Doxil & Carboplatin Plus HER2+ in Metastatic Breast Cancer
- Conditions
- Metastatic Breast Cancer
- Interventions
- Registration Number
- NCT00303108
- Lead Sponsor
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 136
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm 1 Pegylated liposomal doxorubicin 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. Arm 1 trastuzumab 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. Arm 1 Carboplatin 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.
- Primary Outcome Measures
Name Time Method Objective Response Rate (ORR) 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
Name Time Method Duration of Response 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) 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 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.
Trial Locations
- Locations (53)
Missouri Cancer Associates
🇺🇸Columbia, Missouri, United States
Texas Cancer Center
🇺🇸Arlington, Texas, United States
Hematology Oncology Associates of IL
🇺🇸Chicago, Illinois, United States
Central Indiana Cancer Centers
🇺🇸Indianapolis, Indiana, United States
Comprehensive Cancer Centers of Nevada
🇺🇸Las Vegas, Nevada, United States
Texas Oncology, PA
🇺🇸Houston, Texas, United States
Minnesota Oncology Hematology, PA
🇺🇸Minneapolis, Minnesota, United States
Hematology Oncology Associates
🇺🇸Phoenix, Arizona, United States
New Mexico Cancer Care Associates
🇺🇸Santa Fe, New Mexico, United States
Northern AZ Hematology & Oncology Associates-Sedona
🇺🇸Sedona, Arizona, United States
Florida Cancer Institute
🇺🇸New Port Richey, Florida, United States
Ocala Oncology Center
🇺🇸Ocala, Florida, United States
Cancer Care & Hematology Specialists of Chicagoland, PC
🇺🇸Niles, Illinois, United States
Kansas City Cancer Centers-Southwest
🇺🇸Overland Park, Kansas, United States
Maryland Oncology Hematology, PA
🇺🇸Columbia, Maryland, United States
Flavio Kruter, MD, PA
🇺🇸Westminster, Maryland, United States
New York Oncology Hematology, PC
🇺🇸Albany, New York, United States
Texas Oncology, P.A.-Amarillo
🇺🇸Amarillo, Texas, United States
Texas Cancer Center - Abilene (South)
🇺🇸Abilene, Texas, United States
Raleigh Hematology Oncology Associates
🇺🇸Cary, North Carolina, United States
Ruth Oratz MD
🇺🇸New York, New York, United States
Greater Dayton Cancer Center
🇺🇸Kettering, Ohio, United States
Texas Oncology, PA-Bedford
🇺🇸Bedford, Texas, United States
Texas Cancer Center at Medical City
🇺🇸Dallas, Texas, United States
Mamie McFaddin Ward Cancer Center
🇺🇸Beaumont, Texas, United States
Texas Cancer Center-Denton
🇺🇸Denton, Texas, United States
The TexasCancer Center
🇺🇸Dallas, Texas, United States
El Paso Cancer Treatment Ctr
🇺🇸El Paso, Texas, United States
Lake Vista Cancer Center
🇺🇸Lewisville, Texas, United States
South Texas Cancer Center-McAllen
🇺🇸McAllen, Texas, United States
Longview Cancer Center
🇺🇸Longview, Texas, United States
Texas Cancer Center of Mesquite
🇺🇸Mesquite, Texas, United States
Paris Regional Cancer Center
🇺🇸Paris, Texas, United States
Alison Cancer Center
🇺🇸Midland, Texas, United States
West Texas Cancer Center
🇺🇸Odessa, Texas, United States
HOAST-Medical Dr.
🇺🇸San Antonio, Texas, United States
Texas Cancer Center-Sherman
🇺🇸Sherman, Texas, United States
Tyler Cancer Center
🇺🇸Tyler, Texas, United States
Texas Oncology Cancer Center-Sugar Land
🇺🇸Sugar Land, Texas, United States
Texas Oncology Cancer Care and Research Center-Waco
🇺🇸Waco, Texas, United States
Texas Oncology, P.A.
🇺🇸Webster, Texas, United States
Virginia Oncology Associates
🇺🇸Norfolk, Virginia, United States
Fairfax Northern VA Hem-Onc PC
🇺🇸Fairfax, Virginia, United States
Onc and Hem Associates of SW VA, Inc
🇺🇸Salem, Virginia, United States
Puget Sound Cancer Center-Edmonds
🇺🇸Edmonds, Washington, United States
Puget Sound Cancer Center-Seattle
🇺🇸Seattle, Washington, United States
Northwest Cancer Specialists-Vancouver
🇺🇸Vancouver, Washington, United States
Cancer Care Northwest-North
🇺🇸Spokane, Washington, United States
Yakima Valley Mem Hosp/North Star Lodge
🇺🇸Yakima, Washington, United States
Medical Oncology Associates
🇺🇸Kingston, Pennsylvania, United States
Willamette Vallejy Cancer Center
🇺🇸Eugene, Oregon, United States
Birmingham Hematology and Oncology
🇺🇸Birmingham, Alabama, United States
Rocky Mountain Cancer Center-Rose
🇺🇸Denver, Colorado, United States