Know Cancer

or
forgot password

A Randomized Controlled Study of Docetaxel Monotherapy or Docetaxel and DOXIL for the Treatment of Advanced Breast Cancer


Phase 3
18 Years
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

A Randomized Controlled Study of Docetaxel Monotherapy or Docetaxel and DOXIL for the Treatment of Advanced Breast Cancer


This is a randomized (the study medication is assigned by a random order), active control
(study medication will be compared with available standard care of treatment),
parallel-group (each treatment group will be treated simultaneously at the same time and
each participant only receives one treatment regimen as assigned), open-label (both the
investigator and the participant know the intervention received by the participant),
multicenter study designed to determine if women with locally advanced or metastatic breast
cancer, who were previously treated with prior anthracycline therapy in the neoadjuvant
(administration of treatment before surgery) or adjuvant setting (administration of
treatment after surgery), and who also had a disease-free interval of at least 12 months
since the end of their last cytotoxic therapy, would benefit from the addition of DOXIL to
docetaxel therapy. Approximately 751 participants will be randomly assigned to either
receive docetaxel monotherapy or DOXIL in combination with docetaxel therapy. Treatment is
to continue until disease progression or the occurrence of unacceptable treatment related
toxicity. Safety evaluations will include assessments of adverse events which will be
recorded from the first study related procedure until 30 days after the last dose of
medication; clinical laboratory tests and tests for cardiac function (multiple gated
acquisition scan/echocardiogram and electrocardiogram) which will be monitored throughout
the study.


Inclusion Criteria:



- Females with locally advanced or metastatic breast cancer who received prior
anthracycline therapy in the neoadjuvant or adjuvant setting, and had at least a
12-month disease-free interval since the end of their last cytotoxic therapy, were
eligible for the study

- Participants who received prior hormonal therapy, or no more than 1 cytotoxic
chemotherapy regimen (anthracyclines, taxanes, or antitubulin agents were not
permitted), or both for advanced disease

- Participants with normal cardiac function, as evidenced by a normal left ventricular
ejection fraction

Exclusion Criteria:

- More than 1 prior cytotoxic chemotherapy regimen for advanced breast cancer

- Treatment of advanced breast cancer with an anthracycline, paclitaxel, docetaxel,
vinorelbine, or vinblastine (prior treatment of advanced breast cancer with 1 regimen
that included alkylating agents or antimetabolite agents was acceptable)

- Less than 2 months since the last dose of trastuzumab

- Less than 3 weeks since last dose of tamoxifen or fulvestrant, or less than 1 week
since the last dose of other hormonal therapy

- Radiation to areas of disease within 30 days before study enrollment

- History of New York Heart Association Class II or greater cardiac disease or other
clinical evidence of congestive heart failure

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to Progression

Outcome Description:

Time interval in months between the date of randomization and the date of disease progression or death due to progression, whichever occurred first.

Outcome Time Frame:

From date of randomization until date of disease progression or death, whichever occurred first, until approximately 485 events of disease progression or death were observed, as assessed approximately 15 months after the last patient was enrolled

Safety Issue:

No

Principal Investigator

Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

Investigator Role:

Study Director

Investigator Affiliation:

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Authority:

United States: Food and Drug Administration

Study ID:

CR004120

NCT ID:

NCT00091442

Start Date:

September 2004

Completion Date:

December 2008

Related Keywords:

  • Breast Cancer
  • Breast Cancer
  • Advanced breast cancer
  • Breast Tumors
  • Cancer of Breast
  • Human Mammary Carcinoma
  • Mammary Neoplasms, Human
  • DOXIL
  • Docetaxel
  • Breast Neoplasms

Name

Location

Hinsdale, Illinois  60521
Albany, Georgia  31701
Birmingham, Alabama  35294
Fountain Valley, California  92708
Miami, Florida  33176
Albany, New York  12208
Philadelphia, Pennsylvania  19104
Austin, Texas  78705
Louisville, Kentucky  40207
Hackensack, New Jersey  07601
Albuquerque, New Mexico  87131-5636
Metairie, Louisiana  70006
Baltimore, Maryland  21287
Charlotte, North Carolina  
Wilmington, Delaware  
Indianapolis, Indiana  
Charleston, South Carolina  
Providence, Rhode Island  02908
Las Vegas, Nevada  89109
Jackson, Mississippi