TriangleNCT00542451 · STUDY IN CONTEXT
Adjuvant Paclitaxel and Trastuzumab for Node-Negative HER2-Positive Breast Cancer
Draft scope assessment: unclear. Attached because the study's own record names HER2. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
Read the full study record and all posted results →
Linked outcomes
Disease-free survival (DFS) is the proportion of participants ramaing disease free at 3 years based on the Kaplan-Meier method. DFS is defined to end at the time of the first of the following events: local/regional ipsilateral invasive recurrence (or ipsilateral invasive new primary), contralateral invasive breast cancer, distant recurrence, or death from any cause.
DFS is defined as the time from registration to the first of the following events: local/regional ipsilateral invasive recurrence (or ipsilateral invasive new primary), contralateral invasive breast cancer, distant recurrence, or death from any cause. Patients without an event are censored at the date of last evaluation.
cardiac left ventricular dysfunction related adverse events (AE) with any attribution of possibly, probably or definite based on CTCAEv3 as reported on case report forms were counted.
Nervous system disorders related adverse events (AE) with any attribution of possibly, probably or definite based on CTCAEv3 as reported on case report forms were counted.
Patients that eligible for amenorrhea assessment and data collecting will be evaluated by standard method defined per protocol 3.9, through menses assessment survey.
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-itovebi-9827177b
- nct id
- NCT00542451
- trial label
- Adjuvant Paclitaxel and Trastuzumab for Node-Negative HER2-Positive Breast Cancer
- applicability
- unclear
- applicability note
- Attached because the study's own record names HER2. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- regulator-cited
- discovery note
- Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
- outcome Count
- 5
- harms Count
- 1
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-itovebi-9827177b
- nct id
- NCT00542451
- outcome key
- om-0000
- source section id
- NCT00542451-om-0000
- source outcome index
- 0
- endpoint
- 3-year Disease Free Survival (DFS) Rate
- endpoint definition
- Disease-free survival (DFS) is the proportion of participants ramaing disease free at 3 years based on the Kaplan-Meier method. DFS is defined to end at the time of the first of the following events: local/regional ipsilateral invasive recurrence (or ipsilateral invasive new primary), contralateral invasive breast cancer, distant recurrence, or death from any cause.
- time origin
- at 3 years
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-itovebi-9827177b
- nct id
- NCT00542451
- outcome key
- om-0001
- source section id
- NCT00542451-om-0001
- source outcome index
- 1
- endpoint
- Disease Free Survival (DFS) in Patients With Tumors Measuring ≤1 cm or > 1 cm
- endpoint definition
- DFS is defined as the time from registration to the first of the following events: local/regional ipsilateral invasive recurrence (or ipsilateral invasive new primary), contralateral invasive breast cancer, distant recurrence, or death from any cause. Patients without an event are censored at the date of last evaluation.
- time origin
- at 3 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-itovebi-9827177b
- nct id
- NCT00542451
- outcome key
- om-0002
- source section id
- NCT00542451-om-0002
- source outcome index
- 2
- endpoint
- Number of Patients With Grade III/IV Cardiac Left Ventricular Dysfunction
- endpoint definition
- cardiac left ventricular dysfunction related adverse events (AE) with any attribution of possibly, probably or definite based on CTCAEv3 as reported on case report forms were counted.
- time origin
- AE evaluated on treatment every week during paclitaxel and every 9 weeks during trastuzumab monotheryapy, and at progression, and observation years 2-10. Median treatment duration was 11.4 months (range 0 - 23.5 months).
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-itovebi-9827177b
- nct id
- NCT00542451
- outcome key
- om-0003
- source section id
- NCT00542451-om-0003
- source outcome index
- 3
- endpoint
- Number of Patients With Grade III/IV Neurotoxicity
- endpoint definition
- Nervous system disorders related adverse events (AE) with any attribution of possibly, probably or definite based on CTCAEv3 as reported on case report forms were counted.
- time origin
- AE evaluated on treatment every week during paclitaxel and every 9 weeks during trastuzumab monotheryapy, and at progression, and observation years 2-10. Median treatment duration was 11.4 months (range 0 - 23.5 months).
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-itovebi-9827177b
- nct id
- NCT00542451
- outcome key
- om-0004
- source section id
- NCT00542451-om-0004
- source outcome index
- 4
- endpoint
- Number of Patients With Amenorrhea
- endpoint definition
- Patients that eligible for amenorrhea assessment and data collecting will be evaluated by standard method defined per protocol 3.9, through menses assessment survey.
- time origin
- Menses Assessment survey on Q6 months x 1 year, then q6months for year 2 and at progression, and observation years 2-10 or until progression.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- 64 women are evaluable for the amenorrhea assessment
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-itovebi-9827177b
- nct id
- NCT00542451
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Adjuvant Paclitaxel and Trastuzumab for Node-Negative HER2-Positive Breast Cancer
- regimen
- 80 mg of paclitaxel per square meter of body-surface area weekly for 12 weeks and a loading dose of 4 mg of intravenous trastuzumab per kilogram of body weight on day 1, followed by 2 mg per kilogram weekly, for a total of 12 doses. After the completion of 12 weeks of treatment with Trastuzumab. Trastuzumab 6mg/kg over 3 weeks to complete a full year of intravenous treatment with trastuzumab.
- analyzed count
- 406
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00542451-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-itovebi-9827177b
- nct id
- NCT00542451
- outcome key
- om-0001
- arm key
- OG000
- arm label
- [Primary Tumor ≤ 1cm]Adjuvant Paclitaxel + Trastuzumab for Node-Negative HER2-Positive Breast Cancer
- regimen
- 80 mg of paclitaxel per square meter of body-surface area weekly for 12 weeks and a loading dose of 4 mg of intravenous trastuzumab per kilogram of body weight on day 1, followed by 2 mg per kilogram weekly, for a total of 12 doses. After the completion of 12 weeks of treatment with Trastuzumab, the dosing of Trastuzumab could be continued on a weekly basis, or the regimen could be changed to 6 mg per kilogram every 3 weeks for 40 weeks to complete a full year of intravenous treatment with trastuzumab.
- analyzed count
- 201
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00542451-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-itovebi-9827177b
- nct id
- NCT00542451
- outcome key
- om-0001
- arm key
- OG001
- arm label
- [Primary Tumor > 1cm]Adjuvant Paclitaxel + Trastuzumab for Node-Negative HER2-Positive Breast Cancer
- regimen
- 80 mg of paclitaxel per square meter of body-surface area weekly for 12 weeks and a loading dose of 4 mg of intravenous trastuzumab per kilogram of body weight on day 1, followed by 2 mg per kilogram weekly, for a total of 12 doses. After the completion of 12 weeks of treatment with Trastuzumab, the dosing of Trastuzumab could be continued on a weekly basis, or the regimen could be changed to 6 mg per kilogram every 3 weeks for 40 weeks to complete a full year of intravenous treatment with trastuzumab.
- analyzed count
- 205
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00542451-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-itovebi-9827177b
- nct id
- NCT00542451
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Adjuvant Paclitaxel and Trastuzumab for Node-Negative HER2-Positive Breast Cancer
- regimen
- 80 mg of paclitaxel per square meter of body-surface area weekly for 12 weeks and a loading dose of 4 mg of intravenous trastuzumab per kilogram of body weight on day 1, followed by 2 mg per kilogram weekly, for a total of 12 doses. After the completion of 12 weeks of treatment with Trastuzumab, the dosing of Trastuzumab could be continued on a weekly basis, or the regimen could be changed to 6 mg per kilogram every 3 weeks for 40 weeks to complete a full year of intravenous treatment with trastuzumab.
- analyzed count
- 406
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00542451-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-itovebi-9827177b
- nct id
- NCT00542451
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Adjuvant Paclitaxel and Trastuzumab for Node-Negative HER2-Positive Breast Cancer
- regimen
- 80 mg of paclitaxel per square meter of body-surface area weekly for 12 weeks and a loading dose of 4 mg of intravenous trastuzumab per kilogram of body weight on day 1, followed by 2 mg per kilogram weekly, for a total of 12 doses. After the completion of 12 weeks of treatment with Trastuzumab, the dosing of Trastuzumab could be continued on a weekly basis, or the regimen could be changed to 6 mg per kilogram every 3 weeks for 40 weeks to complete a full year of intravenous treatment with trastuzumab.
- analyzed count
- 406
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00542451-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-itovebi-9827177b
- nct id
- NCT00542451
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Adjuvant Paclitaxel and Trastuzumab for Node-Negative HER2-Positive Breast Cancer
- regimen
- 80 mg of paclitaxel per square meter of body-surface area weekly for 12 weeks and a loading dose of 4 mg of intravenous trastuzumab per kilogram of body weight on day 1, followed by 2 mg per kilogram weekly, for a total of 12 doses. After the completion of 12 weeks of treatment with Trastuzumab, the dosing of Trastuzumab could be continued on a weekly basis, or the regimen could be changed to 6 mg per kilogram every 3 weeks for 40 weeks to complete a full year of intravenous treatment with trastuzumab.
- analyzed count
- 64
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00542451-om-0004#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-itovebi-9827177b
- nct id
- NCT00542451
- harm key
- EG000
- source section id
- NCT00542451-ae
- event group key
- EG000
- event group label
- Adjuvant Paclitaxel and Trastuzumab for Node-Negative HER2-Positive Breast Cancer
- serious affected
- 60
- serious at risk
- 406
- other affected
- 406
- other at risk
- 406
- frequency threshold
- 0
- collection period
- AE evaluated on treatment every week during paclitaxel and every 9 weeks during trastuzumab monotheryapy, and at progression, and observation years 2-10. Median treatment duration was 11.4 months (range 0 - 23.5 months).
- event definition
- Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice