Trial · NCT00129389

FAC Versus FAC Plus Weekly Paclitaxel as Adjuvant Treatment of Node Negative High Risk Breast Cancer Patients

NCT00129389, Phase 3, Completed, Spanish Breast Cancer Research Group; results first posted 2019-07-12

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. FAC Versus FAC Plus Weekly Paclitaxel as Adjuvant Treatment of Node Negative High Risk Breast Cancer Patients. Trials, record NCT00129389. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00129389

On this page

Trial

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

Title: FAC Versus FAC Plus Weekly Paclitaxel as Adjuvant Treatment of Node Negative High Risk Breast Cancer Patients
NCT number: NCT00129389
Status: Completed
Phases: Phase 3
Enrollment: 1,925 participants, actual
Lead sponsor: Spanish Breast Cancer Research Group
Conditions: Breast Cancer
Interventions: Fluorouracil, Doxorubicin, Cyclophosphamide, Paclitaxel
First posted: 2005-08-11
Last updated: 2023-03-07
Other registries' IDs: eudract:2005-003109-10
Results first posted: 2019-07-12

Source ClinicalTrials.gov

Registered outcomes2

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

List	Outcome	Time frame	Description
Primary	Disease-free Survival (DFS) Event	Up to 5 years	DFS is defined as the evidence of local, regional or metastatic recurrence, second primary cancer (with the exception of carcinoma of squamous cells or basal cells of the skin, cervical carcinoma in situ or lobular or ductal carcinoma in situ of the breast) or death for any reason.
Secondary	Overall Survival (OS) Event	Up to 5 years	OS event is defined as the death from any cause.

Source ClinicalTrials.gov

Outcomes2

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Disease-free Survival (DFS) Event	Up to 5 years		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Overall Survival (OS) Event	Up to 5 years		Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group4

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

Outcome	Group	Value	Units
Disease-free Survival (DFS) Event	Arm A: FAC	98	Participants
Disease-free Survival (DFS) Event	Arm B: FAC-wP	71	Participants
Overall Survival (OS) Event	Arm A: FAC	40	Participants
Overall Survival (OS) Event	Arm B: FAC-wP	31	Participants

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Arm A: FAC	974
Overall Study	STARTED	Arm B: FAC-wP	951
Overall Study	COMPLETED	Arm A: FAC	941
Overall Study	COMPLETED	Arm B: FAC-wP	811
Overall Study	NOT COMPLETED	Arm A: FAC	33
Overall Study	NOT COMPLETED	Arm B: FAC-wP	140

Source ClinicalTrials.gov

Adverse events172

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	Neutrophils/Granulocytes	Blood and lymphatic system disorders	Arm A: FAC	250	974
other	Neutrophils/Granulocytes	Blood and lymphatic system disorders	Arm B: FAC-wP	203	951
other	Febrile neutropenia	General disorders	Arm A: FAC	36	974
other	Febrile neutropenia	General disorders	Arm B: FAC-wP	25	951
other	Infection without neutropenia	Infections and infestations	Arm A: FAC	3	974
other	Infection without neutropenia	Infections and infestations	Arm B: FAC-wP	13	951
other	Infection with unknown ANC	Infections and infestations	Arm A: FAC	3	974
other	Infection with unknown ANC	Infections and infestations	Arm B: FAC-wP	11	951
other	Lymphopenia	Blood and lymphatic system disorders	Arm A: FAC	10	974
other	Lymphopenia	Blood and lymphatic system disorders	Arm B: FAC-wP	8	951

1 to 10 of 172Source ClinicalTrials.gov

See all 172 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Arm A: FAC	40	974
Total, all-cause mortality	Arm B: FAC-wP	31	951
Total, other adverse events	Arm A: FAC	442	974
Total, other adverse events	Arm B: FAC-wP	523	951
Total, serious adverse events	Arm A: FAC	60	974
Total, serious adverse events	Arm B: FAC-wP	61	951

Source ClinicalTrials.gov

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
23733779	RESULT	PubMed
40207789	DERIVED	PubMed
42859303	DERIVED	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 comparisons4

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

Comparison	Source
Arm A: FAC vs Arm B: FAC-wP: Overall Survival (OS) Event	Trial comparisons
Arm A: FAC vs Arm B: FAC-wP: deaths from any cause	Trial comparisons
Arm A: FAC vs Arm B: FAC-wP: Disease-free Survival (DFS) Event	Trial comparisons
Arm A: FAC vs Arm B: FAC-wP: 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/NCT00129389

GET https://conductscience.org/api/trials/v1/NCT00129389/events?page=2

API reference For AI assistants