Trastuzumab and Oxaliplatin in Patients With Metastatic Breast Cancer
A Phase II Trial of Trastuzumab and Oxaliplatin in Patients With Metastatic Breast Cancer
1 other identifier
interventional
25
1 country
7
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 breast-cancer
Started Feb 2006
Typical duration for phase_2 breast-cancer
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2006
CompletedFirst Submitted
Initial submission to the registry
February 24, 2006
CompletedFirst Posted
Study publicly available on registry
February 28, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedResults Posted
Study results publicly available
December 13, 2012
CompletedOctober 28, 2021
October 1, 2021
2.7 years
February 24, 2006
November 15, 2012
October 13, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Objective Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment
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.
18 months
Secondary Outcomes (1)
Time to Progression
18 months
Study Arms (1)
Intervention
EXPERIMENTALPatients with HER2 positive breast cancer received treatment with oxaliplatin 130 mg/m2 IV day 1 and trastuzumab 6 mg/kg (following 8 mg/kg loading dose during cycle 1). Cycles were repeated every 21 days.
Interventions
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 cycles. For the first cycle, trastuzumab will be administered before oxaliplatin; however for subsequent cycles, oxaliplatin will be infused prior to trastuzumab
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- SCRI Development Innovations, LLClead
- Sanoficollaborator
Study Sites (7)
Graves-Gilbert Clinic
Bowling Green, Kentucky, 42101, United States
Hematology Oncology Life Center
Alexandria, Louisiana, 71301, United States
Baton Rouge General Medical Center
Baton Rouge, Louisiana, 70806, United States
Oncology Hematology Care
Cincinnati, Ohio, 45242, United States
Spartanburg Regional Medical Center
Spartanburg, South Carolina, 29303, United States
Chattanooga Oncology and Hematology Associates
Chattanooga, Tennessee, 37404, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, 37205, United States
Related Publications (1)
Yardley DA, Daniel D, Stipanov M, Drosick DR, Mainwaring M, Peyton J, Shastry M, Hainsworth JD. A phase II trial of oxaliplatin and trastuzumab in the treatment of HER2-positive metastatic breast cancer. Cancer Invest. 2010 Oct;28(8):865-71. doi: 10.3109/07357901003631031.
PMID: 20690802RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- John D. Hainsworth, MD
- Organization
- Sarah Cannon Research Institute
Study Officials
- PRINCIPAL INVESTIGATOR
Denise A. Yardley, MD
SCRI Development Innovations, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 24, 2006
First Posted
February 28, 2006
Study Start
February 1, 2006
Primary Completion
October 1, 2008
Study Completion
October 1, 2010
Last Updated
October 28, 2021
Results First Posted
December 13, 2012
Record last verified: 2021-10