Combination Chemotherapy and Trastuzumab in Treating Women With Metastatic Breast Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2003 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003612
First received: November 1, 1999
Last updated: February 6, 2009
Last verified: September 2003
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Biological: trastuzumab
Drug: carboplatin
Drug: paclitaxel
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 92
Study Start Date: April 1999
Detailed Description:

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003612

  Show 25 Study Locations
Sponsors and Collaborators
North Central Cancer Treatment Group
Investigators
Study Chair: Edith A. Perez, MD Mayo Clinic
  More Information

Additional Information:
Publications:
Perez EA, Rowland KM, Suman VJ, et al.: N98-32-52: efficacy and tolerability of two schedules of paclitaxel, carboplatin and trastuzumab in women with HER2 positive metastatic breast cancer: a North Central Cancer Treatment Group randomized phase II trial. [Abstract] Breast Cancer Res Treat 82 (Suppl 1): A-216, S47, 2003.
Rowland KM, Suman VJ, Ingle JN, et al.: NCCTG 98-32-52: randomized phase II trial of weekly versus every 3-week administration of paclitaxel, carboplatin and trastuzumab in women with HER2 positive metastatic breast cancer (MBC). [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-31, 2003.

ClinicalTrials.gov Identifier: NCT00003612     History of Changes
Other Study ID Numbers: CDR0000066689, NCCTG-983252
Study First Received: November 1, 1999
Last Updated: February 6, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV breast cancer
recurrent breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Trastuzumab
Carboplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on July 22, 2014