Doxil & Carboplatin Plus HER2+ in Metastatic Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00303108|
Recruitment Status : Completed
First Posted : March 15, 2006
Results First Posted : November 3, 2016
Last Update Posted : November 3, 2016
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Breast Cancer||Drug: Pegylated liposomal doxorubicin Drug: Carboplatin Drug: trastuzumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||136 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Doxil and Carboplatin, Plus Herceptin in HER2+ Patients, in Metastatic Breast Cancer|
|Study Start Date :||December 2005|
|Actual Primary Completion Date :||March 2010|
|Actual Study Completion Date :||June 2011|
Experimental: Arm 1
Patients will receive IV Doxil 30 mg/m2 and carboplatin AUC=5 on Day 1 of each cycle. A cycle consists of 28 days. In addition, HER2+ (IHC3+ and FISH+) patients only will receive a one-time loading dose of Herceptin 8 mg/kg IV on Day 1 of Cycle 1 and 4 mg/kg on Day 1 and Day 15 of every cycle thereafter.
Drug: Pegylated liposomal doxorubicin
30 mg/m2 IV on Day 1 of each 28 day cycle
Other Name: Doxil
AUC=5 on Day 1 of each 28 day cycle
4 mg/kg on Days 1 and 15 of each cycle(loading dose of 8 mg/kg on Day 1 of Cycle 1 only)
Other Name: Herceptin
- Objective Response Rate (ORR) [ Time Frame: From date of randomization until the date of first documented progression or date of intolerable toxicity, whichever came first, assessed up to 54 months. ]Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective response (OR) = CR + PR.
- Duration of Response [ Time Frame: From date of randomization until the date of first documented progression or date of intolerable toxicity, whichever came first, assessed up to 54 months. ]Duration from date of stating treatment to the date of first CR or PR.
- Progression-free Survival (PFS) [ Time Frame: 30 months ]
PFS is measured from the date of randomization to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at last contact date.
Progression is defined as appearance of one or more new lesions. Unequivocal progression of existing non-target lesions. Although a clear progression of "non-target" lesions only is exceptional, in such circumstances, the opinion of the Treating Physician should prevail, and the progression status should be confirmed at a later time by the review panel.
- 1-year Overall Survival [ Time Frame: 1 year ]OS is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00303108
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|Principal Investigator:||Rufus P Collea, MD||US Oncology Research|