Paclitaxel With or Without Trastuzumab in Treating Patients With or Without HER-2/Neu Breast Cancer That is Inoperable, Recurrent, or Metastatic
NCT ID: NCT00003440
Last Updated: 2013-06-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
580 participants
INTERVENTIONAL
1998-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Chemotherapy Plus Monoclonal Antibody Therapy in Treating Women With Stage II or Stage IIIA Breast Cancer That Overexpresses HER2
NCT00003992
Trastuzumab Plus Paclitaxel in Treating Women With Metastatic Breast Cancer That Overexpresses HER2
NCT00005635
Efficacy and Safety Study of Trastuzumab and Paclitaxel Based Regimens to Treat HER2-positive Breast Cancer
NCT01428414
Carboplatin+Nab-paclitaxel, Plus Trastuzumab (HER2+) or Bevacizumab (HER2-) in the Neoadjuvant Setting
NCT00618657
Paclitaxel With or Without Trastuzumab Following Peripheral Stem Cell Transplantation in Treating Patients With Refractory Stage IV Breast Cancer
NCT00004013
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
I. To determine whether "dose dense" (DD) treatment with paclitaxel via weekly 1-hour infusion has a significantly higher response rate than "standard" (S) paclitaxel treatment, regardless of human epidermal growth factor receptor 2 (HER-2/neu) status and assignment to Herceptin (trastuzumab).
II. To determine if the addition of Herceptin to DD or S paclitaxel significantly improves the response rate as compared to DD or S paclitaxel alone for HER-2/neu non-overexpressing metastatic breast cancer (e.g., 0 or 1+).
III. To determine whether the addition of Herceptin to chemotherapy treatment modifies the quality of life experienced by patients with HER-2/neu non-overexpressing metastatic breast cancer.
IV. To determine whether the quality of life experienced by patients with metastatic breast cancer who have been treated with "standard" paclitaxel treatment differ from that of patients treated with "dose dense" paclitaxel treatment.
V. To correlate amplification and overexpression of the growth factor receptor ErbB2 by immunohistochemistry and fluorescent in-situ hybridization (FISH) with response rate, time to progression, and overall survival of patients with metastatic breast cancer treated with paclitaxel chemotherapy and paclitaxel + Herceptin.
VI. To correlate ErbB2 shed extracellular domain (ECD) with response rate, time to progression, and overall survival of patients with metastatic breast cancer treated with different doses and schedules of paclitaxel and paclitaxel + Herceptin. In addition, to follow patterns of ErbB2/ECD after treatment and upon relapse.
SECONDARY OBJECTIVES:
I. To evaluate time to progression and survival of patients with HER-2 overexpressing metastatic breast cancer treated with either DD or S paclitaxel plus weekly Herceptin.
II. To evaluate time to progression and survival of patients with HER-2 non-overexpressing metastatic breast cancer treated with either DD or S paclitaxel alone or DD or S paclitaxel plus weekly Herceptin.
III. To evaluate cardiac toxicity as measured by changes in LVEF from baseline to follow-up measurements.
OUTLINE; Patients are assigned to 1 of 2 treatment groups.
GROUP I (HER2/neu non-overexpressors): Patients are randomized to 1 of 4 treatment arms.
ARM A: Patients receive paclitaxel intravenously (IV) over 3 hours every 3 weeks.
ARM B: Patients receive paclitaxel IV over 1 hour weekly.
ARM C: Patients receive paclitaxel as in Arm A. Patients also receive trastuzumab IV weekly.
ARM D: Patients receive paclitaxel as in Arm B and trastuzumab as in Arm C.
GROUP II (HER2/neu overexpression): Patients are assigned to 1 of 2 treatment arms.
ARM E: Patients receive paclitaxel and trastuzumab as in Arm C.
ARM F: Patients receive paclitaxel and trastuzumab as in Arm D.
