Paclitaxel With or Without Trastuzumab in Treating Patients With or Without HER-2/Neu Breast Cancer That is Inoperable, Recurrent, or Metastatic

NCT00003440 | Completed Phase 3

• 3 other identifiers: NCI-2012-02792CALGB-9840U10CA031946
• Study Type: interventional
• Target: 580
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized phase III studies how well two different regimens of paclitaxel with or without trastuzumab works in treating patients with or without HER-2/Neu breast cancer that is inoperable, recurrent, or metastatic. Drugs used in chemotherapy, such as paclitaxel, use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as trastuzumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known what regimen of paclitaxel is more effective with or without trastuzumab in treating patients with breast cancer.

Conditions

HER2-negative Breast Cancer; HER2-positive Breast Cancer; Recurrent Breast Cancer; Stage IIIC Breast Cancer; Stage IV Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Response rate (complete response [CR]) and partial response [PR])

  Multivariate logistic regression will be used to relate patient characteristics and pretreatment clinical variables with tumor response (complete or partial). Interim analyses will use a chi square statistic to compare response incidence by treatment arm with two-sided bounds constructed from the O'Brien-Fleming approach

  Up to 5 years

Secondary Outcomes (7)

• Overall survival

  Up to 5 years

• Time to disease progression:

  Up to 5 years

• Duration of response

  Length of time between response and disease progression, assessed up to 5 years

• Cardiac toxicity as measured by changes in LVEF

  From baseline to up to 5 years

• Toxicity as assessed by CALGB Expanded Common Toxicity Criteria

  Up to 5 years

Study Arms (6)

Arm A (paclitaxel)

EXPERIMENTAL

Patients receive paclitaxel intravenously (IV) over 3 hours every 3 weeks.

Drug: paclitaxel; Procedure: quality-of-life assessment; Other: laboratory biomarker analysis

Arm B (paclitaxel)

ACTIVE COMPARATOR

Patients receive paclitaxel IV over 1 hour weekly.

Drug: paclitaxel; Procedure: quality-of-life assessment; Other: laboratory biomarker analysis

Arm C (paclitaxel, trastuzumab)

EXPERIMENTAL

Patients receive paclitaxel as in Arm I. Patients also receive trastuzumab IV weekly.

Drug: paclitaxel; Biological: trastuzumab; Procedure: quality-of-life assessment; Other: laboratory biomarker analysis

Arm D (paclitaxel, trastuzumab)

ACTIVE COMPARATOR

Patients receive paclitaxel as in Arm II and trastuzumab as in Arm III.

Drug: paclitaxel; Biological: trastuzumab; Procedure: quality-of-life assessment; Other: laboratory biomarker analysis

Am E (paclitaxel, trastuzumab)

EXPERIMENTAL

Patients receive paclitaxel and trastuzumab as in Arm C.

Drug: paclitaxel; Biological: trastuzumab; Procedure: quality-of-life assessment; Other: laboratory biomarker analysis

Arm F (paclitaxel, trastuzumab)

ACTIVE COMPARATOR

Patients receive paclitaxel and trastuzumab as in Arm D.

Drug: paclitaxel; Biological: trastuzumab; Procedure: quality-of-life assessment; Other: laboratory biomarker analysis

Interventions

paclitaxel DRUG

Given IV over 1 hour or 3 hours

Also known as: Anzatax, Asotax, TAX, Taxol

Am E (paclitaxel, trastuzumab); Arm A (paclitaxel); Arm B (paclitaxel); Arm C (paclitaxel, trastuzumab); Arm D (paclitaxel, trastuzumab); Arm F (paclitaxel, trastuzumab)

trastuzumab BIOLOGICAL

Given IV

Also known as: anti-c-erB-2, Herceptin, MOAB HER2

Am E (paclitaxel, trastuzumab); Arm C (paclitaxel, trastuzumab); Arm D (paclitaxel, trastuzumab); Arm F (paclitaxel, trastuzumab)

quality-of-life assessment PROCEDURE

Ancillary studies

Also known as: quality of life assessment

Am E (paclitaxel, trastuzumab); Arm A (paclitaxel); Arm B (paclitaxel); Arm C (paclitaxel, trastuzumab); Arm D (paclitaxel, trastuzumab); Arm F (paclitaxel, trastuzumab)

laboratory biomarker analysis OTHER

Correlative studies

Am E (paclitaxel, trastuzumab); Arm A (paclitaxel); Arm B (paclitaxel); Arm C (paclitaxel, trastuzumab); Arm D (paclitaxel, trastuzumab); Arm F (paclitaxel, trastuzumab)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed adenocarcinoma of the female breast which is inoperable, recurrent or metastatic
• 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:

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Cancer and Leukemia Group B

Chicago, Illinois, 60606, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Paclitaxel; Taxes; Trastuzumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Economics; Health Care Economics and Organizations; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Andrew Seidman

  Cancer and Leukemia Group B

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: January 27, 2003
• Study Start: July 1, 1998
• Primary Completion: July 1, 2004
• Last Updated: June 4, 2013

Record last verified: 2013-06

Locations

US (1)