Combination Chemotherapy and Trastuzumab in Treating Women With Metastatic Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00003612
First received: November 1, 1999
Last updated: July 1, 2016
Last verified: July 2016

November 1, 1999
July 1, 2016
April 1999
December 2005   (final data collection date for primary outcome measure)
response rate [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00003612 on ClinicalTrials.gov Archive Site
  • time to progression [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • median survival [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Combination Chemotherapy and Trastuzumab in Treating Women With Metastatic Breast Cancer
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

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.

PURPOSE: Phase II trial to study the effectiveness of combining paclitaxel, carboplatin, and trastuzumab in treating women who have metastatic breast cancer that overexpresses HER2.

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).

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
  • Biological: trastuzumab
  • Drug: carboplatin
  • Drug: paclitaxel
  • Experimental: Schedule A: paclitaxel + carboplatin + trastuzumab

    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.

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

    Interventions:
    • Biological: trastuzumab
    • Drug: carboplatin
    • Drug: paclitaxel
  • Experimental: Schedule B: paclitaxel + carboplatin + trastuzumab

    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.

    Interventions:
    • Biological: trastuzumab
    • Drug: carboplatin
    • Drug: paclitaxel

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
92
Not Provided
December 2005   (final data collection date for primary outcome measure)

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
Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00003612
NCCTG-983252, CDR0000066689
No
Not Provided
Not Provided
Alliance for Clinical Trials in Oncology
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Study Chair: Edith A. Perez, MD Mayo Clinic
Alliance for Clinical Trials in Oncology
July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP