Trial · NCT01367002

Evaluation of Carboplatin/Paclitaxel With and Without Trastuzumab (Herceptin) in Uterine Serous Cancer

NCT01367002, Phase 2, Completed, Yale University; results first posted 2023-04-18

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Evaluation of Carboplatin/Paclitaxel With and Without Trastuzumab (Herceptin) in Uterine Serous Cancer. Trials, record NCT01367002. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01367002

On this page

Trial

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

Title: Evaluation of Carboplatin/Paclitaxel With and Without Trastuzumab (Herceptin) in Uterine Serous Cancer
NCT number: NCT01367002
Status: Completed
Phases: Phase 2
Enrollment: 61 participants, actual
Lead sponsor: Yale University
Conditions: Endometrial Cancer
Interventions: Carboplatin/Paclitaxel, Trastuzumab
First posted: 2011-06-06
Last updated: 2023-05-17
Results first posted: 2023-04-18

Source ClinicalTrials.gov

Registered outcomes4

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

List	Outcome	Time frame	Description
Primary	Progression Free Survival Differences Between Treatment Arms.	6 years	Progression free survival differences between treatment arms.
Secondary	To Assess the Safety Profile of Trastuzumab in USPC Patients by CTCAE v4.0	6 years	To assess the safety profile of trastuzumab in USPC patients by CTCAE v4.0. Presented are counts of those that experience any Serious Adverse Events or All Other Adverse Events.
Secondary	To Assess Objective Response Rate (ORR)	6 years	To assess objective response rate (ORR)
Secondary	To Assess Overall Survival (OS)	6 years	To assess overall survival (OS), presented are the number of participants that survived through the duration of the study period.

Source ClinicalTrials.gov

Outcomes4

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Progression Free Survival Differences Between Treatment Arms.	6 years	Only patients eligible to be assessed for progression free survival.	months	MEDIAN
SECONDARY	To Assess the Safety Profile of Trastuzumab in USPC Patients by CTCAE v4.0	6 years		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	To Assess Objective Response Rate (ORR)	6 years	Among those with recurrent disease- see baseline characteristics table.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	To Assess Overall Survival (OS)	6 years		Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group16

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

Outcome	Group	Category	Value	Spread	Units
Progression Free Survival Differences Between Treatment Arms.	Carboplatin/Paclitaxel		8.049	95% Confidence Interval 7.129 to 9.692	months
Progression Free Survival Differences Between Treatment Arms.	Trastuzumab		12.945	95% Confidence Interval 10.448 to 18.103	months
To Assess the Safety Profile of Trastuzumab in USPC Patients by CTCAE v4.0	Carboplatin/Paclitaxel	Serious Adverse Events	6		Participants
To Assess the Safety Profile of Trastuzumab in USPC Patients by CTCAE v4.0	Trastuzumab	Serious Adverse Events	14		Participants
To Assess the Safety Profile of Trastuzumab in USPC Patients by CTCAE v4.0	Carboplatin/Paclitaxel	All Other Adverse Events	28		Participants
To Assess the Safety Profile of Trastuzumab in USPC Patients by CTCAE v4.0	Trastuzumab	All Other Adverse Events	32		Participants
To Assess Objective Response Rate (ORR)	Carboplatin/Paclitaxel	Complete Response (CR)	2		Participants
To Assess Objective Response Rate (ORR)	Trastuzumab	Complete Response (CR)	1		Participants
To Assess Objective Response Rate (ORR)	Carboplatin/Paclitaxel	Partial Response (PR)	4		Participants
To Assess Objective Response Rate (ORR)	Trastuzumab	Partial Response (PR)	3		Participants

1 to 10 of 16Source ClinicalTrials.gov

See all 16 results by group

Participant flow10

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Carboplatin/Paclitaxel	29
Overall Study	STARTED	Trastuzumab	32
Overall Study	Participants Receive Drug	Carboplatin/Paclitaxel	28
Overall Study	Participants Receive Drug	Trastuzumab	32
Overall Study	Participants Evaluable for PFS	Carboplatin/Paclitaxel	28
Overall Study	Participants Evaluable for PFS	Trastuzumab	30
Overall Study	COMPLETED	Carboplatin/Paclitaxel	28
Overall Study	COMPLETED	Trastuzumab	30
Overall Study	NOT COMPLETED	Carboplatin/Paclitaxel	1
Overall Study	NOT COMPLETED	Trastuzumab	2

Source ClinicalTrials.gov

Adverse events442

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	Events
other	Anemia	Blood and lymphatic system disorders	Carboplatin/Paclitaxel	13	28	33
other	Anemia	Blood and lymphatic system disorders	Trastuzumab	16	32	60
other	Blood and lymphatic system disorders - Other	Blood and lymphatic system disorders	Carboplatin/Paclitaxel	2	28	3
other	Blood and lymphatic system disorders - Other	Blood and lymphatic system disorders	Trastuzumab	8	32	28
other	Febrile neutropenia	Blood and lymphatic system disorders	Carboplatin/Paclitaxel	0	28	0
other	Febrile neutropenia	Blood and lymphatic system disorders	Trastuzumab	1	32	2
other	Thrombotic thrombocytopenic purpura	Blood and lymphatic system disorders	Carboplatin/Paclitaxel	0	28	0
other	Thrombotic thrombocytopenic purpura	Blood and lymphatic system disorders	Trastuzumab	1	32	1
other	Allergic reaction	Immune system disorders	Carboplatin/Paclitaxel	1	28	1
other	Allergic reaction	Immune system disorders	Trastuzumab	1	32	1

1 to 10 of 442Source ClinicalTrials.gov

See all 442 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Carboplatin/Paclitaxel	21	28
Total, all-cause mortality	Trastuzumab	21	32
Total, other adverse events	Carboplatin/Paclitaxel	28	28
Total, other adverse events	Trastuzumab	32	32
Total, serious adverse events	Carboplatin/Paclitaxel	6	28
Total, serious adverse events	Trastuzumab	14	32

Source ClinicalTrials.gov

Papers18

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
1526508	BACKGROUND	PubMed
3652025	BACKGROUND	PubMed
7959265	BACKGROUND	PubMed
8088602	BACKGROUND	PubMed
8751561	BACKGROUND	PubMed
10739691	BACKGROUND	PubMed
11426978	BACKGROUND	PubMed
12006548	BACKGROUND	PubMed
12648575	BACKGROUND	PubMed
15169803	BACKGROUND	PubMed

1 to 10 of 18

See all 18 papers

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 comparisons3

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

Comparison	Source
Carboplatin/Paclitaxel vs Trastuzumab: To Assess Overall Survival (OS)	Trial comparisons
Carboplatin/Paclitaxel vs Trastuzumab: deaths from any cause	Trial comparisons
Carboplatin/Paclitaxel vs Trastuzumab: serious adverse events	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/NCT01367002

GET https://conductscience.org/api/trials/v1/NCT01367002/events?page=2

API reference For AI assistants