Combination Chemotherapy and Trastuzumab in Treating Women With Metastatic Breast Cancer

Overview

  • Study type

    Interventional
  • Study phase

    II
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Scottsdale/Phoenix, Arizona: 1601-98
    • Jacksonville, Florida: 1601-98
    • Rochester, Minnesota: 1601-98
    NCT ID: NCT00003612
    Sponsor Protocol Number: 983252

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility 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

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Alvaro Moreno Aspitia, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Jacksonville, Fla.

Mayo Clinic principal investigator

Alvaro Moreno Aspitia, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Rochester, Minn.

Mayo Clinic principal investigator

Alvaro Moreno Aspitia, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

.
CLS-20154136

Mayo Clinic Footer