Cetuximab and Cisplatin in the Treatment of "Triple Negative" (Estrogen Receptor [ER] Negative, Progesterone Receptor [PgR] Negative, and Human Epidermal Growth Factor Receptor 2 [HER2] Negative) Metastatic Breast Cancer

Phase 2

Completed

• Conditions: Breast Neoplasm
• Interventions: Drug: cisplatin; Drug: cetuximab, cisplatin

• Registration Number: NCT00463788
• Lead Sponsor: Merck KGaA, Darmstadt, Germany

Brief Summary

The primary objective of this study is to determine whether overall response to cetuximab combined with cisplatin is better than overall response to cisplatin alone together with showing that the overall response for cetuximab and cisplatin was above a pre-specified threshold of 0.2 in the treatment of "triple negative" metastatic breast cancer.

The secondary objective of this study is to compare the differences between the two treatment groups using the following criteria : Progression-Free Survival (PFS) Time, Overall Survival (OS), Time to Response (TTR) and Safety.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-04-19
• Study First Submitted QC: 2007-04-19
• Study First Posted: 2007-04-20
• Study Start: 2007-06
• Primary Completion: 2009-07
• Study Completion: 2011-02
• Results First Submitted: 2012-06-05
• Results First Submitted QC: 2012-09-07
• Results First Posted: 2012-10-10
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-20
• Last Update Posted: 2014-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 181

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
cisplatin	cisplatin	-
cisplatin and cetuximab	cetuximab, cisplatin	-

Primary Outcome Measures

Name	Time	Method
Best Overall Response (BOR)	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	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).

Secondary Outcome Measures

Name	Time	Method
Time to Response (TTR)	Time from the first dose of study treatment (cetuximab or cisplatin) to first assessment of CR or PR, reported between day of first participant randomized, 20 June 2007, until cut-off date, 31 July 2009	The TTR was determined for participants whose confirmed BOR (based on RECIST) was either a CR or a PR . It was defined as the time from the first dose study treatment until the date of the first assessment of confirmed CR or PR.
Safety- Number of Participants Experiencing Any Adverse Event (AE)	Time from first dose up to 30 days after last dose of study treatment, reported between day of first dose of study treatment, 20 June 2007, until cut-off date 05 April 2010	Number of participants experiencing any AE. AEs: Any untoward medical occurrence in the form of signs, clinically significant abnormalities in laboratory findings, diseases, symptoms, or worsening of complications.
Progression-Free Survival (PFS) Time	Time from randomization to disease progression, death or last tumour assessment, reported between day of first participant randomized, 20 June 2007, until cut-off date, 31 July 2009	The PFS was defined as the duration from randomization until radiological progression according to investigator (based on RECIST) or death due to any cause. Only deaths within 85 days of last tumor assessment were considered. Participants without event were censored on the date of last tumor assessment.
Overall Survival (OS) Time	Time from randomization to death or last day known to be alive, reported between day of first participant randomized, 20 June 2007, until cut-off date, 05 April 2010	The OS time was defined as the time from randomization to death. Participants without event were censored at the last date known to be alive or at the clinical cut-off date, whatever was earlier.

Trial Locations

Locations (1)

Research Site; 🇬🇧 Manchester, United Kingdom