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Randomized Phase II Trial With Cetuximab and Cisplatin in the Treatment of ER-negative, PgR-negative, HER2-negative Metastatic Breast Carcinoma ("Basal Like")


Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Neoplasm

Thank you

Trial Information

Randomized Phase II Trial With Cetuximab and Cisplatin in the Treatment of ER-negative, PgR-negative, HER2-negative Metastatic Breast Carcinoma ("Basal Like")


Inclusion Criteria:



- Histologically confirmed diagnosis of metastatic breast cancer (Stage IV)

- Estrogen Receptor [ER] negative, PgR negative and HER2 less than 3+ expression by
immunohistochemistry (IHC)

- No more than 1 prior chemotherapy received for treating this metastatic breast cancer

- No more than 1 prior anthracycline and/or taxane regimen (either adjuvant or
metastatic setting)

- Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

- Prior platinum agent

- Prior mitomycin

- Known history of brain metastases

- Other protocol-defined exclusion criteria may apply

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Best Overall Response (BOR)

Outcome Description:

Percentage of participants with best overall (objective) response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST).

Outcome Time Frame:

Evaluations were performed every 6 weeks until progression reported between day of first participant randomized, 20 June 2007, until cut-off date, 31 July 2009

Safety Issue:

No

Principal Investigator

José Baselga, Prof.

Investigator Role:

Principal Investigator

Investigator Affiliation:

General Hospital, Boston, Massachusetts, USA

Authority:

Australia: Department of Health and Ageing Therapeutic Goods Administration

Study ID:

EMR 200027-051

NCT ID:

NCT00463788

Start Date:

June 2007

Completion Date:

February 2011

Related Keywords:

  • Breast Neoplasm
  • cancer
  • breast
  • metastatic
  • triple negative
  • Breast Neoplasms
  • Neoplasms

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