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Randomized Phase II Trial of Paclitaxel, Carboplatin and rhuMAb Her-2 (Herceptin) as First-Line Chemotherapy in Patients With Metastatic Breast Cancer Who Overexpress Her-2


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

Thank you

Trial Information

Randomized Phase II Trial of Paclitaxel, Carboplatin and rhuMAb Her-2 (Herceptin) as First-Line Chemotherapy in Patients With Metastatic Breast Cancer Who Overexpress Her-2


OBJECTIVES:

- Compare the response rate associated with two different treatment schedules of
paclitaxel, carboplatin, and trastuzumab (Herceptin) in women with overexpressed HER-2
growth factor receptor and metastatic breast cancer. (Schedule A closed to accrual
effective 05/16/2003).

- Compare the time to progression and median survival in patients treated with these
schedules.

- Compare the toxicity of these treatment schedules in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to prior adjuvant
therapy (none vs less than 6 months vs at least 6 months), estrogen receptor (ER) status and
progesterone receptor (PR) status at initial diagnosis (ER positive/PR positive or unknown
vs ER positive/PR negative vs ER positive or unknown/PR negative), menopausal status (pre vs
post), and performance status (0 or 1 vs 2). Patients are assigned to 1 of 2 treatment
schedules.

- Schedule A: Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over
30 minutes and then trastuzumab (Herceptin) IV over 90 minutes on day 1 of week 1.
Treatment repeats every 3 weeks for up to 8 courses in the absence of disease
progression or unacceptable toxicity. Patients then receive trastuzumab IV over 30
minutes every 3 weeks until disease progression. (Schedule A closed to accrual
effective 05/16/2003).

- Schedule B: Patients receive paclitaxel IV over 1 hour followed by carboplatin IV over
15 minutes on day 1 of weeks 1-3 and trastuzumab IV over 90 minutes immediately after
carboplatin on day 1. Treatment repeats every 4 weeks for up to 6 courses in the
absence of disease progression or unacceptable toxicity. Patients then receive
trastuzumab IV over 30 minutes every 3 weeks until disease progression.

Patients are followed every 3 months for 2 years and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 36-92 patients (18-46 per treatment schedule) will be accrued
for this study within 7-18.5 months. (Schedule A closed to accrual effective 05/16/2003).

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed metastatic adenocarcinoma of the breast

- Strong overexpression of HER-2 by immunohistochemistry (3+)

- 0-2+ tumors allowed if demonstrate amplification by FISH

- Bidimensionally measurable disease

- Brain metastasis must not represent sole site of disease

- No untreated brain metastasis receiving radiotherapy

- Previously treated brain metastases in continued response to radiotherapy and/or
surgery for at least 2 months allowed

- Hormone receptor status:

- Positive or negative

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Sex:

- Female

Menopausal status:

- Not specified

Performance status:

- ECOG 0-2

Life expectancy:

- At least 3 months

Hematopoietic:

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

Hepatic:

- Bilirubin no greater than 1.5 mg/dL

- AST no greater than 3 times upper limit of normal (ULN) (5 times ULN if liver
metastases present)

Renal:

- Creatinine no greater than 1.5 times ULN

Cardiovascular:

- No myocardial infarction within the past 6 months

- No congestive heart failure or unstable angina

- No clinically significant pericardial effusion or arrhythmia

Other:

- No other invasive malignancy within the past 5 years except curatively treated basal
cell or squamous cell skin cancer or carcinoma in situ of the cervix

- No active uncontrolled infection

- No prior allergic reaction to Cremophor EL, anesthetics, or muscle relaxants

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No concurrent filgrastim (G-CSF)

Chemotherapy:

- Prior adjuvant chemotherapy allowed

- Prior taxane therapy allowed

- No prior cisplatin or carboplatin

- No prior chemotherapy for metastatic disease

Endocrine therapy:

- Not specified

Radiotherapy:

- See Disease Characteristics

- No prior radiotherapy to more than 25% of marrow

- At least 4 weeks since prior radiotherapy

- No concurrent radiotherapy

Surgery:

- See Disease Characteristics

- At least 4 weeks since prior surgery and recovered

Other:

- At least 7 days since prior parenteral antibiotics

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Edith A. Perez, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000066689

NCT ID:

NCT00003612

Start Date:

April 1999

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage IV breast cancer
  • recurrent breast cancer
  • Breast Neoplasms

Name

Location

Mayo Clinic Cancer CenterRochester, Minnesota  55905
CCOP - WichitaWichita, Kansas  67214-3882
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
CCOP - DuluthDuluth, Minnesota  55805
CCOP - Scottsdale Oncology ProgramScottsdale, Arizona  85259-5404
CCOP - Cedar Rapids Oncology ProjectCedar Rapids, Iowa  52403-1206
Siouxland Hematology-OncologySioux City, Iowa  51101-1733
CCOP - OchsnerNew Orleans, Louisiana  70121
CCOP - Merit Care HospitalFargo, North Dakota  58122
Rapid City Regional HospitalRapid City, South Dakota  57709
CCOP - Sioux Community Cancer ConsortiumSioux Falls, South Dakota  57105-1080
CCOP - Geisinger Clinic and Medical CenterDanville, Pennsylvania  17822-2001
CCOP - St. Vincent Hospital Cancer Center, Green BayGreen Bay, Wisconsin  54301
CCOP - Toledo Community HospitalToledo, Ohio  43623-3456
Mayo ClinicJacksonville, Florida  32224
Medcenter One Health SystemBismarck, North Dakota  58501
CentraCare Health PlazaSaint Cloud, Minnesota  56303
Carle Cancer CenterUrbana, Illinois  61801
Altru Cancer CenterGrand Forks, North Dakota  58206