Cetuximab and Cisplatin in the Treatment of "Triple Negative" (Estrogen Receptor Negative, Progesterone Receptor Negative, and HER2 Negative) Metastatic Breast Cancer - Full Text View

Sponsored by:	Merck KGaA
Information provided by:	EMD Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00463788

Purpose

The purpose of this study is to determine whether overall response to cetuximab combined with cisplatin is better than overall response to cisplatin alone in the treatment of "triple negative" metastatic breast cancer.

Condition	Intervention	Phase
Breast Neoplasm	Drug: cetuximab, cisplatin Drug: Cisplatin	Phase II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Cisplatin Cetuximab Progesterone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Randomized Phase II Trial With Cetuximab and Cisplatin in the Treatment of ER-Negative, PgR-Negative, HER2-Negative Metastatic Breast Carcinoma ("Basal Like")

Further study details as provided by EMD Pharmaceuticals:

Primary Outcome Measures:

Overall response, defined as having a best overall confirmed complete response (CR) or partial response (PR) during study. [ Time Frame: various timepoints ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Progression-free survival time [ Time Frame: various timepoints ] [ Designated as safety issue: No ]
overall survival time [ Time Frame: various timepoints ] [ Designated as safety issue: No ]
time to response [ Time Frame: various timepoints ] [ Designated as safety issue: No ]

Estimated Enrollment:	180
Study Start Date:	June 2007
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: cetuximab, cisplatin Subjects in Arm 1 will receive an initial dose of 400 mg/m2 followed by weekly doses of 250 mg/m2. All doses will be given by i.v. (intravenous) infusion. Subjects in both treatment Arms (1 and 2) will receive cisplatin (75 mg/m² i.v. on Day 1) every 3 weeks, with a maximum of 6 cycles. Administration of the Investigational Medicinal Product (IMP) in both arms will be stopped upon the first occurrence of disease progression (except in Arm 2 where switch to cetuximab is possible), unacceptable toxicity or withdrawal of consent.
2: Active Comparator	Drug: Cisplatin Subjects will receive cisplatin (75 mg/m² i.v. on Day 1) every 3 weeks, with a maximum of 6 cycles. Administration of the Investigational Medicinal Product (IMP) will be stopped upon the first occurrence of disease progression (except in Arm 2 where switch to cetuximab is possible), unacceptable toxicity or withdrawal of consent.

Arms

Assigned Interventions

1: Experimental

Drug: cetuximab, cisplatin

Subjects in Arm 1 will receive an initial dose of 400 mg/m2 followed by weekly doses of 250 mg/m2. All doses will be given by i.v. (intravenous) infusion.

Subjects in both treatment Arms (1 and 2) will receive cisplatin (75 mg/m² i.v. on Day 1) every 3 weeks, with a maximum of 6 cycles.

Administration of the Investigational Medicinal Product (IMP) in both arms will be stopped upon the first occurrence of disease progression (except in Arm 2 where switch to cetuximab is possible), unacceptable toxicity or withdrawal of consent.

2: Active Comparator

Drug: Cisplatin

Subjects will receive cisplatin (75 mg/m² i.v. on Day 1) every 3 weeks, with a maximum of 6 cycles.

Administration of the Investigational Medicinal Product (IMP) will be stopped upon the first occurrence of disease progression (except in Arm 2 where switch to cetuximab is possible), unacceptable toxicity or withdrawal of consent.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histologically-confirmed diagnosis of metastatic breast cancer (Stage IV).
ER-negative, PgR negative and HER2 < 3+ expression by IHC
No more than one prior chemotherapy received for treating this metastatic breast cancer
No more than one prior anthracycline and/or taxane regimen (either adjuvant or metastatic setting)

Exclusion Criteria:

Prior platinum agent
Prior mitomycin
Known history of brain metastases.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00463788

Contacts

Contact: Oliver Leip, Ph.D.

+49(0)6151 72 ext 9503

oliver.leip@merck.de

Show 46 Study Locations

Sponsors and Collaborators

Merck KGaA

Investigators

Principal Investigator:

José Baselga, Prof.

Vall d'Hebron University Hospital, Oncology Service, P Vall d'Hebron 119-129, Barcelona 08035, Spain

More Information

Responsible Party:	Merck KGaA ( Dr. Oliver Leip, Clinical Trial Manager )
Study ID Numbers:	EMR 200027-051
Study First Received:	April 19, 2007
Last Updated:	September 10, 2008
ClinicalTrials.gov Identifier:	NCT00463788
Health Authority:	Spain: Spanish Agency of Medicines

Keywords provided by EMD Pharmaceuticals:

cancer
breast
metastatic
triple negative

Study placed in the following topic categories:

Progesterone
Cisplatin
Skin Diseases
Cetuximab

Breast Neoplasms
Breast Diseases
Carcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Antineoplastic Agents

Therapeutic Uses
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009