Trial · NCT00463788

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

NCT00463788, Phase 2, Completed, Merck KGaA, Darmstadt, Germany; results first posted 2012-10-10

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. 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. Trials, record NCT00463788. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00463788

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: 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
NCT number: NCT00463788
Status: Completed
Phases: Phase 2
Enrollment: 181 participants, actual
Lead sponsor: Merck KGaA, Darmstadt, Germany
Conditions: Breast Neoplasm
Interventions: cetuximab, cisplatin, cisplatin
First posted: 2007-04-20
Last updated: 2014-02-13
Results first posted: 2012-10-10
Limitations and caveats: Participants were randomized to 2 groups in a 2:1 ratio.

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	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	FAS population included all participants who were randomized as described in the pre-assignment details.	percentage of participants	NUMBER
SECONDARY	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	FAS population included all participants who were randomized as described in the pre-assignment details.	months	MEDIAN
SECONDARY	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	FAS population included all participants who were randomized as described in the pre-assignment details.	months	MEDIAN
SECONDARY	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	FAS population included all participants who were randomized as described in the pre-assignment details.	months	MEDIAN
SECONDARY	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	Safety population included all the participants who received at least 1 dose of study medication (that is cisplatin or cetuximab).	participants	NUMBER

Source ClinicalTrials.gov

Results by group10

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Best Overall Response (BOR)	Cisplatin and Cetuximab	20.0	95% Confidence Interval 13.1 to 28.5	percentage of participants
Best Overall Response (BOR)	Cisplatin	10.3	95% Confidence Interval 3.9 to 21.2	percentage of participants
Progression-Free Survival (PFS) Time	Cisplatin and Cetuximab	3.7	95% Confidence Interval 2.8 to 4.3	months
Progression-Free Survival (PFS) Time	Cisplatin	1.5	95% Confidence Interval 1.4 to 2.8	months
Overall Survival (OS) Time	Cisplatin and Cetuximab	12.9	95% Confidence Interval 9.6 to 15.6	months
Overall Survival (OS) Time	Cisplatin	9.4	95% Confidence Interval 6.7 to 14.2	months
Time to Response (TTR)	Cisplatin and Cetuximab	1.4	95% Confidence Interval 1.3 to 1.4	months
Time to Response (TTR)	Cisplatin	1.3	95% Confidence Interval 1.2 to 1.4	months
Safety- Number of Participants Experiencing Any Adverse Event (AE)	Cisplatin and Cetuximab	114		participants
Safety- Number of Participants Experiencing Any Adverse Event (AE)	Cisplatin	57		participants

Source ClinicalTrials.gov

Participant flow8

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Cisplatin and Cetuximab	115
Overall Study	STARTED	Cisplatin	58
Overall Study	Treated	Cisplatin and Cetuximab	114
Overall Study	Treated	Cisplatin	57
Overall Study	COMPLETED	Cisplatin and Cetuximab	6
Overall Study	COMPLETED	Cisplatin	4
Overall Study	NOT COMPLETED	Cisplatin and Cetuximab	109
Overall Study	NOT COMPLETED	Cisplatin	54

Source ClinicalTrials.gov

Adverse events345

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Neutropenia	Blood and lymphatic system disorders	Cisplatin and Cetuximab	33	114
other	Neutropenia	Blood and lymphatic system disorders	Cisplatin	10	57
other	Neutropenia	Blood and lymphatic system disorders	Cisplatin Alone Switched to Cetuximab	3	31
other	Anaemia	Blood and lymphatic system disorders	Cisplatin and Cetuximab	13	114
other	Anaemia	Blood and lymphatic system disorders	Cisplatin	12	57
other	Anaemia	Blood and lymphatic system disorders	Cisplatin Alone Switched to Cetuximab	4	31
other	Thrombocytopenia	Blood and lymphatic system disorders	Cisplatin and Cetuximab	7	114
other	Thrombocytopenia	Blood and lymphatic system disorders	Cisplatin	2	57
other	Thrombocytopenia	Blood and lymphatic system disorders	Cisplatin Alone Switched to Cetuximab	0	31
other	Leukopenia	Blood and lymphatic system disorders	Cisplatin and Cetuximab	7	114

1 to 10 of 345Source ClinicalTrials.gov

See all 345 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Cisplatin and Cetuximab
Total, all-cause mortality	Cisplatin
Total, all-cause mortality	Cisplatin Alone Switched to Cetuximab
Total, other adverse events	Cisplatin and Cetuximab	112	114
Total, other adverse events	Cisplatin	55	57
Total, other adverse events	Cisplatin Alone Switched to Cetuximab	28	31
Total, serious adverse events	Cisplatin and Cetuximab	41	114
Total, serious adverse events	Cisplatin	13	57
Total, serious adverse events	Cisplatin Alone Switched to Cetuximab	6	31

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
22248721	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Cisplatin and Cetuximab vs Cisplatin: Safety- Number of Participants Experiencing Any Adverse Event (AE)

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00463788

GET https://conductscience.org/api/trials/v1/NCT00463788/events?page=2

API reference For AI assistants