


Principal Investigator

Denise A. Yardley, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sarah Cannon Research Institute


United States: Food and Drug Administration

Study ID:




Start Date:

February 2006

Completion Date:

October 2010

Related Keywords:

  • Breast Cancer
  • Metastatic
  • HER2/neu+
  • Breast Neoplasms



Spartanburg Regional Medical CenterSpartanburg, South Carolina  29303
Baton Rouge General Medical CenterBaton Rouge, Louisiana  70821-2511
Chattanooga Oncology and Hematology AssociatesChattanooga, Tennessee  37404
Tennessee Oncology, PLLCClarksville, Tennessee  37043
Hematology Oncology Life CenterAlexandria, Louisiana  71301
Oncology Hematology CareCincinnati, Ohio  45242
Graves-Gilbert ClinicBowling Green, Kentucky  42101