In all arms, courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
After the completion of study treatment, patients are followed up periodically for up to 5 years.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm A (paclitaxel)
Patients receive paclitaxel intravenously (IV) over 3 hours every 3 weeks.
paclitaxel
Given IV over 1 hour or 3 hours
quality-of-life assessment
Ancillary studies
laboratory biomarker analysis
Correlative studies
Arm B (paclitaxel)
Patients receive paclitaxel IV over 1 hour weekly.
paclitaxel
Given IV over 1 hour or 3 hours
quality-of-life assessment
Ancillary studies
laboratory biomarker analysis
Correlative studies
Arm C (paclitaxel, trastuzumab)
Patients receive paclitaxel as in Arm I. Patients also receive trastuzumab IV weekly.
paclitaxel
Given IV over 1 hour or 3 hours
trastuzumab
Given IV
quality-of-life assessment
Ancillary studies
laboratory biomarker analysis
Correlative studies
Arm D (paclitaxel, trastuzumab)
Patients receive paclitaxel as in Arm II and trastuzumab as in Arm III.
paclitaxel
Given IV over 1 hour or 3 hours
trastuzumab
Given IV
quality-of-life assessment
Ancillary studies
laboratory biomarker analysis
Correlative studies
Am E (paclitaxel, trastuzumab)
Patients receive paclitaxel and trastuzumab as in Arm C.
paclitaxel
Given IV over 1 hour or 3 hours
trastuzumab
Given IV
quality-of-life assessment
Ancillary studies
laboratory biomarker analysis
Correlative studies
Arm F (paclitaxel, trastuzumab)
Patients receive paclitaxel and trastuzumab as in Arm D.
paclitaxel
Given IV over 1 hour or 3 hours
trastuzumab
Given IV
quality-of-life assessment
Ancillary studies
laboratory biomarker analysis
Correlative studies
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
paclitaxel
Given IV over 1 hour or 3 hours
trastuzumab
Given IV
quality-of-life assessment
Ancillary studies
laboratory biomarker analysis
Correlative studies
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* HER-2/neu status must be known at the time of protocol registration; HER-2/neu assessment will be based on FISH analysis of either the primary tumor or a metastatic site; a scoring of 0 or 1+ by immunohistochemistry (IHC) is considered negative; 2+ is considered negative unless confirmed by FISH positivity, in which case it should be considered positive; 3+ by IHC is considered positive; for centers using FISH only, a positive FISH assay by itself is sufficient to determine HER-2 positivity
* Patients with the following prior therapy are eligible:
* Patients with 0-1 prior chemotherapy regimens for metastatic or locally advanced breast cancer, with the following exception: no prior taxane for metastatic/locally advanced breast cancer
* Patients with 0-1 prior chemotherapy regimens in the adjuvant setting; if adjuvant regimen included a taxane, patient must have been disease free for at least 12 months from completion of adjuvant therapy until relapse
* Patients must be \> 2 weeks from prior surgery, other than simple biopsy or placement of venous access device; patients must be \> 4 weeks from prior chemotherapy; patients must be \>6 weeks from nitrosoureas, melphalan, or mitomycin
* Patients must be \> 4 weeks from prior hormonal therapy unless tumor measurements document clear progression while on treatment; if progression is documented and toxicity from hormonal regimen has resolved, patients may be placed on study \> 1 week from prior hormonal therapy
* Prior Herceptin therapy is not allowed
* Patients with central nervous system metastases are eligible only if the patient has completed cranial irradiation at least 6 months prior, is currently asymptomatic, and is not currently receiving corticosteroids for this condition; patients with leptomeningeal carcinoma (carcinomatous meningitis) are not eligible
* MESURABLE DISEASE: Any mass reproducibly measurable in two perpendicular dimensions, examples include:
* Pulmonary nodules
* Hepatic lesions
* Skin nodules (if two measurements can be assigned)
* Lymph nodes
* The following lesions do not qualify as measurable:
* Central nervous system (CNS) lesions
* Bone disease only; lytic lesions should be documented and followed
* Lymphangitic pulmonary metastases (patients with lymphangitic metastases are eligible if there are other sites of metastatic disease which can be measured)
* Lesions which have been irradiated unless there is definite documentation of progression since radiotherapy
* A baseline assessment of left ventricular ejection fraction within 8 weeks of registration is required (echocardiogram or resting multi gated acquisition scan \[MUGA\] (radionuclide cineangiography \[RNCA\]) nuclear scintigraphy); patients with a left ventricular ejection fraction (LVEF) \< 45% are ineligible
* Granulocytes \>= 1500/ul
* Platelet count \>= 100,000/ul
* Creatinine =\< 2.0 mg/dl
* Bilirubin within institutional normal limits
* Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase \[AST\])
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Andrew Seidman
Role: PRINCIPAL_INVESTIGATOR
Cancer and Leukemia Group B
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cancer and Leukemia Group B
Chicago, Illinois, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CALGB-9840
Identifier Type: -
Identifier Source: secondary_id
NCI-2012-02792
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.