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Doxil & Carboplatin Plus HER2+ in Metastatic Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00303108
Recruitment Status : Completed
First Posted : March 15, 2006
Results First Posted : November 3, 2016
Last Update Posted : November 3, 2016
Ortho Biotech, Inc.
Tibotec Pharmaceutical Limited
Information provided by (Responsible Party):
US Oncology Research

Brief Summary:
The purpose of this study is to determine the ORR associated with Doxil in combination with carboplatin in HER2- (negative) MBC (and with Herceptin in HER2+ MBC).

Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Drug: Pegylated liposomal doxorubicin Drug: Carboplatin Drug: trastuzumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 136 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
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

Drug: Carboplatin
AUC=5 on Day 1 of each 28 day cycle

Drug: trastuzumab
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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Has metastatic breast cancer with documented HER2- or HER2+ (IHC3+ or FISH+) disease
  • Has measurable MBC, with at least 1 measurable lesion per RECIST criteria (see Section 10). Irradiated lesions cannot be used to assess response but can be used to assess progression.
  • Has had no prior treatment with Doxil or carboplatin; may have had adjuvant Herceptin if treatment was completed more than 1 year prior to study
  • Has had no adjuvant chemotherapy within 1 year prior to study, but may have received prior anthracyclines as adjuvant chemotherapy
  • For taxane-pretreated patients (adjuvant or metastatic), has had no more than 1 prior chemotherapy regimen for MBC
  • For taxane-naïve patients, has had no prior chemotherapy for MBC
  • Has had cumulative doses of < 300 mg/m2 prior doxorubicin or < 450 mg/m2 prior epirubicin
  • Has normal cardiac function as evidenced by a LVEF within institutional normal limits by multiple gated acquisition (MUGA) scan. An echocardiogram (ECHO) may be used if MUGA is not available, but the same test must be used throughout the study to evaluate LVEF.
  • Has an ECOG Performance Status (PS) 0-2 (see Appendix I)
  • Is a male or female greater than or equal to 18 years of age
  • Laboratory Values - Please refer to protocol section 4.2 for specific laboratory values.
  • Has a negative serum pregnancy test within 7 days prior to registration (woman of childbearing potential [WOCBP; not surgically sterilized and between menarche and 1 year postmenopause])
  • If fertile, patient (male or female) has agreed to use an acceptable method of birth control (eg, abstinence, intrauterine device, oral contraceptives, barrier device with spermicide or surgical sterilization) to avoid pregnancy for the duration of the study and for a period of 3 months thereafter.
  • Has signed a Patient Informed Consent Form
  • Has signed a Patient Authorization Form (HIPAA Form)
  • Has a life expectancy of > 3 months

Exclusion Criteria:

  • Has had a myocardial infarction (MI) within 6 months of trial enrollment, or has New York Heart Association (NYHA; see Appendix IV) Class II or greater heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, clinically significant pericardial disease, or electrocardiographic evidence of acute ischemic or active conduction system abnormalities
  • Has a history of hypersensitivity reactions attributed to a conventional formulation of doxorubicin HCL or the components of Doxil
  • Has evaluable only disease; eg, bone only, pleural, peritoneal only disease
  • Is receiving concurrent immunotherapy, hormonal therapy, or radiation therapy. Patients receiving immunosuppressant therapy for autoimmune disease may enroll on the trial after a drug washout period of 2 weeks.
  • Is receiving concurrent investigational therapy or has received such therapy within 30 days
  • Has evidence of brain metastases requiring steroids and/or radiation or any documented leptomeningeal disease
  • Has a serious uncontrolled intercurrent medical or psychiatric illness, including serious infection or history of uncontrolled seizures, CNS disorders deemed by the Treating Physician to be clinically significant, precluding informed consent
  • Has a history of other malignancy within the last 5 years (except cured basal cell carcinoma of skin and carcinoma in situ of uterine cervix), which could affect the diagnosis or assessment of any of the study drugs
  • Is a pregnant or lactating woman
  • Is unable to comply with requirements of study

Information from the National Library of Medicine

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 identifier (NCT number): NCT00303108

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Sponsors and Collaborators
US Oncology Research
Ortho Biotech, Inc.
Tibotec Pharmaceutical Limited
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Principal Investigator: Rufus P Collea, MD US Oncology Research

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: US Oncology Research Identifier: NCT00303108     History of Changes
Other Study ID Numbers: 04111
First Posted: March 15, 2006    Key Record Dates
Results First Posted: November 3, 2016
Last Update Posted: November 3, 2016
Last Verified: September 2016
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Liposomal doxorubicin
Antineoplastic Agents
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological