Trial · NCT00014222

Combination Chemotherapy With or Without Colony-stimulating Factors in Treating Women With Breast Cancer

NCT00014222, Phase 3, Completed, NCIC Clinical Trials Group; results first posted 2020-03-10

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Combination Chemotherapy With or Without Colony-stimulating Factors in Treating Women With Breast Cancer. Trials, record NCT00014222. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00014222

On this page

Trial

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

Title: Combination Chemotherapy With or Without Colony-stimulating Factors in Treating Women With Breast Cancer
NCT number: NCT00014222
Status: Completed
Phases: Phase 3
Enrollment: 2,104 participants, actual
Lead sponsor: NCIC Clinical Trials Group
Conditions: Breast Cancer
Interventions: epoetin alfa, filgrastim, cyclophosphamide, doxorubicin hydrochloride, epirubicin hydrochloride, fluorouracil, paclitaxel
First posted: 2003-01-27
Last updated: 2020-10-05
Results first posted: 2020-03-10

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	13 years	Disease free survival was defined as the time from randomization to the time of recurrence of the primary disease. Local or nodal recurrence and metastatic disease were considered a recurrence of the primary tumour. Patients who had contralateral breast cancer or a second primary malignancy, or died from some cause other than disease were censored as relapse-free at the time of death. Patients who had not relapsed were censored at longest follow-up or at non-breast cancer death. As required, adjudication was used to assess reports of recurrence.
Secondary	Overall Survival	13 years	Overall survival was defined as the time from randomization to the time of death from any cause, with censoring at longest follow-up.

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	13 years	Intent to treat population was used for this analysis,.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Overall Survival	13 years	Intention to treat population.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group12

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

Outcome	Group	Category	Value	Units
Disease Free Survival	Arm 1: CEF	Disease Recurrence	141	Participants
Disease Free Survival	Arm 2: EC/T	Disease Recurrence	135	Participants
Disease Free Survival	Arm 3: AC/T	Disease Recurrence	191	Participants
Disease Free Survival	Arm 1: CEF	No recurrence	560	Participants
Disease Free Survival	Arm 2: EC/T	No recurrence	566	Participants
Disease Free Survival	Arm 3: AC/T	No recurrence	511	Participants
Overall Survival	Arm 1: CEF	Death	123	Participants
Overall Survival	Arm 2: EC/T	Death	107	Participants
Overall Survival	Arm 3: AC/T	Death	146	Participants
Overall Survival	Arm 1: CEF	Alive	578	Participants

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow9

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Arm 1: CEF	701
Overall Study	STARTED	Arm 2: EC/T	701
Overall Study	STARTED	Arm 3: AC/T	702
Overall Study	COMPLETED	Arm 1: CEF	680
Overall Study	COMPLETED	Arm 2: EC/T	688
Overall Study	COMPLETED	Arm 3: AC/T	675
Overall Study	NOT COMPLETED	Arm 1: CEF	21
Overall Study	NOT COMPLETED	Arm 2: EC/T	13
Overall Study	NOT COMPLETED	Arm 3: AC/T	27

Source ClinicalTrials.gov

Adverse events435

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	Lymphedema	Blood and lymphatic system disorders	Arm 1: CEF	31	680
other	Lymphedema	Blood and lymphatic system disorders	Arm 2: EC/T	26	688
other	Lymphedema	Blood and lymphatic system disorders	Arm 3: AC/T	51	675
other	Edema	Cardiac disorders	Arm 1: CEF	112	680
other	Edema	Cardiac disorders	Arm 2: EC/T	108	688
other	Edema	Cardiac disorders	Arm 3: AC/T	110	675
other	Cardiac LVF	Cardiac disorders	Arm 1: CEF	185	680
other	Cardiac LVF	Cardiac disorders	Arm 2: EC/T	147	688
other	Cardiac LVF	Cardiac disorders	Arm 3: AC/T	130	675
other	Palpitations	Cardiac disorders	Arm 1: CEF	29	680

1 to 10 of 435Source ClinicalTrials.gov

See all 435 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Arm 1: CEF	123	701
Total, all-cause mortality	Arm 2: EC/T	107	701
Total, all-cause mortality	Arm 3: AC/T	146	702
Total, other adverse events	Arm 1: CEF	680	680
Total, other adverse events	Arm 2: EC/T	688	688
Total, other adverse events	Arm 3: AC/T	673	675
Total, serious adverse events	Arm 1: CEF	83	680
Total, serious adverse events	Arm 2: EC/T	86	688
Total, serious adverse events	Arm 3: AC/T	23	675

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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 comparisons0

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

None in this release.

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/NCT00014222

GET https://conductscience.org/api/trials/v1/NCT00014222/events?page=2

API reference For AI assistants