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Phase II Study of Doxil and Carboplatin, Plus Herceptin in HER2+ Patients, in Metastatic Breast Cancer

Phase 2
18 Years
Not Enrolling
Metastatic Breast Cancer

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Trial Information

Phase II Study of Doxil and Carboplatin, Plus Herceptin in HER2+ Patients, in Metastatic Breast Cancer

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

- 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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Primary Objective

Outcome Description:

To determine the ORR associated with Doxil in combination with carboplatin in HER2- (negative) MBC (and with Herceptin in HER2+ MBC)

Safety Issue:


Principal Investigator

Rufus P Collea, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

US Oncology Research


United States: Food and Drug Administration

Study ID:




Start Date:

December 2005

Completion Date:

March 2010

Related Keywords:

  • Metastatic Breast Cancer
  • Breast Neoplasms



Texas Oncology, P.A. Dallas, Texas  75246
Virginia Oncology Associates Newport News, Virginia  23606
Comprehensive Cancer Centers of Nevada Las Vegas, Nevada  89109
Ocala Oncology Center Ocala, Florida  34474
Missouri Cancer Associates Columbia, Missouri  65201
New Mexico Cancer Care Associates Santa Fe, New Mexico  87505-7670
Tyler Cancer Center Tyler, Texas  75702
Texas Oncology, PA Dallas, Texas  75246-2006
Northwest Cancer Specialists-Vancouver Vancouver, Washington  98684
Medical Oncology Associates Kingston, Pennsylvania  18704
Florida Cancer Institute New Port Richey, Florida  34652
Central Indiana Cancer Centers Indianapolis, Indiana  46227
Texas Cancer Center at Medical City Dallas, Texas  75230
West Texas Cancer Center Odessa, Texas  79761
Hematology Oncology Associates Phoenix, Arizona  85012
Greater Dayton Cancer Center Kettering, Ohio  45409
Birmingham Hematology and Oncology Birmingham, Alabama  35235
Texas Cancer Center Abilene, Texas  79606
Mamie McFaddin Ward Cancer Center Beaumont, Texas  77702
Lake Vista Cancer Center Lewisville, Texas  75067
Longview Cancer Center Longview, Texas  75601
Texas Cancer Center of Mesquite Mesquite, Texas  75150
Cancer Care Northwest-North Spokane, Washington  99218
Raleigh Hematology Oncology Associates Cary, North Carolina  27511
Minnesota Oncology Hematology, PA Minneapolis, Minnesota  55404
New York Oncology Hematology, PC Albany, New York  12208
Paris Regional Cancer Center Paris, Texas  75460
Hematology Oncology Associates of IL Chicago, Illinois  60611
Maryland Oncology Hematology, PA Columbia, Maryland  21044
Rocky Mountain Cancer Center-Rose Denver, Colorado  80220
El Paso Cancer Treatment Ctr El Paso, Texas  79915
South Texas Cancer Center-McAllen McAllen, Texas  78503
Texas Cancer Center-Sherman Sherman, Texas  75090
Texas Oncology Cancer Center-Sugar Land Sugar Land, Texas  77479
Puget Sound Cancer Center-Seattle Seattle, Washington  98133
Yakima Valley Mem Hosp/North Star Lodge Yakima, Washington  98902
Fairfax Northern VA Hem-Onc PC Fairfax, Virginia  22031
Puget Sound Cancer Center-Edmonds Edmonds, Washington  98026
Kansas City Cancer Centers-Southwest Overland Park, Kansas  66210
Texas Cancer Center-Denton Denton, Texas  76210
Northern AZ Hematology & Oncology Associates-Sedona Sedona, Arizona  86336
Cancer Care & Hematology Specialists of Chicagoland, PC Niles, Illinois  60714
Flavio Kruter, MD, PA Westminster, Maryland  21157
Ruth Oratz MD New York, New York  10016
Willamette Vallejy Cancer Center Eugene, Oregon  97401
Texas Cancer Center - Abilene (South) Abilene, Texas  79606
Texas Oncology, P.A.-Amarillo Amarillo, Texas  79106
Texas Oncology, PA-Bedford Bedford, Texas  76022
The TexasCancer Center Dallas, Texas  75237
Alison Cancer Center Midland, Texas  79701
HOAST-Medical Dr. San Antonio, Texas  78229
Texas Oncology Cancer Care and Research Center-Waco Waco, Texas  76712
Onc and Hem Associates of SW VA, Inc Salem, Virginia  24153